TRI OTIC Dailymed

Indications:

Gentamicin-betamethasone-clotrimazole 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 And Precautions:

WARNINGS: The use of gentamicin-betamethasone-clotrimazole 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 gentamicin-betamethasone-clotrimazole ointment immediately and flush the ear canal thoroughly with a non-ototoxic 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 gentamicin-betamethasone-clotrimazole 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.

Toxicology:

Clinical and safety studies with Gentamicin sulfate, Betamethasone valerate, and Clotrimazole ointment have shown a wide safety margin at the recommended dose level in dogs (see PRECAUTIONS and/or SIDE EFFECTS).

Side Effects:

Gentamicin: While aminoglycosides are absorbed poorly from skin, intoxication may occur when aminoglycosides are applied topically for prolonged periods of time to large wounds, burns, or any denuded skin, particularly if there is renal insufficiency. All aminoglycosides have the potential to produce reversible and irreversible vestibular, cochlear and renal toxicity. Betamethasone: Side effects such as SAP and SGPT enzyme elevations, weight loss, anorexia, polydipsia, and polyuria have occurred following the use of parenteral or systemic synthetic corticosteroids in dogs. Vomiting and diarrhea (occasionally bloody) have been observed in dogs and cats.Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapy. Clotrimazole: The following have been reported occasionally in humans in connection with the use of clotrimazole: erythema, stinging, bulering, peeling, edema, pruritus, urticaria, and general irritation of the skin not present before therapy.

Contact Information:

To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Med-Pharmex at (800) 587-4306. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae

Dosage And Administration:

The extemal ear should be thoroughly cleaned and dried before treatment. Remove foreign material, debris, crusted exudates, etc., wilh 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 10 g, 15 g and 25 g bottle (2 drops from the 215 g bottle) of gentamicin-betamethasone-clotrimazole ointment twice daily into the ear canal of dogs weighing less than 30 Ibs.

Instill 8 drops from the 7.5 g and 15 g tube, and 10 g, 15 g and 25 g bottle (4 drops from the 215 g bottle) twice daily into the ear canal of dogs weighing 30 Ibs. or more.

Massage external ear canal carefully after instillation to ensure appropriate distribution of medication.

Therapy should continue for 7 consecutive days.

How Supplied:

Gentamicin-betamethasone-clotrimazole ointment is available in 7.5 gram and 15 gram tubes as well as in 10 gram, 15 gram, 25 gram and 215 gram plastic bottles.

Storage:

Store between 2° and 25°C (36° and 77°F).    Shake well before use when using the 215 gram bottle.



Manufactured by: Med-Pharmex, Inc.Pomona, CA 91767

Rev. July 2023

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