What is diltiazem? Diltiazem is a calcium channel blocker. It works by relaxing the muscles of your heart and blood vessels. Diltiazem is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. Diltiazem may also be used for purposes not listed in this medication guide. Warnings You should not use diltiazem if you have very low blood pressure, a serious heart condition such as "sick sinus syndrome" or "second- or third-degree AV block" (unless you have a pacemaker), or if you have recently had a heart attack and you have a build-up of fluid in your lungs. Before taking diltiazem, tell your doctor if you have kidney disease, liver disease, or congestive heart failure. Diltiazem 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 medication without first talking to your doctor. If you stop taking diltiazem suddenly, your condition may become worse. Diltiazem may be only part of a complete program of treatment that also includes diet, exercise, and other medications. Follow your diet, medication, and exercise routines very closely. 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. However, if you have symptoms of low blood pressure (dizziness, fainting, weakness, or blurred vision), call your doctor and stop taking diltiazem. Before taking this medicine You should not use diltiazem if you are allergic to it, or if you have: a serious heart condition such as "sick sinus syndrome" or "second- or third-degree AV block" (unless you have a pacemaker); very low blood pressure; or if you have recently had a heart attack and you have a build-up of fluid in your lungs. To make sure diltiazem is safe for you, tell your doctor if you have: kidney disease; liver disease; congestive heart failure; or if you also take digoxin, or a beta blocker (such as atenolol, carvedilol, metoprolol, propranolol, sotalol, and others). It is not known whether diltiazem will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Diltiazem can pass into breast milk and may harm a nursing baby. You should not breastfeed while using this medicine. How should I take diltiazem? Take diltiazem exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended. Do not crush, chew, break, or open an extended-release diltiazem tablet or capsule. Swallow it whole. To make swallowing easier, ask your doctor or pharmacist if you can open a diltiazem capsule and sprinkle the medicine into a spoonful of applesauce. Swallow right away without chewing. Do not save the mixture for later use. Use diltiazem regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You should not stop using diltiazem suddenly. Stopping suddenly may make your condition worse. 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. Your blood pressure will need to be checked often. You may also need frequent blood tests. Store diltiazem 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. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of diltiazem can be fatal. Overdose symptoms may include slow heartbeat, weakness, chest pain, shortness of breath, or fainting. What to avoid Grapefruit and grapefruit juice may interact with diltiazem and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor. Diltiazem may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol while taking diltiazem. Avoid taking herbal supplements containing St. John's wort at the same time you are taking diltiazem. Diltiazem side effects Get emergency medical help if you have signs of an allergic reaction to diltiazem: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: slow heartbeats; pounding heartbeats or fluttering in your chest; a light-headed feeling, like you might pass out; shortness of breath (even with mild activity), swelling, rapid weight gain; nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); 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 diltiazem side effects may include: swelling; dizziness, weakness; headache; nausea; or rash. 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 diltiazem? Many drugs can interact with diltiazem, and your doctor may need to change your treatment plan if you use certain other medicines. The following are common drugs that interact with diltiazem; Medications used in anesthesia; Anti-anxiety medications called benzodiazepines (such as midazolam, triazolam, and others) as well as busipirone; Beta-blockers (such as atenolol, carvedilol, metoprolol, propranolol, sotalol, and others); Carbamazepine; Cimetidine; Clonidine; Digitalis; Quinidine; Rifampin; and Cholesterol medication called statins (such as atorvastatin, lovastatin, simvastatin, rosuvastatin, and others) Not all possible interactions are listed in this medication guide. Other prescription and over-the-counter medicines, vitamins, and herbal products may interact with diltiazem. Tell your doctor about all medicines you use, and those you start or stop using. Give a list of all your medicines to any healthcare provider who treats you.

