Azulfidine EN-Tabs (Sulfasalazine Delayed Release Tablets) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 26, 2012

Azulfidine

Ulcerative Colitis »

What is Ulcerative Colitis?

Ulcerative colitis is a chronic inflammation of the large intestine (colon). The colon is the part of the digestive system where waste material is stored. The rectum is the end of the colon adjacent to the anus. In patients with ulcerative colitis, ulcers and inflammation of the inner lining of the colon lead to symptoms of abdominal pain, diarrhea, and rectal bleeding.

Ulcerative colitis is closely related to another condition of inflammation of the intestines called Crohn's disease. Together, they are frequently referred to as inflammatory bowel disease (IBD). Ulcerative colitis and Crohn's diseases are chronic conditions that can last years to decades. They affect approximately 500,000 to 2 million people In the United States. Men and women are affected equally. They most commonly begin during adolescence and early adulthood, but they also can begin during childhood and later in life.

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Azulfidine EN-Tabs

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Azulfidine EN-tabs®
(sulfasalazine) Delayed Release Tablets, USP

Enteric-coated Tablets

DRUG DESCRIPTION

AZULFIDINE EN-tabs Tablets contain sulfasalazine, formulated in a delayed release tablet (enteric-coated), 500 mg, for oral administration.

AZULFIDINE EN-tabs (sulfasalazine delayed release tablets) Tablets are film coated with cellulose acetate phthalate to retard disintegration of the tablet in the stomach and reduce potential irritation of the gastric mucosa.

Therapeutic Classification: Anti-inflammatory agent and/or immunomodulatory agent.

Chemical Designation: 5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic acid.

Chemical Structure:

Azulfidine EN-tabs® (sulfasalazine) Structural Formula Illustration

Molecular Formula: C₁₈H₁₄N₄O₅S

What are the possible side effects of sulfasalazine oral (Azulfidine, Azulfidine EN-tabs, Sulfazine)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sulfasalazine and call your doctor at once if you have any of these serious side effects:

fever, sore throat, or other flu symptoms;
pale skin, easy bruising;
dark urine, jaundice (yellowing of the skin or eyes);
pain or burning when you urinate;
urinating less than usual...

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What are the precautions when taking sulfasalazine delayed release tablets (Azulfidine EN-Tabs)?

Before taking sulfasalazine, tell your doctor or pharmacist if you are allergic to it; or to sulfa drugs; or to aspirin and related drugs (salicylates, NSAIDs such as ibuprofen); or to mesalamine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: intestinal blockage, urinary blockage, a certain blood disorder (porphyria).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, blood disorders (e.g., aplastic anemia), a certain...

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Last reviewed on RxList: 10/30/2009
This monograph has been modified to include the generic and brand name in many instances.