Otomax Ointment

Antimicrobial - Anti-Inflammatory

• Gentamicin: Gentamicin sulfate is an aminoglycoside antibiotic active against a wide variety of pathogenic gram-negative and gram-positive bacteria. Gentamicin is bactericidal and acts by inhibiting normal protein synthesis in susceptible microorganisms. Specifically, gentamicin is active against the following organisms commonly isolated from canine ears: Staphylococcus aureus, other Staphylococcus spp., Pseudomonas aeruginosa, Proteus spp., and Escherichia coli.
  
  
• Betamethasone: Betamethasone valerate is a synthetic adrenocorticoid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticosteroid activity. Betamethasone valerate, the 17-valerate ester of betamethasone, has been shown to provide anti-inflammatory and anti-pruritic activity in the topical management of corticosteroid-responsive otitis externa.
  
  Topical corticosteroids can be absorbed from normal, intact skin. Inflammation can increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.
  
  
• Clotrimazole: Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes and yeasts. The primary action of clotrimazole is against dividing and growing organisms.
  
  Clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida spp., and Malassezia pachydermatis (Pityrosporum canis). Resistance to clotrimazole is very rare among the fungi that cause superficial mycoses.
  

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

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

Warnings: The use of OTOMAX has been associated with deafness or partial hearing loss in a small number of sensitive dogs (eg, geriatric). The hearing deficit is usually temporary. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of OTOMAX immediately and flush the ear canal thoroughly with a non-ototoxic solution.
Administration of recommended doses of OTOMAX 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. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of OTOMAX.

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, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin not present before therapy.

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

Storage: Store between 2° and 25°C (36° and 77°F).

Presentation: OTOMAX is available in 7.5 gram (NDC 0061-0387-03) and 15 gram tubes as well as in a 215 gram plastic bottle (NDC 0061-0387-01) and a 30 gram plastic bottle.