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The veterinary medicinal product is a fixed combination of three active substances (corticosteroid, antifungal agent, and antibiotic): Betamethasone acetate belongs to the class of diester glucocorticosteroids with potential endogenous glucocorticoid action, relieves inflammation and itching and improves clinical symptoms observed in external otitis. Terbinafine is an allylamine with pronounced fungicidal activity. It selectively inhibits the early stage of ergosterol synthesis, a major component of yeast and fungal membranes, including Malassezia pachydermatis (MIC90 2 µg/ml). Terbinafine has a different mode of action compared to azole antimycotics. Therefore, there is no cross-resistance with azole antimycotics. Florfenicol is a bacteriostatic antibiotic that acts by inhibiting protein synthesis. Its spectrum of action includes Gram-positive and Gram-negative bacteria, including Staphylococcus pseudintermedius (MIC90 of 8 µg/ml). Due to the high antimicrobial concentrations in the ear canal and the multitude of factors conditioning otitis of the external ear, in vitro sensitivity may not be directly related to clinical success. The veterinary medicinal product dissolves in ear wax and is slowly cleared from the ear by mechanical means. Systemic absorption of all active substances has been determined in studies with repeated administration after the use of the veterinary medicinal product in both ear canals of healthy mongrel dogs. Absorption is observed mainly during the first two to four days after application, with the active substances’ low plasma concentrations (1 to 42 ng/ml). Many factors, including the integrity of the epidermal barrier, determine the degree of percutaneous absorption of products for local application. Inflammation may increase the percutaneous absorption of veterinary medicinal products.
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