What is diltiazem? Diltiazem is a calcium channel blocker. It works by relaxing the muscles of your heart and blood vessels. Diltiazem is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. Diltiazem may also be used for purposes not listed in this medication guide. Warnings You should not use diltiazem if you have very low blood pressure, a serious heart condition such as "sick sinus syndrome" or "second- or third-degree AV block" (unless you have a pacemaker), or if you have recently had a heart attack and you have a build-up of fluid in your lungs. Before taking diltiazem, tell your doctor if you have kidney disease, liver disease, or congestive heart failure. Diltiazem 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 medication without first talking to your doctor. If you stop taking diltiazem suddenly, your condition may become worse. Diltiazem may be only part of a complete program of treatment that also includes diet, exercise, and other medications. Follow your diet, medication, and exercise routines very closely. 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. However, if you have symptoms of low blood pressure (dizziness, fainting, weakness, or blurred vision), call your doctor and stop taking diltiazem. Before taking this medicine You should not use diltiazem if you are allergic to it, or if you have: a serious heart condition such as "sick sinus syndrome" or "second- or third-degree AV block" (unless you have a pacemaker); very low blood pressure; or if you have recently had a heart attack and you have a build-up of fluid in your lungs. To make sure diltiazem is safe for you, tell your doctor if you have: kidney disease; liver disease; congestive heart failure; or if you also take digoxin, or a beta blocker (such as atenolol, carvedilol, metoprolol, propranolol, sotalol, and others). It is not known whether diltiazem will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Diltiazem can pass into breast milk and may harm a nursing baby. You should not breastfeed while using this medicine. How should I take diltiazem? Take diltiazem exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended. Do not crush, chew, break, or open an extended-release diltiazem tablet or capsule. Swallow it whole. To make swallowing easier, ask your doctor or pharmacist if you can open a diltiazem capsule and sprinkle the medicine into a spoonful of applesauce. Swallow right away without chewing. Do not save the mixture for later use. Use diltiazem regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You should not stop using diltiazem suddenly. Stopping suddenly may make your condition worse. 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. Your blood pressure will need to be checked often. You may also need frequent blood tests. Store diltiazem 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. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of diltiazem can be fatal. Overdose symptoms may include slow heartbeat, weakness, chest pain, shortness of breath, or fainting. What to avoid Grapefruit and grapefruit juice may interact with diltiazem and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor. Diltiazem may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol while taking diltiazem. Avoid taking herbal supplements containing St. John's wort at the same time you are taking diltiazem. Diltiazem side effects Get emergency medical help if you have signs of an allergic reaction to diltiazem: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: slow heartbeats; pounding heartbeats or fluttering in your chest; a light-headed feeling, like you might pass out; shortness of breath (even with mild activity), swelling, rapid weight gain; nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); 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 diltiazem side effects may include: swelling; dizziness, weakness; headache; nausea; or rash. 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 diltiazem? Many drugs can interact with diltiazem, and your doctor may need to change your treatment plan if you use certain other medicines. The following are common drugs that interact with diltiazem; Medications used in anesthesia; Anti-anxiety medications called benzodiazepines (such as midazolam, triazolam, and others) as well as busipirone; Beta-blockers (such as atenolol, carvedilol, metoprolol, propranolol, sotalol, and others); Carbamazepine; Cimetidine; Clonidine; Digitalis; Quinidine; Rifampin; and Cholesterol medication called statins (such as atorvastatin, lovastatin, simvastatin, rosuvastatin, and others) Not all possible interactions are listed in this medication guide. Other prescription and over-the-counter medicines, vitamins, and herbal products may interact with diltiazem. Tell your doctor about all medicines you use, and those you start or stop using. Give a list of all your medicines to any healthcare provider who treats you.

What is doxazosin? Doxazosin is an alpha-adrenergic (AL-fa ad-ren-ER-jik) blockers. It relaxes your veins and arteries so that blood can more easily pass through them. It also relaxes the muscles in the prostate and bladder neck, making it easier to urinate. Doxazosin is used to treat hypertension (high blood pressure), or to improve urination in men with benign prostatic hyperplasia (enlarged prostate). The extended-release form of doxazosin (Cardura XL) is for use only in treating benign prostatic hyperplasia and should not be used to treat hypertension. Warnings Doxazosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using doxazosin. Do not stop using this medicine before surgery unless your surgeon tells you. You should not use this medication if you are allergic to doxazosin or similar medicines such as alfuzosin (Uroxatral), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), or terazosin (Hytrin). Doxazosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. Be careful if you drive or do anything that requires you to be alert. