"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(Generic versions may still be available.)
Zagam® (sparfloxacin) Tablets contain sparfloxacin, a synthetic broad-spectrum antimicrobial agent for oral administration. Sparfloxacin, an aminodifluoroquinolone, is 5-Amino-1-cyclopropyl-7-(cis-3,5-dimethyl-1-piperazinyl)-6,8-difluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid. Its empirical formula is C19H22F2N4O3 and it has the following chemical structure:
Sparfloxacin has a molecular weight of 392.41. It occurs as a yellow crystalline powder. It is sparingly soluble in glacial acetic acid or chloroform, very slightly soluble in ethanol (95%), and practically insoluble in water and ether. It dissolves in dilute acetic acid or 0.1 N sodium hydroxide.
Zagam (sparfloxacin) is available as a 200-mg round, white film-coated tablet. Each 200-mg tablet contains the following inactive ingredients: microcrystalline cellulose NF, corn starch NF, L-hydroxypropylcellulose NF, magnesium stearate NF, and colloidal silicone dioxide NF. The film coating contains: methylhydroxypropylcellulose USP, polyethylene glycol 6000, and titanium dioxide USP.
Last reviewed on RxList: 4/7/2009
This monograph has been modified to include the generic and brand name in many instances.
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