Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
MUPIROCIN (UNII: D0GX863OA5) (MUPIROCIN - UNII:D0GX863OA5)
DirectRX
TOPICAL
PRESCRIPTION DRUG
Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to: S. aureusand S. pyogenes. This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components.
Abbreviated New Drug Application
MUPIROCIN- MUPIROCIN OINTMENT DIRECTRX ---------- MUPIROCIN SPL UNCLASSIFIED SECTION For Dermatologic Use Rx Only DESCRIPTION SECTION Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a bland water miscible ointment base (polyethylene glycol ointment, NF) consisting of polyethylene glycol 400 and polyethylene glycol 3350. Mupirocin is a naturally occurring antibiotic. The chemical name is (E)-(2S,3R,4R,5S)-5- [(2S,3S,4S,5S)-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2H-pyran-2- crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin is C26H44O9 and the molecular weight is 500.62. CLINICAL PHARMACOLOGY SECTION Application of 14C-labeled mupirocin ointment to the lower arm of normal male subjects followed by occlusion for 24 hours showed no measurable systemic absorption (<1.1 nanogram mupirocin per milliliter of whole blood). Measurable radioactivity was present in the stratum corneum of these subjects 72 hours after application. Following intravenous or oral administration, mupirocin is rapidly metabolized. The principal metabolite, monic acid, is eliminated by renal excretion, and demonstrates no antibacterial activity. In a study conducted in 7 healthy adult male subjects, the elimination half-life after intravenous administration of mupirocin was 20 to 40 minutes for mupirocin and 30 to 80 minutes for monic acid. The pharmacokinetics of mupirocin has not been studied in individuals with renal insufficiency. Microbiology - Mupirocin is an antibacterial agent produced by fermentation using the organism Pseudomonas fluorescens. It is active against a wide range of gram-positive bacteria including methicillin- resistant Staphylococcus aureus (MRSA). It is also active against certain gram-negative bacteria. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase. Due to this unique mode of action, mupirocin demonstrates no in vitro cross-resistance with other classes Прочитать полный документ