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Tell your doctor about all other medications you use, especially other blood pressure medications including diuretics (water pills). Before taking this medicine You should not use this medicine if you are allergic to doxazosin or similar medicines such as alfuzosin (Uroxatral), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), or terazosin (Hytrin). To make sure doxazosin is safe for you, tell your doctor if you have: a blockage in your digestive tract (stomach or intestines); severe constipation; liver disease; or low blood pressure. Doxazosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using this medicine before surgery unless your surgeon tells you to. It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether doxazosin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine. How should I take doxazosin? Take doxazosin exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended. Doxazosin lowers blood pressure and may cause dizziness or fainting, especially when you first start taking it, or when you start taking it again. You may feel very dizzy when you first wake up. Be careful when standing or sitting up from a lying position. Call your doctor if you have severe dizziness or feel like you might pass out. While using doxazosin, your blood pressure or prostate may need to be checked often. If you stop taking doxazosin for any reason, ask your doctor before you start taking it again. You may need a dose adjustment. 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 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. If you miss your doses for several days in a row, call your doctor before restarting the medication. You may need a lower 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 extreme dizziness or fainting. What to avoid Doxazosin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. To prevent dizziness, avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Drinking alcohol with this medicine can cause side effects. Doxazosin side effects Get emergency medical help if you have signs of an allergic reaction to doxazosin: hives; difficulty 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; severe ongoing stomach pain or bloating; new or worsening chest pain; trouble breathing; or a penis erection that is painful or lasts 4 hours or longer. Common doxazosin side effects may include: low blood pressure, dizziness; drowsiness; headache; or feeling weak or tired. 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.   Dosing information Usual Adult Dose for Hypertension: Initial dose: 1 mg orally once a day. Maintenance dose: 1 to 16 mg orally once a day. Usual Adult Dose for Benign Prostatic Hyperplasia: Initial dose: Immediate-release: 1 mg orally once a day. Extended-release: 4 mg orally once a day with breakfast Maintenance dose: Immediate-release: 1 to 8 mg orally once a day. Extended-release: 4 to 8 mg orally once a day with breakfast. Depending on the patient's symptomatic response and tolerability, the dose may be increased to 8 mg (the maximum recommended dose). The recommended titration interval is 3 to 4 weeks. If switching from immediate-release doxazosin tablets to extended-release tablets, therapy should be initiated with the lowest dose (4 mg once daily). Prior to starting therapy with doxazosin extended-release tablets, the final evening dose of immediate-release tablets should not be taken. If doxazosin extended-release tablets are discontinued for several days, therapy should be restarted using the 4 mg once daily dose. Usual Geriatric Dose for Hypertension: Initial dose: 0.5 mg orally once a day.   What other drugs will affect doxazosin? Tell your doctor about all your current medicines and any you start or stop using, especially: an antibiotic; an antidepressant; medicine to treat HIV or AIDS; or sildenafil (Viagra) or other erectile dysfunction medicines. This list is not complete. Other drugs may interact with doxazosin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

What is enalapril? Enalapril is an ACE inhibitor. ACE stands for angiotensin converting enzyme. Enalapril is used to treat high blood pressure (hypertension) in adults and children who are at least 1 month old. Enalapril is also used to treat congestive heart failure (CHF). CHF is a disorder of the ventricles (the lower chambers of the heart) which decreases the heart’s ability to pump blood to the body. Warnings Do not use enalapril if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. You should not use enalapril if you have ever had angioedema. Do not take enalapril within 36 hours before or after taking any medicine that contains sacubatril (such as Entresto). If you have diabetes, do not use enalapril together with any medication that contains aliskiren (such as Tekturna or Tekamlo). Enalapril can affect your heart or your electrolyte levels. Call your doctor if you have chest pain, pounding heartbeats or fluttering in your chest, a slow heart rate or weak pulse, a tingly feeling, muscle weakness, or muscle tightness or contraction. Before taking this medicine You should not use enalapril if you are allergic to it, or if you have: you have a history of angioedema; you recently took a heart medicine called sacubatril; or if you are allergic to any other ACE inhibitor, such as benazepril, captopril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril. Do not take enalapril within 36 hours before or after taking medicine that contains sacubatril (such as Entresto). If you have diabetes, do not use enalapril together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo). You may also need to avoid taking enalapril with aliskiren if you have kidney disease. To make sure enalapril is safe for you, tell your doctor if you have: kidney disease (or if you are on dialysis); liver disease; a history of blood clot or stroke (including TIA or "mini-stroke"); an electrolyte imbalance (such as high levels of potassium in your blood); or heart disease. Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. Enalapril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Enalapril can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using this medicine. How should I take enalapril? Take enalapril exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended. You may take enalapril with or without food. 