Posatex Otic Suspension - 7.5g

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Product Code : P0000001840

Posatex Otic Suspension

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POSATEX OTIC SUSPENSION

Antibacterial - Anti-Inflammatory - Antifungal

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).

Orbifloxacin, Mometasone Furoate Monohydrate and Posaconazole, 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.

For Otic Use in Dogs Only

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.

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-term use of topical otic corticosteroids has been associated with adrenocortical suppression and iatrogenic hyperadrenocorticism in dogs (see ANIMAL SAFETY).

The safe use of POSATEX Otic Suspension in dogs used for breeding purposes, during pregnancy or in lactating bitches, has not been evaluated. The systemic administration of quinolones has been shown to produce cartilage erosions of weight bearing joints and other signs of arthropathy in immature animals of various species.

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.

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

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

STORAGE INFORMATION: Store at temperatures between 2°-30°C (35.6°-86°F).

Shake well before use.

How Supplied: POSATEX Otic Suspension is available in 7.5 g (NDC 0061-0089-01), 15 g (NDC 0061-0089-02), and 30 g plastic bottles.


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