Zoetis
FLUOCINOLONE ACETONIDE 0.01% AND DIMETHYL SULFOXIDE 60%
For animal use only
NADA 045-512, Approved by FDA
CAUTION
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
FORMULATION
Each mL of the solution contains 0.01% fluocinolone acetonide (6α,9α-difluoro-11 ß,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione, cyclic 16,17-acetal with acetone) and 60% dimethyl sulfoxide in propylene glycol and citric acid.
GENERAL
Fluocinolone acetonide is an odorless crystalline powder essentially white in color. Other physical characteristics include:
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Melting point
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265°-277°C.
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Molecular weight
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452.50
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The structural formulation is:
Dimethyl sulfoxide (DMSO) an oxidation product of dimethyl sulfide, is the lowest member of the group of alkyl sulfoxides with a general formula of RSOR. Its structural formula is:
It mixes freely with water with the evolution of heat and lowers the freezing point of aqueous solutions. It is soluble in many other compounds including ethanol, acetone, diethyl ether, glycerin, toluene, benzene and chloroform. DMSO is a solvent for many aromatic and unsaturated hydrocarbons as well as inorganic salts and nitrogen-containing compounds. DMSO has a high dielectric constant due to the polarity of the sulfur-oxygen bond. Its basicity is slightly greater than water due to enhanced electron density at the oxygen atom. It forms crystalline salts with strong protic acids and coordinates with Lewis acids. If modifies hydrogen bonding.
INDICATIONS
SYNOTIC Otic Solution Veterinary is indicated for the relief of pruritus and inflammation associated with acute and chronic otitis in the dog.
ADMINISTRATION AND DOSAGE
The recommended dose of SYNOTIC Otic Solution Veterinary is 4 to 6 drops (0.2 mL) per ear administered twice daily into the ear canal for a maximum period of 14 days. The total dosage used should not exceed 17 mL. It is recommended that the affected ear canal be cleansed by some appropriate method prior to the instillation of the solution. Following instillation, gentle external massage of the ear canal may aid in promoting an even distribution of the medication.
PRECAUTIONS
There should be careful initial evaluation and follow-up 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 corticosteroid, animals with a generalized infection should not be treated with this product without proper supportive antimicrobial therapy. Preparations with DMSO should not be used in pregnant animals since studies in chick embryos and guinea pigs have indicated it is teratogenic and embryotoxic.
SYNOTIC (fluocinolone acetonide and dimethyl sulfoxide) Otic Solution Veterinary is recommended for topical application to the ear canal of the dog only.
DO NOT ADMINISTER BY ANY OTHER ROUTE.
CAUTION
VERY HYGROSCOPIC. CLOSE VIAL TIGHTLY AFTER USE. AVOID FREEZING AND EXCESSIVE HEAT.
WARNING
Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.
