What is balsalazide? The Colazal brand of balsalazide is used to treat mild to moderate active ulcerative colitis in adults and children who are at least 5 years old. The Giazo brand of balsalazide is used to treat mild to moderate active ulcerative colitis in men who are at least 18 years old. Balsalazide 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 balsalazide if you are allergic to balsalazide or mesalamine, or to aspirin or other salicylates (including Kaopectate, Pamprin, Pepto-Bismol, Tricosal, Trilisate, and others). Tell your doctor if you have ever had: kidney disease; liver disease; or a stomach condition called pyloric stenosis. Balsalazide tablets contain sodium. Talk to your doctor before using this form of balsalazide if you are on a low salt diet. Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether balsalazide will harm an unborn baby. However, having active ulcerative colitis during pregnancy may cause premature delivery or low birth weight. The benefit of treating ulcerative colitis may outweigh any risks to the baby. If you are breastfeeding, tell your doctor if you notice diarrhea in the nursing baby. Balsalazide capsules should not be given to a child younger than 5 years old. Balsalazide tablets should not be given to anyone under 18 years old. How should I take balsalazide? Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Balsalazide can be taken with or without food. If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away. Medicine from the capsule may stain your teeth or tongue yellow/orange when mixed with food. Do not save the mixture for later use. Call your doctor if your symptoms do not improve, or if they get worse. Balsalazide is usually taken only for a short time (8 to 12 weeks). Follow your doctor's dosing instructions very carefully. 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 balsalazide? Follow your doctor's instructions about any restrictions on food, beverages, or activity. Balsalazide 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: pain or burning when you urinate; worsening colitis symptoms--fever, stomach pain, cramps, or bloody diarrhea; kidney problems--little or no urinating, swelling, rapid weight gain; liver problems--upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet. Common side effects may include: headache; mild or occasional nausea, vomiting, stomach pain, diarrhea; joint pain; fever; or cold symptoms such as stuffy nose, sneezing, sore throat. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   Balsalazide dosing information Usual Adult Dose for Ulcerative Colitis -- Active: Oral capsules: Usual dose: Three 750 mg capsules orally 3 times a day for up to 8 weeks -Some patients in the clinical trials required up to 12 weeks of treatment. -Safety and efficacy beyond 12 weeks have not been established. GIAZO(R) tablets; male patients: Three 1.1 gram tablets orally twice a day, with or without food, for up to 8 weeks -Effectiveness in female patients was not demonstrated in clinical trials. -Safety and efficacy beyond 8 weeks have not been established. Use(s): Treatment of mildly to moderately active ulcerative colitis. Usual Pediatric Dose for Ulcerative Colitis -- Active: 5 years and older, oral capsules: Three 750 mg capsules orally 3 times a day for up to 8 weeks OR One 750 mg capsule orally 3 times a day for up to 8 weeks Comments: -Safety and efficacy beyond 8 weeks have not been established Use(s): Treatment of mildly to moderately active ulcerative colitis.   What other drugs will affect balsalazide? Other drugs may affect balsalazide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

What is mesalamine? Mesalamine is used to treat mild to moderate ulcerative colitis. Mesalamine is also used to prevent the symptoms of ulcerative colitis from recurring. Some brands of mesalamine are for use only in adults, and some brands are for use in children who are at least 5 years old. Mesalamine may also be used for purposes not listed in this medication guide. Warnings Stop using mesalamine and call your doctor at once if you have severe stomach pain, stomach cramping, bloody diarrhea (may occur with fever, headache, and skin rash). Before taking this medicine You should not use mesalamine if you are allergic to mesalamine, aspirin, sulfasalazine, or salicylates (such as Disalcid, Doans Pills, Dolobid, Kaopectate, Nuprin Backache, Pepto-Bismol, Tricosal, Trilisate, and others). Tell your doctor if you have ever had: a kidney stone or kidney disease; liver disease; a blockage in your stomach or intestines (such as pyloric stenosis); or a skin condition such as eczema. Some forms of mesalamine contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU). Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether mesalamine will harm an unborn baby. However, having untreated or uncontrolled ulcerative colitis during pregnancy may cause complications such as low birth weight or premature birth. The benefit of treating ulcerative colitis may outweigh any risks to the baby. It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk. If you are breastfeeding, tell your doctor if you notice diarrhea in the nursing baby. Do not give this medicine to a child without medical advice. Some brands of mesalamine are not approved for use in anyone younger than 18 years old. Delzicol should not be given to a child younger than 5 years old. How should I take mesalamine? Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using mesalamine. Take Asacol HD on an empty stomach, at least 1 hour before or 2 hours after a meal. Lialda should be taken with a meal. You may take Apriso with or without food. Drink plenty of liquids to help prevent kidney stones. Other brands of mesalamine can be taken with or without food. Follow your doctor's instructions or the directions on your medicine label. Swallow the capsule or tablet whole and do not crush, chew, or break it. Tell your doctor if you have trouble swallowing the pill. If you cannot swallow a Pentasa capsule whole, open it and sprinkle the medicine into a spoonful of yogurt or applesauce. Swallow the mixture right away without chewing. Do not save it for later use. Tell your doctor if you find undissolved mesalamine tablets in your stool. Call your doctor if your ulcerative colitis symptoms do not improve, or if they get worse. This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using mesalamine. You may need frequent blood tests to check your blood cells or kidney function. 