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. Your blood pressure will need to be checked often. Your kidney or liver function may also need to be tested. Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking enalapril. This can lead to very low blood pressure, electrolyte disorders, or kidney failure. 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. If you need surgery, tell the surgeon ahead of time that you are using enalapril. Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use. Store the liquid medicine in the refrigerator, do not freeze. Throw away any liquid medicine not used within 60 days.   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. What to avoid Drinking alcohol can further lower your blood pressure and may increase certain side effects of enalapril. Do not use salt substitutes or potassium supplements while taking enalapril, unless your doctor has told you to. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Enalapril side effects Get emergency medical help if you have signs of an allergic reaction to enalapril: hives; severe stomach pain; 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; slow heartbeats; pounding heartbeats or fluttering in your chest; little or no urination; jaundice (yellowing of the skin or eyes); numbness, tingling, or burning pain in your hands or feet; fever, chills, cold or flu symptoms; easy bruising, unusual bleeding; or high potassium - nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement. Common enalapril side effects may include: dizziness, feeling tired; cough; or feeling light-headed. 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 enalapril? Tell your doctor about all medicines you use, and those you start or stop using during your treatment with enalapril, especially: lithium; a diuretic or "water pill"; gold injections to treat arthritis; or NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others. This list is not complete. Other drugs may interact with enalapril, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

What is eplerenone? Eplerenone is used to lower the risk of death from heart failure after a heart attack. Eplerenone is also used to treat high blood pressure (hypertension). Eplerenone may also be used for purposes not listed in this medication guide. Warnings You may not be able to take eplerenone if you have severe kidney disease, high potassium levels in your blood, or type 2 diabetes with increased levels of albumin (a protein) in your urine. Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together. Before taking this medicine You may not be able to take this medicine if you are allergic to eplerenone, or if you have: high potassium levels in your blood (hyperkalemia); severe kidney disease; or type 2 diabetes with increased levels of albumin (a protein) in your urine. Some medicines can cause unwanted or dangerous effects when used with eplerenone. Your doctor may change your treatment plan if you also use: nefazodone; a potassium supplement; an antibiotic--clarithromycin, telithromycin; antifungal medicine--itraconazole, ketoconazole; a diuretic or "water pill"--amiloride, spironolactone, triamterene; or antiviral medicine to treat HIV/AIDS--indinavir, nelfinavir, ritonavir, saquinavir. Tell your doctor if you have ever had: kidney disease; diabetes; liver disease; high cholesterol or triglycerides; or if you take other heart or blood pressure medications. Tell your doctor if you are pregnant or breastfeeding. It is not known whether eplerenone 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). Heart failure can get worse during pregnancy and may cause complications such as premature birth. The benefit of treating hypertension or heart failure may outweigh any risks to the baby. This medicine may affect fertility (ability to have children) in men. How should I take eplerenone? 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. Eplerenone may be taken with or without food. You may need blood tests, and your blood pressure will need to be checked often. If you have high blood pressure, keep using eplerenone 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. What should I avoid while taking eplerenone? Do not use potassium supplements or salt substitutes, unless your doctor has told you to. This drug side effects Get emergency medical help if you have signs of an allergic reaction: hives; severe stomach pain; difficulty 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; diarrhea, vomiting; little or no urination; fast or irregular heartbeats; trouble breathing; swelling in your feet or lower legs; or high potassium--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement. Common side effects may include: high potassium; headache; or 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.   Eplerenone dosing information Usual Adult Dose for Congestive Heart Failure: Initial dose: 25 mg orally once a day; titrate to the target dose preferably within 4 weeks as tolerated. Target dose: 50 mg orally once a day Use: To improve survival of stable patients with symptomatic heart failure with reduced ejection fraction (40% or less) after an acute myocardial infarction. Usual Adult Dose for Hypertension: Initial dose: 50 mg orally once a day Maintenance dose: 50 mg orally once or twice a day Maximum dose: 100 mg/day Comments: -Full therapeutic effect is apparent within 4 weeks. -Patients with inadequate blood pressure response to the initial dose may be increased to 50 mg twice a day.   What other drugs will affect eplerenone? Tell your doctor about all your current medicines. Many drugs can affect eplerenone, especially: lithium; heart or blood pressure medicine--amiodarone, benazepril, diltiazem, dronedarone, enalapril, lidocaine, lisinopril, olmesartan, valsartan, verapamil, and others; or; NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others. This list is not complete and many other drugs may affect eplerenone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.  

