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Mometamax Otic Solution (15 ml Bottle)
Prescription Required
Product ID: *V**MOMETAMAX15
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Product Summary
  • VETERINARY PRESCRIPTION REQUIRED
  • This drug has not been approved for use in humans.

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

Approved for otic (ear) use in dogs only.


Description:

Each gram of Mometamax Otic Suspension contains gentamicin sulfate, USP equivalent to 3 mg gentamicin base; mometasone furoate monohydrate equivalent to 1 mg mometasone; and 10 mg clotrimazole, USP in a mineral oil-based system containing a plasticized hydrocarbon gel.


Indications:

Mometamax is indicated for the treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. incl. P. aeruginosa, coagulase positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci.)


Features and Benefits (reported by the manufacturer):

Once-a-day treatment that helps promote client compliance to ensure treatment success.

Contains:

  • Mometasone furoate monohydrate - A new generation veterinary steroid 7.7 times more potent than betamethasone
  • Clotrimazole - otic antifungal
  • Gentamicin - Broad-spectrum antibacterial

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 these components 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 MOMETAMAX Otic Suspension 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 that received corticosteroids during pregnancy.

Field 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:

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.

Administration of recommended doses of Mometamax Otic Suspension beyond 7 days may result in delayed wound healing.

If overgrowth of nonsusceptible bacteria or fungi occurs, treatment should be discontinued and appropriate therapy instituted.

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.


Adverse Reactions:

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.

Mometasone: ALP (SAP) and ALT (SGPT) enzyme elevations, weight loss, anorexia, polydipsia, polyuria, neutrophilia, and lymphopenia have occurred following the use of parenteral, high-dose, and/or prolonged or systemic synthetic corticosteroids in dogs. 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.

Mometamax Otic Suspension: In field studies following once-daily treatment with Mometamax Otic Suspension, ataxia, proprioceptive deficits, and increased water consumption were observed in less than 1% of 164 dogs. In a field study following twice-daily treatment with MOMETAMAX Otic Suspension, inflammation of the pinna and diarrhea were observed in less than 1% of 141 dogs.


General Dosing and Administration:

The external ear canal should be thoroughly cleaned and dried before treatment. Verify that the eardrum is intact.

For dogs weighing less than 30 lbs, instill 4 drops of Mometamax Otic Suspension once daily into the ear canal.

For dogs weighing 30 lbs or more, instill 8 drops once daily into the ear canal.

Therapy should continue for 7 consecutive days.


Storage:

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

Shake well before use.

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