MURICIN- mupirocin ointment

MURICIN by

Drug Labeling and Warnings

MURICIN by is a Animal medication manufactured, distributed, or labeled by Dechra Veterinary Products, Fougera Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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ANADA# 200-418. Approved by FDA.

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 Muricin® 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, broadspectrum antibiotic. The chemical name is (E)-(2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic 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 Staphylococcus aureus and Staphylococcus intermedius.

INDICATIONS FOR USE:

Muricin® 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. Muricin® 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. Muricin® 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:

•   Muricin® Ointment is supplied in 15-gram tubes.
•   NDC: 17033-420-15.

STORAGE AND HANDLING

•   Store between 15° and 30°C (59° and 86°F).
  Keep Out of Reach of Children

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1. Remove entire Applicator Assembly, puncture tube with white portion of the cap.

2. Replace entire Applicator Assembly.

3. To dispense, remove the white portion of the cap.

4. After use replace white cap to close.

IMPORTANT:

The opening of this product is covered by a metal tamper-resistant seal.

If this seal has been punctured or is not visible, do not use and return product to place of purchase.

SPL UNCLASSIFIED SECTION

MANUFACTURED FOR:
Dechra Veterinary Products
Overland Park, KS 66211

I420 DECHRA R1/08 #131

PRINCIPAL DISPLAY PANEL - 15 g Carton

MURICIN®
mupirocin ointment 2%
For dermatologic use on dogs
NET WT 15 g
ANADA # 200-418. Approved by FDA.
NDC 17033-420-15

PRINCIPAL DISPLAY PANEL - 15 g Container

NET WT 15g
MURICIN®
mupirocin
ointment 2 %
For dermatologic use on dogs
NDC 17033-420-15
ANADA #200-418.
Approved by FDA.

INGREDIENTS AND APPEARANCE

MURICIN 
mupirocin ointment

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 17033-420
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 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17033-420-15	1 in 1 CARTON
1		15 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200418	03/08/2007

Labeler - Dechra Veterinary Products (362142734)

Registrant - Fougera Pharmaceuticals Inc. (043838424)