Country: United States
Language: English
Source: NLM (National Library of Medicine)
GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG), MOMETASONE FUROATE (UNII: 04201GDN4R) (MOMETASONE - UNII:8HR4QJ6DW8), CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)
Dechra Veterinary Products, LLC
AURICULAR (OTIC)
PRESCRIPTION
INDICATIONS: Mometavet™ Otic Suspension is indicated for the treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P . aeruginosa ], coagulase-positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci). CONTRAINDICATIONS: If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Do not use in dogs with known perforation of eardrums.
H O W SUPPLIED: Mometavet™ Otic Suspension is available in 7.5 g plastic bottles, 15 g plastic bottles, 30 g plastic bottles, and 215 g plastic bottles. NDC 17033-273-75 - - - 7.5 g bottle NDC 17033-273-15 - - - 15 g bottle NDC 17033-273-30 - - - 30 g bottle NDC 17033-273-21 - - - 215 g bottle
Abbreviated New Animal Drug Application
MOMETAVET- GENTAMICIN SULFATE, MOMETASONE FUROATE ANHYDROUS, AND CLOTRIMAZOLE SUSPENSION DECHRA VETERINARY PRODUCTS, LLC ---------- MOMETAVET (GENTAMICIN SULFATE, MOMETASONE FUROATE ANHYDROUS, AND CLOTRIAMZOLE OTIC SUSPENSION) APPROVED BY FDA UNDER ANADA # 200-536 VETERINARY FOR OTIC USE IN DOGS ONLY CAUTION FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF A LICENSED VETERINARIAN. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. DESCRIPTION: Each gram of Mometavet™ Otic Suspension contains gentamicin sulfate equivalent to 3 mg gentamicin base; mometasone furoate anhydrous equivalent to 1 mg mometasone; and 10 mg clotrimazole in a mineral oil-based system containing a plasticized hydrocarbon gel. PHARMACOLOGY: GENTAMICIN: Gentamicin sulfate is an aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive bacteria. _In vitro _tests have determined that gentamicin is bactericidal and acts by inhibiting normal protein synthesis in susceptible microorganisms. In clinical trials, gentamicin was shown to have a range of activity against the following organisms commonly isolated from infected canine ears: _Pseudomonas _spp. (including _P. aeruginosa_), coagulase-positive staphylococci, _Enterococcus faecalis, Proteus mirabilis _and beta-hemolytic streptococci. MOMETASONE: Mometasone furoate anhydrous is a synthetic adrenocorticoid characterized by a novel (2') furoate 17-ester having chlorine at the 9 and 21 positions, which have shown to possess high topical potency. Systemic absorption of mometasone furoate ointment was found to be minimal (2%) over 1 week when applied topically to dogs with intact skin. In a 6-month dermal toxicity study using 0.1% mometasone ointment on healthy intact skin in dogs, systemic effects typical of corticosteroid therapy were noted. The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal, intact skin. Read the complete document