What is methylphenidate? Methylphenidate is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control. Methylphenidate is used to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and narcolepsy. Methylphenidate should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. Warnings Methylphenidate may be habit-forming. Misuse can cause addiction, overdose, or death. Tell your doctor if you have had problems with drug or alcohol abuse. Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect. Do not use methylphenidate if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine. Methylphenidate may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder. You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes. Call your doctor right away if you have: signs of heart problems - chest pain, feeling light-headed or short of breath; signs of psychosis - paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems - unexplained wounds on your fingers or toes. Tell your doctor if you have a history of drug or alcohol addiction. Keep the medication where others cannot get to it. Before taking this medicine You should not use methylphenidate if you are allergic to it. You should not take Concerta if you have: glaucoma; a personal or family history of tics (muscle twitches) or Tourette's syndrome; or severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse). Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have: heart problems or a congenital heart defect; high blood pressure; or a family history of heart disease or sudden death. Do not use methylphenidate if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine. Tell your doctor if you also use opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with methylphenidate could cause a serious condition called serotonin syndrome. Tell your doctor if you or anyone in your family has ever had: depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions; blood circulation problems in the hands or feet; alcoholism or drug addiction; or if you take Adhansia - an allergy to aspirin or yellow food dye. To make sure methylphenidate is safe for you, tell your doctor if you have:: problems with the esophagus, stomach, or intestines; `motor tics (muscle twitches) or Tourette's syndrome; or seizures, epilepsy, or an abnormal brain wave test (EEG). Becoming dependent on methylphenidate during pregnancy can cause premature birth or low birth weight. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of methylphenidate on the baby. Ask a doctor if it is safe to breastfeed while using this medicine. If you are breastfeeding, tell your doctor if you notice symptoms in the baby such as agitation, sleep problems, feeding problems, or reduced weight gain. methylphenidate is not approved for use by anyone younger than 6 years old. How should I take methylphenidate? Take methylphenidate exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Methylphenidate may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away this medicine is against the law. Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes. Most brands of methylphenidate are taken 1 or 2 times during the day. Jornay PM is for use only at night between 6:30 and 9:30 pm. You may take methylphenidate with or without food, but take it the same way each time. Swallow the extended-release capsule or tablet whole and do not crush, chew, or break it. If you cannot swallow an extended-release capsule whole, open it and mix the medicine with soft food such as applesauce, pudding or yogurt. Swallow the mixture right away without chewing. You must chew the chewable tablet before you swallow it. Measure liquid medicine with the supplied measuring device (not a kitchen spoon). Allow the orally disintegrating tablet to dissolve in your mouth without chewing. Tell your doctor if you have a planned surgery. Your treatment may also include counseling or other treatments. Your doctor will need to check your progress on a regular basis. Your heart and blood pressure may also need to be checked often. Store tightly closed at room temperature, away from moisture, heat, and light. Keep your medicine in a place where no one can use it improperly. Do not keep leftover medicine. Ask your pharmacist about a drug take-back program. You may also mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag and throw the bag in the trash.   What happens if I miss a dose? Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of methylphenidate could be fatal. Overdose symptoms may include nausea, dry mouth, vomiting, diarrhea, anxiety, agitation, restlessness, tremor, muscle twitches, rapid breathing, confusion, hallucinations, dilated pupils, muscle pain or weakness, fever, sweating, headache, pounding in your neck or ears, fast or pounding heartbeats, feeling light-headed, fainting, seizure (convulsions), or coma. What should I avoid while taking methylphenidate? Avoid drinking alcohol. Avoid driving or hazardous activity until you know how methylphenidate will affect you. Your reactions could be impaired. Methylphenidate side effects Get emergency medical help if you have signs of an allergic reaction to methylphenidate: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: signs of heart problems - chest pain, trouble breathing, feeling like you might pass out; signs of psychosis - hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia; signs of circulation problems - numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or penis erection that is painful or lasts 4 hours or longer. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea. Methylphenidate can affect growth in children. Your child's height and weight may need to be checked often. Tell your doctor if your child is not growing at a normal rate. Common methylphenidate side effects may include: sweating, increased blood pressure; mood changes, anxiety, feeling nervous or irritable, trouble sleeping; fast heart rate, pounding heartbeats or fluttering in your chest; loss of appetite, weight loss; dry mouth, nausea, vomiting, stomach pain, indigestion; or headache, dizziness. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   What other drugs will affect methylphenidate? Tell your doctor about all your other medicines, especially: an antidepressant; or blood pressure medication; This list is not complete. Other drugs may interact with methylphenidate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

What is methylphenidate? Methylphenidate is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control. Methylphenidate is used to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and narcolepsy. Methylphenidate should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. Warnings Methylphenidate may be habit-forming. Misuse can cause addiction, overdose, or death. Tell your doctor if you have had problems with drug or alcohol abuse. Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect. Do not use methylphenidate if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine. Methylphenidate may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder. You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes. Call your doctor right away if you have: signs of heart problems - chest pain, feeling light-headed or short of breath; signs of psychosis - paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems - unexplained wounds on your fingers or toes. Tell your doctor if you have a history of drug or alcohol addiction. Keep the medication where others cannot get to it. Before taking this medicine You should not use methylphenidate if you are allergic to it. You should not take Concerta if you have: glaucoma; a personal or family history of tics (muscle twitches) or Tourette's syndrome; or severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse). Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have: heart problems or a congenital heart defect; high blood pressure; or a family history of heart disease or sudden death. Do not use methylphenidate if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine. Tell your doctor if you also use opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with methylphenidate could cause a serious condition called serotonin syndrome. Tell your doctor if you or anyone in your family has ever had: depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions; blood circulation problems in the hands or feet; alcoholism or drug addiction; or if you take Adhansia - an allergy to aspirin or yellow food dye. To make sure methylphenidate is safe for you, tell your doctor if you have:: problems with the esophagus, stomach, or intestines; `motor tics (muscle twitches) or Tourette's syndrome; or seizures, epilepsy, or an abnormal brain wave test (EEG). Becoming dependent on methylphenidate during pregnancy can cause premature birth or low birth weight. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of methylphenidate on the baby. Ask a doctor if it is safe to breastfeed while using this medicine. If you are breastfeeding, tell your doctor if you notice symptoms in the baby such as agitation, sleep problems, feeding problems, or reduced weight gain. methylphenidate is not approved for use by anyone younger than 6 years old. How should I take methylphenidate? Take methylphenidate exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Methylphenidate may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away this medicine is against the law. Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes. Most brands of methylphenidate are taken 1 or 2 times during the day. Jornay PM is for use only at night between 6:30 and 9:30 pm. You may take methylphenidate with or without food, but take it the same way each time. Swallow the extended-release capsule or tablet whole and do not crush, chew, or break it. If you cannot swallow an extended-release capsule whole, open it and mix the medicine with soft food such as applesauce, pudding or yogurt. Swallow the mixture right away without chewing. You must chew the chewable tablet before you swallow it. Measure liquid medicine with the supplied measuring device (not a kitchen spoon). Allow the orally disintegrating tablet to dissolve in your mouth without chewing. Tell your doctor if you have a planned surgery. Your treatment may also include counseling or other treatments. Your doctor will need to check your progress on a regular basis. Your heart and blood pressure may also need to be checked often. Store tightly closed at room temperature, away from moisture, heat, and light. Keep your medicine in a place where no one can use it improperly. Do not keep leftover medicine. Ask your pharmacist about a drug take-back program. You may also mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag and throw the bag in the trash.   What happens if I miss a dose? Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of methylphenidate could be fatal. Overdose symptoms may include nausea, dry mouth, vomiting, diarrhea, anxiety, agitation, restlessness, tremor, muscle twitches, rapid breathing, confusion, hallucinations, dilated pupils, muscle pain or weakness, fever, sweating, headache, pounding in your neck or ears, fast or pounding heartbeats, feeling light-headed, fainting, seizure (convulsions), or coma. What should I avoid while taking methylphenidate? Avoid drinking alcohol. Avoid driving or hazardous activity until you know how methylphenidate will affect you. Your reactions could be impaired. Methylphenidate side effects Get emergency medical help if you have signs of an allergic reaction to methylphenidate: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: signs of heart problems - chest pain, trouble breathing, feeling like you might pass out; signs of psychosis - hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia; signs of circulation problems - numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or penis erection that is painful or lasts 4 hours or longer. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea. Methylphenidate can affect growth in children. Your child's height and weight may need to be checked often. Tell your doctor if your child is not growing at a normal rate. Common methylphenidate side effects may include: sweating, increased blood pressure; mood changes, anxiety, feeling nervous or irritable, trouble sleeping; fast heart rate, pounding heartbeats or fluttering in your chest; loss of appetite, weight loss; dry mouth, nausea, vomiting, stomach pain, indigestion; or headache, dizziness. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   What other drugs will affect methylphenidate? Tell your doctor about all your other medicines, especially: an antidepressant; or blood pressure medication; This list is not complete. Other drugs may interact with methylphenidate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

What is methylphenidate? Methylphenidate is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control. Methylphenidate is used to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and narcolepsy. Methylphenidate should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. Warnings Methylphenidate may be habit-forming. Misuse can cause addiction, overdose, or death. Tell your doctor if you have had problems with drug or alcohol abuse. Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect. Do not use methylphenidate if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine. Methylphenidate may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder. You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes. Call your doctor right away if you have: signs of heart problems - chest pain, feeling light-headed or short of breath; signs of psychosis - paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems - unexplained wounds on your fingers or toes. Tell your doctor if you have a history of drug or alcohol addiction. Keep the medication where others cannot get to it. Before taking this medicine You should not use methylphenidate if you are allergic to it. You should not take Concerta if you have: glaucoma; a personal or family history of tics (muscle twitches) or Tourette's syndrome; or severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse). Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have: heart problems or a congenital heart defect; high blood pressure; or a family history of heart disease or sudden death. Do not use methylphenidate if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine. Tell your doctor if you also use opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with methylphenidate could cause a serious condition called serotonin syndrome. Tell your doctor if you or anyone in your family has ever had: depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions; blood circulation problems in the hands or feet; alcoholism or drug addiction; or if you take Adhansia - an allergy to aspirin or yellow food dye. To make sure methylphenidate is safe for you, tell your doctor if you have:: problems with the esophagus, stomach, or intestines; `motor tics (muscle twitches) or Tourette's syndrome; or seizures, epilepsy, or an abnormal brain wave test (EEG). Becoming dependent on methylphenidate during pregnancy can cause premature birth or low birth weight. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of methylphenidate on the baby. Ask a doctor if it is safe to breastfeed while using this medicine. If you are breastfeeding, tell your doctor if you notice symptoms in the baby such as agitation, sleep problems, feeding problems, or reduced weight gain. methylphenidate is not approved for use by anyone younger than 6 years old. How should I take methylphenidate? Take methylphenidate exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Methylphenidate may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away this medicine is against the law. Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes. Most brands of methylphenidate are taken 1 or 2 times during the day. Jornay PM is for use only at night between 6:30 and 9:30 pm. You may take methylphenidate with or without food, but take it the same way each time. Swallow the extended-release capsule or tablet whole and do not crush, chew, or break it. If you cannot swallow an extended-release capsule whole, open it and mix the medicine with soft food such as applesauce, pudding or yogurt. Swallow the mixture right away without chewing. You must chew the chewable tablet before you swallow it. Measure liquid medicine with the supplied measuring device (not a kitchen spoon). Allow the orally disintegrating tablet to dissolve in your mouth without chewing. Tell your doctor if you have a planned surgery. Your treatment may also include counseling or other treatments. Your doctor will need to check your progress on a regular basis. Your heart and blood pressure may also need to be checked often. Store tightly closed at room temperature, away from moisture, heat, and light. Keep your medicine in a place where no one can use it improperly. Do not keep leftover medicine. Ask your pharmacist about a drug take-back program. You may also mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag and throw the bag in the trash.   What happens if I miss a dose? Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of methylphenidate could be fatal. Overdose symptoms may include nausea, dry mouth, vomiting, diarrhea, anxiety, agitation, restlessness, tremor, muscle twitches, rapid breathing, confusion, hallucinations, dilated pupils, muscle pain or weakness, fever, sweating, headache, pounding in your neck or ears, fast or pounding heartbeats, feeling light-headed, fainting, seizure (convulsions), or coma. What should I avoid while taking methylphenidate? Avoid drinking alcohol. Avoid driving or hazardous activity until you know how methylphenidate will affect you. Your reactions could be impaired. Methylphenidate side effects Get emergency medical help if you have signs of an allergic reaction to methylphenidate: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: signs of heart problems - chest pain, trouble breathing, feeling like you might pass out; signs of psychosis - hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia; signs of circulation problems - numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or penis erection that is painful or lasts 4 hours or longer. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea. Methylphenidate can affect growth in children. Your child's height and weight may need to be checked often. Tell your doctor if your child is not growing at a normal rate. Common methylphenidate side effects may include: sweating, increased blood pressure; mood changes, anxiety, feeling nervous or irritable, trouble sleeping; fast heart rate, pounding heartbeats or fluttering in your chest; loss of appetite, weight loss; dry mouth, nausea, vomiting, stomach pain, indigestion; or headache, dizziness. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   What other drugs will affect methylphenidate? Tell your doctor about all your other medicines, especially: an antidepressant; or blood pressure medication; This list is not complete. Other drugs may interact with methylphenidate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

What is metoclopramide? Metoclopramide increases muscle contractions in the upper digestive tract. This speeds up the rate at which the stomach empties into the intestines. Metoclopramide oral (taken by mouth) is used for 4 to 12 weeks to treat heartburn caused by gastroesophageal reflux in people who have used other medications without relief. Metoclopramide oral is also used to treat gastroparesis (slow stomach emptying) in people with diabetes, which can cause heartburn and stomach discomfort after meals. Metoclopramide injection is used to treat severe diabetic gastroparesis. The injection is also used to prevent nausea and vomiting caused by chemotherapy or surgery, or to aid in certain medical procedures involving the stomach or intestines. Warnings Do not use this medicine if you've ever had muscle movement problems after using metoclopramide or similar medicines, or if you've had a movement disorder called tardive dyskinesia. You also should not use this medicine if you've had stomach or intestinal problems (a blockage, bleeding, or a hole or tear), epilepsy or other seizure disorder, or an adrenal gland tumor (pheochromocytoma). NEVER USE METOCLOPRAMIDE IN LARGER AMOUNTS THAN RECOMMENDED, OR FOR LONGER THAN 12 WEEKS. High doses or long-term use can cause a serious movement disorder that may not be reversible. The longer you use metoclopramide, the more likely you are to develop this movement disorder. The risk of this side effect is higher in diabetics and older adults (especially women). Before you take metoclopramide, tell your doctor if you have kidney or liver disease, congestive heart failure, high blood pressure, diabetes, Parkinson's disease, or a history of depression. Do not drink alcohol. It can increase some of the side effects of metoclopramide. Stop using metoclopramide and call your doctor at once if you have tremors or uncontrolled muscle movements, fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing, depressed mood, thoughts of suicide or hurting yourself, hallucinations, anxiety, agitation, seizure, or jaundice (yellowing of your skin or eyes). Before taking this medicine You should not use metoclopramide if you are allergic to it, or if you have: tardive dyskinesia (a disorder of involuntary movements); stomach or intestinal problems such as a blockage, bleeding, or perforation (a hole or tear in your stomach or intestines); epilepsy or other seizure disorder; an adrenal gland tumor (pheochromocytoma); or if you've ever had muscle movement problems after using metoclopramide or similar medicines. Tell your doctor if you have ever had: liver or kidney disease; problems with muscle movements; congestive heart failure or a heart rhythm disorder; high blood pressure; seizures; breast cancer; Parkinson's disease; diabetes; or depression or mental illness. This medicine may contain phenylalanine. Check the medication label if you have phenylketonuria (PKU). Tell your doctor if you are pregnant. Metoclopramide may harm an unborn baby if you use the medicine during late pregnancy. It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks. Metoclopramide is not approved for use by anyone younger than 18 years old. How should I use metoclopramide? Take metoclopramide exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Use the medicine exactly as directed. A metoclopramide injection is given into a muscle or as an infusion into a vein. A healthcare provider will give the injection, usually during surgery, chemotherapy, or a medical procedure. Metoclopramide oral is taken for only 4 to 12 weeks. NEVER USE METOCLOPRAMIDE IN LARGER AMOUNTS THAN RECOMMENDED, OR FOR LONGER THAN 12 WEEKS. High doses or long-term use of metoclopramide can cause a serious movement disorder that may not be reversible. The longer you use metoclopramide, the more likely you are to develop this movement disorder. The risk of this side effect is higher in diabetics and older adults (especially women). Metoclopramide is usually taken 30 minutes before meals and at bedtime, or only with meals that usually cause heartburn. Follow your doctor's dosing instructions very carefully. Do not use two different forms of metoclopramide (such as tablets and oral syrup) at the same time. Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon). To take the orally disintegrating tablet (ODT): Remove a tablet from its blister pack only when you are ready to take the tablet. Use dry hands and take care not to damage a tablet while pushing it out of the blister. Place the tablet in your mouth and allow it to dissolve, without chewing or swallowing it whole. You may sip liquid if needed to help swallow the dissolved tablet. Store at room temperature in a tightly-closed container, away from moisture and heat. Keep the bottle tightly closed. After you stop taking metoclopramide, you may have unpleasant withdrawal symptoms such as headache, dizziness, or nervousness. Dosing information Usual Adult Dose for Nausea/Vomiting: Postoperative nausea and vomiting: Parenteral: 10 to 20 mg IM at or near the end of surgery Usual Adult Dose for Gastroesophageal Reflux Disease: Oral: 10 to 15 mg up to 4 times a day 30 minutes before meals and at bedtime, depending upon symptoms being treated and clinical response. Therapy should not exceed 12 weeks. Usual Adult Dose for Small Intestine Intubation: If the tube has not passed the pylorus with conventional methods in 10 minutes, a single (undiluted) dose may be administered IV slowly over 1 to 2 minutes: Adults and pediatric patients greater than or equal to 14 years: 10 mg IV as a single dose administered over 1 to 2 minutes. Usual Adult Dose for Radiographic Exam: Adults and pediatric patients greater than or equal to 14 years: 10 mg IV as a single dose administered over 1 to 2 minutes to facilitate gastric emptying where delayed gastric emptying interferes with radiological examination of the stomach and/or small intestine. Usual Adult Dose for Gastroparesis: During the earliest manifestations of diabetic gastric stasis, oral administration may be initiated. If severe symptoms are present, therapy should begin with IM or IV administration for up to 10 days until symptoms subside at which time the patient can be switched to oral therapy. Since diabetic gastric stasis is often recurrent, therapy should be reinstituted at the earliest manifestation. Parenteral: 10 mg 4 times daily, IV (slowly over a 1 to 2 minute period) or IM for up to 10 days. Oral: 10 mg 4 times daily, 30 minutes before meals and at bedtime, for 2 to 8 weeks depending on clinical response. Usual Adult Dose for Nausea/Vomiting -- Chemotherapy Induced: IV infusion: 1 to 2 mg/kg/dose (depending on the emetogenic potential of the agent) IV (infused over a period of not less than 15 minutes) 30 minutes before administration of chemotherapy. The dose may be repeated twice at 2 hour intervals following the initial dose. If vomiting is still not suppressed, the same dose may be repeated 3 more times at 3 hour intervals. For doses higher than 10 mg, the injection should be diluted in 50 mL of a parenteral solution. Normal saline is the preferred diluent. If acute dystonic reactions occur, 50 mg of diphenhydramine hydrochloride may be injected IM. Usual Adult Dose for Migraine: Use for treatment of migraine headaches is not an FDA approved indication; however, metoclopramide has shown efficacy in studies at a dose of 10 to 20 mg IV once (used in combination with analgesics or ergot derivatives). Usual Pediatric Dose for Gastroesophageal Reflux Disease: Metoclopramide is not approved by the FDA for gastroesophageal reflux disease in pediatric patients; however, the following doses have been studied: Oral, IM, IV: Infants and Children: 0.4 to 0.8 mg/kg/day in 4 divided doses Usual Pediatric Dose for Small Intestine Intubation: Metoclopramide IV is approved by the FDA for pediatric use to facilitate small bowel intubation by causing gastric emptying where delayed gastric emptying interferes with radiological examination of the stomach and/or small intestine. If the tube has not passed the pylorus with conventional methods in 10 minutes, a single (undiluted) dose may be administered IV slowly over 1 to 2 minutes: Less than 6 years: 0.1 mg/kg IV as a single dose 6 to 14 years: 2.5 to 5 mg IV as a single dose Children greater than 14 years: 10 mg as a single dose Usual Pediatric Dose for Nausea/Vomiting -- Chemotherapy Induced: Metoclopramide is not approved by the FDA for chemotherapy induced nausea and vomiting in pediatric patients; however, the following doses have been studied: IV: 1 to 2 mg/kg/dose IV every 30 minutes before chemotherapy and every 2 to 4 hours Usual Pediatric Dose for Nausea/Vomiting -- Postoperative: Metoclopramide is not approved by the FDA for postoperative nausea and vomiting in pediatric patients; however, the following doses have been studied: IV: Children less than or equal to 14 years: 0.1 to 0.2 mg/kg/dose (maximum dose: 10 mg/dose); repeat every 6 to 8 hours as needed Children greater than 14 years and Adults: 10 mg; repeat every 6 to 8 hours as needed   What happens if I miss a dose? Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include drowsiness, confusion, or uncontrolled muscle movements. What to avoid Drinking alcohol with this medicine can cause side effects. Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired. Metoclopramide side effects Get emergency medical help if you have signs of an allergic reaction to metoclopramide: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop taking metoclopramide and call your doctor at once if you have any of these SIGNS OF A SERIOUS MOVEMENT DISORDER, which may occur within the first 2 days of treatment: tremors or shaking in your arms or legs; uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or any new or unusual muscle movements you cannot control. Call your doctor at once if you have: confusion, depression, thoughts of suicide or hurting yourself; slow or jerky muscle movements, problems with balance or walking; mask-like appearance in your face; a seizure; anxiety, agitation, jittery feeling, trouble staying still, trouble sleeping; swelling, feeling short of breath, rapid weight gain; or severe nervous system reactionvery stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out. Common metoclopramide side effects may include: feeling restless; feeling drowsy or tired; lack of energy; nausea, vomiting; headache, confusion; or sleep problems (insomnia). This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   What other drugs will affect metoclopramide? Using metoclopramide with other drugs that make you drowsy can worsen this effect. Ask your doctor before you take opioid pain medication, a sleeping pill, a muscle relaxer, or medicine for anxiety, depression, or seizures. Tell your doctor about all your current medicines. Many drugs can affect metoclopramide, especially: acetaminophen (Tylenol); cyclosporine (Gengraf, Neoral, Sandimmune); digoxin (digitalis, Lanoxin); glycopyrrolate (Robinul); insulin; levodopa (Larodopa, Atamet, Parcopa, Sinemet); mepenzolate (Cantil); tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap); atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop); bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare); blood pressure medications; bronchodilators such as ipratroprium (Atrovent) or tiotropium (Spiriva); irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin), or propantheline (Pro-Banthine); an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate); or medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (Clozaril, FazaClo), haloperidol (Haldol), olanzapine (Zyprexa, Symbyax), prochlorperazine (Compazine), risperidone (Risperdal), thiothixene (Navane), and others. This list is not complete and there are many other drugs that can interact with metoclopramide. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

