posaconazole

POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa, and Enterococcus faecalis).

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

Posatex® Otic Suspension

For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius and Pseudomonas aeruginosa) in dogs.

Mometamax Single™

INDICATIONS: POSATEX® Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa, and Enterococcus faecalis).

Posatex® Otic Suspension (Orbifloxacin, Mometasone Furoate Monohydrate and Posaconazole, Suspension)

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.

Mometamax Single™ (gentamicin, posaconazole, andmometasone furoate otic suspension)

CLINICAL PHARMACOLOGY: Mometamax Single is a combination of three active ingredients: gentamicin (antibacterial), posaconazole (antifungal), and mometasone furoate (steroidal anti-inflammatory). Gentamicin is an aminoglycoside bactericidal antibiotic which acts by binding to the 30S ribosomal subunit leading to inhibition of bacterial protein synthesis. Posaconazole is a triazole antifungal which selectively inhibits an enzyme involved in the biosynthesis of ergosterol. Mometasone furoate is a corticosteroid that binds to glucocorticoid receptors resulting in anti-inflammatory activity.

Mometamax Single™ (gentamicin, posaconazole, andmometasone furoate otic suspension)

CONTRAINDICATIONS: POSATEX® Otic Suspension is contraindicated in dogs with known or suspected hypersensitivity to quinolones, mometasone furoate monohydrate, or posaconazole. Do not use in dogs with known tympanic perforation (see PRECAUTIONS ).

Posatex® Otic Suspension (Orbifloxacin, Mometasone Furoate Monohydrate and Posaconazole, Suspension)

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.

Mometamax Single™ (gentamicin, posaconazole, andmometasone furoate otic suspension)

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

Mometamax Single™ (gentamicin, posaconazole, andmometasone furoate otic suspension)

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%)

Mometamax Single™ (gentamicin, posaconazole, andmometasone furoate otic suspension)

ADVERSE REACTIONS: In the field study, 143 dogs were treated with POSATEX® Otic Suspension. Of those, 1 dog with bilateral otitis externa developed hearing loss. POSATEX® Otic Suspension treatment was discontinued and the condition resolved after one week. To report suspected adverse reactions, call 1-800-224-5318. For a copy of the Material Safety Data Sheet (MSDS) call 1-800-770-8878.

Posatex® Otic Suspension (Orbifloxacin, Mometasone Furoate Monohydrate and Posaconazole, Suspension)

For dogs weighing less than 30 lbs. instill 4 drops of POSATEX 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. Four drops of POSATEX Otic Suspension delivers approximately 1.0 mg of orbifloxacin, 0.1 mg of mometasone furoate monohydrate, and 0.1 mg of posaconazole.

Otic

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

Posatex® Otic Suspension

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.

Otic

Mometamax Single™

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.

AURICULAR (OTIC)

Mometamax Single™ (gentamicin, posaconazole, andmometasone furoate otic suspension)

DOSAGE AND ADMINISTRATION: Shake well before use. For dogs weighing less than 30 lbs. instill 4 drops of POSATEX® 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.

AURICULAR (OTIC)

Posatex® Otic Suspension (Orbifloxacin, Mometasone Furoate Monohydrate and Posaconazole, Suspension)