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Our Applications Cover Diverse Corporate Markets

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FORMULATION:

Each Film-Coated Tablet contains: Cefuroxime axetil equivalent to CEFUROXIME USP. . . . . 500mg

PRODUCT DESCRIPTION: Cefuroxime  Film CoatedTablet: White to off-white film-coated, oblong shaped biconvex ta  t plain on one side and bisected on the olfler side containing 500 mg of Cefuroxime (as axetil). It complies with the USP specifications for Cefuroxime axetil tablets

DESCRIPTION: Cefuroxime Axetil is a mixture of the diastereoisomers of cefuroxime axetil. A white or almost white powder. The amorphous form is insoluble in water and in ether; slightly soluble in dehydrated alcohol;  freely soluble in acetone; soluble in chloroform, in ethyl acetate, and in methyl alcohol. The crystalline form is insoluble in water and in ether; slightly soluble in dehydrated alcohol; freely soluble in acetone; sparingly soluble in chloroform, in ethyl acetate, and in methyl alcohol. Store in airtight containers

Cefuroxime axetil is absorbed from the gastrointestinal tract and is rapidly hydrolyzed in the intestinal mucosa and blood to cefuroxime; absorption is enhanced in the presence of local. Peak plasma concentrations are reported about 2 to 3 hours after an oral dose. The sodium salt is given by intramuscular or intravenous injection. Peak plasma concentrations of about 27µg per ml have been achieved 45 minutes after an intramuscular dose of 750 mg with measurable amounts present 8 hours after a dose. Up to 50% of cefuroxime in the circulation is bound to plasma proteins. The plasma half-life is about 70 minutes and is prolonged in patients with renal impairment and in neonates.

Cefuroxime is bactericidal and has a similar spectrum of antimicrobial action and pattern of resistance to those of cefamandole. It is more resistant to hydrolysis by beta-lactamases than cefamandole, and therefore may be more active against beta-lactamase producing strains, Haemophilus inftuenzae and Neisseria gonorrhea. However, treatment failures have occurred in patients with H.inftuenzae meningitis given cefuroxime and might be associated with a relatively high minimum bactericidal concentration when compared with the minimum inhibitor concentration or with a significant inoculum effect. The reduced affinity of penicillin-binding proteins for cefuroxime has also been reported to be responsible for resistance in a beta-lactamase-negative strain of H. inftuenzae