MUPIROCIN ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

MUPIROCIN

Composition:

MUPIROCIN 20 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Mupirocin Ointment USP, 2% is supplied             NDC 54868-4958-0       22 gram tube Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. *Bactroban® Nasal is a registered trademark of SmithKline Pharmaceuticals. E. FOUGERA & CO. A division of Nycomed US Inc. MELVILLE, NEW YORK 11747 I2352B R9/07

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MUPIROCIN - MUPIROCIN OINTMENT
PHYSICIANS TOTAL CARE, INC.
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MUPIROCIN OINTMENT USP, 2%
Rx only
For Dermatologic Use
DESCRIPTION
Each gram of mupirocin ointment USP, 2% contains 20 mg mupirocin 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 seven 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 _