centany- mupirocin ointment

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

mupirocin (UNII: D0GX863OA5) (mupirocin - UNII:D0GX863OA5)

Disponibbli minn:

OrthoNeutrogena, Division of Ortho-McNeil Pharmaceutical, Inc.

INN (Isem Internazzjonali):

mupirocin

Għamla farmaċewtika:

OINTMENT

Rotta amministrattiva:

TOPICAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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.

Sommarju tal-prodott:

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

Karatteristiċi tal-prodott

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