What is felodipine? Felodipine is a calcium channel blocker that is used to treat hypertension (high blood pressure) in adults. Lowering blood pressure can help lower your risk of a stroke or heart attack. Felodipine 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 felodipine if you are allergic to it. Tell your doctor if you have ever had: liver disease; or congestive heart failure. Felodipine may harm an unborn baby or cause problems with labor and delivery. Tell your doctor if you are pregnant or plan to become pregnant. You should not breast-feed while using felodipine. Felodipine is not approved for use by anyone younger than 18 years old. How should I take felodipine? 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 felodipine with or without food, but take it the same way each time. Swallow the tablet whole and do not crush, chew, or break it. Your blood pressure will need to be checked often. You may also need to take other medications, exercise, limit salt intake, stop smoking, and manage other conditions such as diabetes or heart disease. Follow your doctor's instructions very closely. Use all medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. 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. Keep using felodipine 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 heartbeats, warmth or tingling, and feeling like you might pass out. What should I avoid while taking felodipine? Drinking alcohol can lower your blood pressure further and may increase certain side effects of felodipine. Grapefruit may interact with felodipine and lead to unwanted side effects. Avoid the use of grapefruit products. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Felodipine 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; chest pain; feeling short of breath; or swelling or rapid weight gain. Felodipine can cause mild gum swelling. Pay special attention to your dental hygiene while taking felodipine. Brush and floss your teeth regularly. Common side effects may include: swelling in your arms, hands, legs, or feet; headache; or flushing (sudden warmth, redness, or tingly feeling). 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.   Felodipine dosing information Usual Adult Dose for Hypertension: Initial dose: 5 mg orally once a day Maintenance dose: 2.5 to 10 mg orally once a day Comments: If needed, dose adjustments should generally occur at intervals of at least 2 weeks. Usual Geriatric Dose for Hypertension: Initial dose: 2.5 to 5 mg orally once a day Maintenance dose: 2.5 to 10 mg orally once a day Comments: If needed, dose adjustments should generally occur at intervals of at least 2 weeks. Usual Pediatric Dose for Hypertension: (Not approved by FDA) NIH and NHLBI recommendations: 1 year or older: Initial dose: 2.5 mg orally once a day Maintenance dose: 2.5 to 10 mg orally once a day Maximum dose: 10 mg/day   What other drugs will affect felodipine? 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 felodipine. 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.

What is hydralazine? Hydralazine is a vasodilator that works by relaxing the muscles in your blood vessels to help them dilate (widen). This lowers blood pressure and allows blood to flow more easily through your veins and arteries. Hydralazine is used to treat high blood pressure (hypertension). Hydralazine may also be used for purposes not listed in this medication guide. Warnings You should not use hydralazine if you have coronary artery disease, or rheumatic heart disease affecting the mitral valve. Before taking this medicine You should not use hydralazine if you are allergic to it, or if you have: coronary artery disease; or rheumatic heart disease affecting the mitral valve. To make sure hydralazine is safe for you, tell your doctor if you have ever had: kidney disease; systemic lupus erythematosus; angina (chest pain); or a stroke. It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Hydralazine can pass into breast milk, but effects on the nursing baby are not known. Tell your doctor if you are breast-feeding. Hydralazine is not approved for use by anyone younger than 18 years old. How should I take hydralazine? Follow all directions on your prescription label. Do not take hydralazine in larger or smaller amounts or for longer than recommended. Your blood pressure will need to be checked often. You may also need frequent blood tests. Keep using this medicine 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 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 rapid heartbeats, warmth or tingling under your skin, chest pain, or fainting. What should I avoid while taking hydralazine? Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Hydralazine 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 or pressure, pain spreading to your jaw or shoulder; fast or pounding heartbeats; a light-headed feeling, like you might pass out; numbness, tingling, or burning pain in your hands or feet; painful or difficult urination; little or no urination; or lupus-like syndrome--joint pain or swelling with fever, swollen glands, muscle aches, chest pain, vomiting, unusual thoughts or behavior, and patchy skin color. Common side effects may include: chest pain, fast heart rate; headache; or nausea, vomiting, diarrhea, loss of appetite. 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 hydralazine? Tell your doctor about all your current medicines and any you start or stop using, especially: diazoxide (an injectable blood pressure medication); or an MAO inhibitor--isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others. This list is not complete. Other drugs may interact with hydralazine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

