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Balsalazide information from DrugsUpdate  

See Available Brands of Balsalazide in India

P - Caution when used during pregnancy
L - Caution when used during lactation

Balsalazide is an anti-inflammatory drug used in the treatment of inflammatory bowel disease. It is sold under the name "Colazal" in the US and "Colazide" in the UK. It is also sold in generic form in the US by several generic manufacturers. It is usually administered as the disodium salt. Balsalazide releases mesalazine, also known as 5-aminosalicylic acid, or 5-ASA, in the large intestine. Its advantage over that drug in the treatment of Ulcerative colitis is believed to be the delivery of the active agent past the small intestine to the large intestine, the active site of ulcerative colitis.

Pharmacodynamics

Pharmacokinetics

Balsalazide is delivered intact to the colon where it is enzymatically cleaved by colonic bacterial azoreductases to release 5-aminosalicylic acid (5-ASA) which is the active component and the inert 4-aminobenzoyl-β-alanine. The mechanism of action of 5-ASA is unknown, but its action appears to be local rather than systemic. It is possible that 5-ASA inhibits the action of cyclooxgenase and leukotriene synthesis, thus diminishing the formation of inflammatory metabolites in the colon via these two pathways.


Absorption Very little of an oral dose is absorbed in the GI tract. Almost the entire dose reaches the site of action in the colon.


Metabolism Broken down by colonic bacterial to 5-ASA (active) and 4-aminobenzoylalanine (inert carrier). Approx 25% of released 5-ASA is absorbed and aceylated; a small percentage of 4-aminobenzoylalanine is absorbed and acetylated during the 1st pass effect in the liver.


Excretion Acetylated metabolites are removed in the urine.

Balsalazide Indications / Balsalazide Uses

Information Not Available

Balsalazide Adverse Reactions / Balsalazide Side Effects

Diarrhoea, nausea, vomiting, abdominal pain, exacerbation of symptoms of colitis, headache, hypersensitivity reactions (including rash and urticaria). Adverse effects that occur rarely include acute pancreatitis, hepatitis, myocarditis, pericarditis, lung disorders (including eosinophilia and fibrosing alveolitis), peripheral neuropathy, blood disorders (including agranulocytosis, aplastic anaemia, leucopenia, methaemoglobinaemia, neutropenia, and thrombocytopenia), renal dysfunction (interstitial nephritis, nephrotic syndrome), myalgia, arthralgia, skin reactions (including lupus erythematosus-like syndrome, Stevens-Johnson syndrome), alopecia.

Precautions

Information Not Available

Special Precautions

Renal impairment, pregnancy, lactation; blood disorders can occur.

Other Drug Interactions

Meglitinide antidiabetics (eg, repaglinide), sulfonylureas (eg, glipizide), or valproic acid because the risk of their side effects may be increased by Balsalazide Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), probenecid, or sulfinpyrazone because their effectiveness may be decreased by Balsalazide

Other Interactions

Information Not Available

Dosage

Oral Ulcerative colitis Adult: Acute attack: 2.25 g tid (max: 6.75 g/day), until remission occurs or up to 12 wk. Maintenance: 1.5 g bid, adjusted according to response. Max: 6 g daily. Child: 5-17 yr: 750 mg tid or 2.25 g tid, treatment may continue for up to 8 wk.

Food(before/after)

Should be taken with food (Take w/ or immediately after meals)

List of Contraindications

Balsalazide and Pregnancy

Caution when used during pregnancy Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Balsalazide and Lactation

Caution when used during lactation

Balsalazide and Children

Information Not Available

Balsalazide and Geriatic

Information Not Available

Balsalazide and Other Contraindications

Hypersensitivity to salicylates or any other ingredients of the cap or balsalazide metabolites.

Storage

Oral: Store at 25 ℃

Lab interference

Oral: Store at 25 ℃

Balsalazide brands in India:

Balacol Colorex Cozabal Intazide

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