Terbinafine and betamethasone

Indications

DuOtic™ is indicated for the treatment of otitis externa in dogs, associated with susceptible strains of yeast (Malassezia pachydermatis).

Dosage and Administration

DuOtic™ should be administered by a veterinary professional. Wear eye protection when administering DuOtic™ (see Human Safety Warnings , Precautions , Post-approval Experience , and Target Animal Safety ). Splatter may occur if the dog shakes its head following administration. Persons near the dog during administration should also take steps to avoid ocular exposure. Clean and dry the external ear canal before administering the initial dose of the product. Verify the tympanic membrane is intact prior to each administration (see Precautions , Contraindications , Target Animal Safety and Post-approval Experience ). Administer one dose (1 tube) per affected ear. Repeat administration in 7 days. Open tube by twisting the soft tip. Insert the flexible tip in the affected external ear canal and squeeze entire tube contents into the external ear canal. After application, gently massage the base of the ear to allow the gel to penetrate the lower part of the ear canal. Restrain dog to minimize post-application head shaking to reduce potential for splatter of product, and accidental eye exposure in people and dogs (see Post-Approval Experience and Target Animal Safety ). Do not clean the ear canal for 45 days after the initial administration to allow contact of the gel with the ear canal. Cleaning the ear may affect product effectiveness (see

Contraindications

Do not use in dogs with known tympanic perforation (see

Warnings

Human Safety Warnings: DuOtic™ may cause eye injury and irritation (see Precautions , Post-approval Experience and Target Animal Safety ). In case of accidental eye contact, flush thoroughly with water for at least 15 minutes. If wearing contact lenses, rinse eyes first then remove contact lenses and continue to rinse. If symptoms develop, seek medical advice. Not for use in humans. Keep this and all medications out of reach of children. Consult a physician in case of accidental ingestion by humans. In case of accidental skin contact, wash area thoroughly with water.

Precautions

). Do not use in dogs with a hypersensitivity to terbinafine or corticosteroids.

Adverse Reactions

). The safe use of DuOtic™ has not been evaluated in dogs that are pregnant, lactating or intended for breeding. ADVERSE REACTIONS: The following adverse reactions were reported during the course of a US field study for treatment of otitis externa in dogs treated with DuOtic™ with 1 tube per affected ear(s) and repeated after 7 days: Number (%) of dogs with Adverse Reactions by Treatment Adverse Reaction DuOtic™ (n=120) Control (n=119) Elevated alanine aminotransferase Four dogs were reported to have an increase in alanine aminotransferase at Study Exit. The levels reported in subsequent clinical chemistries returned to normal in three dogs, while no follow up was performed for the fourth dog. 4 (3.3%) 0 (0.0%) Conjunctivitis 1 (0.8%) 0 (0.0%) Ocular discharge 1 (0.8%) 2 (1.7%) Ear discharge 0 (0.0%) 1 (0.8%) Ear pruritus 3 (2.5%) 4 (3.4%) Post-Approval Experience: The following adverse events are based on post-approval adverse drug experience reporting for Osurnia ® (florfenicol, terbinafine, betamethasone acetate). The presentation and concentrations of terbinafine and betamethasone acetate in DuOtic™ are identical to the concentrations of these active ingredients in Osurnia ® . Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data. In humans , accidental exposure leading to corneal ulcers and other ocular injuries such as eye irritation, burning, stinging, and itchiness have been reported to occur when the dog shook its head after application of Osurnia ® . In dogs , the adverse events reported for Osurnia ® are presented below in decreasing order of reporting frequency: Deafness, ear discharge, pinnal irritation and ear pain, emesis, head shaking, internal ear disorder (head tilt and vestibular), ataxia, vocalization, corneal ulcer, keratoconjunctivitis sicca, nystagmus, tympanic rupture, and cranial nerve disorder (facial paralysis). Osurnia ® is not approved for use in cats . The adverse events reported following extra-label use in cats are presented below in decreasing order of reporting frequency: Ataxia, anorexia, Horner's syndrome (third eyelid prolapse and miosis), internal ear disorder (head tilt and vestibular), anisocoria, lethargy, head shake, emesis, nystagmus, deafness, and tympanic rupture.

Description

DuOtic™ contains 10 mg terbinafine and 1 mg betamethasone acetate per mL and the inactive ingredients propylene carbonate, glycerol formal, hypromellose, phospholipid, oleic acid and butylated hydroxytoluene in an off-white to slightly yellow translucent gel.

Information for Owners

Owners should be aware that adverse reactions may occur following administration of DuOtic™ and should observe their dog for signs such as deafness, ear pain and irritation, vomiting, head shaking, head tilt, incoordination, eye pain and ocular discharge (see Animal Safety and Post-approval Experience ). Owners should be advised to contact their veterinarian if any of the above signs are observed. Owners should also be informed that splatter may occur if the dog shakes its head following administration of DuOtic™ which may lead to eye exposure. As a result, eye injuries in humans and dogs have been reported including corneal ulcers following the use of a similar product (Osurnia ® ). Owners should be careful to avoid ocular exposure (see

Storage

Store at or below 77° F (25° C), with excursions up to 104° F (40° C).

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming terbinafine and betamethasone as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.