Pharmacokinetics for Balsalazide and Key Metabolites (5—ASA and N-Ac-5- ASA) with Administration of COLAZAL Following a Fast, a High-Fat Meal, and Drug Contents
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چکیده
COLAZAL (balsalazide disodium) Capsules (kôl a zal) 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 antiinflammatory drug. Each daily dose of COLAZAL (6.75 grams) is equivalent to 2.4 grams 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:
منابع مشابه
Low dose balsalazide (1.5 g twice daily) and mesalazine (0.5 g three times daily) maintained remission of ulcerative colitis but high dose balsalazide (3.0 g twice daily) was superior in preventing relapses.
BACKGROUND Balsalazide is a new 5-aminosalicylic acid (5-ASA) containing prodrug. Its efficacy in comparison with standard mesalazine therapy and the optimum dose for maintaining remission of ulcerative colitis are still unclear. AIMS To compare the relapse preventing effect and safety profile of two doses of balsalazide and a standard dose of Eudragit coated mesalazine. METHODS A total of ...
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BACKGROUND Limited data are available on mesalamine (5-aminosalicylic acid; 5-ASA) use in pediatric ulcerative colitis (UC). AIM To evaluate pharmacokinetic and safety profiles of 5-ASA and metabolite acetyl-5-ASA (Ac-5-ASA) after once-daily, oral administration of multimatrix mesalamine to children and adolescents with UC. METHODS Participants (5-17 years of age; 18-82 kg, stratified by we...
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