Posatex Otic Suspension

Generic name: orbifloxacin, mometasone furoate, and posaconazole otic Suspension
Dosage form: FOR ANIMAL USE ONLY

Antibacterial, anti-inflammatory, antifungal

For Otic Use in Dogs Only

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

Federal law prohibits the extralabel use of this drug in food-producing animals.

DESCRIPTION: Each gram of POSATEX® Otic Suspension contains 10 mg of orbifloxacin; mometasone furoate monohydrate equivalent to 1 mg mometasone furoate; and 1 mg of posaconazole in a mineral oil based system containing a plasticized hydrocarbon gel.

Four drops of POSATEX® Otic Suspension delivers approximately 1.0 mg orbifloxacin, 0.1 mg of mometasone furoate monohydrate, and 0.1 mg of posaconazole.

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).

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.

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).

WARNINGS:

Human Warnings: Not for use in humans. Keep out of reach of children.

Animal Warnings: Do not administer orally. Immediately discontinue use of POSATEX® Otic Suspension if hearing loss is observed during treatment (see ADVERSE REACTIONS).

PRECAUTIONS: The use of POSATEX® Otic Suspension in dogs with perforated tympanic membranes has not been evaluated. The integrity of the tympanic membranes should be confirmed before administering this product.

Avoid prolonged or repeated use of POSATEX® Otic Suspension. Long-ter...