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Colazal

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Colazal

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 (insomnia);
  • nausea, vomiting, stomach pain,...

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 other aminosalicylates (such as mesalamine, olsalazine); or to salicylates (e.g., aspirin, 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: a certain stomach/intestinal condition (e.g., pyloric stenosis), liver disease, kidney disease.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication contains sodium. Consult your...

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.

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Colazal - User Reviews

Colazal User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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