What is irbesartan? Irbesartan is an angiotensin II receptor blocker (sometimes called an ARB). Irbesartan is used to treat high blood pressure (hypertension) in adults and children at least 6 years old. Lowering blood pressure may lower your risk of a stroke or heart attack. Irbesartan is also used to treat kidney problems caused by type 2 diabetes. Irbesartan may also be used for purposes not listed in this medication guide. Warnings Do not use if you are pregnant. Stop using and tell your doctor right away if you become pregnant. If you have diabetes, do not take irbesartan with any medication that contains aliskiren (a blood pressure medicine). Before taking this medicine You should not use irbesartan if you are allergic to it. If you have diabetes, do not take irbesartan with any medication that contains aliskiren (a blood pressure medicine). You may also need to avoid taking irbesartan with aliskiren if you have kidney disease. Tell your doctor if you have ever had: a heart condition other than one being treated with irbesartan; kidney disease (or if you are on dialysis); or if you are on a low-salt diet. Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Irbesartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. If you plan to get pregnant, ask your doctor for a safer medicine to use before and during pregnancy. Having high blood pressure during pregnancy may cause complications in the mother and the baby. You should not breastfeed while using irbesartan. How should I take irbesartan? 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. Irbesartan may be taken with or without food. Your blood pressure will need to be checked often. Your kidney function may also need to be checked. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking irbesartan. It may take up to 2 weeks before your blood pressure is under control. Keep using this medicine 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. Treatment may also include diet, exercise, lowering cholesterol, not smoking, and controlling diabetes. 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 heartbeats or fainting. What should I avoid while taking irbesartan? Do not use potassium supplements or salt substitutes, unless your doctor has told you to. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Irbesartan 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; little or no urination; high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement. Common side effects may include: dizziness; feeling light-headed; or high potassium. 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.   Irbesartan dosing information Usual Adult Dose for Hypertension: Initial dose: 150 mg orally once a day -Maintenance 150 to 300 mg orally once a day Maximum dose: 300 mg orally once a day Comments: -May be used alone or in combination with other antihypertensive agents. Use: Treatment of hypertension. Usual Adult Dose for Diabetic Nephropathy: 300 mg orally once a day Comments: -This drug has been shown to reduce the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or ESRD (need for dialysis or renal transplantation). Use: Treatment of diabetic nephropathy in patients with type 2 diabetes and hypertension with an elevated serum creatinine and proteinuria (greater than 300 mg/day).   What other drugs will affect irbesartan? Tell your doctor about all your other medicines, especially: heart or blood pressure medication; lithium; or NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others. This list is not complete. Other drugs may affect irbesartan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

What is labetalol? Labetalol is a beta-blocker that is used to treat hypertension (high blood pressure). Labetalol oral is sometimes given with other blood pressure medications. Labetalol injection is used when hypertension is severe. Labetalol may also be used for purposes not listed in this medication guide. Warnings Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies. Before taking this medicine You should not use labetalol if you are allergic to it, or if you have: asthma; "AV block" (2nd or 3rd degree); uncontrolled heart failure; very low blood pressure; slow heartbeats that have caused you to faint; or if your heart cannot pump blood properly. Tell your doctor if you have ever had: congestive heart failure; angina (chest pain); liver disease; emphysema, chronic bronchitis, or other breathing problems; pheochromocytoma (tumor of the adrenal gland); diabetes; coronary artery bypass surgery (sometimes called "CABG"); kidney disease; or allergies. Labetalol can affect your pupils. If you need eye surgery, tell the surgeon about your use of labetalol, even if you no longer take it. Labetalol may cause low blood pressure, low blood sugar, slow heartbeats, or breathing problems in a newborn if the mother uses labetalol during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant. Ask a doctor if it is safe to breastfeed while using this medicine. Not approved for use by anyone younger than 18 years old. How should I use labetalol? 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. Labetalol oral is taken by mouth. Labetalol injection is given in a vein by a healthcare provider when hypertension is severe. After the injection you may need to remain lying down for up to 3 hours. You may feel light-headed when you first stand up. Your blood pressure will need to be checked often, and you may need other medical tests. If you have diabetes, check your blood sugar regularly. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. Labetalol can cause false results with certain lab tests of the urine, including a drug-screening urine test. Tell the laboratory staff that you use labetalol. Tell your doctor if you have a planned surgery. You should not stop using labetalol suddenly. Stopping suddenly may make your condition worse. 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, wheezing, chest tightness, trouble breathing, extreme dizziness, seizure, or fainting. What should I avoid while using labetalol? Avoid driving or hazardous activity until you know how labetalol 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 can further lower your blood pressure and may increase certain side effects of labetalol. Labetalol 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. Call your doctor at once if you have: a light-headed feeling, like you might pass out; slow heart rate, weak pulse, fainting, slow breathing (breathing may stop); shortness of breath (even with mild exertion), swelling, rapid weight gain; severe headache, blurred vision, pounding in your neck or ears; or liver problems--loss of appetite, stomach pain (upper right side), flu-like symptoms, itching, dark urine, jaundice (yellowing of the skin or eyes). Severe dizziness or fainting may be more likely in older adults. Common side effects may include: dizziness, drowsiness, tiredness; nausea, vomiting; sudden warmth, skin redness, sweating; numbness; or tingly feeling in your scalp. 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 labetalol? Tell your doctor about all your other medicines, especially: any other blood pressure medicine; aminophylline, theophylline; cimetidine; heart medication; insulin or oral diabetes medicine; an antidepressant--amitriptyline, doxepin, desipramine, imipramine, nortriptyline, and others; or a bronchodilator--albuterol, formoterol, levalbuterol, metaproterenol, olodaterol, salmeterol, and others. This list is not complete. Other drugs may affect labetalol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

