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Mupirocin

Putney, Inc.
Putney, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Mupirocin Ointment 2%

For Dermatologic Use On Dogs

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

DESCRIPTION: Each gram of Mupirocin Ointment 2% 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-4S-methylhexyl)-3R,4R-dihydroxytetrahydropyran-2S-yl]-3-methylbut-2(E)-enoyloxy-nonanoic acid. The chemical structure is:

Mupirocin

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-lactamase-producing 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 2% 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.

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 2% is not for ophthalmic use.

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.

DOSAGE AND ADMINISTRATION: Prior to treatment, the lesion should be cleansed. Mupirocin Ointment 2% 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 2% is supplied in 15-gram tubes.

Store at controlled room temperature, 68-77°F (20-25°C).

Keep Out of Reach of Children

ANADA #200-524, Approved by FDA

Manufactured for:

Putney, Inc.

Portland, Maine 04101 USA

1-866-683-0660

Made in the U.K.

PRINCIPAL DISPLAY PANEL - 15 GRAM TUBE

Putney NDC 26637-821-15

Mupirocin Ointment 2%

For Dermatologic Use On Dogs

ANADA #200-524, Approved by FDA

15 grams

Each gram contains: 20 mg of mupirocin in polyethylene glycol 400 and polyethylene glycol 3350.

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

DOSAGE AND ADMINISTRATION: Prior to treatment, the lesion should be cleansed. Mupirocin Ointment 2% 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.

Read accompanying directions carefully.

Store at controlled room temperature, 68-77°F (20-25°C).

Keep Out of Reach of Children

Manufactured for:

Putney, Inc.

Portland, Maine 04101 USA

1-866-683-0660

Made in the U.K.

Rev. May 2013

Mupirocin

PRINCIPAL DISPLAY PANEL - 15 GRAM CARTON

Putney NDC 26637-821-15

Mupirocin Ointment 2%

For Dermatologic Use On Dogs

ANADA #200-524, Approved by FDA

15 grams

Mupirocin

Mupirocin

Mupirocin OINTMENT

Product Information

Product Type Prescription animal drug label Item Code (Source) NDC:26637-821
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Mupirocin MUPIROCIN 20 mg

Inactive Ingredients

Ingredient Name Strength
polyethylene glycol 400
POLYETHYLENE GLYCOL 3350

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 TUBE
2 NDC:26637-821-15 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200524 2013-11-01


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