What is metolazone? Metolazone is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention. Metolazone is used to treat fluid retention (edema) in people with congestive heart failure, or a kidney disorder such as nephrotic syndrome. Metolazone is also used to treat high blood pressure (hypertension). Metolazone may also be used for purposes not listed in this medication guide. Warnings You should not use metolazone if you are unable to urinate, or if you have severe liver disease. What should I discuss with my doctor before taking metolazone? You should not use metolazone if you are allergic to it, or if you have: severe liver disease; or if you are unable to urinate. To make sure metolazone is safe for you, tell your doctor if you have: an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); a heart rhythm disorder; an allergy to sulfa drugs; liver disease; kidney disease; diabetes; gout; or systemic lupus erythematosus. Using metolazone during pregnancy could cause side effects in the newborn baby, such as blood cell problems, or jaundice (yellowing of the skin or eyes). Tell your doctor if you are pregnant or if you become pregnant while using metolazone. Metolazone can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine. Metolazone is not approved for use by anyone younger than 18 years old. How should I take metolazone? Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended. Metolazone is usually taken only once per day. You may need to limit salt in your diet while taking this medicine. Follow your doctor's instructions carefully. While using metolazone, you may need frequent blood tests. Your blood and urine may both be tested if you have been vomiting or are dehydrated. Metolazone can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using metolazone. If you need surgery, tell the surgeon ahead of time that you are using metolazone. You may need to stop using the medicine for a short time. If you are being treated for high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life. Store the tablets at room temperature away from heat, light, and moisture. What happens if I miss a dose? Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include severe dizziness or drowsiness, dry mouth, thirst, muscle weakness, feeling light-headed, or fainting. What should I avoid while taking metolazone? Drinking alcohol with metolazone can cause side effects. Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough. Metolazone side effects Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: chest pain; pounding heartbeats or fluttering in your chest; easy bruising or bleeding; a light-headed feeling, like you might pass out; liver problems--nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady; other signs of an electrolyte imbalance--dry mouth, nausea, vomiting, weakness, drowsiness, lack of energy, muscle pain, little or no urination, or feeling restless; or severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling. Common side effects may include: dizziness, spinning sensation; drowsiness, tiredness; depressed mood; muscle or joint pain; numbness or tingly feeling; nausea, stomach pain, loss of appetite; or diarrhea, constipation. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   Metolazone dosing information Usual Adult Dose for Hypertension: Initial dose: 2.5 mg orally once a day (Zaroxolyn) or 0.5 mg orally once a day (Mykrox). Usual Adult Dose for Edema: Initial dose: 5 mg orally once a day (Zaroxolyn) or 0.5 mg orally once a day (Mykrox).   What other drugs will affect metolazone? Taking metolazone with other drugs that make you make you light-headed can worsen this effect. Ask your doctor before taking metolazone with a narcotic pain medicine, muscle relaxer, or medicine for anxiety or seizures. Tell your doctor about all your current medicines and any you start or stop using, especially: any other blood pressure medication; digoxin, digitalis; furosemide or other diuretics (water pills); insulin or oral diabetes medicine; lithium; methenamine; vitamin D (at high doses); a blood thinner--warfarin, Coumadin, Jantoven; NSAIDs (nonsteroidal anti-inflammatory drugs)--ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; salicylates--aspirin, Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others; or steroid medicine--prednisone and others. This list is not complete. Other drugs may interact with metolazone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

DESCRIPTION Metoprolol tartrate USP is a selective beta1-adrenoreceptor blocking agent, available as 25 mg, 50 mg and 100 mg tablets for oral administration. Metoprolol tartrate USP is (±)-1-(isopropylamino)-3-[p-2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt. Its structural formula is: Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Each tablet for oral administration contains 25 mg, 50 mg or 100 mg of Metoprolol tartrate USP and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch (maize), sodium starch glycolate, talc and titanium dioxide. In addition, the 50 mg product contains FD&C Red No. 40 Aluminum Lake and the 100 mg product contains FD&C Blue No. 1 Aluminum Lake and FD&C Blue No. 2 Aluminum Lake as coloring agents. FDA approved dissolution method acceptance criterion differs from the USP dissolution method acceptance criterion. Metoprolol Tartrate Tablet - Clinical Pharmacology Mechanism of Action Metoprolol Tartrate Tablets USP is a beta1-selective (cardioselective) adrenergic receptor blocker. This preferential effect is not absolute, however, and at higher plasma concentrations, Metoprolol Tartrate Tablets USP also inhibits beta2-adrenoreceptors, chiefly located in the bronchial and vascular musculature. Clinical pharmacology studies have demonstrated the beta-blocking activity of metoprolol, as shown by (1) reduction in heart rate and cardiac output at rest and upon exercise, (2) reduction of systolic blood pressure upon exercise, (3) inhibition of isoproterenol-induced tachycardia, and (4) reduction of reflex orthostatic tachycardia. Hypertension The mechanism of the antihypertensive effects of beta-blocking agents has not been fully elucidated. However, several possible mechanisms have been proposed: (1) competitive antagonism of catecholamines at peripheral (especially cardiac) adrenergic neuron sites, leading to decreased cardiac output; (2) a central effect leading to reduced sympathetic outflow to the periphery; and (3) suppression of renin activity. Angina Pectoris By blocking catecholamine-induced increases in heart rate, in velocity and extent of myocardial contraction and in blood pressure, Metoprolol Tartrate Tablets USP reduces the oxygen requirements of the heart at any given level of effort, thus making it useful in the long-term management of angina pectoris. Myocardial Infarction The precise mechanism of action of Metoprolol Tartrate Tablets USP in patients with suspected or definite myocardial infarction is not known. Pharmacodynamics Relative beta1 selectivity is demonstrated by the following: (1) In healthy subjects, Metoprolol Tartrate Tablets USP is unable to reverse the beta2-mediated vasodilating effects of epinephrine. This contrasts with the effect of nonselective (beta1 plus beta2) beta-blockers, which completely reverse the vasodilating effects of epinephrine. (2) In asthmatic patients, Metoprolol Tartrate Tablets USP reduces FEV1 and FVC significantly less than a nonselective beta-blocker, propranolol, at equivalent beta1-receptor blocking doses. Metoprolol Tartrate Tablets USP has no intrinsic sympathomimetic activity, and membrane-stabilizing activity is detectable only at doses much greater than required for beta blockade. Animal and human experiments indicate that Metoprolol Tartrate Tablets USP slows the sinus rate and decreases AV nodal conduction. Significant beta-blocking effect (as measured by reduction of exercise heart rate) occurs within one hour after oral administration, and its duration is dose-related. For example, a 50% reduction of the maximum effect after single oral doses of 20 mg, 50 mg and 100 mg occurred at 3.3 hours, 5.0 hours and 6.4 hours, respectively, in normal subjects. After repeated oral dosages of 100 mg twice daily, a significant reduction in exercise systolic blood pressure was evident at 12 hours. When the drug was infused over a 10-minute period, in normal volunteers, maximum beta blockade was achieved at approximately 20 minutes. Equivalent maximal beta-blocking effect is achieved with oral and intravenous doses in the ratio of approximately 2.5:1. There is a linear relationship between the log of plasma levels and reduction of exercise heart rate. However, antihypertensive activity does not appear to be related to plasma levels. Because of variable plasma levels attained with a given dose and lack of a consistent relationship of antihypertensive activity to dose, selection of proper dosage requires individual titration. In several studies of patients with acute myocardial infarction, intravenous followed by oral administration of Metoprolol Tartrate Tablets USP caused a reduction in heart rate, systolic blood pressure and cardiac output. Stroke volume, diastolic blood pressure and pulmonary artery end diastolic pressure remained unchanged. In patients with angina pectoris, plasma concentration measured at one hour is linearly related to the oral dose within the range of 50 mg to 400 mg. Exercise heart rate and systolic blood pressure are reduced in relation to the logarithm of the oral dose of metoprolol. The increase in exercise capacity and the reduction in left ventricular ischemia are also significantly related to the logarithm of the oral dose. Pharmacokinetics Absorption The estimated oral bioavailability of immediate-release metoprolol is about 50% be- cause of pre-systemic metabolism which is saturable leading to non-proportionate increase in the exposure with increased dose. Distribution Metoprolol is extensively distributed with a reported volume of distribution of 3.2 to 5.6 L/kg. About 10% of metoprolol in plasma is bound to serum albumin. Metoprolol is known to cross the placenta and is found in breast milk. Metoprolol is also known to cross the blood brain barrier following oral administration and CSF concentrations close to that observed in plasma have been reported. Metoprolol is not a significant P-glycoprotein substrate. Metabolism Metoprolol Tartrate Tablets USP is primarily metabolized by CYP2D6. Metoprolol is a racemic mixture of R- and S-enantiomers, and when administered orally, it exhibits stereoselective metabolism that is dependent on oxidation phenotype. CYP2D6 is absent (poor metabolizers) in about 8% of Caucasians and about 2% of most other populations. Poor CYP2D6 metabolizers exhibit several-fold higher plasma concentrations of Metoprolol Tartrate Tablets USP than extensive metabolizers with normal CYP2D6 activity thereby decreasing Metoprolol Tartrate Tablets USP’s cardioselectivity. Elimination Elimination of Metoprolol Tartrate Tablets USP is mainly by biotransformation in the liver. The mean elimination half-life of metoprolol is 3 to 4 hours; in poor CYP2D6 metabolizers the half-life may be 7 to 9 hours. Approximately 95% of the dose can be recovered in urine. In most subjects (extensive metabolizers), less than 5% of an oral dose and less than 10% of an intravenous dose are excreted as unchanged drug in the urine. In poor metabolizers, up to 30% or 40% of oral or intravenous doses, respectively, may be excreted unchanged; the rest is excreted by the kidneys as metabolites that appear to have no beta blocking activity. The renal clearance of the stereoisomers does not exhibit stereo-selectivity in renal excretion. Special Populations Geriatric Patients The geriatric population may show slightly higher plasma concentrations of metoprolol as a combined result of a decreased metabolism of the drug in elderly population and a decreased hepatic blood flow. However, this increase is not clinically significant or therapeutically relevant. Renal Impairment The systemic availability and half-life of Metoprolol Tartrate Tablets USP in patients with renal failure do not differ to a clinically significant degree from those in normal subjects. Hepatic Impairment Since the drug is primarily eliminated by hepatic metabolism, hepatic impairment may impact the pharmacokinetics of metoprolol. The elimination half-life of metoprolol is considerably prolonged, depending on severity (up to 7.2 h). Clinical Studies Hypertension In controlled clinical studies, Metoprolol Tartrate Tablets USP has been shown to be an effective antihypertensive agent when used alone or as concomitant therapy with thiazide-type diuretics, at dosages of 100 mg to 450 mg daily. In controlled, comparative, clinical studies, Metoprolol Tartrate Tablets USP has been shown to be as effective an antihypertensive agent as propranolol, methyldopa and thiazide-type diuretics, to be equally effective in supine and standing positions. Angina Pectoris In controlled clinical trials, Metoprolol Tartrate Tablets USP, administered two or four times daily, has been shown to be an effective antianginal agent, reducing the number of angina attacks and increasing exercise tolerance. The dosage used in these studies ranged from 100 mg to 400 mg daily. A controlled, comparative, clinical trial showed that Metoprolol Tartrate Tablets USP was indistinguishable from propranolol in the treatment of angina pectoris. Myocardial Infarction In a large (1,395 patients randomized), double-blind, placebo-controlled clinical study, Metoprolol Tartrate Tablets USP was shown to reduce 3-month mortality by 36% in patients with suspected or definite myocardial infarction. Patients were randomized and treated as soon as possible after their arrival in the hospital, once their clinical condition had stabilized and their hemodynamic status had been carefully evaluated. Subjects were ineligible if they had hypotension, bradycardia, peripheral signs of shock and/or more than minimal basal rales as signs of congestive heart failure. Initial treatment consisted of intravenous followed by oral administration of Metoprolol Tartrate Tablets USP or placebo, given in a coronary care or comparable unit. Oral maintenance therapy with Metoprolol Tartrate Tablets USP or placebo was then continued for 3 months. After this double-blind period, all patients were given Metoprolol Tartrate Tablets USP and followed up to one year. The median delay from the onset of symptoms to the initiation of therapy was 8 hours in both the Metoprolol Tartrate Tablets USP and placebo treatment groups. Among patients treated with Metoprolol Tartrate Tablets USP, there were comparable reductions in 3-month mortality for those treated early (no more than 8 hours) and those in whom treatment was started later. Significant reductions in the incidence of ventricular fibrillation and in chest pain following initial intravenous therapy were also observed with Metoprolol Tartrate Tablets USP and were independent of the interval between onset of symptoms and initiation of therapy. In this study, patients treated with metoprolol received the drug both very early (intra-venously) and during a subsequent 3-month period, while placebo patients received no beta-blocker treatment for this period. The study thus was able to show a benefit from the overall metoprolol regimen but cannot separate the benefit of very early intravenous treatment from the benefit of later beta-blocker therapy. Nonetheless, because the overall regimen showed a clear beneficial effect on survival without evidence of an early adverse effect on survival, one acceptable dosage regimen is the precise regimen used in the trial. Because the specific benefit of very early treatment remains to be defined, however, it is also reasonable to administer the drug orally to patients at a later time as is recommended for certain other beta-blockers. Indications and Usage for Metoprolol Tartrate Tablet Hypertension Metoprolol Tartrate Tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris Metoprolol Tartrate Tablets USP are indicated in the long-term treatment of angina pectoris. Myocardial Infarction Metoprolol Tartrate Tablets USP are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous Metoprolol Tartrate Tablets USP. Oral Metoprolol Tartrate Tablets USP therapy can be initiated after intravenous Metoprolol Tartrate Tablets USP therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (seeDOSAGE AND ADMINISTRATION ,CONTRAINDICATIONS and WARNINGS). Contraindications Hypertension and Angina Metoprolol Tartrate Tablets USP are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see WARNINGS). Hypersensitivity to Metoprolol Tartrate Tablets USP and related derivatives, or to any of the excipients; hypersensitivity to other beta-blockers (cross-sensitivity between beta blockers can occur). Sick-sinus syndrome. Severe peripheral arterial circulatory disorders. Myocardial Infarction Metoprolol Tartrate Tablets USP is contraindicated in patients with a heart rate of less than 45 beats/min; second- and third-degree heart block; significant first-degree heart block (P-R interval no less than 0.24 sec); systolic blood pressure less than 100 mmHg; or moderate to severe cardiac failure (see WARNINGS). Warnings Heart Failure Beta blockers, like Metoprolol Tartrate Tablets USP, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock. If signs or symptoms of heart failure develop, treat the patient according to recommended guidelines. It may be necessary to lower the dose of Metoprolol Tartrate Tablets USP or to discontinue it. Ischemic Heart Disease Do not abruptly discontinue Metoprolol Tartrate Tablets USP therapy in patients with coronary artery disease. Severe exacerbation of angina, myocardial infarction and ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of therapy with beta-blockers. When discontinuing chronically administered Metoprolol Tartrate Tablets USP, particularly in patients with coronary artery disease, the dosage should be gradually reduced over a period of 1 to 2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, Metoprolol Tartrate Tablets USP administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician’s advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue Metoprolol Tartrate Tablets USP therapy abruptly even in patients treated only for hypertension. Use During Major Surgery Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. Bradycardia Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of Metoprolol Tartrate Tablets USP. Patients with first-degree atrioventricular block, sinus node dysfunction or conduction disorders may be at increased risk. Monitor heart rate and rhythm in patients receiving Metoprolol Tartrate Tablets USP. If severe bradycardia develops, reduce or stop Metoprolol Tartrate Tablets USP. Exacerbation of Bronchospastic Disease Patients with bronchospastic disease, should, in general, not receive beta-blockers, including Metoprolol Tartrate Tablets USP. Because of its relative beta1 selectivity, however, Metoprolol Tartrate Tablets USP may be used in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment. Because beta1 selectivity is not absolute use the lowest possible dose of Metoprolol Tartrate Tablets USP and consider administering Metoprolol Tartrate Tablets USP in smaller doses 3 times daily, instead of larger doses two times daily, to avoid the higher plasma levels associated with the longer dosing interval (see DOSAGE AND ADMINISTRATION). Bronchodilators, including beta2 agonists, should be readily available or administered concomitantly. Diabetes and Hypoglycemia Beta-blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected. Pheochromocytoma If Metoprolol Tartrate Tablets USP is used in the setting of pheochromocytoma, it should be given in combination with an alpha blocker, and only after the alpha blocker has been initiated. Administration of beta blockers alone in the setting of pheochromocytoma has been associated with a paradoxical increase in blood pressure due to the attenuation of beta-mediated vasodilatation in skeletal muscle. Thyrotoxicosis Metoprolol Tartrate Tablets USP may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Avoid abrupt withdrawal of beta-blockade, which might precipitate a thyroid storm. Precautions Risk of Anaphylactic Reactions While taking beta blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction. Information for Patients Advise patients to take Metoprolol Tartrate Tablets USP regularly and continuously, as directed, with or immediately following meals. If a dose should be missed, the patient should take only the next scheduled dose (without doubling it). Patients should not discontinue Metoprolol Tartrate Tablets USP without consulting the physician. Advise patients (1) to avoid operating automobiles and machinery or engaging in other tasks requiring alertness until the patient’s response to therapy with Metoprolol Tartrate Tablets USP have been determined; (2) to contact the physician if any difficulty in breathing occurs; (3) to inform the physician or dentist before any type of surgery that he or she is taking Metoprolol Tartrate Tablets USP. Drug Interactions Catecholamine-Depleting Drugs Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents or monoamine oxidase (MAO) inhibitors. Observe patients treated with Metoprolol Tartrate Tablets USP plus a catecholamine depletor for evidence of hypotension or marked bradycardia, which may produce vertigo, syncope, or postural hypotension. In addition, possibly significant hypertension may theoretically occur up to 14 days following discontinuation of the concomitant administration with an irreversible MAO inhibitor. Digitalis Glycosides and Beta-Blockers Both digitalis glycosides and beta blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Monitor heart rate and PR interval. Calcium Channel Blockers Concomitant administration of a beta-adrenergic antagonist with a calcium channel blocker may produce an additive reduction in myocardial contractility because of negative chronotropic and inotropic effects. CYP2D6 Inhibitors Potent inhibitors of the CYP2D6 enzyme may increase the plasma concentration of Metoprolol Tartrate Tablets USP which would mimic the pharmacokinetics of CYP2D6 poor metabolizer (see PHARMACOKINETICS section). Increase in plasma concentrations of metoprolol would decrease the cardioselectivity of metoprolol. Known clinically significant potent inhibitors of CYP2D6 are antidepressants such as fluvoxamine, fluoxetine, paroxetine, sertraline, bupropion, clomipramine and desipramine; antipsychotics such as chlorpromazine, fluphenazine, haloperidol and thioridazine; antiarrhythmics such as quinidine or propafenone; antiretrovirals such as ritonavir; antihistamines such as diphenhydramine; antimalarials such as hydroxychloroquine or quinidine; antifungals such as terbinafine. Hydralazine Concomitant administration of hydralazine may inhibit presystemic metabolism of metoprolol leading to increased concentrations of metoprolol. Alpha-Adrenergic Agents Antihypertensive effect of alpha-adrenergic blockers such as guanethidine, betanidine, reserpine, alpha-methyldopa or clonidine may be potentiated by beta-blockers including Metoprolol Tartrate Tablets USP. Beta-adrenergic blockers may also potentiate the postural hypotensive effect of the first dose of prazosin, probably by preventing reflex tachycardia. On the contrary, beta adrenergic blockers may also potentiate the hypertensive response to withdrawal of clonidine in patients receiving concomitant clonidine and beta-adrenergic blocker. If a patient is treated with clonidine and Metoprolol Tartrate Tablets USP concurrently, and clonidine treatment is to be discontinued, stop Metoprolol Tartrate Tablets USP several days before clonidine is withdrawn. Rebound hypertension that can follow withdrawal of clonidine may be increased in patients receiving concurrent beta-blocker treatment. Ergot Alkaloid Concomitant administration with beta-blockers may enhance the vasoconstrictive action of ergot alkaloids. Dipyridamole In general, administration of a beta-blocker should be withheld before dipyridamole testing, with careful monitoring of heart rate following the dipyridamole injection. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have been conducted to evaluate carcinogenic potential. In a 2-year study in rats at three oral dosage levels of up to 800 mg/kg per day, there was no increase in the development of spontaneously occurring benign or malignant neoplasms of any type. The only histologic changes that appeared to be drug related were an increased incidence of generally mild focal accumulation of foamy macrophages in pulmonary alveoli and a slight increase in biliary hyperplasia. In a 21-month study in Swiss albino mice at three oral dosage levels of up to 750 mg/kg per day, benign lung tumors (small adenomas) occurred more frequently in female mice receiving the highest dose than in untreated control animals. There was no increase in malignant or total (benign plus malignant) lung tumors, or in the overall incidence of tumors or malignant tumors. This 21-month study was repeated in CD-1 mice, and no statistically or biologically significant differences were observed between treated and control mice of either sex for any type of tumor. All mutagenicity tests performed (a dominant lethal study in mice, chromosome studies in somatic cells, a Salmonella/mammalian-microsome mutagenicity test, and a nucleus anomaly test in somatic interphase nuclei) were negative. Reproduction toxicity studies in mice, rats and rabbits did not indicate teratogenic potential for metoprolol tartrate. Embryotoxicity and/or fetotoxicity in rats and rabbits were noted starting at doses of 50 mg/kg in rats and 25 mg/kg in rabbits, as demonstrated by increases in preimplantation loss, decreases in the number of viable fetuses per dose, and/or decreases in neonatal survival. High doses were associated with some maternal toxicity, and growth delay of the offspring in utero, which was reflected in minimally lower weights at birth. The oral NOAELs for embryo-fetal development in mice, rats and rabbits were considered to be 25, 200, and 12.5 mg/kg. This corresponds to dose levels that are approximately 0.3 times, 4 times, and 0.5 times, respectively, when based on surface area, the maximum human oral dose (8 mg/kg/day) of metoprolol tartrate. Metoprolol tartrate has been associated with reversible adverse effects on spermatogenesis starting at oral dose levels of 3.5 mg/kg in rats (a dose that is only 0.1 times the human dose, when based on surface area), although other studies have shown no effect of metoprolol tartrate on reproductive performance in male rats. Pregnancy Category C Upon confirming the diagnosis of pregnancy, women should immediately inform the doctor. Metoprolol Tartrate Tablets USP has been shown to increase postimplantation loss and decrease neonatal survival in rats at doses up to 11 times the maximum daily human dose of 450 mg, when based on surface area. Distribution studies in mice confirm exposure of the fetus when Metoprolol Tartrate Tablets USP is administered to the pregnant animal. These limited animal studies do not indicate direct or indirect harmful effects with respect to teratogenicity (see CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY). There are no adequate and well-controlled studies in pregnant women. The amount of data on the use of metoprolol in pregnant women is limited. The risk to the fetus/ mother is unknown. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers Metoprolol Tartrate Tablets USP is excreted in breast milk in a very small quantity. An infant consuming 1 liter of breast milk daily would receive a dose of less than 1 mg of the drug. Fertility The effects of Metoprolol Tartrate Tablets USP on the fertility of human have not been studied. Metoprolol Tartrate Tablets USP showed effects on spermatogenesis in male rats at a therapeutic dose level, but had no effect on rates of conception at higher doses in animal fertility studies (see CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY). Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical trials of Metoprolol Tartrate Tablets USP in hypertension did not include sufficient numbers of elderly patients to determine whether patients over 65 years of age differ from younger subjects in their response to Metoprolol Tartrate Tablets USP. Other reported clinical experience in elderly hypertensive patients has not identified any difference in response from younger patients. In worldwide clinical trials of Metoprolol Tartrate Tablets USP in myocardial infarction, where approximately 478 patients were over 65 years of age (0 over 75 years of age), no age-related differences in safety and effectiveness were found. Other reported clinical experience in myocardial infarction has not identified differences in response between the elderly and younger patients. However, greater sensitivity of some elderly individuals taking Metoprolol Tartrate Tablets USP cannot be categorically ruled out. Therefore, in general, it is recommended that dosing proceed with caution in this population. Adverse Reactions Hypertension and Angina Most adverse effects have been mild and transient. Central Nervous System Tiredness and dizziness have occurred in about 10 of 100 patients. Depression has been reported in about 5 of 100 patients. Mental confusion and short-term memory loss have been reported. Headache, nightmares, and insomnia have also been reported. Cardiovascular Shortness of breath and bradycardia have occurred in approximately 3 of 100 patients. Cold extremities; arterial insufficiency, usually of the Raynaud type; palpitations; congestive heart failure; peripheral edema; and hypotension have been reported in about 1 of 100 patients. Gangrene in patients with preexisting severe peripheral circulatory disorders has also been reported very rarely (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS). Respiratory Wheezing (bronchospasm) and dyspnea have been reported in about 1 of 100 patients (see WARNINGS). Rhinitis has also been reported. Gastrointestinal Diarrhea has occurred in about 5 of 100 patients. Nausea, dry mouth, gastric pain, constipation, flatulence, and heartburn have been reported in about 1 of 100 patients. Vomiting was a common occurrence. Post-marketing experience reveals very rare reports of hepatitis, jaundice and nonspecific hepatic dysfunction. Isolated cases of transaminase, alkaline phosphatase, and lactic dehydrogenase elevations have also been reported. Hypersensitive Reactions Pruritus or rash have occurred in about 5 of 100 patients. Very rarely, photosensitivity and worsening of psoriasis has been reported. Miscellaneous Peyronie’s disease has been reported in fewer than 1 of 100,000 patients. Musculoskeletal pain, blurred vision, and tinnitus have also been reported. There have been rare reports of reversible alopecia, agranulocytosis, and dry eyes. Discontinuation of the drug should be considered if any such reaction is not otherwise explicable. There have been very rare reports of weight gain, arthritis, and retroperitoneal fibrosis (relationship to Metoprolol Tartrate Tablets USP has not been definitely established). The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with Metoprolol Tartrate Tablets USP. Myocardial Infarction Central Nervous System Tiredness has been reported in about 1 of 100 patients. Vertigo, sleep disturbances, hallucinations, headache, dizziness, visual disturbances, confusion, and reduced libido have also been reported, but a drug relationship is not clear. Cardiovascular In the randomized comparison of Metoprolol Tartrate Tablets USP and placebo described in the CLINICAL PHARMACOLOGY section, the following adverse reactions were reported: Metoprolol Tartrate Tablets, USP    Placebo Hypotension (systolic BP of less than 90 mmHg)    27.4%    23.2% Bradycardia (heart rate of less than 40 beats/min)    15.9%    6.7% Second- or third-degree heart block    4.7%    4.7% First-degree heart block (P-R of no less than 0.26 sec)    5.3%    1.9% Heart failure    27.5%    29.6% Respiratory Dyspnea of pulmonary origin has been reported in fewer than 1 of 100 patients Gastrointestinal Nausea and abdominal pain have been reported in fewer than 1 of 100 patients. Dermatologic Rash and worsened psoriasis have been reported, but a drug relationship is not clear. Miscellaneous Unstable diabetes and claudication have been reported, but a drug relationship is not clear. Potential Adverse Reactions A variety of adverse reactions not listed above have been reported with other beta-adrenergic blocking agents and should be considered potential adverse reactions to Metoprolol Tartrate Tablets USP. Central Nervous System Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emo- tional lability, slightly clouded sensorium, and decreased performance on neuropsy- chometrics. Cardiovascular Intensification of AV block (see CONTRAINDICATIONS). Hematologic Agranulocytosis, nonthrombocytopenic purpura and thrombocytopenic purpura. Hypersensitive Reactions Fever combined with aching and sore throat, laryngospasm and respiratory distress. Post-Marketing Experience The following adverse reactions have been reported during post-approval use of Metoprolol Tartrate Tablets USP: confusional state, an increase in blood triglycerides and a decrease in High Density Lipoprotein (HDL). Because these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency. Overdosage Acute Toxicity Several cases of overdosage have been reported, some leading to death. Oral LD50’s (mg/kg): mice, 1,158 to 2,460; rats, 3,090 to 4,670. Signs and Symptoms Potential signs and symptoms associated with overdosage with Metoprolol Tartrate Tablets USP are bradycardia, hypotension, bronchospasm, myocardial infarction, cardiac failure and death. Management There is no specific antidote. In general, patients with acute or recent myocardial infarction may be more hemodynamically unstable than other patients and should be treated accordingly (see WARNINGS, MYOCARDIAL INFARCTION). On the basis of the pharmacologic actions of Metoprolol Tartrate Tablets USP, the following general measures should be employed: Elimination of the Drug Gastric lavage should be performed. Other clinical manifestations of overdose should be managed symptomatically based on modern methods of intensive care. Hypotension Administer a vasopressor, e.g., levarterenol or dopamine. Bronchospasm Administer a beta2-stimulating agent and/or a theophylline derivative. Cardiac Failure Administer digitalis glycoside and diuretic. In shock resulting from inadequate cardiac contractility, consider administration of dobutamine, isoproterenol or glucagon. Metoprolol Tartrate Tablet Dosage and Administration Hypertension Individualize the dosage of Metoprolol Tartrate Tablets USP. Metoprolol Tartrate Tablets USP should be taken with or immediately following meals. The usual initial dosage of Metoprolol Tartrate Tablets USP is 100 mg daily in single or divided doses, whether used alone or added to a diuretic. Increase the dosage at weekly (or longer) intervals until optimum blood pressure reduction is achieved. In general, the maximum effect of any given dosage level will be apparent after one week of therapy. The effective dosage range of Metoprolol Tartrate Tablets USP is 100 mg to 450 mg per day. Dosages above 450 mg per day have not been studied. While once-daily dosing is effective and can maintain a reduction in blood pressure throughout the day, lower doses (especially 100 mg) may not maintain a full effect at the end of the 24-hour period, and larger or more frequent daily doses may be required. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. Beta1 selectivity diminishes as the dose of Metoprolol Tartrate Tablets USP is increased. Angina Pectoris The dosage of Metoprolol Tartrate Tablets USP should be individualized. Metoprolol Tartrate Tablets USP should be taken with or immediately following meals. The usual initial dosage of Metoprolol Tartrate Tablets USP is 100 mg daily, given in two divided doses. Gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is pronounced slowing of the heart rate. The effective dosage range of Metoprolol Tartrate Tablets USP is 100 mg to 400 mg per day. Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, gradually decrease the dosage over a period of 1 to 2 weeks (see WARNINGS). Myocardial Infarction Early Treatment During the early phase of definite or suspected acute myocardial infarction, initiate treatment with Metoprolol Tartrate Tablets USP as soon as possible after the patient’s arrival in the hospital. Such treatment should be initiated in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized. Begin treatment in this early phase with the intravenous administration of three bolus injections of 5 mg of Metoprolol Tartrate Tablets USP each; give the injections at approximately 2-minute intervals. During the intravenous administration of Metoprolol Tartrate Tablets USP, monitor blood pressure, heart rate, and electrocardiogram. In patients who tolerate the full intravenous dose (15 mg), initiate Metoprolol Tartrate Tablets USP, 50 mg every 6 hours, 15 minutes after the last intravenous dose and continue for 48 hours. Thereafter, the maintenance dosage is 100 mg twice daily (see LATE TREATMENT below). Start patients who appear not to tolerate the full intravenous dose on Metoprolol Tartrate Tablets USP either 25 mg or 50 mg every 6 hours (depending on the degree of intolerance) 15 minutes after the last intravenous dose or as soon as their clinical condition allows. In patients with severe intolerance, discontinue Metoprolol Tartrate Tablets USP (see WARNINGS). Late Treatment Start patients with contraindications to treatment during the early phase of suspected or definite myocardial infarction, patients who appear not to tolerate the full early treatment, and patients in whom the physician wishes to delay therapy for any other reason on Metoprolol Tartrate Tablets USP, 100 mg twice daily, as soon as their clinical condition allows. Continue therapy for at least 3 months. Although the efficacy of Metoprolol Tartrate Tablets USP beyond 3 months has not been conclusively established, data from studies with other beta-blockers suggest that treatment should be continued for 1 to 3 years. Special Populations Pediatric Patients No pediatric studies have been performed. The safety and efficacy of Metoprolol Tartrate Tablets USP in pediatric patients have not been established. Renal Impairment No dose adjustment of Metoprolol Tartrate Tablets USP is required in patients with renal impairment. Hepatic Impairment Metoprolol Tartrate Tablets USP blood levels are likely to increase substantially in patients with hepatic impairment. Therefore, Metoprolol Tartrate Tablets USP should be initiated at low doses with cautious gradual dose titration according to clinical response. Geriatric Patients (greater than 65 Years) In general, use a low initial starting dose in elderly patients given their greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Method of Administration For oral treatment, the tablets should be swallowed unchewed with a glass of water. Metoprolol Tartrate Tablets USP should always be taken in standardized relation with meals. If the physician asks the patient to take Metoprolol Tartrate Tablets USP either before breakfast or with breakfast, then the patient should continue taking Metoprolol Tartrate Tablets USP with the same schedule during the course of therapy. How is Metoprolol Tartrate Tablet Supplied Metoprolol Tartrate Tablets, USP are available containing 25 mg, 50 mg or 100 mg of metoprolol tartrate USP. The 25 mg tablets are white film-coated, round, scored tablets debossed with Y over 25 on one side of the tablet and scored on the other side. They are available as follows: NDC 69445-004-04 bottles of 100 tablets NDC 69445-004-03 bottles of 500 tablets The 50 mg tablets are pink film-coated, round, scored tablets debossed with Y over 50 on one side of the tablet and scored on the other side. They are available as follows: NDC 69445-005-04 bottles of 100 tablets NDC 69445-005-05 bottles of 1,000 tablets The 100 mg tablets are light blue film-coated, round, scored tablets debossed with Y over 100 on one side of the tablet and scored on the other side. They are available as follows: NDC 69445-006-04 bottles of 100 tablets NDC 69445-006-05 bottles of 1,000 tablets Store at 20° to 25°C (68° to 77°F), excursions permitted to 15- 30°C (59- 86°F). [See USP Controlled Room Temperature.] Protect from moisture and heat. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Yabao Pharmaceutical Co., Ltd. Beijing 101111, China For: YoungTech Pharmaceuticals, Inc. Cranbury, NJ 08512, USA Rev: Nov 2019 METOPROLOL TARTRATE Metoprolol Tartrate Tablet, coated Product Information Product Type    HUMAN PRESCRIPTION DRUG LABEL    Item Code (Source)    NDC:69445-004 Route of Administration    ORAL    DEA Schedule     Active Ingredient/Active Moiety Ingredient Name    Basis of Strength    Strength METOPROLOL TARTRATE (METOPROLOL)    METOPROLOL TARTRATE    25 mg Inactive Ingredients Ingredient Name    Strength ANHYDROUS LACTOSE     SILICON DIOXIDE     CROSCARMELLOSE SODIUM     MAGNESIUM STEARATE     CELLULOSE, MICROCRYSTALLINE     POLYETHYLENE GLYCOL, UNSPECIFIED     POLYVINYL ALCOHOL     STARCH, CORN     SODIUM STARCH GLYCOLATE TYPE A CORN     TALC     TITANIUM DIOXIDE     Product Characteristics Color    WHITE (WHITE)    Score    2 pieces Shape    ROUND (ROUND, DEBOSSED)    Size    6mm Flavor        Imprint Code    Y;25 Contains     Packaging #    Item Code    Package Description 1    NDC:69445-004-04    100 TABLET, COATED in 1 BOTTLE 2    NDC:69445-004-03    500 TABLET, COATED in 1 BOTTLE Marketing Information Marketing Category    Application Number or Monograph Citation    Marketing Start Date    Marketing End Date ANDA    ANDA208955    08/01/2020     METOPROLOL TARTRATE Metoprolol Tartrate Tablet, coated Product Information Product Type    HUMAN PRESCRIPTION DRUG LABEL    Item Code (Source)    NDC:69445-005 Route of Administration    ORAL    DEA Schedule     Active Ingredient/Active Moiety Ingredient Name    Basis of Strength    Strength METOPROLOL TARTRATE (METOPROLOL)    METOPROLOL TARTRATE    50 mg Inactive Ingredients Ingredient Name    Strength ANHYDROUS LACTOSE     SILICON DIOXIDE     CROSCARMELLOSE SODIUM     MAGNESIUM STEARATE     CELLULOSE, MICROCRYSTALLINE     POLYETHYLENE GLYCOL, UNSPECIFIED     POLYVINYL ALCOHOL     STARCH, CORN     SODIUM STARCH GLYCOLATE TYPE A CORN     TALC     TITANIUM DIOXIDE     FD&C RED NO. 40     Product Characteristics Color    PINK (PINK)    Score    2 pieces Shape    ROUND (ROUND, DEBOSSED)    Size    8mm Flavor        Imprint Code    Y;50 Contains     Packaging #    Item Code    Package Description 1    NDC:69445-005-04    100 TABLET, COATED in 1 BOTTLE 2    NDC:69445-005-05    1000 TABLET, COATED in 1 BOTTLE Marketing Information Marketing Category    Application Number or Monograph Citation    Marketing Start Date    Marketing End Date ANDA    ANDA208955    08/01/2020     METOPROLOL TARTRATE Metoprolol Tartrate Tablet, coated Product Information Product Type    HUMAN PRESCRIPTION DRUG LABEL    Item Code (Source)    NDC:69445-006 Route of Administration    ORAL    DEA Schedule     Active Ingredient/Active Moiety Ingredient Name    Basis of Strength    Strength METOPROLOL TARTRATE (METOPROLOL)    METOPROLOL TARTRATE    100 mg Inactive Ingredients Ingredient Name    Strength ANHYDROUS LACTOSE     SILICON DIOXIDE     CROSCARMELLOSE SODIUM     MAGNESIUM STEARATE     CELLULOSE, MICROCRYSTALLINE     POLYETHYLENE GLYCOL, UNSPECIFIED     POLYVINYL ALCOHOL     STARCH, CORN     SODIUM STARCH GLYCOLATE TYPE A CORN     TALC     TITANIUM DIOXIDE     FD&C BLUE NO. 1     FD&C BLUE NO. 2     Product Characteristics Color    BLUE (BLUE)    Score    2 pieces Shape    ROUND (ROUND, DEBOSSED)    Size    10mm Flavor        Imprint Code    Y;100 Contains     Packaging #    Item Code    Package Description 1    NDC:69445-006-04    100 TABLET, COATED in 1 BOTTLE 2    NDC:69445-006-05    1000 TABLET, COATED in 1 BOTTLE Marketing Information Marketing Category    Application Number or Monograph Citation    Marketing Start Date    Marketing End Date ANDA    ANDA208955    08/01/2020     Labeler - Youngtech Pharmaceuticals, Inc. (078622595) Registrant - Youngtech Pharmaceuticals, Inc. (078622595) Establishment Name    Address    ID/FEI    Operations Yabao Pharmaceutical Co. Ltd.        421252976    manufacture(69445-004, 69445-005, 69445-006) Establishment Name    Address    ID/FEI    Operations Zhejiang Yongtai Pharmaceutical Co., Ltd.        544302778    API MANUFACTURE(69445-004, 69445-005, 69445-006) Youngtech Pharmaceuticals, Inc.

