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.
Intervet/Merck Animal Health
Rx Medication Sold Only To Licensed Veterinarians & Pharmacies. Current License Must Be On File Prior To Shipping.
