Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
Gentamicin Sulfate (UNII: 8X7386QRLV) (Gentamicin - UNII:T6Z9V48IKG), Mometasone Furoate Monohydrate (UNII: MTW0WEG809) (Mometasone - UNII:8HR4QJ6DW8), Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65)
Butler Animal Health Supply
AURICULAR (OTIC)
PRESCRIPTION
F-27078915 NADA #141-177, Approved by FDA. PRODUCT INFORMATION 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. INDICATIONS Maxi-Otic 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 ], coagulasepositive 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.
HOW SUPPLIED Maxi-Otic Otic Suspension is available in 7.5 g (NDC 11695-7025-7), 15 g (NDC 11695-7025-1), 30 g (NDC 11695-7025-3), and 215 g (NDC 11695-7025-2) plastic bottles. Store between 2° and 25°C (36° and 77°F). Shake well before use.
New Animal Drug Application
MAXI-OTIC- GENTAMICIN SULFATE, MOMETASONE FUROATE MONOHYDRATE, AND CLOTRIMAZOLE SUSPENSION BUTLER ANIMAL HEALTH SUPPLY ---------- MAXI-OTIC™ (GENTAMICIN SULFATE, USP; MOMETASONE FUROATE MONOHYDRATE; AND CLOTRIMAZOLE, USP, OTIC SUSPENSION) F-27078915 NADA #141-177, Approved by FDA. PRODUCT INFORMATION 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 Maxi-Otic™ Otic Suspension contains gentamicin sulfate, USP equivalent to 3 mg gentamicin base; mometasone furoate monohydrate equivalent to 1 mg mometasone; and 10 mg clotrimazole, USP in a mineral oilbased system containing a plasticized hydrocarbon gel. PHARMACOLOGY GENTAMICIN: Gentamicin sulfate is an aminoglycoside antibiotic active against a wide variety of gram- negative and grampositive 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_), coagulasepositive staphylococci, _Enterococcus faecalis,_ _Proteus mirabilis _and beta-hemolytic streptococci. MOMETASONE: Mometasone furoate monohydrate 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 cortic Leggi il documento completo