DESCRIPTION Metoprolol tartrate USP is a selective beta1-adrenoreceptor blocking agent, available as 25 mg, 50 mg and 100 mg tablets for oral administration. Metoprolol tartrate USP is (±)-1-(isopropylamino)-3-[p-2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt. Its structural formula is: Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Each tablet for oral administration contains 25 mg, 50 mg or 100 mg of Metoprolol tartrate USP and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch (maize), sodium starch glycolate, talc and titanium dioxide. In addition, the 50 mg product contains FD&C Red No. 40 Aluminum Lake and the 100 mg product contains FD&C Blue No. 1 Aluminum Lake and FD&C Blue No. 2 Aluminum Lake as coloring agents. FDA approved dissolution method acceptance criterion differs from the USP dissolution method acceptance criterion. Metoprolol Tartrate Tablet - Clinical Pharmacology Mechanism of Action Metoprolol Tartrate Tablets USP is a beta1-selective (cardioselective) adrenergic receptor blocker. This preferential effect is not absolute, however, and at higher plasma concentrations, Metoprolol Tartrate Tablets USP also inhibits beta2-adrenoreceptors, chiefly located in the bronchial and vascular musculature. Clinical pharmacology studies have demonstrated the beta-blocking activity of metoprolol, as shown by (1) reduction in heart rate and cardiac output at rest and upon exercise, (2) reduction of systolic blood pressure upon exercise, (3) inhibition of isoproterenol-induced tachycardia, and (4) reduction of reflex orthostatic tachycardia. Hypertension The mechanism of the antihypertensive effects of beta-blocking agents has not been fully elucidated. However, several possible mechanisms have been proposed: (1) competitive antagonism of catecholamines at peripheral (especially cardiac) adrenergic neuron sites, leading to decreased cardiac output; (2) a central effect leading to reduced sympathetic outflow to the periphery; and (3) suppression of renin activity. Angina Pectoris By blocking catecholamine-induced increases in heart rate, in velocity and extent of myocardial contraction and in blood pressure, Metoprolol Tartrate Tablets USP reduces the oxygen requirements of the heart at any given level of effort, thus making it useful in the long-term management of angina pectoris. Myocardial Infarction The precise mechanism of action of Metoprolol Tartrate Tablets USP in patients with suspected or definite myocardial infarction is not known. Pharmacodynamics Relative beta1 selectivity is demonstrated by the following: (1) In healthy subjects, Metoprolol Tartrate Tablets USP is unable to reverse the beta2-mediated vasodilating effects of epinephrine. This contrasts with the effect of nonselective (beta1 plus beta2) beta-blockers, which completely reverse the vasodilating effects of epinephrine. (2) In asthmatic patients, Metoprolol Tartrate Tablets USP reduces FEV1 and FVC significantly less than a nonselective beta-blocker, propranolol, at equivalent beta1-receptor blocking doses. Metoprolol Tartrate Tablets USP has no intrinsic sympathomimetic activity, and membrane-stabilizing activity is detectable only at doses much greater than required for beta blockade. Animal and human experiments indicate that Metoprolol Tartrate Tablets USP slows the sinus rate and decreases AV nodal conduction. Significant beta-blocking effect (as measured by reduction of exercise heart rate) occurs within one hour after oral administration, and its duration is dose-related. For example, a 50% reduction of the maximum effect after single oral doses of 20 mg, 50 mg and 100 mg occurred at 3.3 hours, 5.0 hours and 6.4 hours, respectively, in normal subjects. After repeated oral dosages of 100 mg twice daily, a significant reduction in exercise systolic blood pressure was evident at 12 hours. When the drug was infused over a 10-minute period, in normal volunteers, maximum beta blockade was achieved at approximately 20 minutes. Equivalent maximal beta-blocking effect is achieved with oral and intravenous doses in the ratio of approximately 2.5:1. There is a linear relationship between the log of plasma levels and reduction of exercise heart rate. However, antihypertensive activity does not appear to be related to plasma levels. Because of variable plasma levels attained with a given dose and lack of a consistent relationship of antihypertensive activity to dose, selection of proper dosage requires individual titration. In several studies of patients with acute myocardial infarction, intravenous followed by oral administration of Metoprolol Tartrate Tablets USP caused a reduction in heart rate, systolic blood pressure and cardiac output. Stroke volume, diastolic blood pressure and pulmonary artery end diastolic pressure remained unchanged. In patients with angina pectoris, plasma concentration measured at one hour is linearly related to the oral dose within the range of 50 mg to 400 mg. Exercise heart rate and systolic blood pressure are reduced in relation to the logarithm of the oral dose of metoprolol. The increase in exercise capacity and the reduction in left ventricular ischemia are also significantly related to the logarithm of the oral dose. Pharmacokinetics Absorption The estimated oral bioavailability of immediate-release metoprolol is about 50% be- cause of pre-systemic metabolism which is saturable leading to non-proportionate increase in the exposure with increased dose. Distribution Metoprolol is extensively distributed with a reported volume of distribution of 3.2 to 5.6 L/kg. About 10% of metoprolol in plasma is bound to serum albumin. Metoprolol is known to cross the placenta and is found in breast milk. Metoprolol is also known to cross the blood brain barrier following oral administration and CSF concentrations close to that observed in plasma have been reported. Metoprolol is not a significant P-glycoprotein substrate. Metabolism Metoprolol Tartrate Tablets USP is primarily metabolized by CYP2D6. Metoprolol is a racemic mixture of R- and S-enantiomers, and when administered orally, it exhibits stereoselective metabolism that is dependent on oxidation phenotype. CYP2D6 is absent (poor metabolizers) in about 8% of Caucasians and about 2% of most other populations. Poor CYP2D6 metabolizers exhibit several-fold higher plasma concentrations of Metoprolol Tartrate Tablets USP than extensive metabolizers with normal CYP2D6 activity thereby decreasing Metoprolol Tartrate Tablets USP’s cardioselectivity. Elimination Elimination of Metoprolol Tartrate Tablets USP is mainly by biotransformation in the liver. The mean elimination half-life of metoprolol is 3 to 4 hours; in poor CYP2D6 metabolizers the half-life may be 7 to 9 hours. Approximately 95% of the dose can be recovered in urine. In most subjects (extensive metabolizers), less than 5% of an oral dose and less than 10% of an intravenous dose are excreted as unchanged drug in the urine. In poor metabolizers, up to 30% or 40% of oral or intravenous doses, respectively, may be excreted unchanged; the rest is excreted by the kidneys as metabolites that appear to have no beta blocking activity. The renal clearance of the stereoisomers does not exhibit stereo-selectivity in renal excretion. Special Populations Geriatric Patients The geriatric population may show slightly higher plasma concentrations of metoprolol as a combined result of a decreased metabolism of the drug in elderly population and a decreased hepatic blood flow. However, this increase is not clinically significant or therapeutically relevant. Renal Impairment The systemic availability and half-life of Metoprolol Tartrate Tablets USP in patients with renal failure do not differ to a clinically significant degree from those in normal subjects. Hepatic Impairment Since the drug is primarily eliminated by hepatic metabolism, hepatic impairment may impact the pharmacokinetics of metoprolol. The elimination half-life of metoprolol is considerably prolonged, depending on severity (up to 7.2 h). Clinical Studies Hypertension In controlled clinical studies, Metoprolol Tartrate Tablets USP has been shown to be an effective antihypertensive agent when used alone or as concomitant therapy with thiazide-type diuretics, at dosages of 100 mg to 450 mg daily. In controlled, comparative, clinical studies, Metoprolol Tartrate Tablets USP has been shown to be as effective an antihypertensive agent as propranolol, methyldopa and thiazide-type diuretics, to be equally effective in supine and standing positions. Angina Pectoris In controlled clinical trials, Metoprolol Tartrate Tablets USP, administered two or four times daily, has been shown to be an effective antianginal agent, reducing the number of angina attacks and increasing exercise tolerance. The dosage used in these studies ranged from 100 mg to 400 mg daily. A controlled, comparative, clinical trial showed that Metoprolol Tartrate Tablets USP was indistinguishable from propranolol in the treatment of angina pectoris. Myocardial Infarction In a large (1,395 patients randomized), double-blind, placebo-controlled clinical study, Metoprolol Tartrate Tablets USP was shown to reduce 3-month mortality by 36% in patients with suspected or definite myocardial infarction. Patients were randomized and treated as soon as possible after their arrival in the hospital, once their clinical condition had stabilized and their hemodynamic status had been carefully evaluated. Subjects were ineligible if they had hypotension, bradycardia, peripheral signs of shock and/or more than minimal basal rales as signs of congestive heart failure. Initial treatment consisted of intravenous followed by oral administration of Metoprolol Tartrate Tablets USP or placebo, given in a coronary care or comparable unit. Oral maintenance therapy with Metoprolol Tartrate Tablets USP or placebo was then continued for 3 months. After this double-blind period, all patients were given Metoprolol Tartrate Tablets USP and followed up to one year. The median delay from the onset of symptoms to the initiation of therapy was 8 hours in both the Metoprolol Tartrate Tablets USP and placebo treatment groups. Among patients treated with Metoprolol Tartrate Tablets USP, there were comparable reductions in 3-month mortality for those treated early (no more than 8 hours) and those in whom treatment was started later. Significant reductions in the incidence of ventricular fibrillation and in chest pain following initial intravenous therapy were also observed with Metoprolol Tartrate Tablets USP and were independent of the interval between onset of symptoms and initiation of therapy. In this study, patients treated with metoprolol received the drug both very early (intra-venously) and during a subsequent 3-month period, while placebo patients received no beta-blocker treatment for this period. The study thus was able to show a benefit from the overall metoprolol regimen but cannot separate the benefit of very early intravenous treatment from the benefit of later beta-blocker therapy. Nonetheless, because the overall regimen showed a clear beneficial effect on survival without evidence of an early adverse effect on survival, one acceptable dosage regimen is the precise regimen used in the trial. Because the specific benefit of very early treatment remains to be defined, however, it is also reasonable to administer the drug orally to patients at a later time as is recommended for certain other beta-blockers. Indications and Usage for Metoprolol Tartrate Tablet Hypertension Metoprolol Tartrate Tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris Metoprolol Tartrate Tablets USP are indicated in the long-term treatment of angina pectoris. Myocardial Infarction Metoprolol Tartrate Tablets USP are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous Metoprolol Tartrate Tablets USP. Oral Metoprolol Tartrate Tablets USP therapy can be initiated after intravenous Metoprolol Tartrate Tablets USP therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (seeDOSAGE AND ADMINISTRATION ,CONTRAINDICATIONS and WARNINGS). Contraindications Hypertension and Angina Metoprolol Tartrate Tablets USP are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see WARNINGS). Hypersensitivity to Metoprolol Tartrate Tablets USP and related derivatives, or to any of the excipients; hypersensitivity to other beta-blockers (cross-sensitivity between beta blockers can occur). Sick-sinus syndrome. Severe peripheral arterial circulatory disorders. Myocardial Infarction Metoprolol Tartrate Tablets USP is contraindicated in patients with a heart rate of less than 45 beats/min; second- and third-degree heart block; significant first-degree heart block (P-R interval no less than 0.24 sec); systolic blood pressure less than 100 mmHg; or moderate to severe cardiac failure (see WARNINGS). Warnings Heart Failure Beta blockers, like Metoprolol Tartrate Tablets USP, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock. If signs or symptoms of heart failure develop, treat the patient according to recommended guidelines. It may be necessary to lower the dose of Metoprolol Tartrate Tablets USP or to discontinue it. Ischemic Heart Disease Do not abruptly discontinue Metoprolol Tartrate Tablets USP therapy in patients with coronary artery disease. Severe exacerbation of angina, myocardial infarction and ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of therapy with beta-blockers. When discontinuing chronically administered Metoprolol Tartrate Tablets USP, particularly in patients with coronary artery disease, the dosage should be gradually reduced over a period of 1 to 2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, Metoprolol Tartrate Tablets USP administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician’s advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue Metoprolol Tartrate Tablets USP therapy abruptly even in patients treated only for hypertension. Use During Major Surgery Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. Bradycardia Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of Metoprolol Tartrate Tablets USP. Patients with first-degree atrioventricular block, sinus node dysfunction or conduction disorders may be at increased risk. Monitor heart rate and rhythm in patients receiving Metoprolol Tartrate Tablets USP. If severe bradycardia develops, reduce or stop Metoprolol Tartrate Tablets USP. Exacerbation of Bronchospastic Disease Patients with bronchospastic disease, should, in general, not receive beta-blockers, including Metoprolol Tartrate Tablets USP. Because of its relative beta1 selectivity, however, Metoprolol Tartrate Tablets USP may be used in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment. Because beta1 selectivity is not absolute use the lowest possible dose of Metoprolol Tartrate Tablets USP and consider administering Metoprolol Tartrate Tablets USP in smaller doses 3 times daily, instead of larger doses two times daily, to avoid the higher plasma levels associated with the longer dosing interval (see DOSAGE AND ADMINISTRATION). Bronchodilators, including beta2 agonists, should be readily available or administered concomitantly. Diabetes and Hypoglycemia Beta-blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected. Pheochromocytoma If Metoprolol Tartrate Tablets USP is used in the setting of pheochromocytoma, it should be given in combination with an alpha blocker, and only after the alpha blocker has been initiated. Administration of beta blockers alone in the setting of pheochromocytoma has been associated with a paradoxical increase in blood pressure due to the attenuation of beta-mediated vasodilatation in skeletal muscle. Thyrotoxicosis Metoprolol Tartrate Tablets USP may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Avoid abrupt withdrawal of beta-blockade, which might precipitate a thyroid storm. Precautions Risk of Anaphylactic Reactions While taking beta blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction. Information for Patients Advise patients to take Metoprolol Tartrate Tablets USP regularly and continuously, as directed, with or immediately following meals. If a dose should be missed, the patient should take only the next scheduled dose (without doubling it). Patients should not discontinue Metoprolol Tartrate Tablets USP without consulting the physician. Advise patients (1) to avoid operating automobiles and machinery or engaging in other tasks requiring alertness until the patient’s response to therapy with Metoprolol Tartrate Tablets USP have been determined; (2) to contact the physician if any difficulty in breathing occurs; (3) to inform the physician or dentist before any type of surgery that he or she is taking Metoprolol Tartrate Tablets USP. Drug Interactions Catecholamine-Depleting Drugs Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents or monoamine oxidase (MAO) inhibitors. Observe patients treated with Metoprolol Tartrate Tablets USP plus a catecholamine depletor for evidence of hypotension or marked bradycardia, which may produce vertigo, syncope, or postural hypotension. In addition, possibly significant hypertension may theoretically occur up to 14 days following discontinuation of the concomitant administration with an irreversible MAO inhibitor. Digitalis Glycosides and Beta-Blockers Both digitalis glycosides and beta blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Monitor heart rate and PR interval. Calcium Channel Blockers Concomitant administration of a beta-adrenergic antagonist with a calcium channel blocker may produce an additive reduction in myocardial contractility because of negative chronotropic and inotropic effects. CYP2D6 Inhibitors Potent inhibitors of the CYP2D6 enzyme may increase the plasma concentration of Metoprolol Tartrate Tablets USP which would mimic the pharmacokinetics of CYP2D6 poor metabolizer (see PHARMACOKINETICS section). Increase in plasma concentrations of metoprolol would decrease the cardioselectivity of metoprolol. Known clinically significant potent inhibitors of CYP2D6 are antidepressants such as fluvoxamine, fluoxetine, paroxetine, sertraline, bupropion, clomipramine and desipramine; antipsychotics such as chlorpromazine, fluphenazine, haloperidol and thioridazine; antiarrhythmics such as quinidine or propafenone; antiretrovirals such as ritonavir; antihistamines such as diphenhydramine; antimalarials such as hydroxychloroquine or quinidine; antifungals such as terbinafine. Hydralazine Concomitant administration of hydralazine may inhibit presystemic metabolism of metoprolol leading to increased concentrations of metoprolol. Alpha-Adrenergic Agents Antihypertensive effect of alpha-adrenergic blockers such as guanethidine, betanidine, reserpine, alpha-methyldopa or clonidine may be potentiated by beta-blockers including Metoprolol Tartrate Tablets USP. Beta-adrenergic blockers may also potentiate the postural hypotensive effect of the first dose of prazosin, probably by preventing reflex tachycardia. On the contrary, beta adrenergic blockers may also potentiate the hypertensive response to withdrawal of clonidine in patients receiving concomitant clonidine and beta-adrenergic blocker. If a patient is treated with clonidine and Metoprolol Tartrate Tablets USP concurrently, and clonidine treatment is to be discontinued, stop Metoprolol Tartrate Tablets USP several days before clonidine is withdrawn. Rebound hypertension that can follow withdrawal of clonidine may be increased in patients receiving concurrent beta-blocker treatment. Ergot Alkaloid Concomitant administration with beta-blockers may enhance the vasoconstrictive action of ergot alkaloids. Dipyridamole In general, administration of a beta-blocker should be withheld before dipyridamole testing, with careful monitoring of heart rate following the dipyridamole injection. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have been conducted to evaluate carcinogenic potential. In a 2-year study in rats at three oral dosage levels of up to 800 mg/kg per day, there was no increase in the development of spontaneously occurring benign or malignant neoplasms of any type. The only histologic changes that appeared to be drug related were an increased incidence of generally mild focal accumulation of foamy macrophages in pulmonary alveoli and a slight increase in biliary hyperplasia. In a 21-month study in Swiss albino mice at three oral dosage levels of up to 750 mg/kg per day, benign lung tumors (small adenomas) occurred more frequently in female mice receiving the highest dose than in untreated control animals. There was no increase in malignant or total (benign plus malignant) lung tumors, or in the overall incidence of tumors or malignant tumors. This 21-month study was repeated in CD-1 mice, and no statistically or biologically significant differences were observed between treated and control mice of either sex for any type of tumor. All mutagenicity tests performed (a dominant lethal study in mice, chromosome studies in somatic cells, a Salmonella/mammalian-microsome mutagenicity test, and a nucleus anomaly test in somatic interphase nuclei) were negative. Reproduction toxicity studies in mice, rats and rabbits did not indicate teratogenic potential for metoprolol tartrate. Embryotoxicity and/or fetotoxicity in rats and rabbits were noted starting at doses of 50 mg/kg in rats and 25 mg/kg in rabbits, as demonstrated by increases in preimplantation loss, decreases in the number of viable fetuses per dose, and/or decreases in neonatal survival. High doses were associated with some maternal toxicity, and growth delay of the offspring in utero, which was reflected in minimally lower weights at birth. The oral NOAELs for embryo-fetal development in mice, rats and rabbits were considered to be 25, 200, and 12.5 mg/kg. This corresponds to dose levels that are approximately 0.3 times, 4 times, and 0.5 times, respectively, when based on surface area, the maximum human oral dose (8 mg/kg/day) of metoprolol tartrate. Metoprolol tartrate has been associated with reversible adverse effects on spermatogenesis starting at oral dose levels of 3.5 mg/kg in rats (a dose that is only 0.1 times the human dose, when based on surface area), although other studies have shown no effect of metoprolol tartrate on reproductive performance in male rats. Pregnancy Category C Upon confirming the diagnosis of pregnancy, women should immediately inform the doctor. Metoprolol Tartrate Tablets USP has been shown to increase postimplantation loss and decrease neonatal survival in rats at doses up to 11 times the maximum daily human dose of 450 mg, when based on surface area. Distribution studies in mice confirm exposure of the fetus when Metoprolol Tartrate Tablets USP is administered to the pregnant animal. These limited animal studies do not indicate direct or indirect harmful effects with respect to teratogenicity (see CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY). There are no adequate and well-controlled studies in pregnant women. The amount of data on the use of metoprolol in pregnant women is limited. The risk to the fetus/ mother is unknown. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers Metoprolol Tartrate Tablets USP is excreted in breast milk in a very small quantity. An infant consuming 1 liter of breast milk daily would receive a dose of less than 1 mg of the drug. Fertility The effects of Metoprolol Tartrate Tablets USP on the fertility of human have not been studied. Metoprolol Tartrate Tablets USP showed effects on spermatogenesis in male rats at a therapeutic dose level, but had no effect on rates of conception at higher doses in animal fertility studies (see CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY). Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical trials of Metoprolol Tartrate Tablets USP in hypertension did not include sufficient numbers of elderly patients to determine whether patients over 65 years of age differ from younger subjects in their response to Metoprolol Tartrate Tablets USP. Other reported clinical experience in elderly hypertensive patients has not identified any difference in response from younger patients. In worldwide clinical trials of Metoprolol Tartrate Tablets USP in myocardial infarction, where approximately 478 patients were over 65 years of age (0 over 75 years of age), no age-related differences in safety and effectiveness were found. Other reported clinical experience in myocardial infarction has not identified differences in response between the elderly and younger patients. However, greater sensitivity of some elderly individuals taking Metoprolol Tartrate Tablets USP cannot be categorically ruled out. Therefore, in general, it is recommended that dosing proceed with caution in this population. Adverse Reactions Hypertension and Angina Most adverse effects have been mild and transient. Central Nervous System Tiredness and dizziness have occurred in about 10 of 100 patients. Depression has been reported in about 5 of 100 patients. Mental confusion and short-term memory loss have been reported. Headache, nightmares, and insomnia have also been reported. Cardiovascular Shortness of breath and bradycardia have occurred in approximately 3 of 100 patients. Cold extremities; arterial insufficiency, usually of the Raynaud type; palpitations; congestive heart failure; peripheral edema; and hypotension have been reported in about 1 of 100 patients. Gangrene in patients with preexisting severe peripheral circulatory disorders has also been reported very rarely (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS). Respiratory Wheezing (bronchospasm) and dyspnea have been reported in about 1 of 100 patients (see WARNINGS). Rhinitis has also been reported. Gastrointestinal Diarrhea has occurred in about 5 of 100 patients. Nausea, dry mouth, gastric pain, constipation, flatulence, and heartburn have been reported in about 1 of 100 patients. Vomiting was a common occurrence. Post-marketing experience reveals very rare reports of hepatitis, jaundice and nonspecific hepatic dysfunction. Isolated cases of transaminase, alkaline phosphatase, and lactic dehydrogenase elevations have also been reported. Hypersensitive Reactions Pruritus or rash have occurred in about 5 of 100 patients. Very rarely, photosensitivity and worsening of psoriasis has been reported. Miscellaneous Peyronie’s disease has been reported in fewer than 1 of 100,000 patients. Musculoskeletal pain, blurred vision, and tinnitus have also been reported. There have been rare reports of reversible alopecia, agranulocytosis, and dry eyes. Discontinuation of the drug should be considered if any such reaction is not otherwise explicable. There have been very rare reports of weight gain, arthritis, and retroperitoneal fibrosis (relationship to Metoprolol Tartrate Tablets USP has not been definitely established). The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with Metoprolol Tartrate Tablets USP. Myocardial Infarction Central Nervous System Tiredness has been reported in about 1 of 100 patients. Vertigo, sleep disturbances, hallucinations, headache, dizziness, visual disturbances, confusion, and reduced libido have also been reported, but a drug relationship is not clear. Cardiovascular In the randomized comparison of Metoprolol Tartrate Tablets USP and placebo described in the CLINICAL PHARMACOLOGY section, the following adverse reactions were reported: Metoprolol Tartrate Tablets, USP    Placebo Hypotension (systolic BP of less than 90 mmHg)    27.4%    23.2% Bradycardia (heart rate of less than 40 beats/min)    15.9%    6.7% Second- or third-degree heart block    4.7%    4.7% First-degree heart block (P-R of no less than 0.26 sec)    5.3%    1.9% Heart failure    27.5%    29.6% Respiratory Dyspnea of pulmonary origin has been reported in fewer than 1 of 100 patients Gastrointestinal Nausea and abdominal pain have been reported in fewer than 1 of 100 patients. Dermatologic Rash and worsened psoriasis have been reported, but a drug relationship is not clear. Miscellaneous Unstable diabetes and claudication have been reported, but a drug relationship is not clear. Potential Adverse Reactions A variety of adverse reactions not listed above have been reported with other beta-adrenergic blocking agents and should be considered potential adverse reactions to Metoprolol Tartrate Tablets USP. Central Nervous System Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emo- tional lability, slightly clouded sensorium, and decreased performance on neuropsy- chometrics. Cardiovascular Intensification of AV block (see CONTRAINDICATIONS). Hematologic Agranulocytosis, nonthrombocytopenic purpura and thrombocytopenic purpura. Hypersensitive Reactions Fever combined with aching and sore throat, laryngospasm and respiratory distress. Post-Marketing Experience The following adverse reactions have been reported during post-approval use of Metoprolol Tartrate Tablets USP: confusional state, an increase in blood triglycerides and a decrease in High Density Lipoprotein (HDL). Because these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency. Overdosage Acute Toxicity Several cases of overdosage have been reported, some leading to death. Oral LD50’s (mg/kg): mice, 1,158 to 2,460; rats, 3,090 to 4,670. Signs and Symptoms Potential signs and symptoms associated with overdosage with Metoprolol Tartrate Tablets USP are bradycardia, hypotension, bronchospasm, myocardial infarction, cardiac failure and death. Management There is no specific antidote. In general, patients with acute or recent myocardial infarction may be more hemodynamically unstable than other patients and should be treated accordingly (see WARNINGS, MYOCARDIAL INFARCTION). On the basis of the pharmacologic actions of Metoprolol Tartrate Tablets USP, the following general measures should be employed: Elimination of the Drug Gastric lavage should be performed. Other clinical manifestations of overdose should be managed symptomatically based on modern methods of intensive care. Hypotension Administer a vasopressor, e.g., levarterenol or dopamine. Bronchospasm Administer a beta2-stimulating agent and/or a theophylline derivative. Cardiac Failure Administer digitalis glycoside and diuretic. In shock resulting from inadequate cardiac contractility, consider administration of dobutamine, isoproterenol or glucagon. Metoprolol Tartrate Tablet Dosage and Administration Hypertension Individualize the dosage of Metoprolol Tartrate Tablets USP. Metoprolol Tartrate Tablets USP should be taken with or immediately following meals. The usual initial dosage of Metoprolol Tartrate Tablets USP is 100 mg daily in single or divided doses, whether used alone or added to a diuretic. Increase the dosage at weekly (or longer) intervals until optimum blood pressure reduction is achieved. In general, the maximum effect of any given dosage level will be apparent after one week of therapy. The effective dosage range of Metoprolol Tartrate Tablets USP is 100 mg to 450 mg per day. Dosages above 450 mg per day have not been studied. While once-daily dosing is effective and can maintain a reduction in blood pressure throughout the day, lower doses (especially 100 mg) may not maintain a full effect at the end of the 24-hour period, and larger or more frequent daily doses may be required. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. Beta1 selectivity diminishes as the dose of Metoprolol Tartrate Tablets USP is increased. Angina Pectoris The dosage of Metoprolol Tartrate Tablets USP should be individualized. Metoprolol Tartrate Tablets USP should be taken with or immediately following meals. The usual initial dosage of Metoprolol Tartrate Tablets USP is 100 mg daily, given in two divided doses. Gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is pronounced slowing of the heart rate. The effective dosage range of Metoprolol Tartrate Tablets USP is 100 mg to 400 mg per day. Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, gradually decrease the dosage over a period of 1 to 2 weeks (see WARNINGS). Myocardial Infarction Early Treatment During the early phase of definite or suspected acute myocardial infarction, initiate treatment with Metoprolol Tartrate Tablets USP as soon as possible after the patient’s arrival in the hospital. Such treatment should be initiated in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized. Begin treatment in this early phase with the intravenous administration of three bolus injections of 5 mg of Metoprolol Tartrate Tablets USP each; give the injections at approximately 2-minute intervals. During the intravenous administration of Metoprolol Tartrate Tablets USP, monitor blood pressure, heart rate, and electrocardiogram. In patients who tolerate the full intravenous dose (15 mg), initiate Metoprolol Tartrate Tablets USP, 50 mg every 6 hours, 15 minutes after the last intravenous dose and continue for 48 hours. Thereafter, the maintenance dosage is 100 mg twice daily (see LATE TREATMENT below). Start patients who appear not to tolerate the full intravenous dose on Metoprolol Tartrate Tablets USP either 25 mg or 50 mg every 6 hours (depending on the degree of intolerance) 15 minutes after the last intravenous dose or as soon as their clinical condition allows. In patients with severe intolerance, discontinue Metoprolol Tartrate Tablets USP (see WARNINGS). Late Treatment Start patients with contraindications to treatment during the early phase of suspected or definite myocardial infarction, patients who appear not to tolerate the full early treatment, and patients in whom the physician wishes to delay therapy for any other reason on Metoprolol Tartrate Tablets USP, 100 mg twice daily, as soon as their clinical condition allows. Continue therapy for at least 3 months. Although the efficacy of Metoprolol Tartrate Tablets USP beyond 3 months has not been conclusively established, data from studies with other beta-blockers suggest that treatment should be continued for 1 to 3 years. Special Populations Pediatric Patients No pediatric studies have been performed. The safety and efficacy of Metoprolol Tartrate Tablets USP in pediatric patients have not been established. Renal Impairment No dose adjustment of Metoprolol Tartrate Tablets USP is required in patients with renal impairment. Hepatic Impairment Metoprolol Tartrate Tablets USP blood levels are likely to increase substantially in patients with hepatic impairment. Therefore, Metoprolol Tartrate Tablets USP should be initiated at low doses with cautious gradual dose titration according to clinical response. Geriatric Patients (greater than 65 Years) In general, use a low initial starting dose in elderly patients given their greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Method of Administration For oral treatment, the tablets should be swallowed unchewed with a glass of water. Metoprolol Tartrate Tablets USP should always be taken in standardized relation with meals. If the physician asks the patient to take Metoprolol Tartrate Tablets USP either before breakfast or with breakfast, then the patient should continue taking Metoprolol Tartrate Tablets USP with the same schedule during the course of therapy. How is Metoprolol Tartrate Tablet Supplied Metoprolol Tartrate Tablets, USP are available containing 25 mg, 50 mg or 100 mg of metoprolol tartrate USP. The 25 mg tablets are white film-coated, round, scored tablets debossed with Y over 25 on one side of the tablet and scored on the other side. They are available as follows: NDC 69445-004-04 bottles of 100 tablets NDC 69445-004-03 bottles of 500 tablets The 50 mg tablets are pink film-coated, round, scored tablets debossed with Y over 50 on one side of the tablet and scored on the other side. They are available as follows: NDC 69445-005-04 bottles of 100 tablets NDC 69445-005-05 bottles of 1,000 tablets The 100 mg tablets are light blue film-coated, round, scored tablets debossed with Y over 100 on one side of the tablet and scored on the other side. They are available as follows: NDC 69445-006-04 bottles of 100 tablets NDC 69445-006-05 bottles of 1,000 tablets Store at 20° to 25°C (68° to 77°F), excursions permitted to 15- 30°C (59- 86°F). [See USP Controlled Room Temperature.] Protect from moisture and heat. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Yabao Pharmaceutical Co., Ltd. Beijing 101111, China For: YoungTech Pharmaceuticals, Inc. Cranbury, NJ 08512, USA Rev: Nov 2019 METOPROLOL TARTRATE Metoprolol Tartrate Tablet, coated Product Information Product Type    HUMAN PRESCRIPTION DRUG LABEL    Item Code (Source)    NDC:69445-004 Route of Administration    ORAL    DEA Schedule     Active Ingredient/Active Moiety Ingredient Name    Basis of Strength    Strength METOPROLOL TARTRATE (METOPROLOL)    METOPROLOL TARTRATE    25 mg Inactive Ingredients Ingredient Name    Strength ANHYDROUS LACTOSE     SILICON DIOXIDE     CROSCARMELLOSE SODIUM     MAGNESIUM STEARATE     CELLULOSE, MICROCRYSTALLINE     POLYETHYLENE GLYCOL, UNSPECIFIED     POLYVINYL ALCOHOL     STARCH, CORN     SODIUM STARCH GLYCOLATE TYPE A CORN     TALC     TITANIUM DIOXIDE     Product Characteristics Color    WHITE (WHITE)    Score    2 pieces Shape    ROUND (ROUND, DEBOSSED)    Size    6mm Flavor        Imprint Code    Y;25 Contains     Packaging #    Item Code    Package Description 1    NDC:69445-004-04    100 TABLET, COATED in 1 BOTTLE 2    NDC:69445-004-03    500 TABLET, COATED in 1 BOTTLE Marketing Information Marketing Category    Application Number or Monograph Citation    Marketing Start Date    Marketing End Date ANDA    ANDA208955    08/01/2020     METOPROLOL TARTRATE Metoprolol Tartrate Tablet, coated Product Information Product Type    HUMAN PRESCRIPTION DRUG LABEL    Item Code (Source)    NDC:69445-005 Route of Administration    ORAL    DEA Schedule     Active Ingredient/Active Moiety Ingredient Name    Basis of Strength    Strength METOPROLOL TARTRATE (METOPROLOL)    METOPROLOL TARTRATE    50 mg Inactive Ingredients Ingredient Name    Strength ANHYDROUS LACTOSE     SILICON DIOXIDE     CROSCARMELLOSE SODIUM     MAGNESIUM STEARATE     CELLULOSE, MICROCRYSTALLINE     POLYETHYLENE GLYCOL, UNSPECIFIED     POLYVINYL ALCOHOL     STARCH, CORN     SODIUM STARCH GLYCOLATE TYPE A CORN     TALC     TITANIUM DIOXIDE     FD&C RED NO. 40     Product Characteristics Color    PINK (PINK)    Score    2 pieces Shape    ROUND (ROUND, DEBOSSED)    Size    8mm Flavor        Imprint Code    Y;50 Contains     Packaging #    Item Code    Package Description 1    NDC:69445-005-04    100 TABLET, COATED in 1 BOTTLE 2    NDC:69445-005-05    1000 TABLET, COATED in 1 BOTTLE Marketing Information Marketing Category    Application Number or Monograph Citation    Marketing Start Date    Marketing End Date ANDA    ANDA208955    08/01/2020     METOPROLOL TARTRATE Metoprolol Tartrate Tablet, coated Product Information Product Type    HUMAN PRESCRIPTION DRUG LABEL    Item Code (Source)    NDC:69445-006 Route of Administration    ORAL    DEA Schedule     Active Ingredient/Active Moiety Ingredient Name    Basis of Strength    Strength METOPROLOL TARTRATE (METOPROLOL)    METOPROLOL TARTRATE    100 mg Inactive Ingredients Ingredient Name    Strength ANHYDROUS LACTOSE     SILICON DIOXIDE     CROSCARMELLOSE SODIUM     MAGNESIUM STEARATE     CELLULOSE, MICROCRYSTALLINE     POLYETHYLENE GLYCOL, UNSPECIFIED     POLYVINYL ALCOHOL     STARCH, CORN     SODIUM STARCH GLYCOLATE TYPE A CORN     TALC     TITANIUM DIOXIDE     FD&C BLUE NO. 1     FD&C BLUE NO. 2     Product Characteristics Color    BLUE (BLUE)    Score    2 pieces Shape    ROUND (ROUND, DEBOSSED)    Size    10mm Flavor        Imprint Code    Y;100 Contains     Packaging #    Item Code    Package Description 1    NDC:69445-006-04    100 TABLET, COATED in 1 BOTTLE 2    NDC:69445-006-05    1000 TABLET, COATED in 1 BOTTLE Marketing Information Marketing Category    Application Number or Monograph Citation    Marketing Start Date    Marketing End Date ANDA    ANDA208955    08/01/2020     Labeler - Youngtech Pharmaceuticals, Inc. (078622595) Registrant - Youngtech Pharmaceuticals, Inc. (078622595) Establishment Name    Address    ID/FEI    Operations Yabao Pharmaceutical Co. Ltd.        421252976    manufacture(69445-004, 69445-005, 69445-006) Establishment Name    Address    ID/FEI    Operations Zhejiang Yongtai Pharmaceutical Co., Ltd.        544302778    API MANUFACTURE(69445-004, 69445-005, 69445-006) Youngtech Pharmaceuticals, Inc.