What is lisinopril? Lisinopril is an ACE inhibitor. ACE stands for angiotensin converting enzyme. Lisinopril is used to treat high blood pressure (hypertension) in adults and children who are at least 6 years old. Lisinopril is also used to treat congestive heart failure in adults, or to improve survival after a heart attack. Warnings Do not use lisinopril if you are pregnant. It could harm the unborn baby. Stop using this medicine and tell your doctor right away if you become pregnant. You should not use this medicine if you have ever had angioedema. Do not take lisinopril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto). If you have diabetes, do not use lisinopril together with any medication that contains aliskiren (such as Amturnide, Tekturna, Tekamlo). You may also need to avoid taking lisinopril with aliskiren if you have kidney disease. Before taking this medicine You should not use lisinopril if you are allergic to it, or if you: have a history of angioedema; recently took a heart medicine called sacubitril; or are allergic to any other ACE inhibitor, such as benazepril, captopril, enalapril, fosinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril. Do not take lisinopril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto). If you have diabetes, do not use lisinopril together with any medication that contains aliskiren (such as Tekturna or Tekamlo). You may also need to avoid taking lisinopril with aliskiren if you have kidney disease. To make sure this medicine is safe for you, tell your doctor if you have ever had: kidney disease (or if you are on dialysis); liver disease; or high levels of potassium in your blood. Do not use lisinopril if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. This medicine can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking this medicine. It is not known whether lisinopril passes into breast milk or if it could harm a nursing baby. You should not breastfeed while using this medicine. How should I take lisinopril? Take lisinopril exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended. Drink plenty of water each day while you are taking this medicine. Lisinopril can be taken with or without food. 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. Your blood pressure will need to be checked often. Your kidney function and electrolytes may also need to be checked. Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medicine. This can lead to very low blood pressure, electrolyte disorders, or kidney failure while you are taking lisinopril. If you need surgery, tell the surgeon ahead of time that you are using lisinopril. If you have high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. Store at room temperature away from moisture and heat. Do not freeze the oral liquid. Dosing information Usual Adult Dose for Hypertension: Initial dose: 10 mg orally once a day; 5 mg orally once a day Maintenance dose: 20 to 40 mg orally once a day Maximum dose: 80 mg orally once a day Comments: -The initial dose is 5 mg orally once a day in patients receiving a diuretic. -The 80 mg dose is used but does not appear to give greater effect. -If blood pressure is not controlled with lisinopril alone, a low dose of a diuretic may be added (e.g., hydrochlorothiazide, 12.5 mg). After the addition of a diuretic, it may be possible to reduce the dose of lisinopril. Usual Adult Dose for Congestive Heart Failure: Initial dose: 2.5 to 5 mg orally once a day Maintenance dose: Dosage should be increased as tolerated Maximum dose: 40 mg orally once a day Comments: -The diuretic dose may need to be adjusted to help minimize hypovolemia, which may contribute to hypotension. The appearance of hypotension after the initial dose of lisinopril does not preclude subsequent careful dose titration with the drug. Usual Adult Dose for Myocardial Infarction: Initial dose: 5 mg orally (within 24 hours of the onset of acute myocardial infarction) Subsequent doses: 5 mg orally after 24 hours, then 10 mg orally after 48 hours. Maintenance dose: 10 mg orally once a day. Dosing should continue for at least 6 weeks. Comments: -Therapy should be initiated at 2.5 mg in patients with a low systolic blood pressure (less than or equal to 120 mm Hg and greater than 100 mmHg) during the first 3 days after the infarct. If prolonged hypotension occurs (systolic blood pressure less than 90 mmHg for more than 1 hour) therapy should be withdrawn. Usual Adult Dose for Diabetic Nephropathy: Initial dose: 10 to 20 mg orally once a day Maintenance dose: 20 to 40 mg orally once a day Dosage may be titrated upward every 3 days Comments: -Not an approved indication. Usual Geriatric Dose for Hypertension: Initial dose: 2.5 to 5 mg orally once a day Maintenance dose: Dosages should be increased at 2.5 mg to 5 mg per day at 1 to 2 week intervals. Maximum dose: 40 mg orally once a day Usual Pediatric Dose for Hypertension: Pediatric patients greater than or equal to 6 years of age: Initial dose: 0.07 mg/kg orally once a day (Maximum initial dose is 5 mg once a day) Maintenance dose: Dosage should be adjusted according to blood pressure response at 1 to 2 week intervals. Maximum dose: Doses above 0.61 mg/kg or greater than 40 mg have not been studied in pediatric patients Comments: -This drug is not recommended in pediatric patients less than 6 years old or in pediatric patients with glomerular filtration rate less than 30 mL/min.   