Dimethyl sulfoxide (DMSO) enhances the percutaneous absorption of medications.
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
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.
Fluocinolone acetonide is chemically related to prednisolone and possesses
marked anti-inflammatory properties when applied topically. It has been shown to
have over 100 times the anti-inflammatory activity of hydrocortisone.
Fluocinolone acetonide decreases edema, inflammation, erythema, infiltration and
pruritus with its associated scratching and excoriation.
Dosage and Administration: 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.
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.
Precautions: Very hygroscopic. Close vial tightly after use. Avoid
freezing and excessive heat.
Federal law restricts this drug to use by or on the order of
a licensed veterinarian
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.
Side Effects: A transient, but mild, stinging sensation may be
experienced by some animals when the solution is applied to denuded areas. The
effect will disappear as healing progresses. A temporary increase in temperature
of the area may also be noted.
Corticosteroid therapy will generally cause a remission of signs of allergic
origin. However, until the causative agent is identified and removed from the
animal's environment, the condition may recur when therapy is terminated.
Ordinarily, side effects are not encountered with topically applied
corticosteroids; but as with all drugs, some animals may exhibit unfavorable
local and/or systemic reactions. A local reaction may be due to sensitization to
the corticosteroid or one of the other components of the solution.
DMSO enhances the percutaneous absorption of topically applied
corticosteroids and the veterinarian should be aware of possible systemic
reactions in this situation. Accordingly, this product is contraindicated
wherever systemic corticosteroids would be dangerous. Adrenal suppression,
weight loss and increased susceptibility to infections may be evidenced with the
use of this drug, especially in overdosage. Therefore, care should be taken to
assure that the recommended dosage is not exceeded.
In the presence of local and/or systemic side effects, the drug should be
withdrawn. When a local reaction occurs other therapeutic measures should be
instituted. Therapy can usually be resumed at a lower dose once systemic signs
abate, without further recurrence of the problem.
Absorption of DMSO following topical application may result in an odorous breath
described as oyster or garlic-like with an unpleasant taste. Some animals and
clients may find this objectionable but these effects are transient and not
considered to be of serious consequence.
How Supplied: Synotic (fluocinolone acetonide and dimethyl sulfoxide)
Otic Solution Veterinary available in dropper vials of 8 mL
Fort Dodge Laboratories
