Colazal (balsalazide disodium)

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Last reviewed · Source: First Databank (FDB) drug data

Overview

Balsalazide is a GI anti-inflammatory agent.

Balsalazide is a GI anti-inflammatory agent. Balsalazide is a prodrug of mesalamine (5-aminosalicylic acid) and has little or no pharmacologic activity until enzymatically cleaved in the colon to provide mesalamine and the inert 4-aminobenzoyl-beta-alanine. Thus, the spectrum of pharmacologic activity of balsalazide generally is similar to that of mesalamine.

Mesalamine exhibits anti-inflammatory activity in the GI tract. Although the exact mechanism of action of mesalamine has not been fully elucidated, the drug appears to exert its anti-inflammatory effects locally, in the GI tract, rather than systemically. Limited data indicate that mesalamine may reduce inflammation in the colon by inhibiting cyclooxygenase, an enzyme that catalyzes the formation of prostaglandin precursors (endoperoxides) from arachidonic acid.

Mesalamine also inhibits leukotriene synthesis, possibly by inhibiting lipoxygenase, an enzyme that catalyzes the formation of leukotrienes and hydroxyeicosatetraenoic acids (HETEs) from arachidonic acid and its metabolites. Although the role of arachidonic acid metabolites in the pathogenesis of inflammatory bowel disease remains to be determined, mucosal production of these metabolites, both through the cyclooxygenase and the lipoxygenase pathways, appears to be increased in patients with inflammatory bowel disease.

Following oral administration, balsalazide disodium passes intact into the colon where the azo-linkage is cleaved by intestinal flora to form mesalamine and 4-aminobenzoyl-beta-alanine. A small portion of mesalamine is absorbed and undergoes N4-acetylation. Balsalazide and/or its metabolites are excreted principally in feces.

Approximately 65% of an administered dose is excreted in feces as mesalamine, 4-aminobenzoyl-beta-alanine, or N-acetylated metabolites, and up to 25% is excreted in urine as N-acetylated metabolites; less than 1% of the dose is excreted in urine or feces as unchanged drug. (For further information on chemistry, pharmacology, and pharmacokinetics of mesalamine, see Mesalamine 56:36.)

Each g of balsalazide disodium (as commercially available 750-mg capsules) provides approximately 5 mEq (115 mg) of sodium.

USES: Balsalazide is used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain. Balsalazide belongs to a class of drugs known as aminosalicylates.

It works by decreasing swelling in the colon.

Generic name: balsalazide disodium
Pronunciation: (bal-SAL-a-zide)

Reference product & biosimilars

No reference, biosimilar or interchangeable associated with this drug.

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Indications

The following indications are listed for Colazal:

  • Ulcerative Colitis

Also known as: Colitis Ulcerativa.

Dosing

No dosing information is available for this tab.

Drug interactions

No formal drug interaction studies have been performed.

Contraindications

Known hypersensitivity to salicylates, balsalazide, or its metabolites, or any ingredient in the formulation.

Adverse reactions

Adverse effects occurring in 4% or more of patients receiving balsalazide include headache, abdominal pain, diarrhea, nausea, vomiting, respiratory infection, arthralgia, flatulence, and fatigue.

Some adverse effects (e.g., abdominal pain, fatigue, nausea) appear to occur more frequently in women. The manufacturer states that certain adverse effects (e.g., abdominal pain, rectal bleeding, anemia) may be manifestations of ulcerative colitis.

Precautions

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ICD codes

No ICD codes are available for this drug.

Formulary status

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Last reviewed · Source: First Databank (FDB) drug data