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:

Proficient Rx LP

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. aureus and S. pyogenes . This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components.

產品總結:

Mupirocin Ointment USP, 2% is available as follows: 22 gram tube (NDC 63187-261-22) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. *Bactroban Nasal® is a registered trademark of GlaxoSmithKline.

授权状态:

Abbreviated New Drug Application

产品特点

MUPIROCIN- MUPIROCIN OINTMENT
PROFICIENT RX LP
----------
MUPIROCIN OINTMENT USP, 2%
For Dermatologic Use
_RX ONLY_
DESCRIPTION
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_)-(2_S_,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 500.62. The chemical structure is:
CLINICAL PHARMACOLOGY
Application of
C-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
26
44
9
14
this unique mode of action, mupirocin demonstrates no _in