Benefits:AntibacterialAnti-inflammatoryAntifungal 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 POSATEXOtic 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 a er one week. To report suspected adverse reactions, call 1-800-224-5318. ANIMAL SAFETY: POSATEX Otic Suspension was administered at 1,3, and 5 times the recommended dosage for 21 consecutive days. The control group received the vehicle in both ears at the clinical dose given five times per day. There was a slight decrease in serum cortisol concentration a er ACTH stimulation on Day 21 in the 5X group. Erythema was noted in all groups. Aural pain, swelling, or heat were each noted in 3 separate dogs in the 5X group. STORAGE INFORMATION: Store at temperatures between 2°-30°C 35.6°-86°F. Shake well before use. Approved by FDA. Made in Germany. Posatex Otic Suspension 7.5GM. I do not receive this product or any others in exchange for this article, I do get a commission for readers clicking the buy now links which helps to differ the cost of hosting this blog and I sincerely hope this article site helps you with your search for Vet Approved Rx products.