SYNOTIC OTIC OTIC- fluocinolone acetonide and dimethyl sulfoxide solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M), DIMETHYL SULFOXIDE (UNII: YOW8V9698H) (DIMETHYL SULFOXIDE - UNII:YOW8V9698H)

Available from:

Zoetis Inc.

Administration route:

AURICULAR (OTIC)

Prescription type:

PRESCRIPTION

Therapeutic indications:

SYNOTIC Otic Solution Veterinary is indicated for the relief of pruritus and inflammation associated with acute and chronic otitis in the dog.

Product summary:

SYNOTIC® (fluocinolone acetonide and dimethyl sulfoxide) Otic Solution Veterinary available in dropper vials of 8 mL and 60 mL.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

SYNOTIC OTIC OTIC- FLUOCINOLONE ACETONIDE AND DIMETHYL SULFOXIDE
SOLUTION
ZOETIS INC.
----------
SYNOTIC
OTIC SOLUTION
Synotic®
(FLUOCINOLONE ACETONIDE 0.01%
AND DIMETHYL SULFOXIDE 60%)
Otic Solution
FOR ANIMAL USE ONLY
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-
11β,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:
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
ma