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 mesalamine? If you have a skin condition such as eczema, mesalamine could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb mesalamine. Mesalamine 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. Stop using mesalamine and call your doctor at once if you have: severe stomach pain, stomach cramping, bloody diarrhea; fever, headache, general ill feeling; rash, itching, eye redness; bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; low white blood cell counts--fever, chills, mouth sores, skin sores, sore throat, cough, feeling light-headed, trouble breathing; signs of a kidney stone--severe pain in your side and back, frequent need to urinate, foul-smelling urine, dark or cloudy urine; kidney problems--increased or decreased urination, swelling, weight gain; or liver problems--loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Low white blood cell counts may be more likely in older adults. Common side effects may include: burping, constipation, nausea, vomiting, stomach pain, diarrhea, gas; dizziness; cold symptoms such as stuffy nose, sneezing, sore throat; back pain; headache; rash; or abnormal liver function tests. 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 mesalamine?   Mesalamine can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve). Tell your doctor about all your other medicines, especially: azathioprine or 6-mercaptopurine. This list is not complete. Other drugs may affect mesalamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

What is sulfasalazine? Sulfasalazine is used to treat ulcerative colitis (UC), and to decrease the frequency of UC attacks. Sulfasalazine will not cure ulcerative colitis, but it can reduce the number of attacks you have. Sulfasalazine is also used to treat rheumatoid arthritis in children and adults who have used other arthritis medicines that did not work or have stopped working. Sulfasalazine may also be used for purposes not listed in this medication guide. Warnings You should not use sulfasalazine if you have porphyria, a blockage in your bladder or intestines, or if you are allergic to sulfa drugs, aspirin, or similar medicines called salicylates. Before taking this medicine You should not use sulfasalazine if you are allergic to it, or if you have: a blockage in your bladder or intestines; porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system); an allergy to sulfa drugs; or an allergy to aspirin or other salicylates (such as Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others). Tell your doctor if you have ever had: frequent infections; asthma; low blood cell counts; or liver or kidney disease. Tell your doctor if you are pregnant. Taking sulfasalazine can make it harder for your body to absorb folic acid, and folic acid helps prevent major birth defects of the baby's brain or spine. You may need to take folic acid supplements if you take sulfasalazine during pregnancy. Follow your doctor's instructions. Sulfasalazine can pass into breast milk and may cause diarrhea or bloody stools in a nursing baby. Tell your doctor if you are breast-feeding. Sulfasalazine is not approved for use by anyone younger than 2 years old. How should I take sulfasalazine? Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Take sulfasalazine after a meal. Swallow the tablet whole and do not crush, chew, or break it. You will need frequent medical tests. Drink plenty of liquids to keep your kidneys working properly while you are taking sulfasalazine. Sulfasalazine can affect the results of certain medical tests. Tell any doctor who treats you that you are using sulfasalazine. Sulfasalazine may cause your skin or urine to appear orange-yellow in color. Call your doctor if you also have yellowing of your eyes, brown urine, or stomach pain. These may be signs of liver problems. If you are treating arthritis, do not stop using any of your other arthritis medicines until your doctor tells you to. Sulfasalazine may not improve your symptoms right away, and you may still need your other medicines for awhile. Sulfasalazine is only part of a complete treatment for rheumatoid arthritis that may also include rest and physical therapy. Follow your doctor's instructions very closely. Store at room temperature away from moisture and heat.   What happens if I miss a dose? Take the 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 vomiting, stomach pain, drowsiness, or seizure. What should I avoid while taking sulfasalazine? Follow your doctor's instructions about any restrictions on food, beverages, or activity. Sulfasalazine side effects Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling). Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as: fever, chills, sore throat; mouth sores, red or swollen gums; pale skin, easy bruising, unusual bleeding; or chest discomfort, wheezing, dry cough or hack, rapid weight loss. Also call your doctor at once if you have: fever with headache, rash, and vomiting; a skin rash, no matter how mild; severe nausea or vomiting when you first start taking sulfasalazine; little or no urination, urine that looks foamy; puffy eyes, swelling in your ankles or feet, weight gain; or liver problems--loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes). Common side effects may include: nausea, vomiting, upset stomach, loss of appetite; headache; rash; or low sperm count in men. 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 sulfasalazine? Other drugs may affect sulfasalazine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.