FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
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.
Additionally, corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Corticosteroids administered to dogs during pregnancy have also resulted in other congenital anomalies, including deformed forelegs, phocomelia and anasarca.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
SYNOTIC Otic Solution Veterinary is indicated for the relief of pruritus and inflammation associated with acute and chronic otitis in the dog.
History
There is currently no drug history available for this drug.
Other Information
Fluocinolone acetonide is an odorless crystalline powder essentially white in color. Other physical characteristics include:
Melting point | 265°–277°C. |
Molecular weight | 452.50 |
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. It modifies hydrogen bonding.
Propylene glycol is well established as being nonsensitizing, nontoxic and has antimicrobial activity. It has been selected for this formulation because of several useful properties: There is a low surface tension permitting great spreadability and penetration; its drying properties make it valuable in moist areas; the corticosteroid is highly soluble and stable in this vehicle; and a relatively slow rate of evaporation maintains the solution state for an adequate time to allow distribution and contact with all parts of the ear.
Sources
Synotic Otic Manufacturers
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Fort Dodge Animal Health, Div Of Wyeth
Synotic Otic | Fort Dodge Animal Health, Div Of Wyeth
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. Care should be taken to avoid contact of the medication with the dog's eyes. Contact of the bare hand with the medication should also be avoided.
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