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 patients with known hypersensitivity to any of the constituents of the product.

Product summary:

Mupirocin Ointment USP, 2% is supplied in 22 g (NDC 63187-151-22) tubes. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MUPIROCIN- MUPIROCIN OINTMENT
PROFICIENT RX LP
----------
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, NF) consisting
of polyethylene
glycol 400 NF and polyethylene glycol 3350 NF. 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 adminstration, 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 _in vit