What is hydrochlorothiazide and metoprolol? Hydrochlorothiazide is a thiazide diuretic (water pill). Metoprolol is a beta-blocker. Hydrochlorothiazide and metoprolol is a combination medicine used to treat high blood pressure (hypertension). Hydrochlorothiazide and metoprolol may also be used for purposes not listed in this medication guide. Warnings You should not use hydrochlorothiazide and metoprolol if you have a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker), slow heartbeats that have caused you to faint, or if your heart cannot pump blood properly. You should not use hydrochlorothiazide and metoprolol if you are unable to urinate. Do not stop using this medicine suddenly, even if you feel fine. Stopping suddenly may cause serious or life-threatening heart problems. Follow your doctor's instructions about tapering your dose. Before taking this medicine You should not use this medicine if you are allergic to hydrochlorothiazide or metoprolol, or if you have: a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker), or if your heart cannot pump blood properly; slow heartbeats that have caused you to faint; severe or uncontrolled heart failure; an allergy to sulfa drugs; or if you are unable to urinate. Tell your doctor if you have ever had: congestive heart failure; slow heartbeats; blood circulation problems; asthma or other breathing disorder; peripheral vascular disease such as Raynaud's syndrome; diabetes; a thyroid disorder; kidney disease (or if you are on dialysis); pheochromocytoma (tumor of the adrenal gland); glaucoma; lupus; gout; or high cholesterol or triglycerides. Tell your doctor if you are pregnant or breastfeeding. Hydrochlorothiazide and metoprolol is not approved for use by anyone younger than 18 years old. How should I take hydrochlorothiazide and metoprolol? Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed. You may take hydrochlorothiazide and metoprolol with or without food. Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, or heavy sweating. Call your doctor if you are sick with vomiting or diarrhea. Your blood pressure will need to be checked often. You may also need frequent blood tests. If you are diabetic, check your blood sugar carefully. Taking hydrochlorothiazide and metoprolol can make it harder for you to tell when you have low blood sugar. Do not change your medication dose or schedule without your doctor's advice. If you need surgery, tell the surgeon ahead of time that you are using hydrochlorothiazide and metoprolol. Keep using hydrochlorothiazide and metoprolol as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life. Do not stop using hydrochlorothiazide and metoprolol suddenly, even if you feel fine. Stopping suddenly may cause serious or life-threatening heart problems. Follow your doctor's instructions about tapering your dose. Store at room temperature away from moisture and heat. What happens if I miss a dose? Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include fast or slow heart rate, trouble breathing, or fainting. What should I avoid while taking hydrochlorothiazide and metoprolol? Avoid driving or hazardous activity until you know how hydrochlorothiazide and metoprolol will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Drinking alcohol with this medicine can cause side effects. Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough. Hydrochlorothiazide may increase your risk of skin cancer. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Your doctor may want you to have skin examinations on a regular basis. Hydrochlorothiazide and metoprolol side effects Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: bronchospasm (wheezing, chest tightness, trouble breathing); slow heart rate, weak pulse, fainting, slow breathing (breathing may stop); blurred vision, tunnel vision, eye pain, or seeing halos around lights; low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or low sodium level --headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady. Common side effects may include: tired feeling; or stuffy nose, sore throat. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.  

