Antimicrobial - Anti-Inflammatory
Otomax Ointment For Dogs is indicated for the treatment of canine acute and
chronic otitis externa associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin. By virtue of it's three components - Gentamicin-Betamethasone-Clotrimazole - Otomox has antibacterial, anti-inflammatory, and antifungal
activity. Otomax reduces discomfort, redness, swelling, exudate, and odor, and exerts a strong
Dosage and Administration: The external ear should be thoroughly cleaned
and dried before treatment. Remove foreign material, debris, crusted exudates,
etc., with suitable non-irritating solutions. Excessive hair should be clipped
from the treatment area. After verifying that the eardrum is intact, instill 4
drops (2 drops from the 215 g bottle) of OTOMAX twice daily into the ear canal
of dogs weighing less than 30 lbs. Instill 8 drops (4 drops from the 215 g
bottle) twice daily into the ear canal of dogs weighing 30 lbs. or more. Therapy
should continue for 7 consecutive days.
- 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.
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.
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.Shake well before use when using the 215 gram bottle.
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
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
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.
Rx Medication Sold Only To Licensed Veterinarians & Pharmacies. Current License Must Be On File Prior To Shipping.