Mometamax Otic Suspension (Canada)This page contains information on Mometamax Otic Suspension for veterinary use.
The information provided typically includes the following:
- Mometamax Otic Suspension Indications
- Warnings and cautions for Mometamax Otic Suspension
- Direction and dosage information for Mometamax Otic Suspension
Mometamax Otic SuspensionThis treatment applies to the following species:
(Gentamicin Sulphate, USP; Mometasone Furoate Monohydrate, Mfr.Std.; and Clotrimazole, USP)
VETERINARY USE ONLY
Antibiotic, Anti-inflammatory, Antifungal
For Otic Use in Dogs Only
Each gram of MOMETAMAX Otic Suspension contains gentamicin sulphate, USP equivalent to 3 mg gentamicin base; mometasone furoate monohydrate, Mfr.Std. equivalent to 1 mg mometasone; and 10 mg clotrimazole, USP in a mineral oil-based system containing a plasticized hydrocarbon gel.
Mometamax Otic Suspension Indications
MOMETAMAX Otic Suspension is indicated for the treatment of canine otitis externa in dogs caused by yeast susceptible to clotrimazole (Malassezia pachydermatis) and bacteria susceptible to gentamicin (Pseudomonas spp. [including P. aeruginosa], coagulase-positive staphylococci [including S. aureus and S. intermedius], Enterococcus faecalis, Proteus mirabilis and beta-hemolytic streptococci), and for the reduction of tissue inflammation that is commonly associated with this condition.
Dosage and Administration
The external ear canal should be thoroughly cleaned and dried before treatment. Excessive hair should be removed from the treatment area of the external ear. Verify that the eardrum is intact. Shake well before use. For dogs weighing less than 15 kg, per affected ear, instill 4 drops from the 7.5 g, 15 g or 30 g bottle (2 drops from the 215 g bottle) of MOMETAMAX Otic Suspension once daily into the ear canal. For dogs weighing 15 kg or more, per affected ear, instill 8 drops from the 7.5 g, 15 g or 30 g bottle (4 drops from the 215 g bottle) once daily into the ear canal. After application, massage the base of the ear to allow the preparation to penetrate to the lower part of the ear canal. Therapy should continue for 7 consecutive days. Do not exceed the recommended period of treatment or frequency of application.
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.
The use of these components 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. In rare occasions, especially in older dogs, permanent hearing losses or deficits were reported. If hearing loss, vestibular dysfunction (head tilt, circling, rolling, rhythmic movement of the eyes) or hypersensitivity (redness and pain) or other reactions are noted during the course of treatment, discontinue use of MOMETAMAX Otic Suspension immediately and flush the ear canal thoroughly with a non-ototoxic solution. Prior to treatment, it is recommended to conduct a clinical evaluation for evidence of hearing deficit and/or vestibular disorder. Owners should be advised of the potential for adverse reactions and in particular for potential of hearing loss or hypersensitivity. They should be informed of the clinical signs associated with those adverse reactions. Owners should be informed to discontinue the use of Mometamax Otic Suspension and to contact their veterinarian immediately if any sign of adverse reactions is observed.
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.
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 third of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.
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 non-susceptible 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 and suppression of adrenal function.
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.
Not for ophthalmic use. Avoid contact with eyes. In case of accidental contact, rinse with copious amounts of water.
Do not use in cats.
The safe use of Mometamax Otic Suspension has not been evaluated in breeding dogs or in pregnant or lactating bitches.
Keep out of the reach of children. Wash hands carefully after applying the product. In case of accidental contact with the eyes, rinse with copious amounts of water. Do not handle the product if you have known hypersensitivity against compounds in the product.
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 clinical field trials, 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.
Post-approval surveillance: The following adverse reactions are those reported in USA and include all the reactions estimated or not estimated to be related to product. They are listed in order of frequency: Deafness, hypersensitivity, seizures, polyuria-polydipsia, vestibular syndrome, behavior problems, anorexia, diabetes, facial swelling, gastro intestinal disorders (ingestion).
Gentamicin: Gentamicin sulphate is an aminoglycoside antibiotic active against a wide variety of 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. In clinical trials, gentamicin was shown to have a range of activity against the following organisms commonly isolated from infected canine ears: Pseudomonas spp. (including P. aeruginosa), coagulase-positive staphylococci (including S. aureus and S. intermedius), Enterococcus faecalis, Proteus mirabilis and beta-hemolytic streptococci.
Mometasone: Mometasone furoate monohydrate is a synthetic adrenocorticoid characterized by a (2’) furoate 17-ester having chlorine at the 9 and 21 positions, which have shown to possess high topical potency.
Systemic absorption of mometasone furoate ointment was found to be low; 2% (1.2-4.1%) over one week when applied topically to dogs with intact skin. In a 6-month dermal toxicity study using 0.1% mometasone ointment on healthy intact skin in dogs, systemic effects typical of corticosteroid therapy were noted.
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the integrity of the epidermal barrier. 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 dermatophytes and yeast. The primary action of clotrimazole is against dividing and growing organisms.
In vitro, clotrimazole exhibits fungicidal and fungistatic activity against isolates of Malassezia pachydermatis, Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, and Candida spp. Resistance to clotrimazole is very rare among the fungi that cause superficial mycoses. In an induced otitis externa study using dogs infected with Malassezia pachydermatis, 1% clotrimazole in the vehicle formulation was effective both microbiologically and clinically in terms of reduction of exudates, odor, and swelling.
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-Mometasone-Clotrimazole: By virtue of its three active ingredients, MOMETAMAX Otic Suspension has antibacterial, anti-inflammatory, and antifungal activity. In clinical field trials, MOMETAMAX Otic Suspension was effective in the treatment of otitis externa associated with bacteria and Malassezia pachydermatis. MOMETAMAX Otic Suspension reduced discomfort, redness, swelling, exudate, and odor.
Clinical and safety studies with MOMETAMAX Otic Suspension have shown an adequate safety margin at the recommended dose level in dogs (see CAUTIONS/ADVERSE REACTIONS).
Store at room temperature (15-30°C). Discard the unused product after a full course of treatment.
MOMETAMAX Otic Suspension is available in 7.5 g, 15 g, 30 g and 215 g plastic bottles.
To report an Adverse Reaction: 1-888-306-0069
Intervet Canada Corp., Kirkland, Québec H9H 4M7
NAC No.: 12082222
Intervet Canada Corp.
16750 ROUTE TRANSCANADIENNE, KIRKLAND, QC, H9H 4M7
|Fax:||Toll-free 888-498-4444; local 514-428-7014|
|Every effort has been made to ensure the accuracy of the Mometamax Otic Suspension information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.|
Copyright © 2013 North American Compendiums. Updated: 2013-09-18