What is metronidazole? Metronidazole is an antibiotic that is used to treat bacterial infections of the vagina, stomach, liver, skin, joints, brain and spinal cord, lungs, heart, or bloodstream. Metronidazole is also used to treat trichomoniasis, a sexually transmitted disease caused by a parasite. Usually both sexual partners are treated at the same time, even if one has no symptoms. Do not use metronidazole to treat any condition that has not been checked by your doctor. Warnings You should not use metronidazole if you recently drank alcohol, or have taken disulfiram (Antabuse) within the past 2 weeks. Do not drink alcohol or consume foods or medicines that contain propylene glycol while you are taking metronidazole and for at least 3 days after you stop taking it. Seizures and other nervous system abnormalities have been reported in patients treated with metronidazole. You should stop using this medicine immediately if you experience any neurological symptoms such as seizures, headaches, visual changes, weakness, numbness, or tingling. This medicine will not treat a viral infection such as the common cold or flu. In animal studies (mice and rats), this medicine caused certain types of cancers or tumors. It is not known whether these effects would occur in people using this medicine. Ask your doctor about your risk Before taking this medicine You should not use this medicine if you are allergic to metronidazole, secnidazole, or tinidazole, or if: you drank alcohol in the past 3 days; you consumed foods or medicines that contain propylene glycol in the past 3 days; or you took disulfiram (Antabuse) within the past 14 days. May harm an unborn baby. Do not use metronidazole to treat trichomoniasis during the first trimester of pregnancy. Tell your doctor if you become pregnant. Not all uses of metronidazole are approved for treating children and teenagers. Metronidazole is not approved to treat vaginal infections in girls who have not begun having menstrual periods. To make sure you can safely take this medicine, tell your doctor if you have ever had: liver disease; kidney disease (or if you are on dialysis); a heart rhythm disorder; a stomach or intestinal disease such as Crohn's disease; a blood cell disorder such as anemia (lack of red blood cells) or low white blood cell (WBC) counts; a fungal infection anywhere in your body; or a nerve disorder. Metronidazole has caused cancer in animal studies. However, it is not known whether this would occur in humans. Ask your doctor about your risk. You should not breastfeed within 24 hours after using metronidazole. If you use a breast pump during this time, throw out the milk and do not feed it to your baby. How should I use metronidazole? Take metronidazole exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Metronidazole oral is taken by mouth. The injection is given as an infusion into a vein. A healthcare provider will give you the injection if you are unable to take the medicine by mouth. Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon). Swallow the extended-release tablet whole and do not crush, chew, or break it. If you are treating a vaginal infection, your sexual partner may also need to take metronidazole so you don't become reinfected. Metronidazole is usually given for up to 10 days in a row. You may need to repeat this dosage several weeks later. Keep using this medicine even if your symptoms quickly improve. Skipping doses could make your infection resistant to medication. This medicine will not treat a viral infection (flu or a common cold). Metronidazole will not treat a vaginal yeast infection. You may even develop a new vaginal yeast infection, which may need to be treated with antifungal medication. Tell your doctor if you have symptoms such as itching or discharge during or after treatment with this medicine. Do not share this medicine with another person, even if they have the same symptoms you have. This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine. Store at room temperature away from moisture and heat.   What happens if I miss a dose? Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, numbness, tingling, or problems with balance or muscle movement. What should I avoid while using metronidazole? While taking metronidazole and for 3 days after your last dose: Do not drink alcohol or consume foods, medicines, or other products that contain alcohol or propylene glycol. You may have unpleasant effects such as headaches, nausea, vomiting, stomach cramps, and warmth or tingling under your skin. Metronidazole side effects Get emergency medical help if you have signs of an allergic reaction to metronidazole (hives, itching, warmth or tingling; fever, joint pain; dry mouth, dry vagina; stuffy nose, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling). Call your doctor at once if you have: new or worsening symptoms of infection; painful or difficult urination; confusion; a light-headed feeling (like you might pass out); vaginal itching or discharge; or blisters or ulcers in your mouth, red or swollen gums, trouble swallowing. Stop taking the medicine and call your doctor right away if you have neurologic side effects (more likely to occur while taking metronidazole long term): numbness, tingling, or burning pain in your hands or feet; vision problems, pain behind your eyes, seeing flashes of light; muscle weakness, problems with speech or coordination; trouble speaking or understanding what is said to you; a seizure; or fever, neck stiffness, and increased sensitivity to light. Metronidazole can cause life-threatening liver problems in people with Cockayne syndrome. If you have this condition, stop taking this medicine and contact your doctor if you have signs of liver failure--nausea, stomach pain (upper right side), dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). Side effects may be more likely in older adults. Common metronidazole side effects may include: depression, trouble sleeping, feeling irritable; headache, dizziness, weakness; nausea, vomiting, loss of appetite, stomach pain; diarrhea, constipation; unpleasant metallic taste; rash, itching; vaginal itching or discharge, pain during sex; mouth sores; or swollen, red, or "hairy" tongue. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   What other drugs will affect metronidazole? Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective. Tell your doctor about all your current medicines. Many drugs can affect metronidazole, especially: an antidepressant; asthma medication; busulfan or other cancer medicine; heart or blood pressure medication; lithium or other antipsychotic medicine; medicine to treat malaria, HIV, or other infection; or a blood thinner - warfarin, Coumadin, Jantoven. This list is not complete and many other drugs may interact with metronidazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

What is midodrine? Midodrine works by constricting (narrowing) the blood vessels and increasing blood pressure. Midodrine is used to treat low blood pressure (hypotension) that causes severe dizziness or a light-headed feeling, like you might pass out. midodrine is for use only when low blood pressure affects daily life. Midodrine may not improve your ability to perform daily activities. Midodrine may also be used for purposes not listed in this medication guide. Warnings You should not use midodrine if you have severe heart disease, overactive thyroid, an adrenal gland tumor, kidney disease, if you are unable to urinate, or if your blood pressure is high even while lying down. Midodrine can increase blood pressure even when you are at rest. This medicine should be used only if you have severely low blood pressure that affects your daily life. Midodrine may not improve your ability to perform daily activities. Before taking this medicine You should not use midodrine if you are allergic to it, or if you have: severe heart disease; kidney disease, or if you are unable to urinate; pheochromocytoma (tumor of the adrenal gland); overactive thyroid; or high blood pressure even while lying down. To make sure midodrine is safe for you, tell your doctor if you have: diabetes; glaucoma or a history of vision problems; liver disease; or a history of kidney disease. It is not known whether midodrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether midodrine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby. How should I take midodrine? Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Midodrine is usually taken 3 times per day, with doses spaced at least 3 hours apart. Take your last dose of the day within 3 or 4 hours before bedtime. You may take midodrine with or without food. Take this medicine during your normal waking hours, when your are most likely to be upright and not lying down or napping. Ask your doctor about how to take this medicine if you normally lie down during the day. Midodrine can increase your blood pressure even while you are lying down or sleeping (when blood pressure is usually lowest). Long-term high blood pressure (hypertension) can lead to serious medical problems. Follow your doctor's instructions about the best way to position your body while you are laying down or sleeping. You may need to keep your head elevated to help prevent high blood pressure. Your blood pressure will need to be checked before and during treatment with midodrine. Check your blood pressure while you are lying down, and check it again with your head elevated. Your kidney and liver function may also need to be checked. Midodrine is only part of a treatment program that may also include lifestyle changes, wearing support stockings on your legs, and possibly special medical care. Follow your doctor's instructions very closely. Store at room temperature away from moisture and heat. What happens if I miss a dose? Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. You may need to skip a dose if you will be resting or lying down for a long period of time during your normal waking hours. Talk to your doctor about how to adjust your dose schedule if needed. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Symptoms of a midodrine overdose may include increased blood pressure (flushing, headache, pounding heartbeat, blurred vision), goosebumps, feeling cold, or trouble urinating. What should I avoid while taking midodrine? Avoid taking a dose within less than 3 hours before your normal bedtime. Ask a doctor or pharmacist before using any over-the-counter diet pills, or cough/cold medicine that contains phenylephrine or pseudoephedrine. These medicines may raise your blood pressure. Midodrine side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop taking midodrine and call your doctor at once if you have: severely slowed heart rate--weak pulse, severe dizziness or light-headed feeling; or dangerously high blood pressure--severe headache, pounding sensation in your ears ("hearing" your heartbeats), blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure. Common side effects may include: chills, goosebumps; numbness, tingling, or itching (especially in your scalp); headache, dizziness, tired feeling; nausea; or increased urination, painful or difficult urination, or sudden urge to urinate. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   Midodrine dosing information Usual Adult Dose for Hypotension: 10 mg orally 3 times a day during daytime hours when the patient needs to be upright Comments: -The three daily doses may be given at 3-hour intervals, if needed, but not more frequently. -This drug should not be given after the evening meal or less than 4 hours before bedtime. -This drug should only be continued in patients who appear to attain symptomatic improvement during initial treatment. Use: Treatment of symptomatic orthostatic hypotension (OH) in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment such as support stockings, fluid expansion, and lifestyle alterations.   What other drugs will affect midodrine? Taking midodrine with other drugs that constrict blood vessels can further increase your blood pressure. Tell your doctor about all your current medicines and any you start or stop using, especially: digoxin, digitalis, droxidopa, fludrocortisone an antidepressant; asthma medicine; heart or blood pressure medicine; migraine headache medicine; thyroid medicine such as levothyroid or Synthroid; drugs to treat high blood pressure or a prostate disorder--prazosin, terazosin, or doxazosin; or an MAO inhibitor--isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine. This list is not complete. Other drugs may interact with midodrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

