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|Drug Name and Strength||Mometasone furoate monohydrate 1mg/mL, |
|Indication||Treatment of acute and chronic canine otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.|
|Contraindications||Not for use in animals with known perforation of the eardrum (tympanic membrane) or in pregnant or lactating animals. Not for use concomitantly with drugs known to induce ototoxicity.|
|Actions||Mometasone furoate is a synthetic adrenocorticoid for dermatological use. Mometasone, an analogue of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticosteroid activity. Mometasone furoate has been shown to provide anti-inflammatory and antipruritic activity in the topical management of corticosteroid responsive otitis externa. The mechanism of the anti-inflammatory activity of the topical corticosteroids in general is unclear. However, it is thought that corticosteroids induce a protein (lipocortin) which leads to inhibition of phospholipase A2. Thus inflammatory mediator (prostaglandin) synthesis is reduced and inflammation is lessened. It is postulated that these proteins control the biosynthesis of prostaglandins and leukotrienes by inhibiting the release of arachidonic acid, their common precursor. Topical corticosteroids can be absorbed from normal, intact skin. Inflammation can increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through metabolic pathways similar to systemically administered corticosteroids.Clotrimazole is a broad spectrum antifungal agent 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. In vitro , clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida sp., and Malassezia pachydermatis (formerly Pityrosporum canis). Resistance to clotrimazole is very rare among the fungi that cause superficial mycoses. In studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. These events began rapidly and extensively after addition of the drug. Clotrimazole is very poorly absorbed following dermal application.Gentamicin sulfate is an aminoglycoside antibiotic active against a wide variety of pathogenic Gram-negative and Gram-positive bacteria. In vitro tests have determined that 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 intermedius , other coagulase positive Staphylococcus sp., Pseudomonas aeruginosa , Proteus sp., and Escherichia coli .Due to its three active ingredients, Mometamax Ointment has antibacterial, anti-inflammatory and antifungal activity. In component efficacy studies, the compatibility and additive effect of each of the components were demonstrated. In clinical field trials, Mometamax Ointment was effective in the treatment of otitis externa associated with bacteria and Malassezia pachydermatis . Mometamax Ointment reduced discomfort, redness, swelling, exudate, odour and exerted a strong antimicrobial effect.|
|Precautions||If hypersensitivity to any component occurs, discontinue treatment and institute appropriate therapy. 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, foetal death, retained placenta and metritis.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 occurs, or if hypersensitivity develops, treatment should be discontinued and appropriate therapy instituted.Administration of recommended doses of Mometamax Ointment beyond seven 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 the 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 Mometamax Ointment.The use of Mometamax Ointment has been associated with deafness or partial hearing loss in a small number of sensitive dogs (e.g. geriatric dogs). The hearing deficit is usually temporary. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of Mometamax Ointment immediately and flush the ear canal thoroughly with a nonototoxic solution.Disposal Dispose of empty container by wrapping with paper and putting in garbage.|
|Storage||Store below 25°C (air conditioning).|
|MSDS (external link)||Mometamax 8.5ml MSDS|
|Label (external link)||Mometamax 8.5ml Label|
|Manufacturer||MSD Animal Health|