Otomax

Approved by FDA under NADA # 140-896

PRODUCT INFORMATION

For Otic Use in Dogs Only.

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Keep this and all drugs out of the reach of children.

DESCRIPTION: Each gram of OTOMAX ointment contains gentamicin sulfate, equivalent to 3 mg gentamicin base; betamethasone valerate, equivalent to 1 mg betamethasone; and 10 mg clotrimazole, in a mineral oil-based system containing a plasticized hydrocarbon gel.

INDICATIONS: OTOMAX ointment is indicated for the treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.

CONTRAINDICATIONS: If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Do not use in dogs with known perforation of eardrums.

WARNINGS: The use of OTOMAX ointment has been associated with deafness or partial hearing loss in a small number of sensitive dogs (e.g., geriatric). The hearing deficit is usually temporary. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of OTOMAX ointment immediately and flush the ear canal thoroughly with a nonototoxic solution.

Corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs which received corticosteroids during pregnancy.

Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

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.

Administration of recommended doses of OTOMAX ointment beyond 7 days may result in delayed wound healing. Avoid ingestion. 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.

DOSAGE AND ADMINISTRATION: The external ear should be thoroughly cleaned and dried before treatment. Remove foreign material, debris, crusted exudates, etc., with suitable nonirritating solutions. Excessive hair should be clipped from the treatment area. After verifying that the eardrum is intact, instill 4 drops from the 7.5 g and 15 g tube, and 15 g and 30 g bottle (2 drops from the 215 g bottle) of OTOMAX ointment twice daily into the ear canal of dogs weighing less than 30 lbs. Instill 8 drops from the 7.5 g and 15 g tube, and 15 g and 30 g bottle (4 drops from the 215 g bottle) twice daily into the ear canal of dogs weighing 30 lbs or more. Massage external ear canal carefully after instillation to ensure appropriate distribution of medication. Therapy should continue for 7 consecutive days.

HOW SUPPLIED: OTOMAX ointment is available in 7.5 g and 15 g tubes as well as in 15 g, 30 g, and 215 g plastic bottles.

Distributed by Intervet Inc. (d/b/a Merck Animal Health), Rahway, NJ 07065.

Made in Germany.
Copyright © 1993-2026 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.
Rev. 03/2026

MERCK
Animal Health

246829 R2

7.5 g

Otomax^®
(GENTAMICIN SULFATE,
BETAMETHASONE
VALERATE, AND CLOTRIMAZOLE,
OINTMENT)

Keep Out of Reach of Children.

Caution: Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.

Approved by FDA
under NADA # 140-896

MERCK
Animal Health