What is minocycline? Minocycline is a tetracycline antibiotic that fights bacteria in the body. Minocycline is used to treat many different bacterial infections, such as urinary tract infections, respiratory infections, skin infections, severe acne, chlamydia, tick fever, and others. It is also used for gonorrhoea, syphilis, and other infections as a second-line drug in those with a penicillin allergy. Minocycline may also be used for purposes not listed in this medication guide. Warnings Minocycline can make birth control pills less effective. Ask your doctor about using a non hormonal method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using this medicine. Minocycline can cause fetal harm and pass into breast milk. Minocycline may affect bone and tooth development in a fetus or nursing baby. Do not take this medication without telling your doctor if you are pregnant or breast-feeding a baby. Children should not take this medication. Minocycline can cause permanent yellowing or graying of the teeth in children younger than 8 years old. Minocycline can cause a severe skin rash that can be fatal. Stop taking minocycline if you experience fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling. Do not take iron supplements, multivitamins, calcium supplements, antacids, or laxatives within 2 hours before or after taking this medicine. These products can make this medicine less effective. Throw away any unused medicine after the expiration date on the label has passed. Using expired minocycline can cause damage to your kidneys. Before taking this medicine You should not take this medicine if you are allergic to minocycline or to similar antibiotics such as demeclocycline, doxycycline, or tetracycline. If you are using minocycline to treat gonorrhea, your doctor may test you to make sure you do not also have syphilis, another sexually transmitted disease. To make sure this medicine is safe for you, tell your doctor if you have ever had: liver disease; kidney disease; or asthma or sulfite allergy. You should not use this medicine if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life. Use effective birth control to prevent pregnancy while you are using this medicine, whether you are a man or a woman. Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking minocycline. The use of this medicine by either parent may cause tooth discoloration later in the baby's life. Minocycline can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy. Minocycline passes into breast milk and may affect bone and tooth development in a nursing baby. You should not breast-feed while you are taking this medicine. Do not give this medicine to a child without medical advice. Minocycline can cause permanent yellowing or graying of the teeth in children younger than 8 years old. How should I take minocycline? Take minocycline exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Take this medicine with a full glass of water. You may take minocycline with or without food. Do not crush, chew, or break an extended-release capsule or tablet. Swallow it whole. Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. This medicine will not treat a viral infection such as the flu or a common cold. If you use this medicine long-term, you may need frequent medical tests. You may also need to stop taking minocycline for a short time if you need surgery. This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using minocycline. Store at room temperature away from moisture, heat, and light. Throw away any minocycline not used before the expiration date on the medicine label.   What happens if I miss a dose? Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include dizziness, nausea, or vomiting. What to avoid For 2 hours before or after you take minocycline: Avoid taking antacids, laxatives, multivitamins, or supplements that contain calcium, magnesium, or iron. These other medicines can make it harder for your body to absorb minocycline. Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired. Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to. Minocycline could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Minocycline side effects Get emergency medical help if you have signs of an allergic reaction to minocycline (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling). Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This may be more likely with long-term use of minocycline, and the reaction may occur several weeks after you began using this medicine. Call your doctor at once if you have: little or no urination, swelling in your feet or ankles, feeling tired or short of breath (signs of kidney problems); loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, loss of appetite, easy bruising or bleeding, dark urine, yellowing of the skin or eyes (signs of liver or pancreas problems); joint pain or swelling with fever, swollen glands, muscle aches, chest pain, vomiting, unusual thoughts or behavior, and patchy skin color; severe headaches, ringing in your ears, dizziness, vision problems, pain behind your eyes; or swollen glands, flu symptoms, easy bruising or bleeding, severe tingling or numbness, muscle weakness, chest pain, new or worsening cough with fever, trouble breathing. Common minocycline side effects may include: numbness, tingling, burning pain; hair loss; discoloration of you skin or nails. dizziness, spinning sensation; muscle or joint pain; nausea, diarrhea, loss of appetite; swollen tongue, cough, trouble swallowing; rash, itching; or headache. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   What other drugs will affect minocycline? Tell your doctor about all your other medicines, especially: isotretinoin; a penicillin antibiotic - amoxicillin, ampicillin, dicloxacillin, oxacillin, penicillin, ticarcillin, Amoxil, Moxatag, Augmentin, Principen, and others; a blood thinner - warfarin, Coumadin, Jantoven; or ergot medicine - dihydroergotamine, ergotamine, ergonovine, methylergonovine. This list is not complete. Other drugs may interact with minocycline, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

What is mirtazapine? Mirtazapine is an antidepressant. The way this medication works is still not fully understood. It is thought to positively affect communication between nerve cells in the central nervous system and/or restore chemical balance in the brain. Mirtazapine is used to treat major depressive disorder in adults. It is not known if mirtazapine is safe and effective for use to treat MDD in children. Warnings You should not take mirtazapine if you are also taking tryptophan (sometimes called L-tryptophan). Do not use mirtazapine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine and others. Some people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using mirtazapine. Your family or other caregivers should also be alert to changes in your mood or symptoms. Do not give this medicine to anyone younger than 18 years old without the advice of a doctor. This medicine is not approved for use in children. It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment. Drinking alcohol can increase certain side effects of mirtazapine. Mirtazapine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not stop taking this medicine abruptly. Talk to your doctor before stopping this medicine. Before taking this medicine You should not take this medicine if you are allergic to mirtazapine. Do not use mirtazapine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others. To make sure this medicine is safe for you, tell your doctor if you have ever had: low white blood cell counts; glaucoma; liver or kidney disease; low sodium levels in your blood; a seizure; depression, suicidal thoughts or actions; bipolar disorder (manic depression) in you or a family member; heart problems or stroke; high cholesterol or triglycerides; long QT syndrome (in you or a family member); or low blood pressure. Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with mirtazapine and cause a serious condition called serotonin syndrome. Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms. Tell your doctor if you are pregnant or breastfeeding. The orally disintegrating tablet may contain phenylalanine and could be harmful if you have phenylketonuria (PKU). Mirtazapine is not approved for use by anyone younger than 18 years old. How should I take mirtazapine? Take mirtazapine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Take the medicine at the same time each day, usually at bedtime. Take the regular tablet form of mirtazapine with water. You may take mirtazapine with or without food. Remove an orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet on your tongue and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves. It may take a few weeks for your symptoms to improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment. Do not stop using mirtazapine suddenly, or you could have unpleasant symptoms (such as dizziness, vomiting, agitation, sweating, confusion, numbness, tingling, or electric shock feelings). Ask your doctor how to safely stop using this medicine. Store at room temperature away from moisture, heat, and light. Dosing information Usual Adult Dose for Depression: Initial dose: 15 mg orally once a day at bedtime Maintenance dose: 15 to 45 mg orally once a day Maximum dose: 45 mg/day Comments: -May increase the dose every 1 to 2 weeks to a maximum 45 mg/day according to patient response. -Patients should be periodically reassessed to determine the need for continued use of this drug. Use: Treatment of major depressive disorder Detailed Mirtazapine dosage information What happens if I miss a dose? Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include confusion, memory problems, drowsiness, and fast heart rate. What to avoid Drinking alcohol with mirtazapine can cause side effects. Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired. Mirtazapine side effects Get emergency medical help if you have signs of an allergic reaction to mirtazapine (hives, joint pain, fever, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling). Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Call your doctor at once if you have: racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, being more talkative than usual; blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights; a light-headed feeling, like you might pass out; severe rash, blisters, or swelling on the palms of your hands or the soles of your feet; a seizure; low white blood cell counts - fever, chills, sore throat, cough, sores in your mouth or nose, flu-like symptoms, trouble breathing; or low sodium level - headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea. Common mirtazapine side effects include: drowsiness, dizziness; increased appetite; or weight gain. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   What other drugs will affect mirtazapine? Using mirtazapine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures. Tell your doctor about all your current medicines. Many drugs can affect mirtazapine, especially: cimetidine; diazepam; St. John's wort; tramadol; tryptophan (sometimes called L-tryptophan); an antibiotic - clarithromycin, rifampin, rifampicin, telithromycin; antifungal medicine - itraconazole, ketoconazole; antiviral medicine to treat HIV/AIDS - indinavir, nelfinavir, ritonavir, saquinavir; medicine to treat mood disorders, thought disorders, or mental illness - such as lithium, other antidepressants, or antipsychotics; migraine headache medicine - sumatriptan, rizatriptan, Imitrex, Maxalt, and others; or seizure medicine - carbamazepine, phenytoin. This list is not complete and many Other drugs may interact with mirtazapine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

What is modafinil? Modafinil is a medication that promotes wakefulness. Modafinil is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder. Modafinil may also be used for purposes not listed in this medication guide. Warnings You should not use modafinil if you have ever had an allergic reaction or skin rash while taking modafinil or armodafinil (Nuvigil). Modafinil can cause skin reactions that may be severe enough to need treatment in a hospital. Stop taking this medicine and get emergency medical help if you have a skin rash or hives, blisters or peeling, mouth sores, trouble breathing or swallowing, fever, swelling in your legs, dark urine, yellowing of your skin or eyes, or swelling in your face. Before taking this medicine You should not use this medicine if you have ever had an allergic reaction or skin rash while taking modafinil or armodafinil (Nuvigil). To make sure modafinil is safe for you, tell your doctor if you have: angina (chest pain); cirrhosis or other liver problem; kidney disease; high blood pressure, heart disease, or history of heart attack; a history of mental illness or psychosis; or history of alcoholism or drug addiction. It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Modafinil can make certain birth control less effective. Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Talk with your doctor about the best methods of birth control to use while taking modafinil. It is not known whether modafinil passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby. Modafinil is not approved for use by anyone younger than 17 years old. How should I take modafinil? Follow all directions on your prescription label. Do not take modafinil in larger or smaller amounts or for longer than recommended. Modafinil may be habit-forming. Never share modafinil with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away modafinil is against the law. Modafinil is usually taken each morning to prevent daytime sleepiness, or 1 hour before the start of a work shift to treat work-time sleep disorders. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions. You may take modafinil with or without food. Modafinil is usually given for 12 weeks or less. If you are taking modafinil to treat sleepiness caused by obstructive sleep apnea, you may also be treated with a continuous positive airway pressure (CPAP) machine. This machine is an air pump connected to a mask that gently blows pressurized air into your nose while you sleep. The pump does not breathe for you, but the gentle force of air helps keep your airway open to prevent obstruction. Do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and modafinil may be necessary to best treat your condition. Modafinil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor's instructions about all your other treatments for this disorder. Call your doctor if you continue to have excessive sleepiness even while taking modafinil. Taking modafinil does not take the place of getting enough sleep. Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Modafinil is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription. What happens if I miss a dose? Talk with your doctor about what to do if you miss a dose of modafinil. Avoid taking the medicine if you do not plan to be awake for several hours. Skip the missed dose if it is almost bedtime. Do not take extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking modafinil? modafinil may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid other dangerous activities until you know how modafinil will affect your level of wakefulness. Avoid drinking alcohol while taking modafinil. Modafinil side effects Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Modafinil can cause skin reactions that may be severe enough to need treatment in a hospital. Stop taking this medicine and get emergency medical help if you have: skin rash or hives, blisters or peeling; mouth sores, trouble swallowing; fever, shortness of breath; swelling in your legs; dark urine, jaundice (yellowing of the skin or eyes); or swelling in your face, eyes, lips, tongue, or throat. Stop using modafinil and call your doctor at once if you have: depression, anxiety, suicidal thoughts or actions; hallucinations, unusual thoughts or behavior, aggression, being more active or talkative than usual; chest pain, trouble breathing, uneven heart beats; or the first sign of any skin rash, no matter how minor you think it might be. Common side effects may include: headache, dizziness; feeling nervous or anxious; back pain; nausea, diarrhea, upset stomach; sleep problems (insomnia); or stuffy nose. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   Modafinil dosing information Usual Adult Dose for Narcolepsy: 200 mg orally once a day in the morning Comments: -In obstructive sleep apnea (OSA), this drug is not a treatment for the underlying obstruction. -If continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to and during treatment with this drug. Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with narcolepsy and OSA. Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome: 200 mg orally once a day in the morning Comments: -In obstructive sleep apnea (OSA), this drug is not a treatment for the underlying obstruction. -If continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to and during treatment with this drug. Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with narcolepsy and OSA. Usual Adult Dose for Shift Work Sleep Disorder: 200 mg orally once a day, approximately 1 hour prior to the start of the work shift Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with shift work disorder.   What other drugs will affect modafinil? Other drugs may interact with modafinil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

What is Mometasone furoate cream?   Mometasone furoate is a cream that helps to treat redness, swelling, and irritating skin that links with skin ailments such as eczema, allergies, or dermatitis. Mometasone is a family of medications called corticosteroids. It includes anti-inflammatory properties.  This medication is available in many forms, including cream, ointment, and lotion (solution). A doctor will recommend a product type that depends on the skin condition of your body that needs treatment.    Who should not use mometasone furoate?   Mometasone may not be suitable for a few people. Talk to a doctor or pharmacist before taking it or if you have the following conditions:   Active infection of the skin.  An unexpected allergic reaction to mometasone, foods, dyes, preservatives, or animals.  Acne or rosacea Burned or damaged skin on large parts of your body Skin wasting or thinning. Pregnant or going to become pregnant. If you are a woman who is breast-feeding If you are experiencing diabetes or Cushing’s syndrome (an abnormal condition that develops due to excess hormones corticosteroids)   If your child is two years and older and taking this medicine, consider following the healthcare provider’s guidelines. A healthcare provider does not recommend mometasone cream and ointment in children younger than two years of age and lotion in children above 12.    How to use Mometasone furoate cream?   Mometasone furoate cream is suitable for moist and weepy skin. Ointments are thicker and oily, generally better for dry parts of the skin.    This medicine is applicable for external use only. You will generally need to apply daily mometasone cream on your skin. The quantity of cream you have to use is in fingertip units. It is the quantity you can compress to the end of your finger. A fingertip unit of cream is usually sufficient to treat the portion of the skin that is double the palm size of your hand.    For children, the suitable amount of cream varies depending on their age. You can speak to a healthcare provider.  Following are the step-by-step ways to apply the cream on your skin:   Wash and clean your hands before and after the use of the cream.  Take out the correct quantity of cream.  Spread the cream in a thin film on the affected or irritated area.  Gently put it into your skin in the direction where your hair grows. Apply the cream to overall irritated skin, not only the worst parts.  Avoid using the cream or ointment on the damaged skin or cuts.  Avoid bandaging or wrapping the skin under treatment until you receive instructions.  Try to avoid the intake of this medicine in your eyes. If it occurs, clean it with additional cool water.    You can ask your provider online about how often you should use the cream. If you use this cream for a longer period, you may increase the risk of side effects. Speak to a professional pediatrician about the use of creams in children.    Older people have more chances to develop damaged skin because of increasing age, and it may lead to side effects. This mometasone cream should apply only for a short period and less frequently in older people.  You should note that this medicine is only for you. Therefore, avoid sharing it with others.    What are the side effects of mometasone furoate?   If you see any side effects after using mometasone furoate for a long time, you should inform your healthcare provider immediately. These are the side effects of mometasone furoate you may experience:   Blurry vision  Development of red, pus-filled blisters in the hair unit that are painful  Allergic reactions, such as swelling face, lips, or tongue Lighter or darker patches on your skin are an indicator of skin pigment. Extreme burning and increased itching of the skin Skin thinning that bruises easily Vomiting, feeling tired, dizziness, muscle weakness, behavior or mood changes, reduction in appetite, and weight loss. These are the symptoms of adrenal gland disorders.    Few other side effects that generally do not need medical care, including  The high amount of redness  Burning, itching, or irritating skin The low ability to heal for a skin condition   You can schedule an online meetup with a doctor if these conditions lead to an increase.    Children and teenagers   In a few cases, the normal growth of children and teenagers may reduce with long-term use of mometasone. A doctor will observe your child’s height and weight promptly till they use this medicine. It will give benefits to monitor whether this medicine affects the child's growth.    If the child's growth reduces, it does not show a large amount of effect on their adult height.    Talk to a provider online if you further want to learn about the advantages and risks of mometasone while using it in your child.    What things may interact with this medication?   If the mometasone cream interacts with other medicines, it may affect the working of your medications or increase the risk for extreme side effects. You can note down a list of all the products you intake (such as prescription/nonprescription drugs and herbal products) and inform your provider and pharmacist. Avoid taking, changing, or stopping the dosage of any medicines without the consultation of your provider.    Important facts   Following are the points that you should consider about mometasone furoate, including:   While using a steroid skin treatment, follow the instructions, which help to eliminate side effects.  You can use a mometasone skin treatment when a healthcare provider recommends it. Otherwise, do not use any other or someone else’s medicine.  Usually, mometasone is generally not recommended for sensitive skin on your face. If a doctor tells you, you can use it on your face.  Acne or rosacea will not be treated with mometasone skin treatments. If a doctor tells you to use mometasone on large body parts or for high times, only use it.  If a healthcare provider recommends a high amount of mometasone to relieve your symptoms, you may have to take a steroid emergency card. Consult a doctor or pharmacist.    Schedule an online appointment with a healthcare provider to receive more proper guidance about mometasone cream and skin inflammation, irritation, and itching.  Frequently Asked Questions (FAQ’s)    How long do I need to take mometasone?   You may need to take mometasone for at least 1 or 2 weeks for a longer time, if you have long-term skin problems, including eczema and psoriasis.    Avoid using mometasone on your face for more than five days until the instructions are provided. If your symptoms do not relieve or improve after two weeks (after 5-6 days for a child), consult a doctor for additional recommendations.    Your doctor may advise you to apply a milder cream or ointment if you require treatment for a long time.    Speak to your provider before ending treatment if you take mometasone for a long time. A healthcare provider may suggest you slowly decrease the use of the cream before stopping it. It reduces the risks of the return of your symptoms.    What is the importance of mometasone and how does it work?   Mometasone is a steroid, also known as corticosteroid. Steroids have the function of reducing swelling in the skin and other body parts.    If you experience an allergic reaction or irritation, your skin becomes inflamed, releasing certain chemicals into the skin. It results in developing blood vessels to expand and the irritated skin gets red, swelling, painful, and itchy.    Mometasone cream works on the skin cells to block releasing these chemicals into your skin. It decreases the effect of any swelling, redness, and itching.    What if I take an overdose of cream?   This medicine may be dangerous if you eat it up. If you have a high intake of this medicine and have severe symptoms like difficulty breathing, call 911. You can also contact a poison control center or an emergency room immediately.    What if I miss the dose of cream?   If you ever miss a dose of mometasone cream, use it as early as you remember. If you find yourself missing the dose just before the next dose, avoid taking the missed dose. Take your following dose at regular intervals. Avoid doubling or an extra amount of mometasone cream.    Is mometasone good for the skin?   Mometasone cream helps improve skin after you have taken it for some days. You can talk to a healthcare provider online if your skin does not improve after two weeks or if you see any skin damage in no time.    Is it safe to use mometasone daily?   If you use the mometasone for a long period, it may lead to entering this medicine into your bloodstream. If it occurs, a few low risks may develop severe side effects, including adrenal gland disorders, high blood sugar (hyperglycemia), eye problems, or skin thinning.    Do I use the mometasone cream on my face?   Avoid using mometasone cream on your face except for the guideline of your provider. Generally, the skin's face is fine and delicate. If the intake of mometasone skin treatment thins the skin or damages it, it appears specifically.   You can use this medicine on your face for less than five days if your doctor suggests doing so.  Avoid taking in the amount of mometasone around your eyes or on your eyelids.    Is mometasone an antibiotic Cream?   No, mometasone does not come under an antibiotic. It is a powerful steroid medication that helps treat several skin conditions, such as swelling, redness, and skin irritation.    How to store this medicine?   You can keep the mometasone cream at room temperature. Keep away all medications from your children. Avoid flushing medication into the toilet or sending it into a drain until you receive the instructions. You can avoid using the product when it passes the expiration date or no further requirement.    Can steroids develop eczema to become worse?   Steroids, such as mometasone, help to decrease swelling (inflammation) in your skin. It helps to relieve your symptoms. Steroids do not treat eczema.  If you have symptoms that are worse after the use of mometasone, talk to a provider online.  If you avoid or stop taking medications, skin conditions, such as eczema and psoriasis, can appear more often.    A healthcare provider tells you to slowly reduce the use of mometasone.  Does skin recover after steroid Cream?   Symptoms mostly become worse right after you stop using steroids. Initially, the skin becomes red and then gets itchy. In time, the skin clears, however, you may experience frequent symptoms, also known as flares. The retreat symptoms can present elsewhere from a few months to several years.    Does mometasone furoate cream remove dark spots?   Mometasone helps to treat and lighten melasma (brown patches on your face), chloasma (dark skin because of hormonal changes), and hyperpigmentation (dark skin) due to age spots.    Do I require a steroid card?   If you use steroid medicines, including mometasone, your adrenal glands may not develop enough of the hormones your body requires, like cortisol (stress hormone). It is called adrenal deficiency.    It occurs if you consider taking a large number of doses for a long time or if you have daily use of several kinds of steroids within the same time interval like steroid nasal spray and a steroid inhaler)   A doctor or professional pharmacist will check your risk of adrenal deficiency, depending on the type and dose of steroids you use. They may suggest a steroid emergency card with you.    Is mometasone better for hair loss?   Mometasone lotion can be used for hair loss. You can apply a few drops to your hair and massage it softly.    Is mometasone a weak steroid?   No, mometasone is a powerful steroid that helps to reduce swelling, itching, and skin irritation.    Is mometasone a fungal Cream?   No, mometasone is not a fungal cream.   Is there any food or substance I have to avoid?   No. This medicine is not influenced by whatever you take (food or drink).    Does mometasone cause dry skin?   Mometasone may develop side effects. Speak to a healthcare provider if you have severe symptoms that do not relieve, including itching, redness, irritation, and skin dryness.   

