The use of OTOMAX ointment has been associated with deafness or partial hearing loss in a small number of sensitive dogs (eg, geriatric). Do not use in dogs with known perforation of eardrums. Concomitant use of drugs known to induce ototoxicity should be avoided. If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. OTOMAX ointment is indicated for the treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin. OTOMAX ointment reduced discomfort, redness, swelling, exudate, and odor, and exerted a strong antimicrobial effect.
In clinical field trials, OTOMAX ointment was effective in the treatment of otitis externa associated with bacteria and Malassezia pachydermatis.
In component efficacy studies, the compatibility and additive effect of each of the components were demonstrated. Gentamicin-Betamethasone-Clotrimazole: By virtue of its three active ingredients, OTOMAX ointment has antibacterial, anti-inflammatory, and antifungal activity.
These events began rapidly and extensively after addition of the drug.Ĭlotrimazole is very poorly absorbed following dermal application. In studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused leakage of intra-cellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. In an induced otitis externa infected with Malassezia pachydermatis, 1% clotrimazole in the OTOMAX vehicle was effective both microbiologically and clinically in terms of reduction of exudate, odor, and swelling. Resistance to clotrimazole is very rare among the fungi that cause superficial mycoses. In vitro, clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida spp., and Malassezia pachydermatis (Pityrosporum canis). The primary action of clotrimazole is against dividing and growing organisms. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.Ĭlotrimazole: Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes and yeasts. Inflammation can increase percutaneous absorption. Topical corticosteroids can be absorbed from normal, intact skin. Betamethasone valerate, the 17-valerate ester of betamethasone, has been shown to provide anti-inflammatory and antipruritic activity in the topical management of corticosteroid-responsive otitis externa. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticosteroid activity. Specifically, gentamicin is active against the following organisms commonly isolated from canine ears: Staphylococcus aureus, other Staphylococcus spp., Pseudomonas aeruginosa, Proteus spp., and Escherichia coli.īetamethasone: Betamethasone valerate is a synthetic adrenocorticoid for dermatologic use. In vitro tests have determined that gentamicin is bactericidal and acts by inhibiting normal protein synthesis in susceptible microorganisms. Gentamicin: Gentamicin sulfate is an aminoglycoside antibiotic active against a wide variety of pathogenic gram-negative and gram-positive bacteria. DescriptionĮach gram of OTOMAX ointment contains gentamicin sulfate, equivalent to 3 mg gentamicin base betamethasone valerate, equivalent to 1 mg betamethasone and 10 mg clotrimazole, in a mineral oil-based system containing a plasticized hydrocarbon gel. Keep this and all drugs out of the reach of children. (GENTAMICIN SULFATE, BETAMETHASONE VALERATE AND CLOTRIMAZOLE, OINTMENT)ĬAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
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