Mupirocin <br/>Ointment USP, 2%
Mupirocin Mupirocin Mupirocin Mupirocin polyethylene glycol 400 polyethylene glycol 3350 cream-like
<text> <paragraph> <content styleCode="italics">For dermatologic use on dogs</content> </paragraph> </text> <effectiveTime value="20230927"/> </section> </component> <component> <section> <id root="38e4ad30-1e0b-4977-aaed-1342b0d6a4d4"/> <code code="50745-9" codeSystem="2.16.840.1.113883.6.1" displayName="VETERINARY INDICATIONS SECTION"/> <title>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). 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: Chemical Structure
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° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Keep Out of Reach of Children
<text> <paragraph>Approved by FDA under ANADA # 200-457</paragraph> </text> <effectiveTime value="20230927"/> </section> </component> <component> <section> <id root="7361dba2-038a-4aea-97e3-eb52a863956b"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <text> <paragraph>Mfd. by: Taro Pharmaceutical Industries Ltd.<br/>Haifa Bay, Israel 2624761</paragraph> <paragraph>Dist. by: <content styleCode="bold">Taro Pharmaceuticals U.S.A., Inc.</content> <br/>Hawthorne, NY 10532</paragraph> <paragraph>Revised: November 2020</paragraph> <paragraph>5210551-1120-0 37</paragraph> <paragraph> <renderMultiMedia referencedObject="MM2"/> </paragraph> </text> <effectiveTime value="20230927"/> <component> <observationMedia ID="MM2"> <text>TAKE TIME</text> <value xsi:type="ED" mediaType="image/jpeg"> <reference value="mupirocin-02.jpg"/> </value> </observationMedia> </component> </section> </component> <component> <section> <id root="89844d32-f57c-4aa1-9d9b-bcefc080abb2"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <title>PRINCIPAL DISPLAY PANEL - 22 g Tube Carton NDC 51672-1354-0 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.
Approved by FDA under ANADA # 200-457 Net Weight
22 g Keep Out of Reach of Children. TARO PRINCIPAL DISPLAY PANEL - 22 g Tube Carton