What is montelukast? Montelukast is a leukotriene (loo-koe-TRY-een) inhibitor that is used to prevent asthma attacks in adults and children at least 2 years old. Montelukast is also used to prevent exercise-induced bronchoconstriction (narrowing of the air passages in the lungs) in adults and children who are at least 6 years old. Montelukast is also used to treat symptoms of seasonal or year-round (perennial) allergies in adults and children at least 2 years old, after other treatments did not work. If you already take montelukast to prevent asthma or allergy symptoms, do not use an extra dose to treat exercise-induced bronchoconstriction. Montelukast may also be used for purposes not listed in this medication guide. Warnings Tell your doctor right away if you have signs of blood vessel inflammation: flu-like symptoms, severe sinus pain, a skin rash, numbness or a "pins and needles" feeling in your arms or legs. Stop taking montelukast and call your doctor right away if you have any unusual changes in mood or behavior (such as agitation, confusion, depression, sleep problems, compulsive behaviors, hallucinations, or suicidal thoughts or actions). Before taking this medicine You should not use montelukast if you are allergic to it. Tell your doctor if you have ever had: mental illness or psychosis; or asthma, or a history of severe allergic reaction (sneezing, runny or stuffy nose, wheezing, shortness of breath) after taking aspirin or another NSAID. The chewable tablet may contain phenylalanine and could be harmful if you have phenylketonuria (PKU). Tell your doctor if you are pregnant or breastfeeding. Do not give this medicine to a child without a doctor's advice. How should I take montelukast? Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Montelukast is not a fast-acting rescue medicine for asthma attacks. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working. Montelukast is usually taken once every evening, with or without food. For exercise-induced bronchoconstriction, take a single dose at least 2 hours before exercise, and do not take another dose for at least 24 hours. Swallow the regular tablet whole, with a glass of water. You must chew the chewable tablet before you swallow it. Place the oral granules directly in your mouth and swallow, or mix them with applesauce, mashed carrots, rice, or ice cream. The granules may also be mixed with baby formula or breast milk. Do not use any other type of liquid. Use the mixture within 15 minutes. Do not save for later use. If you also use an oral steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose. Do not change your dose or stop using asthma medication without your doctor's advice. Store at room temperature away from moisture and heat. Do not open a packet of oral granules until you are ready to use the medicine.   What happens if I miss a dose? Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking montelukast? Avoid situations or activities that may trigger an asthma attack. If your asthma symptoms get worse when you take aspirin, avoid taking aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others. Montelukast side effects Get emergency medical help if you have signs of an allergic reaction: hives, blisters, severe itching; difficult breathing; swelling of your face, lips, tongue, or throat. Tell your doctor right away if you have signs of blood vessel inflammation: flu-like symptoms, severe sinus pain, a skin rash, numbness or a "pins and needles" feeling in your arms or legs. Some people using montelukast have had new or worsening mental problems. Stop taking montelukast and call your doctor right away if you have unusual changes in mood or behavior, such as: agitation, aggression, feeling restless or irritable; anxiety, depression, confusion, problems with memory or attention; stuttering, tremors, uncontrolled muscle movements; suicidal thoughts or actions; hallucinations, sleep problems, vivid, dreams, sleep-walking; or compulsive or repetitive behaviors. Common side effects may include: stomach pain, diarrhea; fever or other flu symptoms; ear pain or full feeling, trouble hearing; headache; or cold symptoms such as runny or stuffy nose, sinus pain, cough, sore throat. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   What other drugs will affect montelukast? Other drugs may affect montelukast, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

What is mupirocin topical? Mupirocin is an antibiotic that prevents bacteria from growing on your skin. Mupirocin topical (for use on the skin) is used to treat skin infections such as impetigo (IM-pe-TYE-go) or a "Staph" infection of the skin. Mupirocin topical may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use. Before taking this medicine You should not use mupirocin topical if you are allergic to mupirocin. To make sure mupirocin topical is safe for you, tell your doctor if you have ever had: kidney disease. Do not use mupirocin topical on a child without medical advice. The cream should not be used on a child younger than 3 months old. The ointment may be used on a child as young as 2 months old. It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant. It is not known whether mupirocin topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby. If you apply this medicine to your breast or nipple, wash the areas thoroughly before nursing your baby. How should I use mupirocin topical? Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Do not take by mouth. Topical medicine is for use only on the skin. If this medicine gets in your eyes, nose, or mouth, rinse with water. Wash your hands before and after applying mupirocin topical. Clean and dry the affected skin area. Use a cotton swab or gauze pad to apply a small amount of mupirocin topical as directed. Do not spread mupirocin topical over large areas of skin. Mupirocin topical is usually applied 3 times per day for 10 days. Use only a small amount of the medicine. Use a sterile gauze pad to cover the treated skin. Do not cover treated areas with a bandage, plastic wrap, or other covering that does not allow air to circulate. Call your doctor if your symptoms do not improve within 3 to 5 days, or if your skin condition gets worse. Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Store at room temperature away from moisture and heat. Do not freeze. Keep the medicine tube tightly closed when not in use. What happens if I miss a dose? Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose. What happens if I overdose? An overdose of mupirocin topical is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication. What should I avoid while using mupirocin topical? Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to. Avoid getting mupirocin topical in your eyes, mouth, or nose. A separate product called mupirocin nasal is made for use in the nose. Mupirocin topical is for use only on the skin. Avoid using other medications on the areas you treat with mupirocin topical unless your doctor tells you to. Mupirocin topical side effects Get emergency medical help if you have signs of an allergic reaction: hives; dizziness, fast or pounding heartbeats; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medicine and call your doctor at once if you have: severe stomach pain, diarrhea that is watery or bloody; severe itching, rash, or other irritation of treated skin; unusual skin blistering or peeling; or any signs of a new skin infection. Common side effects may include: burning, stinging; itching; or pain. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   Mupirocin topical dosing information Usual Adult Dose for Secondary Cutaneous Bacterial Infections: Topical cream: Apply a small amount to the affected area 3 times a day for 10 days. Use: For the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible strains of Staphylococcus aureus and Streptococcus pyogenes Usual Adult Dose for Nasal Carriage of Staphylococcus aureus: Nasal ointment: Apply about one-half of the tube contents into 1 nostril and the other half into the other nostril twice a day (morning and evening). Duration of therapy: 5 days Use: For the eradication of nasal colonization with methicillin-resistant S aureus (MRSA) in patients and healthcare workers as part of a comprehensive infection control program to reduce risk of MRSA infection among high-risk patients during institutional outbreaks of MRSA infections Usual Adult Dose for Impetigo: Topical ointment: Apply a small amount to the affected area 3 times a day. Use: For the topical treatment of impetigo due to S aureus and S pyogenes Usual Pediatric Dose for Secondary Cutaneous Bacterial Infections: 3 months or older: Topical cream: Apply a small amount to the affected area 3 times a day for 10 days. Use: For the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible strains of S aureus and S pyogenes Usual Pediatric Dose for Nasal Carriage of Staphylococcus aureus: 12 years or older: Nasal ointment: Apply about one-half of the tube contents into 1 nostril and the other half into the other nostril twice a day (morning and evening). Duration of therapy: 5 days Use: For the eradication of nasal colonization with MRSA in patients and healthcare workers as part of a comprehensive infection control program to reduce risk of MRSA infection among high-risk patients during institutional outbreaks of MRSA infections Usual Pediatric Dose for Impetigo: 2 months or older: Topical ointment: Apply a small amount to the affected area 3 times a day. Use: For the topical treatment of impetigo due to S aureus and S pyogenes   What other drugs will affect mupirocin topical? It is not likely that other drugs you take orally or inject will have an effect on topically applied mupirocin. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

What is mycophenolate mofetil? Mycophenolate mofetil is used with other medicines to prevent organ transplant rejection. Mycophenolate mofetil is for use with a liver or heart transplant in adults. mycophenolate mofetil is for use with a kidney transplant in adults and children at least 3 months old. Mycophenolate mofetil may also be used for purposes not listed in this medication guide. Warnings This medicine can cause a miscarriage or birth defects when used during pregnancy. Both men and women should use effective birth control to prevent pregnancy during and shortly after treatment with mycophenolate mofetil. Using mycophenolate mofetil may increase your risk of cancer, serious infections, or kidney transplant failure. Call your doctor right away if you have symptoms such as: fever, swollen glands, weight loss, vomiting or diarrhea, painful urination, a new skin lesion, any change in your mental state, weakness on one side of your body, or pain near your transplanted kidney. Before taking this medicine You should not use mycophenolate mofetil if you are allergic to mycophenolate mofetil, mycophenolic acid, or polysorbate 80. Talk with your doctor about the risks and benefits of mycophenolate mofetil. This medicine may increase your risk of cancer, serious or fatal infections, or a viral infection that can cause kidney transplant failure. Tell your doctor if you have ever had: a stomach ulcer or problems with digestion; diabetes; hepatitis B or C or other viral infection (may become active or get worse while you are using mycophenolate mofetil); phenylketonuria, or PKU (the liquid form of this medicine may contain phenylalanine); or a rare inherited enzyme deficiency such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome. This medicine can cause a miscarriage or birth defects, especially during the first 3 months of pregnancy. You will need to have a negative pregnancy test before and during treatment with this medicine. If you are able to get pregnant, you must use specific forms of birth control to prevent pregnancy while using mycophenolate mofetil, and for at least 6 weeks after your last dose. Sexually active men and their partners should use effective contraception during treatment and for at least 90 days after the last dose. Mycophenolate mofetil can make birth control pills less effective. Ask your doctor about using an additional barrier form of birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy. You do not need to use additional birth control if you use an intrauterine device (IUD), if you have had a tubal ligation, or if your sexual partner has had a vasectomy. This medicine comes with patient instructions about the most effective non-hormonal forms of birth control to use. Follow these directions carefully. Ask your doctor if you have any questions. If a pregnancy occurs during treatment, do not stop taking mycophenolate mofetil. Call your doctor for instructions. Also call the Mycophenolate Pregnancy Registry (1-800-617-8191). Mycophenolate mofetil is sometimes given to pregnant women. Your doctor will decide whether you should use this medicine if you are unable to use other needed transplant medications. You should not breastfeed while using mycophenolate mofetil. How should I use mycophenolate mofetil? Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. You must remain under the care of a doctor while you are using mycophenolate mofetil. Mycophenolate mofetil injection is given as an infusion into a vein. A healthcare provider will give you this injection. Take oral mycophenolate mofetil on an empty stomach, at least 1 hour before or 2 hours after a meal. Swallow the capsule or tablet whole and do not crush, chew, break, or open it. Tell your doctor if you have trouble swallowing a tablet or capsule. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions. Shake the oral suspension (liquid) before you measure a dose. Use only the dosing syringe provided with this medicine. Mycophenolate mofetil (CellCept) and mycophenolic acid (Myfortic) are not absorbed equally in the body. Avoid medication errors by using only the brand, form, and strength of this medicine that your doctor has prescribed. You will need frequent medical tests. Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use. Throw away any unused liquid that is older than 60 days. The liquid medicine may also be stored in the refrigerator. Do not freeze. What happens if I miss a dose? Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 2 hours. Do not use two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using mycophenolate mofetil? Avoid driving or hazardous activity until you know how mycophenolate mofetil will affect you. Your reactions could be impaired. Mycophenolate mofetil can make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Do not receive a "live" vaccine while using mycophenolate mofetil. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine. You must not donate blood or sperm while using this medicine, and for at least 6 weeks (for blood) or 90 days (for sperm) after your last dose. Mycophenolate mofetil side effects Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Mycophenolate mofetil may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly. Mycophenolate mofetil affects your immune system and may increase your risk of cancer or serious infection. Call your doctor right away if you have: fever of 100.5 degrees F or higher, swollen glands, painful mouth sores, cold or flu symptoms, headache, ear pain; stomach pain, vomiting, diarrhea, weight loss; weakness on one side of your body, loss of muscle control; confusion, thinking problems, loss of interest in things that normally interest you; pain around the transplanted kidney; pain or burning when you urinate; dark urine, jaundice (yellowing of the skin or eyes); tingly or painful blistering rash on one side of your body; swelling, warmth, redness, or oozing around a skin wound; or a new skin lesion, or a mole that has changed in size or color. Also call your doctor at once if you have: bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath. Common side effects may include: stomach pain, nausea, vomiting, diarrhea, constipation; swelling in your ankles or feet; rash; headache, dizziness, tremors; fever, sore throat, cold symptoms, or other signs of infections; abnormal blood tests, high blood sugar; pain anywhere in your body; low blood cell counts; or high or low blood pressure, fast heart rate. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   Mycophenolate mofetil dosing information Usual Adult Dose for Organ Transplant -- Rejection Prophylaxis: -RENAL TRANSPLANTATION: 1 g orally or IV 2 times a day (2 gm per day); [in clinical trials, 1.5 g orally or IV 2 times a day (3 gm per day) was used effectively, however, the safety profile for 3 gm a day was lower] -CARDIAC TRANSPLANTATION: 1.5 g orally or IV 2 times a day (3 gm per day) -HEPATIC TRANSPLANTATION: 1.5 gm orally or 1 gm IV 2 times a day (3 gm per day orally or 2 gm per day IV) Comments: -This drug should be used concomitantly with cyclosporine and corticosteroids. -The IV formulation should be administered over no less than 2 hours. -IV administration is recommended in patients unable to take oral medication; oral administration should be initiated as soon as possible. Usual Geriatric Dose for Organ Transplant -- Rejection Prophylaxis: -RENAL TRANSPLANTATION: 1 g orally or IV 2 times a day (2 gm per day) -CARDIAC TRANSPLANTATION: 1.5 g orally or IV 2 times a day (3 gm per day) -HEPATIC TRANSPLANTATION: 1.5 gm orally or 1 gm IV 2 times a day (3 gm per day orally or 2 gm per day IV) Comments: -This drug should be used concomitantly with cyclosporine and corticosteroids. -The IV formulation should be administered over no less than 2 hours. -IV administration is recommended in patients unable to take oral medication; oral administration should be initiated as soon as possible. Usual Pediatric Dose for Organ Transplant -- Rejection Prophylaxis: -RENAL TRANSPLANTATION: 3 months to 18 years of age: Oral Suspension: 600 mg/m2 orally 2 times a day up to a maximum of 2 grams per day -Pediatric patients with a body surface area of 1.25 to 1.5 m2 may be dosed with the oral capsules at 750 mg orally 2 times a day (1.5 g per day) -Pediatric patients with a body surface area greater than 1.5 m2 may be dosed with the oral capsules at 1 g orally 2 times a day (2 g per day) Comments: -This drug should be used concomitantly with cyclosporine and corticosteroids. -The IV formulation should be administered over no less than 2 hours.-IV administration is recommended in patients unable to take oral medication; oral administration should be initiated as soon as possible.   What other drugs will affect mycophenolate mofetil? If you take sevelamer or an antacid, take your oral mycophenolate mofetil dose 2 hours before you take these other medicines. Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. Tell your doctor about all your current medicines. Many drugs can affect mycophenolate mofetil, especially: azathioprine; cholestyramine; antiviral medicine--acyclovir, ganciclovir, valacyclovir, valganciclovir; an antibiotic--amoxicillin, ciprofloxacin, metronidazole, norfloxacin, rifampin, sulfa drugs; or a stomach acid reducer--esomeprazole, lansoprazole, omeprazole, Nexium, Prevacid, Prilosec, Protonix, and others. This list is not complete and many other drugs may affect mycophenolate mofetil. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

What is mycophenolate mofetil? Mycophenolate mofetil is used with other medicines to prevent organ transplant rejection. Mycophenolate mofetil is for use with a liver or heart transplant in adults. mycophenolate mofetil is for use with a kidney transplant in adults and children at least 3 months old. Mycophenolate mofetil may also be used for purposes not listed in this medication guide. Warnings This medicine can cause a miscarriage or birth defects when used during pregnancy. Both men and women should use effective birth control to prevent pregnancy during and shortly after treatment with mycophenolate mofetil. Using mycophenolate mofetil may increase your risk of cancer, serious infections, or kidney transplant failure. Call your doctor right away if you have symptoms such as: fever, swollen glands, weight loss, vomiting or diarrhea, painful urination, a new skin lesion, any change in your mental state, weakness on one side of your body, or pain near your transplanted kidney. Before taking this medicine You should not use mycophenolate mofetil if you are allergic to mycophenolate mofetil, mycophenolic acid, or polysorbate 80. Talk with your doctor about the risks and benefits of mycophenolate mofetil. This medicine may increase your risk of cancer, serious or fatal infections, or a viral infection that can cause kidney transplant failure. Tell your doctor if you have ever had: a stomach ulcer or problems with digestion; diabetes; hepatitis B or C or other viral infection (may become active or get worse while you are using mycophenolate mofetil); phenylketonuria, or PKU (the liquid form of this medicine may contain phenylalanine); or a rare inherited enzyme deficiency such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome. This medicine can cause a miscarriage or birth defects, especially during the first 3 months of pregnancy. You will need to have a negative pregnancy test before and during treatment with this medicine. If you are able to get pregnant, you must use specific forms of birth control to prevent pregnancy while using mycophenolate mofetil, and for at least 6 weeks after your last dose. Sexually active men and their partners should use effective contraception during treatment and for at least 90 days after the last dose. Mycophenolate mofetil can make birth control pills less effective. Ask your doctor about using an additional barrier form of birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy. You do not need to use additional birth control if you use an intrauterine device (IUD), if you have had a tubal ligation, or if your sexual partner has had a vasectomy. This medicine comes with patient instructions about the most effective non-hormonal forms of birth control to use. Follow these directions carefully. Ask your doctor if you have any questions. If a pregnancy occurs during treatment, do not stop taking mycophenolate mofetil. Call your doctor for instructions. Also call the Mycophenolate Pregnancy Registry (1-800-617-8191). Mycophenolate mofetil is sometimes given to pregnant women. Your doctor will decide whether you should use this medicine if you are unable to use other needed transplant medications. You should not breastfeed while using mycophenolate mofetil. How should I use mycophenolate mofetil? Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. You must remain under the care of a doctor while you are using mycophenolate mofetil. Mycophenolate mofetil injection is given as an infusion into a vein. A healthcare provider will give you this injection. Take oral mycophenolate mofetil on an empty stomach, at least 1 hour before or 2 hours after a meal. Swallow the capsule or tablet whole and do not crush, chew, break, or open it. Tell your doctor if you have trouble swallowing a tablet or capsule. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions. Shake the oral suspension (liquid) before you measure a dose. Use only the dosing syringe provided with this medicine. Mycophenolate mofetil (CellCept) and mycophenolic acid (Myfortic) are not absorbed equally in the body. Avoid medication errors by using only the brand, form, and strength of this medicine that your doctor has prescribed. You will need frequent medical tests. Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use. Throw away any unused liquid that is older than 60 days. The liquid medicine may also be stored in the refrigerator. Do not freeze. What happens if I miss a dose? Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 2 hours. Do not use two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using mycophenolate mofetil? Avoid driving or hazardous activity until you know how mycophenolate mofetil will affect you. Your reactions could be impaired. Mycophenolate mofetil can make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Do not receive a "live" vaccine while using mycophenolate mofetil. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine. You must not donate blood or sperm while using this medicine, and for at least 6 weeks (for blood) or 90 days (for sperm) after your last dose. Mycophenolate mofetil side effects Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Mycophenolate mofetil may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly. Mycophenolate mofetil affects your immune system and may increase your risk of cancer or serious infection. Call your doctor right away if you have: fever of 100.5 degrees F or higher, swollen glands, painful mouth sores, cold or flu symptoms, headache, ear pain; stomach pain, vomiting, diarrhea, weight loss; weakness on one side of your body, loss of muscle control; confusion, thinking problems, loss of interest in things that normally interest you; pain around the transplanted kidney; pain or burning when you urinate; dark urine, jaundice (yellowing of the skin or eyes); tingly or painful blistering rash on one side of your body; swelling, warmth, redness, or oozing around a skin wound; or a new skin lesion, or a mole that has changed in size or color. Also call your doctor at once if you have: bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath. Common side effects may include: stomach pain, nausea, vomiting, diarrhea, constipation; swelling in your ankles or feet; rash; headache, dizziness, tremors; fever, sore throat, cold symptoms, or other signs of infections; abnormal blood tests, high blood sugar; pain anywhere in your body; low blood cell counts; or high or low blood pressure, fast heart rate. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   Mycophenolate mofetil dosing information Usual Adult Dose for Organ Transplant -- Rejection Prophylaxis: -RENAL TRANSPLANTATION: 1 g orally or IV 2 times a day (2 gm per day); [in clinical trials, 1.5 g orally or IV 2 times a day (3 gm per day) was used effectively, however, the safety profile for 3 gm a day was lower] -CARDIAC TRANSPLANTATION: 1.5 g orally or IV 2 times a day (3 gm per day) -HEPATIC TRANSPLANTATION: 1.5 gm orally or 1 gm IV 2 times a day (3 gm per day orally or 2 gm per day IV) Comments: -This drug should be used concomitantly with cyclosporine and corticosteroids. -The IV formulation should be administered over no less than 2 hours. -IV administration is recommended in patients unable to take oral medication; oral administration should be initiated as soon as possible. Usual Geriatric Dose for Organ Transplant -- Rejection Prophylaxis: -RENAL TRANSPLANTATION: 1 g orally or IV 2 times a day (2 gm per day) -CARDIAC TRANSPLANTATION: 1.5 g orally or IV 2 times a day (3 gm per day) -HEPATIC TRANSPLANTATION: 1.5 gm orally or 1 gm IV 2 times a day (3 gm per day orally or 2 gm per day IV) Comments: -This drug should be used concomitantly with cyclosporine and corticosteroids. -The IV formulation should be administered over no less than 2 hours. -IV administration is recommended in patients unable to take oral medication; oral administration should be initiated as soon as possible. Usual Pediatric Dose for Organ Transplant -- Rejection Prophylaxis: -RENAL TRANSPLANTATION: 3 months to 18 years of age: Oral Suspension: 600 mg/m2 orally 2 times a day up to a maximum of 2 grams per day -Pediatric patients with a body surface area of 1.25 to 1.5 m2 may be dosed with the oral capsules at 750 mg orally 2 times a day (1.5 g per day) -Pediatric patients with a body surface area greater than 1.5 m2 may be dosed with the oral capsules at 1 g orally 2 times a day (2 g per day) Comments: -This drug should be used concomitantly with cyclosporine and corticosteroids. -The IV formulation should be administered over no less than 2 hours.-IV administration is recommended in patients unable to take oral medication; oral administration should be initiated as soon as possible.   What other drugs will affect mycophenolate mofetil? If you take sevelamer or an antacid, take your oral mycophenolate mofetil dose 2 hours before you take these other medicines. Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. Tell your doctor about all your current medicines. Many drugs can affect mycophenolate mofetil, especially: azathioprine; cholestyramine; antiviral medicine--acyclovir, ganciclovir, valacyclovir, valganciclovir; an antibiotic--amoxicillin, ciprofloxacin, metronidazole, norfloxacin, rifampin, sulfa drugs; or a stomach acid reducer--esomeprazole, lansoprazole, omeprazole, Nexium, Prevacid, Prilosec, Protonix, and others. This list is not complete and many other drugs may affect mycophenolate mofetil. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

