MUPIROCIN ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Mupirocin ointment USP, 2% is supplied in 22 gram tubes. NDC 63187-015-22 (22-gram tube) Store at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature]. *Bactroban® Nasal is a registered trademark of GlaxoSmithKline. Manufactured by: Glenmark Generics Ltd. Colvale-Bardez, Goa 403 513, India Manufactured for: Glenmark Generics Inc., USA Mahwah, NJ 07430 Questions? 1 [phone] www.glenmarkgenerics.com Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 June 2011

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MUPIROCIN- MUPIROCIN OINTMENT
PROFICIENT RX LP
----------
MUPIROCIN OINTMENT USP, 2%
FOR DERMATOLOGIC USE. NOT FOR OPHTHALMIC USE
DESCRIPTION
Each gram of mupirocin ointment USP, 2% contains 20 mg mupirocin USP
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)-(_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 500.63.
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
unique mode of action, mupirocin demonstrates