国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
mupirocin (UNII: D0GX863OA5) (mupirocin - UNII:D0GX863OA5)
OrthoNeutrogena, Division of Ortho-McNeil Pharmaceutical, Inc.
mupirocin
OINTMENT
TOPICAL
PRESCRIPTION DRUG
Centany (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.
Centany (mupirocin ointment),2% is supplied in 15 gram (NDC 0062-1610-01) and 30 gram (NDC 0062-1610-03) tubes. Store at controlled room temperature 20° to 25°C (68° to 77°F). OrthoNeutrogena Distributed by: OrthoNeutrogena, Division of Ortho-McNeil Pharmaceutical, Inc. Skillman, New Jersey 08558 ©OMP 2004 Rev: April 2004 Printed in USA 635-10-686-3 U.S. Patent No. 6,013,657
CENTANY- MUPIROCIN OINTMENT ORTHONEUTROGENA, DIVISION OF ORTHO-MCNEIL PHARMACEUTICAL, INC. ---------- CENTANY (MUPIROCIN OINTMENT),2% OrthoNeutrogena Rx only For Dermatologic Use DESCRIPTION Each gram of Centany (mupirocin ointment),2% contains 20 mg mupirocin in a soft white ointment base consisting of castor oil, oleyl alcohol, hard fat (Softisan 378) and propylene glycol monostearate. Mupirocin is a naturally occurring antibiotic. The chemical name is (E)-(2S,3_R_,4_R_,5_S_)-5-[(2_S_,3_S_,4_S_,5_S_)- 2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2 _H_-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin is C H O and the molecular weight is 500.63. The chemical structure is: CLINICAL PHARMACOLOGY Following the application of Centany (mupirocin ointment),2% to a 400 cm area on the back of 23 healthy volunteers once daily for 7 days, the mean (range) cumulative urinary excretion of monic acid over 24 hrs following the last administration was 1.25% (0.2% to 3.0%) of the administered dose of mupirocin. The monic acid concentration in urine collected at specified intervals for 24 hrs on Day 7 ranged from <0.050 to 0.637 μg/mL. MICROBIOLOGY: Mupirocin is an antibacterial agent produced by fermentation using the organism _Pseudomonas fluorescens_. Its spectrum of activity includes gram-positive bacteria. It is also active, _in_ _vitro_ only, 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 does not demonstrate cross-resistance with other classes of antimicrobial agents. When mupirocin resistance occurs, it results from the production of a modified isoleucyl-tRNA synthetase or the acquisition, by genetic transfer, of a plasmid mediating a new isoleucyl-tRNA synthetase. High-level plasmid-mediated resistance (MIC > 500 mcg/mL) has been reported in increasing numbers of isolates of _Staphylo 阅读完整的文件