Complete Up To Date Information about Synotic Otic Solution.
NADA Number: 045-512 | |
| Proprietary Name |
Synotic® Otic Solution |
|---|---|
| Sponsor |
Fort Dodge Animal Health, Division of Wyeth |
| Sponsor Address |
800 Fifth Street NW Fort Dodge, IA 50501 USA |
| Ingredients |
Fluocinolone Acetonide Dimethyl Sulfoxide |
| Species |
Dog, restricted during pregnancy |
| Routes of Administration |
Topical |
| Dose Form |
Liquid (solution) |
| Drug Form |
Liquid (solution) |
| Dispensing Status |
RX |
|
Dosage Amount, Indications & Limitations |
524.981e Fluocinolone acetonide dimethyl sulfoxide otic solution. Specifications: Each milliliter of solution contains 0.01 percent fluocinolone acetonide and 60 percent dimethyl sulfoxide with propylene glycol and citric acid. Conditions of use: Dogs Amount: It is administered at 4 to 6 drops (0.2 milliliter) twice daily into the ear canal for a maximum period of 14 days. The total dosage used should not exceed 17 milliliters. The ear canal should be cleansed by some appropriate method prior to installation of the solution and the ear should be massaged gently following installation. Indications: The drug is used in dogs for the relief of pruritis and inflammation associated with acute and chronic otitis. Limitations: There should be careful initial evaluation and followup of infected ears. Incomplete response or exacerbation of corticosteroid-responsive lesions may be due to the presence of an infection which requires identification or antibiotic sensitivity testing, and the use of the appropriate antimicrobial agent. As with any corticoidsteroid, animals with a generalized infection should not be treated with this product without proper supportive antimicrobial therapy. Preparations with dimethyl sulfoxide should not be used in pregnant animals. For use only by or on the order of a licensed veterinarian. |