Mupirocin by Taro Pharmaceuticals U.S.A., Inc. / Taro Pharmaceuticals Inc. / Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd / Teva Pharmaceutical Works Private Limited Company / Taro Pharmaceutical Industries Ltd. MUPIROCIN ointment

Mupirocin by

Drug Labeling and Warnings

Mupirocin by is a Animal medication manufactured, distributed, or labeled by Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceuticals Inc., Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd, Teva Pharmaceutical Works Private Limited Company, Taro Pharmaceutical Industries Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 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-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 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 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 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

SPL UNCLASSIFIED SECTION

ANADA 200-457, Approved by FDA

SPL UNCLASSIFIED SECTION

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

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

Revised: December, 2012

PK-6725-1

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.

INGREDIENTS AND APPEARANCE

MUPIROCIN 
mupirocin ointment

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 51672-1354
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Mupirocin (UNII: D0GX863OA5) (Mupirocin - UNII:D0GX863OA5)	Mupirocin	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
polyethylene glycol 400 (UNII: B697894SGQ)
polyethylene glycol 3350 (UNII: G2M7P15E5P)

Product Characteristics
Color	WHITE (cream-like)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51672-1354-5	1 in 1 CARTON
1		5 g in 1 TUBE
2	NDC: 51672-1354-1	1 in 1 CARTON
2		15 g in 1 TUBE
3	NDC: 51672-1354-0	1 in 1 CARTON
3		22 g in 1 TUBE
4	NDC: 51672-1354-2	1 in 1 CARTON
4		30 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200457	11/29/2010

Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd		654019884	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Teva Pharmaceutical Works Private Limited Company		366709764	API MANUFACTURE