Osurnia Otic Gel
Osurnia is indicated for the treatment of otitis externa in dogs associated with susceptible strains of bacteria (Staphylococcus pseudintermedius) and yeast (Malassezia pachydermatitis).
Important Safety Information
As with all drugs, side effects may occur. In field studies and post-approval experience the most common side effects reported were vomiting, increased liver enzymes and loss of hearing. Other signs reported were ear discharge, ear irritation and pain, vomiting, head shaking, head tilt, ataxia, vocalization, corneal ulcer, keratoconjunctivitis sicca, nystagmus, tympanic rupture, and facial paralysis.
Osurnia® should be administered by a veterinary professional. Do not use in dogs with known tympanic perforation or a hypersensitivity to florfenicol, terbinafine or corticosteroids. Osurnia may cause eye injury and irritation. Wear eye protection when administering Osurnia and restrain the dog to minimize post-application head shaking. Do not use in cats. Refer to the prescribing information for complete details.
OSURNIA contains 10 mg florfenicol, 10 mg terbinafine and 1 mg betamethasone acetate per mL and the inactive ingredients propylene carbonate, glycerol formal, hypromellose, phospholipid, oleic acid and BHT in an off-white to slightly yellow translucent gel.
OSURNIA should be administered by a veterinary professional.
Wear eye protection when administering Osurnia (see Human Safety Warnings, Precautions, Post-Approval Experience and Animal Safety).
Splatter may occur if the dog shakes its head following administration. Persons near the dog during administration should also take steps to avoid ocular exposure.
- Clean and dry the external ear canal before administering the initial dose of the product.
- Verify the tympanic membrane is intact prior to each administration (see Precautions, Contraindications, Animal Safety and Post-Approval Experience).
- Administer one dose (1 tube) per affected ear(s) and repeat administration in 7 days.
- Open tube by twisting the soft tip. Insert the flexible tip in the affected external ear canal(s) and squeeze entire tube contents into the external ear canal(s). After application, gently massage the base of the ear to allow the gel to penetrate the lower part of the ear canal.
- Restrain dog to minimize post-application head shaking to reduce potential for splatter of product, and accidental eye exposure in people and dogs (see Post-Approval Experience and Animal Safety).
- Do not clean the ear canal for 45 days after the initial administration to allow contact of the gel with the ear canal. Cleaning the ear may affect product effectiveness (see Effectiveness). If alternative otic therapies are required, it is recommended to clean the ear(s) before application.
See packaging and / or talk to your veterinarian for further details.
Storage
Osurnia should be refrigerated at 36° to 46°F. Do not freeze. Protect from light. For application comfort, it may be brought to room temperature. Osurnia may be refrigerated for up to 3 months.