FDA approves drug for treating canine yeast ear infections

Photo: 135pixels/Adobe Stock

Officials with the FDA have approved terbinafine and betamethasone acetate otic gel (DuOtic; Dechra) for dogs. This gel is the first animal drug indicated approved by the agency for the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis).

According to the FDA, terbinafine and betamethasone acetate otic gel is also the first otic drug intended to treat otitis externa that does not contain an antibiotic. This allows veterinarians to focus treatment and avoid using antibiotics when dogs have diagnosed yeast-only ear infections.

The drug is a fixed combination of the 2 active substances: terbinafine and betamethasone acetate. Terbinafine is an antifungal and is commonly used in human medicine to treat athlete’s foot. Betamethasone acetate is a glucocorticosteroid with anti-inflammatory activity.

The otic gel dissolves in earwax and is slowly eliminated from the ear. It also fights yeast infections for up to 45 days.

Terbinafine and betamethasone acetate otic gel is only available by a prescription from a licensed veterinarian and should be administered by a veterinary professional. Veterinary medicine professionals should clean and dry the external ear canal before administering the initial dose of the product and should administer one dose (1 tube) per affected ear and repeat administration in 7 days. The dog’s ear canal should not be cleaned for 45 days after the initial administration to allow contact of the gel with the ear canal.

The newly approved gel may cause eye injury and irritation in people and dogs. Individuals who administer this drug in the clinic should wear eye protection, and the dog should be restrained to minimize post-application head shaking to help prevent accidental eye exposure in both humans and dogs.

Terbinafine and betamethasone acetate otic gel contains 10 mg terbinafine and 1 mg betamethasone acetate per mL. It is available in a single use tube with a flexible soft tip, supplied in cartons containing 2 or 20 tubes.

Reference

FDA approves treatment for yeast ear infections in dogs. News release. FDA. March 15, 2024. Accessed March 15, 2024. https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-treatment-yeast-ear-infections-dogs?utm_medium=email&utm_source=govdelivery