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. 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. These events began rapidly and extensively after addition of the drug.Ĭlotrimazole is very poorly absorbed following dermal application.

PRECAUTIONS Identification of infecting organisms should be made either by microscopic roll smear evaluation or by culture as appropriate. Antibiotic susceptibility of the pathogenic organism(s) should be determined prior to use of this preparation. If overgrowth of nonsusceptible bacteria, fungi, or yeasts occur, or if hypersensitivity develops, treatment should be discontinued and appropriate therapy instituted.Īdministration of recommended doses of OTOMAX ointment beyond 7 days may result in delayed wound healing. Adverse systemic reactions have been observed following the oral ingestion of some topical corticosteroid preparations. Patients should be closely observed for the usual signs of adrenocorticoid overdosage which include sodium retention, potassium loss, fluid retention, weight gain, polydipsia, and/or polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effects. Use of corticosteroids, depending on dose, duration, and specific steroid, may result in endogenous steroid production inhibition following drug withdrawal. In patients presently receiving or recently withdrawn from corticosteroid treatments, therapy with a rapidly-acting corticosteroid should be considered in especially stressful situations. Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membrane is not ruptured in order to avoid the possibility of transmitting infection to the middle ear as well as damaging the cochlea or vestibular apparatus from prolonged contact.

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