国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
MUPIROCIN (UNII: D0GX863OA5) (MUPIROCIN - UNII:D0GX863OA5)
DIRECT RX
TOPICAL
PRESCRIPTION DRUG
Mupirocin ointment 2% is indicated for the topical treatment of impetigo due to: Staphylococcus aureus and Streptococcus pyogenes. This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components.
Mupirocin Ointment USP, 2% is supplied in 22 gram tubes. Store at 20o to 25oC (68o to 77oF) [See USP Controlled Room Temperature]. *Bactroban® Nasal is a registered trademark of SmithKline Beecham Pharmaceuticals. Manufactured In Croatia By: PLIVA HRVATSKA d.o.o Zagreb, Croatia Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. F 3/2005
Abbreviated New Drug Application
MUPIROCIN- MUPIROCIN OINTMENT DIRECT RX ---------- MUPIROCIN DESCRIPTION SECTION Each gram of Mupirocin Ointment 2% contains 20 mg mupirocin in a bland water miscible ointment base (polyethylene glycol ointment, N.F.) 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 chemical structure is: C26H44O9 M.W. 500.63 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 seven 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 of antimicrobial agents. Resistance occurs rarely. However, when mupirocin resistance d 完全なドキュメントを読む