Label: POSATEX- orbifloxacin, mometasone furoate, and posaconazole suspension
- NDC Code(s): 0061-0089-01, 0061-0089-02, 0061-0089-03
- Packager: Merck Sharp & Dohme Corp.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Updated November 6, 2020
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- SPL UNCLASSIFIED SECTION
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.
- VETERINARY INDICATIONS
- DOSAGE & ADMINISTRATION
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).
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.
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.
Orbifloxacin: Orbifloxacin is a synthetic fluoroquinolone antibacterial agent. The bactericidal action of fluoroquinolones is concentration-dependent and results from interference with bacterial DNA gyrase and topoisomerase IV. Since these enzymes are needed for bacterial DNA synthesis and transcription, fluoroquinolones disrupt bacterial replication and lead to bacterial cell death.
Mometasone: Mometasone furoate monohydrate is a topical corticosteroid characterized by a (2') furoate 17-ester having chlorine at the 9 and 21 positions.
Posaconazole: Posaconazole is a broad-spectrum triazole antifungal agent. The mechanism by which triazoles exert fungicidal action involves the selective inhibition of the enzyme lanosterol a C14 demethylase (a microsomal cytochrome P-450- dependent enzyme) involved in ergosterol biosynthesis in yeasts and filamentous fungi.
Systemic absorption of the active ingredients was determined in single-dose radiolabelled studies with 14C-orbifloxacin, 3H-mometasone furoate, and 14C-posaconazole contained within the POSATEX® Otic Suspension formulation and placed into the ear canals of normal beagle dogs. Most of the absorption occurred in the first few days after administration. The extent of percutaneous absorption of topical medications is influenced by many factors including the integrity of the epidermal barrier. Inflammation can increase the percutaneous absorption of drugs.
EFFECTIVENESS: The effectiveness of POSATEX® Otic Suspension was evaluated in a placebo-controlled, double-blind, multi-site field study. One hundred and ninety one dogs with naturally occurring clinical otitis externa associated with both yeast and bacteria were randomly allocated to either POSATEX® Otic Suspension or placebo ointment. Of the 160 dogs evaluated for effectiveness, 122 were treated with POSATEX® Otic Suspension and 38 were treated with placebo ointment. Treatments were administered once daily for 7 consecutive days. Assessment of effectiveness was based on improvement in clinical signs at re-evaluation 2-7 days following administration of the last dose.
Compared to the placebo, a significant percent of dogs treated with POSATEX® Otic Suspension showed improvement in clinical signs (discomfort, erythema, and swelling) caused by otitis externa associated with one or more of the following organisms: Malassezia pachydermatis, coagulase positive staphylococci, Pseudomonas aeruginosa, and Enterococcus faecalis.
Percent of Dogs Showing Improvement in Clinical Signs of Otitis Externa Clinical Sign POSATEX® Otic Suspension Group Placebo Group Significance Discomfort 88% 45% p<0.0001 External Ear Canal Erythema 81% 39% p<0.0001 External Ear Canal Swelling 83% 49% p=0.0001
ANIMAL PHARMACOLOGY & OR TOXICOLOGY
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 after ACTH stimulation on Day 21 in the 5× group. Erythema was noted in all groups. Aural pain, swelling, or heat were each noted in 3 separate dogs in the 5× group.
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INGREDIENTS AND APPEARANCE
orbifloxacin, mometasone furoate, and posaconazole suspension
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:0061-0089 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Orbifloxacin (UNII: 660932TPY6) (Orbifloxacin - UNII:660932TPY6) Orbifloxacin 10 mg in 1 g Mometasone Furoate (UNII: 04201GDN4R) (Mometasone - UNII:8HR4QJ6DW8) Mometasone Furoate 1 mg in 1 g posaconazole (UNII: 6TK1G07BHZ) (posaconazole - UNII:6TK1G07BHZ) posaconazole 1 mg in 1 g Inactive Ingredients Ingredient Name Strength Mineral Oil (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0061-0089-01 1 in 1 CARTON 1 7.5 g in 1 BOTTLE, PLASTIC 2 NDC:0061-0089-02 1 in 1 CARTON 2 15 g in 1 BOTTLE, PLASTIC 3 NDC:0061-0089-03 1 in 1 CARTON 3 30 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141266 02/18/2020 Labeler - Merck Sharp & Dohme Corp. (001317601) Establishment Name Address ID/FEI Business Operations Vet Pharma Friesoythe GmbH 341934053 MANUFACTURE, ANALYSIS