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. What to avoid Drinking alcohol can further lower your blood pressure and may increase certain side effects of lisinopril. Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Lisinopril can decrease sweating and you may be more prone to heat stroke. Do not use potassium supplements or salt substitutes while taking this medicine, unless your doctor has told you to. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Lisinopril side effects Get emergency medical help if you have signs of an allergic reaction to lisinopril: hives; severe stomach pain, difficult breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have an allergic reaction if you are African-American. Call your doctor at once if you have: a light-headed feeling, like you might pass out; fever, sore throat; high potassium - nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; kidney problems - little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Common lisinopril side effects may include: headache, dizziness; cough; or chest 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.   What other drugs will affect lisinopril? Tell your doctor about all your current medicines and any you start or stop using, especially: a diuretic or "water pill"; lithium; gold injections to treat arthritis; insulin or oral diabetes medicine; a potassium supplement; medicine to prevent organ transplant rejection - everolimus, sirolimus, tacrolimus, temsirolimus; or NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others. This list is not complete. Other drugs may interact with lisinopril, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

What is losartan? Losartan belongs to a group of drugs called angiotensin II receptor antagonists. It keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow. Losartan is used to treat high blood pressure (hypertension). It is also used to lower the risk of stroke in certain people with heart disease. Losartan is used to slow long-term kidney damage in people with type 2 diabetes who also have high blood pressure. Warnings Do not use losartan if you are pregnant. Stop using and tell your doctor right away if you become pregnant. This medicine can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control. You should not use this medication if you are allergic to losartan. If you have diabetes, do not use losartan together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna). In extremely rare cases, losartan can cause a condition that results in the breakdown of skeletal muscle tissue, potentially leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine. Before taking this medicine If you have diabetes, do not use losartan together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna). You may also need to avoid taking this medicine with aliskiren if you have kidney disease. To make sure this medicine is safe for you, tell your doctor if you have: kidney disease; liver disease; congestive heart failure; an electrolyte imbalance (such as low levels of potassium in your blood); or if you are dehydrated. Do not use if you are pregnant. Stop using and tell your doctor right away if you become pregnant. Losartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control. It is not known whether losartan passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine. How should I take losartan? Take losartan exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended. You may take losartan with or without food. Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to severely low blood pressure or a serious electrolyte imbalance. Your blood pressure will need to be checked often. Visit your doctor regularly. It may take 3 to 6 weeks of using losartan before your blood pressure goes down somewhat. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 3 weeks of treatment. If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. Store at room temperature away from moisture, heat, and light. Dosing information Usual Adult Dose for Diabetic Nephropathy: Initial dose: 50 mg orally once a day. Maintenance dose: 25 to 100 mg orally in 1 to 2 divided doses. Usual Adult Dose for Hypertension: Initial dose: 50 mg orally once a day. Maintenance dose: 25 to 100 mg orally in 1 to 2 divided doses.   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. What should I avoid? Drinking alcohol can further lower your blood pressure and may increase certain side effects of losartan. Do not use potassium supplements or salt substitutes while you are taking this medicine, unless your doctor has told you to. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Losartan side effects Get emergency medical help if you have any of these signs of an allergic reaction to losartan: hives; difficult breathing; swelling of your face, lips, tongue, or throat. In extremely rare cases, losartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to potential kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine. Call your doctor at once if you have: a feeling that you might pass out; pain or burning when you urinate; pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; wheezing, chest pain; drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting; swelling, weight gain, feeling short of breath, urinating less than usual or not at all; or high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling). Common losartan side effects may include: cold or flu symptoms such as stuffy nose, sneezing, sore throat, fever; dry cough; muscle cramps; pain in your legs or back; stomach pain, diarrhea; headache, dizziness; tired feeling; 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 losartan? Tell your doctor about all medicines you use, and those you start or stop using during your treatment with losartan, especially: a diuretic or "water pill"; other blood pressure medications; lithium; celecoxib; or aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others. This list is not complete. Other drugs may interact with losartan, 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.