Gentamicin, mometasone and posaconazole

Indications

Mometamax Single is indicated for the treatment of otitis externa associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius and Pseudomonas aeruginosa ) in dogs.

Dosage and Administration

Mometamax Single should be administered by veterinary personnel. The dose volume is 0.8 mL per affected ear. Verify the tympanic membrane is intact prior to administration (see Contraindications , Animal Safety Warnings and Precautions ). 1. Clean and dry the external ear canal before administering the product. 2. Shake bottle vigorously for 15 seconds. 3. Before first use, unwrap the syringe with the attached adapter. 4. Remove the cap from the bottle and insert the syringe with the attached adapter by pressing it firmly into the top of the bottle using the attached syringe (see figure A ). 5. Invert the bottle and draw up 0.8 mL (see figure B ). 6. Return the bottle to an upright position and remove the syringe from the adapter. Leave the adapter in place in the bottle for all subsequent uses. 7. Replace the cap on the bottle. 8. Place the tip of the syringe at the entrance of the external ear canal and administer the 0.8 mL dose (see figure C ). The applied dose will flow into the ear canal. 9. Gently massage the base of the ear to ensure distribution of the product throughout the ear canal. 10. Restrain the dog post-application to minimize head shaking and to reduce potential splatter of product and accidental eye exposure in people and dogs. 11. Use a new syringe for each affected ear. Shake the bottle vigorously (with the cap on the bottle to prevent leakage) for 15 seconds before drawing up each new dose. 12. The duration of the effect should last 33 days. Cleaning the ear after dosing may affect product effectiveness. 13. Only twenty doses can be accurately withdrawn from the bottle. Discard the bottle 3 months after opening or after 20 doses, whichever comes first. Figure A Figure B Figure C

Contraindications

Do not use in dogs with known tympanic membrane perforation (see Animal Safety Warnings and Precautions ). Do not use in dogs with known or suspected hypersensitivity to gentamicin, posaconazole, or mometasone furoate. WARNINGS AND PRECAUTIONS: USER SAFETY WARNINGS: Not for human use. Keep this and all drugs out of the reach of children. In case of accidental ingestion by humans, contact a physician immediately. In case of accidental skin contact, wash area thoroughly with water. Avoid contact with eyes. If contact with the eyes occurs, flush thoroughly with water for at least 15 minutes. If wearing contact lenses, rinse eyes first then remove the contact lenses and continue to rinse. If symptoms develop, seek medical advice. Humans with known hypersensitivity to gentamicin, posaconazole, and/or mometasone furoate should avoid handling this product. ANIMAL SAFETY WARNINGS AND PRECAUTIONS: For otic use in dogs only. Do not use in cats. Restrain the dog to minimize post-application head shaking. Reducing the potential for splatter of product helps prevent accidental eye exposure in people and dogs (see Dosage and Administration, User Safety Warnings ). The use of Mometamax Single in dogs with perforated tympanic membranes has not been evaluated. The integrity of the tympanic membrane should be confirmed before administering the product. Reevaluate the dog if hearing loss or signs of vestibular dysfunction are observed during treatment. Do not administer orally. Use of topical otic corticosteroids has been associated with adrenocortical suppression and iatrogenic hyperadrenocorticism in dogs (see Target Animal Safety ). Use with caution in dogs with impaired renal function. Gentamicin, one of the active ingredients in Mometamax Single, is associated with nephrotoxicity. The safe use of Mometamax Single in dogs used for breeding purposes, during pregnancy, or during lactation has not been evaluated.

Adverse Reactions

The following adverse reactions were reported during the course of a U.S. field study for treatment of otitis externa in dogs treated with Mometamax Single. Frequency of Adverse Reactions by Treatment Adverse Reaction Mometamax Single (N=245) Control (N=127) Vomiting 21 (8.6%) 4 (3.1%) Decreased appetite 9 (3.7%) 2 (1.6%) Pruritus 8 (3.3%) 2 (1.6%) Ear pruritus 7 (2.9%) 1 (0.8%) Disorientation 3 (1.2%) 0 (0.0%)

Description

Each milliliter of Mometamax Single contains gentamicin sulfate, equivalent to 8.6 mg gentamicin; 2.6 mg of posaconazole; and mometasone furoate monohydrate, equivalent to 2.1 mg mometasone furoate, in a mineral oil-based system containing a plasticized hydrocarbon gel. A 0.8 mL dose volume of Mometamax Single delivers approximately 6.88 mg gentamicin, 2.08 mg posaconazole, and 1.68 mg mometasone furoate.

Storage

Store at temperatures between 2°-30°C (36°-86°F). Discard 3 months after opening or after 20 doses, whichever comes first.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming gentamicin and mometasone and posaconazole as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.