MUPIROCIN ointment

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

MUPIROCIN (UNII: D0GX863OA5) (MUPIROCIN - UNII:D0GX863OA5)

可用日期:

DirectRX

给药途径:

TOPICAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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.

授权状态:

Abbreviated New Drug Application

产品特点

MUPIROCIN- MUPIROCIN OINTMENT
DIRECTRX
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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