What is mycophenolic acid? Mycophenolic acid is used with other medicines to prevent organ rejection after a kidney transplant. mycophenolic acid is for use in adults and children at least 5 years old. Mycophenolic acid may also be used for purposes not listed in this medication guide. Warnings This medicine can cause a miscarriage or birth defects when used during pregnancy. Both men and women should use effective birth control to prevent pregnancy during and shortly after treatment with mycophenolic acid. Using mycophenolic acid may increase your risk of cancer, serious infections, or kidney transplant failure. Call your doctor right away if you have symptoms such as: fever, swollen glands, weight loss, vomiting or diarrhea, painful urination, a new skin lesion, any change in your mental state, weakness on one side of your body, or pain near your transplanted kidney. Before taking this medicine You should not use mycophenolic acid if you are allergic to mycophenolic acid, mycophenolate mofetil, or mycophenolate sodium. Talk with your doctor about the risks and benefits of mycophenolic acid. This medicine can affect your immune system, which may increase your risk of cancer, serious or fatal infections, or kidney transplant failure. Tell your doctor if you have ever had: a stomach ulcer or problems with digestion; hepatitis B or C or other a viral infection (may become active or get worse while you are using mycophenolic acid); or a rare inherited enzyme deficiency such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome. This medicine can cause a miscarriage or birth defects, especially during the first 3 months of pregnancy. You will need to have a negative pregnancy test before and during treatment with this medicine. If you are able to get pregnant, you must use specific forms of birth control to prevent pregnancy while using mycophenolic acid, and for at least 6 weeks after your last dose. Sexually active men and their partners should use effective contraception during treatment and for at least 90 days after the last dose. Mycophenolic acid can make birth control pills less effective. Ask your doctor about using an additional barrier form of birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy. You do not need to use additional birth control if you use an intrauterine device (IUD), if you have had a tubal ligation, or if your sexual partner has had a vasectomy. This medicine comes with patient instructions about the most effective non-hormonal forms of birth control to use. Follow these directions carefully. Ask your doctor if you have any questions. If a pregnancy occurs during treatment, do not stop taking mycophenolic acid. Call your doctor for instructions. Also call the Mycophenolate Pregnancy Registry (1-800-617-8191). Mycophenolic acid is sometimes given to pregnant women. Your doctor will decide whether you should use this medicine if you are unable to use other needed transplant medications. It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk. How should I take mycophenolic acid? Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Take this medicine on an empty stomach, at least 1 hour before or 2 hours after a meal. Swallow the tablet whole and do not crush, chew, or break it. Mycophenolic acid (Myfortic) and mycophenolate mofetil (CellCept) are not absorbed equally in the body. Avoid medication errors by using only the brand, form, and strength of this medicine that your doctor has prescribed. You will need frequent medical tests. Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use. What happens if I miss a dose? Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking mycophenolic acid? Avoid taking an antacid together with mycophenolic acid. Mycophenolic acid can make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Do not receive a "live" vaccine while using mycophenolic acid. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles). Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection. You must not donate blood or sperm while using mycophenolic acid, and for at least 6 weeks (for blood) or 90 days (for sperm) after your last dose. Mycophenolic acid side effects Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Mycophenolic acid may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly. Mycophenolic acid affects your immune system and may increase your risk of cancer or serious infection. Call your doctor right away if you have: fever of 100.5 degrees F or higher, swollen glands, painful mouth sores, cold or flu symptoms, headache, ear pain; stomach pain, vomiting, diarrhea, weight loss; weakness on one side of your body, loss of muscle control; confusion, thinking problems, loss of interest in things that normally interest you; pain or burning when you urinate; dark urine, jaundice (yellowing of the skin or eyes); pain or tenderness around the transplanted kidney; tingly or painful blistering rash on one side of your body; swelling, warmth, redness, or oozing around a skin wound; or a new skin lesion, or a mole that has changed in size or color. Also call your doctor at once if you have: bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or low blood cell counts--fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath. Common side effects may include: upset stomach, nausea, vomiting; diarrhea, constipation; low blood cell counts, infections; sleep problems (insomnia); painful urination; or pain after surgery. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   Mycophenolic acid dosing information Usual Adult Dose for Organ Transplant -- Rejection Prophylaxis: 720 mg orally 2 times daily Comments: -This drug should be used in combination with cyclosporine and corticosteroids. -Take on an empty stomach 1 hour before or 2 hours after food. -Swallow tablets whole; do not crush, chew, or divide. Use: For prophylaxis of organ rejection in kidney transplant Usual Pediatric Dose for Organ Transplant -- Rejection Prophylaxis: 5 years and older: -In conversion (at least 6 months posttransplant): 400 mg/m2 orally 2 times a day (up to a maximum dose of 720 mg 2 times a day) Note: Pediatric patients with a BSA of 1.19 to 1.58 m2 may be dosed either with three of the 180 mg tablets, or one 180 mg tablet plus one 360 mg tablet 2 times a day. Patients with a BSA greater than 1.58 m2 may be dosed either with four of the 180 mg tablets, or two of the 360 mg tablets twice daily. Pediatric doses for patients with BSA less than 1.19 m2 cannot be accurately administered using currently available formulations of this drug. Comments: -This drug should be used in combination with cyclosporine and corticosteroids. -Take on an empty stomach 1 hour before or 2 hours after food. -Swallow tablets whole; do not crush, chew, or divide. Use: For the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant   What other drugs will affect mycophenolic acid? Tell your doctor about all your other medicines, especially: azathioprine; cholestyramine; or antiviral medicine--acyclovir, ganciclovir. This list is not complete. Other drugs may affect mycophenolic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

What is nabumetone? Nabumetone is a nonsteroidal anti-inflammatory drug (NSAID). Nabumetone works by reducing hormones that cause inflammation and pain in the body. Nabumetone is used to relieve the symptoms of rheumatoid arthritis or osteoarthritis. Nabumetone may also be used for purposes not listed in this medication guide. Warnings Nabumetone can increase your risk of fatal heart attack or stroke. Do not use nabumetone just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Nabumetone may also cause stomach or intestinal bleeding, which can be fatal. Before taking this medicine Nabumetone can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Nabumetone may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using nabumetone, especially in older adults. You should not use nabumetone if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID. Tell your doctor if you have ever had: heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke; a heart attack, stroke, or blood clot; stomach ulcers or bleeding; asthma; liver or kidney disease; or fluid retention. If you are pregnant, you should not take nabumetone unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy. You should not breastfeed while using this medicine. Nabumetone is not approved for use by anyone younger than 18 years old. How should I take nabumetone? Follow all directions on your prescription label and read all medication guides. Your doctor may occasionally change your dose. Use the lowest dose that is effective in treating your condition. You may take nabumetone with or without food. If you use nabumetone long-term, you may need frequent medical tests. Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use. What happens if I miss a dose? Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking nabumetone? Avoid drinking alcohol. It may increase your risk of stomach bleeding. Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to nabumetone (such as aspirin, ibuprofen, ketoprofen, or naproxen). Nabumetone could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Nabumetone side effects Get emergency medical help if you have signs of an allergic reaction (hives, sneezing, runny or stuffy nose, wheezing, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling). Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath. Stop using nabumetone and call your doctor at once if you have: shortness of breath (even with mild exertion); swelling or rapid weight gain; the first sign of any skin rash, no matter how mild; signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet. Common side effects may include: stomach pain, indigestion, nausea; diarrhea, constipation, gas; swelling in your hands and feet; headache, dizziness; itching, skin rash; or ringing in your ears. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   Nabumetone dosing information Usual Adult Dose for Osteoarthritis: Initial dose: 1000 mg orally once a day Maintenance dose: 1500 to 2000 mg orally per day in 1 or 2 divided doses Maximum dose: 2000 mg/day Comments: -Patients weighing less than 50 kg may be less likely to require dosages beyond 1000 mg. -Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals. Use: For the relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. Usual Adult Dose for Rheumatoid Arthritis: Initial dose: 1000 mg orally once a day Maintenance dose: 1500 to 2000 mg orally per day in 1 or 2 divided doses Maximum dose: 2000 mg/day Comments: -Patients weighing less than 50 kg may be less likely to require dosages beyond 1000 mg. -Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals. Use: For the relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.   What other drugs will affect nabumetone? Ask your doctor before using nabumetone if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily. Tell your doctor about all your other medicines, especially: lithium; methotrexate; a blood thinner (warfarin, Coumadin, Jantoven); heart or blood pressure medication, including a diuretic or "water pill"; or steroid medicine (such as prednisone). This list is not complete. Other drugs may affect nabumetone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

What is naltrexone? Naltrexone blocks the effects of opioid medication, including pain relief or feelings of well-being that can lead to opioid abuse. An opioid is sometimes called a narcotic. Vivitrol is used as part of a treatment program for drug or alcohol dependence. Naltrexone injection is used to prevent relapse in adults who became dependent on opioid medicine and then stopped using it. Naltrexone can help keep you from feeling a "need" to use the opioid. Naltrexone injection is also used to treat alcoholism by reducing your urge to drink alcohol. This may help you drink less or stop drinking altogether. You should not be drinking at the time you receive your first injection. Naltrexone is not a permanent cure for drug addiction or alcoholism. Warnings You should be treated with naltrexone only if you have not recently used: any opioid medicine, buprenorphine, methadone, or medicine to treat a cold, cough, diarrhea, or pain. Using these medicines in the 7 to 14 days before starting naltrexone can cause sudden opioid withdrawal symptoms. Do not use opioid medication, heroin, or other street drugs while you are receiving this medicine. Doing so could result in dangerous effects, including coma and death. Call your doctor if you have ongoing or worsening pain, redness, itching, bruising, swelling, or a hard lump where the medicine was injected. Naltrexone can harm your liver. Tell your doctor if you have upper stomach pain, dark urine, or yellowing in the whites of your eyes. After receiving naltrexone, your body will be more sensitive to opioids if you use an opioid medicine in the future. Using the same amount you used before could lead to overdose or death. Before taking this medicine You should not receive a naltrexone injection if you still use opioid medicine, or you could have sudden and severe withdrawal symptoms. You should not be treated with naltrexone if you are allergic to it, or if: you are currently addicted to opioids; you are having withdrawal symptoms from opioid addiction; you have used any opioid medicine within the past 7 to 14 days (including fentanyl, Vicodin, OxyContin, and many others); you have used methadone or buprenorphine (Subutex, Butrans, Suboxone, Zubsolv) in the past 14 days; or you have used any medicine to treat a cold, cough, diarrhea, or pain in the past 7 to 14 days. To make sure naltrexone is safe for you, tell your doctor if you have ever had: liver disease; kidney disease; or bleeding problems such as hemophilia. Tell your doctor if you are pregnant or breastfeeding. It is not known whether naltrexone will harm an unborn baby. However, if you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks. How is naltrexone given? Naltrexone is injected into a muscle. This injection is usually given once a month (every 4 weeks) and can be given only by a healthcare professional. Get your naltrexone injection regularly to get the most benefit. You may notice pain, redness, itching, bruising, swelling, or a hard lump where the medicine was injected. Call your doctor if you have this type of reaction, especially if it gets worse or does not clear up within 2 weeks. Naltrexone injections are only part of a complete treatment program that may also include additional forms of counseling and/or monitoring. Follow your doctor's instructions very closely. In case of emergency, wear or carry medical identification to let others know you are using this medicine. After using naltrexone, your body will be more sensitive to opioids. If you use an opioid medicine in the future, you will need to use less than before naltrexone treatment. Using the same amount you used before could lead to overdose or death. Dosing information Usual Adult Dose for Alcohol Dependence: Injection: 380 mg intramuscularly every 4 weeks/once a month Usual Adult Dose for Opiate Addiction: Injection: 380 mg intramuscularly every 4 weeks/once a month Comments: -There is no data specifically addressing switching from buprenorphine or methadone to naltrexone, however some patients have reported severe manifestations of precipitated withdrawal when switched from an opioid agonist to opioid antagonist therapy. -Patients switching from buprenorphine or methadone may be vulnerable to precipitated withdrawal for up to 2 weeks. -Be prepared to manage withdrawal symptomatically with non-opioid medications. -This drug is of value only as a part of a comprehensive management plan that includes measures to ensure the patient takes this medication. Use(s): Blockade of the effects of exogenously administered opioids   What happens if I miss a dose? Call your doctor for instructions if you miss an appointment for your injection. What happens if I overdose? Since this injection is given by a healthcare professional in a medical setting, an overdose is unlikely to occur. However, overdose symptoms may include nausea, stomach pain, drowsiness, dizziness, or a reaction where an injection was given (such as severe pain or skin changes). What should I avoid while using naltrexone? Do not use opioid medication, heroin, or other street drugs while you are receiving naltrexone. Once naltrexone is injected, it cannot be removed from your body. Never try to overcome the effects of naltrexone by taking large doses of opioids. Doing so could result in dangerous effects, including coma and death. Ask your doctor before using any medicine to treat a cold, cough, diarrhea, or pain. These medicines may contain opioids and may not work as well while you are using this medicine. Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries. Naltrexone side effects Get emergency medical help if you have signs of an allergic reaction to naltrexone: hives; chest pain, wheezing, difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat. Using opioid medicine while you are receiving this medicine could stimulate opioid withdrawal symptoms. Common withdrawal symptoms are yawning, sweating, fever, stomach pain, vomiting, diarrhea, watery eyes, runny nose, goose bumps, body aches, shaking, muscle twitching, trouble sleeping, and feeling restless or anxious. Call your doctor at once if you have: weak or shallow breathing; new or worsening cough, wheezing, trouble breathing; severe pain, swelling, blistering, skin changes, a dark scab, or a hard lump where the medicine was injected; liver problems - stomach pain (upper right side), dark urine, tiredness, jaundice (yellowing of the skin or eyes); or symptoms of depression - unusual mood or behavior changes, loss of interest in things you once enjoyed, crying, new sleep problems, thoughts about hurting yourself. You may feel nauseated the first time you receive this medicine. You may also have a headache, tiredness, joint and muscle pain, loss of appetite, and vomiting. Common naltrexone side effects may include: nausea, vomiting, loss of appetite; joint pain, muscle cramps; dizziness, drowsiness; sleep problems (insomnia); tooth pain; or cold symptoms such as stuffy nose, sneezing, sore throat. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   What other drugs will affect naltrexone? Other drugs may interact with naltrexone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

What is naproxen? Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body. Naproxen is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps. It can also be used to treat acute pain caused by other conditions not listed in this medication guide. The delayed-release or extended-release tablets are slower-acting forms of naproxen that are used only for treating chronic conditions such as arthritis or ankylosing spondylitis. These forms will not work fast enough to treat acute pain. Warnings You should not use naproxen if you have a history of allergic reaction to aspirin or other NSAID (nonsteroidal anti-inflammatory drug). Naproxen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Get emergency medical help if you have swelling of the face or throat, chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance. Stop taking naproxen and notify your physician if you notice stomach pain, tiredness or weakness, yellow skin or eyes, nausea, vomiting, bloody or black and sticky bowel movements, skin rash, unexplained weight loss or weight gain, or swelling of the hands and feet. Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults. Before taking this medicine Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults. You should not use naproxen if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID. Ask a doctor before giving naproxen to a child younger than 12 years old. Ask a doctor or pharmacist if it is safe for you to use this medicine if you have: heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke; a history of heart attack, stroke, or blood clot; a history of stomach ulcers or bleeding; asthma; liver or kidney disease; fluid retention: or if you take aspirin to prevent heart attack or stroke. If you are pregnant, you should not take naproxen unless your doctor tells you to. Taking a NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy. It may not be safe to breastfeed while using naproxen. Ask your doctor about any risk. Naproxen is not approved for use by anyone younger than 2 years old. Do not give this medicine to a child without medical advice. How should I take naproxen? Use naproxen exactly as directed on the label, or as prescribed by your doctor. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition. Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one. If you change brands, strengths, or forms of this medicine, your dosage needs may change. Ask your pharmacist if you have any questions about the kind of naproxen you are using. If a child is using this medicine, tell your doctor if the child has any changes in weight. Doses are based on weight in children, and any changes may affect your child's dose. If you use this medicine long-term, you may need frequent medical tests. This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using naproxen. Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.   What happens if I miss a dose? Since naproxen is sometimes used only when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What to avoid Avoid drinking alcohol. It may increase your risk of stomach bleeding. Avoid taking aspirin unless your doctor tells you to. Ask your doctor before taking any other medication for pain, arthritis, fever, or swelling. Many medicines available over the counter contain aspirin, salicylates, or other medicines similar to naproxen (such as ibuprofen or ketoprofen). Taking certain products together can cause you to get too much of this type of medication. Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb naproxen. Naproxen side effects Get emergency medical help if you have signs of an allergic reaction to naproxen: wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat. Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath. Stop using naproxen and call your doctor at once if you have: shortness of breath (even with mild exertion); swelling or rapid weight gain; the first sign of any skin rash, no matter how mild; signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; liver problems - nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); kidney problems - little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling. Common naproxen side effects may include: indigestion, heartburn, stomach pain, nausea; headache, dizziness, drowsiness; bruising, itching, rash; swelling; or ringing in your ears. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   What other drugs will affect naproxen? Ask your doctor before using naproxen if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily. Ask a doctor or pharmacist if it is safe for you to use this medicine if you are also using any of the following drugs: cholestyramine; cyclosporine; digoxin; lithium; methotrexate; pemetrexed; phenytoin or similar seizure medications; probenecid; warfarin (Coumadin, Jantoven) or similar blood thinners; a diuretic or "water pill"; heart or blood pressure medication; or insulin or oral diabetes medicine. This list is not complete. Other drugs may interact with naproxen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

What is naproxen? Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body. Naproxen is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps. It can also be used to treat acute pain caused by other conditions not listed in this medication guide. The delayed-release or extended-release tablets are slower-acting forms of naproxen that are used only for treating chronic conditions such as arthritis or ankylosing spondylitis. These forms will not work fast enough to treat acute pain. Warnings You should not use naproxen if you have a history of allergic reaction to aspirin or other NSAID (nonsteroidal anti-inflammatory drug). Naproxen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Get emergency medical help if you have swelling of the face or throat, chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance. Stop taking naproxen and notify your physician if you notice stomach pain, tiredness or weakness, yellow skin or eyes, nausea, vomiting, bloody or black and sticky bowel movements, skin rash, unexplained weight loss or weight gain, or swelling of the hands and feet. Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults. Before taking this medicine Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults. You should not use naproxen if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID. Ask a doctor before giving naproxen to a child younger than 12 years old. Ask a doctor or pharmacist if it is safe for you to use this medicine if you have: heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke; a history of heart attack, stroke, or blood clot; a history of stomach ulcers or bleeding; asthma; liver or kidney disease; fluid retention: or if you take aspirin to prevent heart attack or stroke. If you are pregnant, you should not take naproxen unless your doctor tells you to. Taking a NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy. It may not be safe to breastfeed while using naproxen. Ask your doctor about any risk. Naproxen is not approved for use by anyone younger than 2 years old. Do not give this medicine to a child without medical advice. How should I take naproxen? Use naproxen exactly as directed on the label, or as prescribed by your doctor. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition. Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one. If you change brands, strengths, or forms of this medicine, your dosage needs may change. Ask your pharmacist if you have any questions about the kind of naproxen you are using. If a child is using this medicine, tell your doctor if the child has any changes in weight. Doses are based on weight in children, and any changes may affect your child's dose. If you use this medicine long-term, you may need frequent medical tests. This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using naproxen. Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.   What happens if I miss a dose? Since naproxen is sometimes used only when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What to avoid Avoid drinking alcohol. It may increase your risk of stomach bleeding. Avoid taking aspirin unless your doctor tells you to. Ask your doctor before taking any other medication for pain, arthritis, fever, or swelling. Many medicines available over the counter contain aspirin, salicylates, or other medicines similar to naproxen (such as ibuprofen or ketoprofen). Taking certain products together can cause you to get too much of this type of medication. Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb naproxen. Naproxen side effects Get emergency medical help if you have signs of an allergic reaction to naproxen: wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat. Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath. Stop using naproxen and call your doctor at once if you have: shortness of breath (even with mild exertion); swelling or rapid weight gain; the first sign of any skin rash, no matter how mild; signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; liver problems - nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); kidney problems - little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling. Common naproxen side effects may include: indigestion, heartburn, stomach pain, nausea; headache, dizziness, drowsiness; bruising, itching, rash; swelling; or ringing in your ears. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   What other drugs will affect naproxen? Ask your doctor before using naproxen if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily. Ask a doctor or pharmacist if it is safe for you to use this medicine if you are also using any of the following drugs: cholestyramine; cyclosporine; digoxin; lithium; methotrexate; pemetrexed; phenytoin or similar seizure medications; probenecid; warfarin (Coumadin, Jantoven) or similar blood thinners; a diuretic or "water pill"; heart or blood pressure medication; or insulin or oral diabetes medicine. This list is not complete. Other drugs may interact with naproxen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

What is nebivolol? Nebivolol is a beta-blocker that is used to treat hypertension (high blood pressure). Lowering blood pressure may lower your risk of a stroke or heart attack. Nebivolol may also be used for purposes not listed in this medication guide. Warnings Do not skip doses or stop taking nebivolol without first talking to your doctor. Before taking this medicine You should not take nebivolol if you are allergic to it, or if you have: a serious heart condition such as heart failure, "AV block" (2nd or 3rd degree), or sick sinus syndrome (unless you have a pacemaker); very slow heartbeats; severe liver disease; or if your heart cannot pump blood properly. Tell your doctor if you have ever had: asthma, bronchitis, emphysema; a heart attack; problems with circulation (especially in your feet and legs); diabetes (taking nebivolol can make it harder for you to tell when you have low blood sugar); a thyroid disorder; liver or kidney disease; allergies; or pheochromocytoma (tumor of the adrenal gland). Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether nebivolol will harm an unborn baby. However, having high blood pressure during pregnancy may cause complications such as diabetes or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating hypertension may outweigh any risks to the baby. You should not breastfeed while using nebivolol. How should I take nebivolol? Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed. You may take nebivolol with or without food. Your blood pressure will need to be checked often. If you need surgery, tell the surgeon ahead of time that you are using nebivolol. You should not skip doses or stop using nebivolol suddenly. Stopping suddenly may make your condition worse or cause serious heart problems, including heart attack. Follow your doctor's instructions about tapering your dose. Keep using nebivolol as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life. Store at room temperature away from moisture and heat. What happens if I miss a dose? Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include slow heart rate, dizziness, vomiting, trouble breathing, or feeling like you might pass out. What should I avoid while taking nebivolol? Avoid driving or hazardous activity until you know how nebivolol will affect you. Your reactions could be impaired. Nebivolol side effects Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: a light-headed feeling, like you might pass out; rapid weight gain; shortness of breath; slow or uneven heartbeats; or numbness or cold feeling in your hands and feet. Common side effects may include: dizziness; swelling in your legs; slow heartbeats; tiredness; or headache. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   Nebivolol dosing information Usual Adult Dose for Hypertension: Initial dose: 5 mg orally once a day Dose adjustment: Titrate dose at 2-week intervals up to 40 mg once a day as needed. Maximum dose: 40 mg per day Comments: -Titrating doses more frequently than every 2 weeks is unlikely to be beneficial. -The dose should be individualized to patient requirements. Use: For the management of hypertension, alone or with another antihypertensive agent.   What other drugs will affect nebivolol? Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. Many drugs can affect nebivolol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.