Colazal (Balsalazide) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 26, 2012

Colazal

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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Colazal

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COLAZAL®
(balsalazide disodium) Capsules

DRUG DESCRIPTION

Each COLAZAL capsule contains 750 mg of balsalazide disodium, a prodrug that is enzymatically cleaved in the colon to produce mesalamine (5-aminosalicylic acid or 5-ASA), an anti-inflammatory drug. Each capsule of COLAZAL (balsalazide) (750 mg) is equivalent to 267 mg of mesalamine. Balsalazide disodium has the chemical name (E)-5-[[-4-[[(2- carboxyethyl) amino]carbonyl] phenyl]azo]-2-hydroxybenzoic acid, disodium salt, dihydrate. Its structural formula is:

COLAZAL (Balsalazide disodium) structural formula illustration

Molecular Weight: 437.32

Molecular Formula: C₁₇H₁₃N₃O₆Na₂•2H₂O

Balsalazide disodium is a stable, odorless orange to yellow microcrystalline powder. It is freely soluble in water and isotonic saline, sparingly soluble in methanol and ethanol, and practically insoluble in all other organic solvents.

Inactive Ingredients: Each hard gelatin capsule contains colloidal silicon dioxide and magnesium stearate. The sodium content of each capsule is approximately 86 mg.

What are the possible side effects of balsalazide (Colazal)?

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

worsening colitis symptoms, such as fever, stomach pain, cramps, or bloody diarrhea;
bleeding from your rectum; or
pale skin, easy bruising, weakness.

Less serious side effects may include:

headache, sleep problems...

Read All Potential Side Effects and See Pictures of Colazal »

What are the precautions when taking balsalazide (Colazal)?

Before taking balsalazide, tell your doctor or pharmacist if you are allergic to it; or to aspirin, NSAIDs (e.g., ibuprofen, celecoxib), or salicylates (e.g., salsalate); 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal blockage (e.g., pyloric stenosis), liver disease, kidney disease.

This medication is similar to aspirin. Children and teenagers should not take aspirin or aspirin-related medications (e.g., salicylates) if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine...

Read All Potential Precautions of Colazal »

Last reviewed on RxList: 9/3/2008
This monograph has been modified to include the generic and brand name in many instances.