Terbinafine/betamethasone acetate, sold under the brand name Duotic is a veterinary medication used for the treatment of otitis externa (ear infections) in dogs.[1] It is a fixed dose combination of terbinafine, an antifungal; and betamethasone acetate, a glucocorticosteroid anti-inflammatory.[1][2]
| Combination of | |
|---|---|
| Terbinafine | Antifungal |
| Betamethasone acetate | Glucocorticosteroid |
| Clinical data | |
| Trade names | Duotic |
| License data | |
| Routes of administration | Ear drop |
| ATCvet code | |
| Legal status | |
| Legal status | |
The combination is the first FDA-approved animal drug intended to treat yeast-only otitis externa in dogs.[2] It is also the first otic drug intended to treat otitis externa that does not contain an antibiotic.[2]
Terbinafine/betamethasone acetate was approved for medical use in the United States in March 2024.[1][2]
Society and culture
editIn October 2024, the Committee for Veterinary Medicinal Products of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the veterinary medicinal product Duotic, Ear gel, intended for dogs.[3] The applicant for this veterinary medicinal product is Dechra Regulatory B.V.[3]
Veterinary uses
editTerbinafine/betamethasone acetate is indicated for the treatment of otitis externa in dogs, associated with susceptible strains of yeast (Malassezia pachydermatis).[1][2]
References
edit- ^ a b c d e https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/15165 Archived 20 March 2024 at the Wayback Machine
This article incorporates text from this source, which is in the public domain.
- ^ a b c d e "FDA Approves Treatment for Yeast Ear Infections in Dogs". U.S. Food and Drug Administration (FDA). 15 March 2024. Archived from the original on 20 March 2024. Retrieved 20 March 2024. This article incorporates text from this source, which is in the public domain.
- ^ a b "Duotic EPAR". European Medicines Agency (EMA). 10 October 2024. Retrieved 12 October 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
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