Azulfidine

Azulfidine is a prescription medication used to treat the symptoms of ulcerative colitis including bowel inflammation, diarrhea (stool frequency), rectal bleeding, and abdominal pain. Azulfidine EN-tabs (delayed-release tablets) is used to treat rheumatoid arthritis in adults and children when other medications have not worked.

Azulfidine belongs to a group of drugs called aminosalicylates. It works by reducing inflammation (swelling) inside the body.

Azulfidine comes as regular and delayed-release tablets (Azulfidine EN-tabs). It is usually taken four times daily after meals. Drink a full glass of water after taking Azulfidine to protect the kidneys and to prevent kidney stones.

Common side effects include loss of appetite, nausea or vomiting, and headache.

Azulfidine is a prescription medication used:

• in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and
• for the prolongation of the remission period between acute attacks of ulcerative colitis

Azulfidine En-tabs (delayed-release tablet) is used to treat ulcerative colitis (as indicated above) as well as:

• in the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs; and
• in the treatment of pediatric patients with polyarticular-course1 juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Pharmacia and Upjohn Company

Serious side effects have been reported. See "Precautions".

Common side effects include:

• diarrhea
• headache
• loss of appetite
• upset stomach
• vomiting
• stomach pain

This is not a complete list of Azulfidine side effects. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• digoxin (Lanoxin)
• folic acid

This is not a complete list of Azulfidine drug interactions. Ask your doctor or pharmacist for more information.

Do not take this medication if:

• you are allergic to sulfasalazine, its metabolites, sulfonamides or salicylates
• you have intestinal or urinary obstruction (blockage)
• you have porphyria (enzyme problems)

This medication may make your skin more sensitive to sunlight. Avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Azulfidine, there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving Azulfidine tell your doctor about all of your medical conditions including:

• if you are allergic to sulfasalazine, sulfapyridine, aspirin, choline magnesium trisalicylate (Triosal, Trilisate), choline salicylate (Arthropan), mesalamine (Asacol, Pentasa, Rowasa), salsalate (Argesic-SA, Disalcid, Salgesic, others), sulfa drugs, trisalicylate (Tricosal, Trilisate),or any other drugs.
• if you have or have ever had asthma, kidney or liver disease, porphyria, blood problems, or blockage in your intestine or urinary tract.
• if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Azulfidine, call your doctor.

Tell your doctor about all of the medications you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Azulfidine falls into category B. There are no well-done studies that have been done in humans with Azulfidine. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

There have been case reports of neural tube defects (NTDs) in infants born to mothers who were exposed to Azulfidine during pregnancy, but the role of Azulfidine in these defects has not been established. However, oral Azulfidine inhibits the absorption and metabolism of folic acid which may interfere with folic acid supplementation and diminish the effect of periconceptional folic acid supplementation that has been shown to decrease the risk of NTDs.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Azulfidine has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Azulfidine, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

• Azulfidine comes as regular and delayed-release (enteric-coated) tablets.
• It usually is taken four times daily after meals in evenly spaced doses.
• Take with a full glass of water.
• Swallow Azulfidine En-tabs (delayed-release tablets) whole; do not crush or chew them.
• Drink plenty of fluids (at least six to eight glasses of water or other beverage per day) while taking this medication.

If you take too much Azulfidine call your local Poison Control center or seek emergency medical attention right away.

• Store at room temperature between 15–30° C (59–86° F).
• Keep this and all medications out of the reach of children.