Mupirocin

Taro Pharmaceuticals U.S.A., Inc.

Mupirocin Ointment USP, 2%

FULL PRESCRIBING INFORMATION: CONTENTS*

• CAUTION
• MUPIROCIN DESCRIPTION
• CLINICAL PHARMACOLOGY
• INDICATIONS FOR USE
• MUPIROCIN CONTRAINDICATIONS
• WARNINGS
• MUPIROCIN ADVERSE REACTIONS
• MUPIROCIN DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

FULL PRESCRIBING INFORMATION

For dermatologic use on dogs

CAUTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

MUPIROCIN DESCRIPTION

Each gram of mupirocin ointment contains 20 mg of mupirocin in a bland, water-washable ointment base consisting of polyethylene glycol 400 and polyethylene glycol 3350 (polyethylene glycol ointment, NF). Mupirocin is a naturally-occurring, broad-spectrum antibiotic. The chemical name is 9-4-[5S-(2S,3S-epoxy-5S-hydroxy-4Smethylhexyl)-3R,4R-dihydroxytetrahydropyran-2S-yl]-3-methylbut-2(E)-enoyloxy-nonanoic acid. The chemical structure is:

CLINICAL PHARMACOLOGY

Mupirocin is a chemical entity produced by fermentation of the organism Pseudomonas fluorescens. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase. Due to this mode of action, mupirocin shows no cross resistance with chloramphenicol, erythromycin, gentamicin, lincomycin, neomycin, novobiocin, penicillin, streptomycin, and tetracycline. Mupirocin is an antimicrobial agent that inhibits the growth of gram-positive and gram-negative bacteria. Bacteria susceptible to the action of mupirocin in vitro include the aerobic isolates of Staphylococcus aureus (including methicillin-resistant strains and β-lactamaseproducing strains), Staphylococcus intermedius, Staphylococcus epidermidis, other coagulase positive or negative Staphylococci, α-hemolytic Streptococci, β group A Streptococci (including S. pyogenes), other β Streptococci (including S. agalactiae), group D Streptococci (including S. faecalis and S. faecium), group Viridans Streptococci, Streptococcus pneumoniae, Corynebacterium hofmanii, Bacillus subtilis, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Enterobacter cloacae, Enterobacter aerogenes, Citrobacter freundii, Hemophilus influenzae (including β-lactamase-producing strains), Neisseria gonorrheae (including β-lactamase-producing strains), Neisseria meningitidis, Branhamella catarrhalis and Pasteurella multocida, and the anaerobic isolates of Peptostreptococcus anaerobius, Clostridium difficile, and Clostridium sporogenes.

Clinical significance of the in vitro data is unknown except for susceptible strains of Staphylcoccus aureus and Staphylococcus intermedius.

INDICATIONS FOR USE

Mupirocin ointment is indicated for the topical treatment of canine bacterial infections of the skin, including superficial pyoderma, caused by susceptible strains of Staphylococcus aureus and Staphylococcus intermedius.

MUPIROCIN CONTRAINDICATIONS

This drug is contraindicated in animals with a history of sensitivity reactions to any of its components.

WARNINGS

Because of the potential hazard of nephrotoxicity due to the polyethylene glycol content of the base, care should be exercised when using this product in treating extensive deep lesions where absorption of large quantities of polyethylene glycol is possible.

Safety of use in pregnant or breeding animals has not been determined.

Mupirocin ointment is not for ophthalmic use.

MUPIROCIN ADVERSE REACTIONS

No adverse reactions have been reported with this product. If a skin reaction such as irritation should occur, treatment should be discontinued and appropriate therapy instituted.

MUPIROCIN DOSAGE AND ADMINISTRATION

Prior to treatment, the lesion should be cleansed. Mupirocin ointment should be applied to the affected area twice a day. Apply a sufficient amount of ointment to completely cover the infected area. Maximum duration of treatment should not exceed 30 days.

HOW SUPPLIED

Mupirocin ointment is supplied in 5 g, 15 g, 22 g, and 30 g tubes.

Store at 20°-25°C (68° - 77°F) [see USP Controlled Room Temperature]

Keep Out of Reach of Children

ANADA 200-457, Approved by FDA

Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1

Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532

Issue: December, 2010

PK-6725-0 151

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

NDC 51672-1354-1

Net Weight
15 g

Mupirocin
Ointment USP, 2%

For dermatologic use on dogs.

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
ANADA 200-457, Approved by FDA

Keep Out of Reach of Children.