Synotic Otic Otic: Product Information (Page 2 of 2)

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.

It is known that 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In the presence of local and/or systemic side effects, the drug should be withdrawn.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.

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.

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.

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.

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STORAGE INFORMATION

Store at controlled room temperature 20°-25°C (68°-77°F) with excursions between 15°-30°C (59°-86°F). CAUTION: VERY HYGROSCOPIC. CLOSE VIAL TIGHTLY AFTER USE.

HOW SUPPLIED

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

REFERENCES

1. Stoughton, R. B. and Fritsch, W., INFLUENCE OF DIMETHYLSULFOXIDE (DMSO) ON HUMAN PERCUTANEOUS ABSORPTION 1964 Arch. Derm. 90, 512–517 Nov. 1964.

2. Stoughton, R. B., HEXACHLOROPHENE DEPOSITION IN HUMAN STRATUM CORNEUM. ENHANCEMENT BY DIMETHYLACETAMIDE, DIMETHYLSULFOXIDE, AND METHYLETHYLETHER 1966 Arch. Derm. 94, 646–648 Nov. 1966.

3. Katz, R. and Hood, R. W., TOPICAL THIABENDAZOLE FOR CREEPING ERUPTION 1966 Arch. Derm. 94, 643–645 Nov. 1966.

4. Sperber, P. A., TREATMENT OF CREEPING ERUPTION WITH ORALLY AND TOPICALLY ADMINISTERED THIABENDAZOLE 1967 J. Fla. M. A., 1059–61 Nov. 1967.

5. Sulzberger, M. B., Cortese, T. A., Fishman, L., Wiley, H. S. and Peyakovich, P. S., SOME EFFECTS OF DMSO ON HUMAN SKIN IN VIVO 1967 Ann. N. Y. Acad. Sci. 141, 437–450 March 1967.

6. Smith, Q. T. and Allison, D. J., UTEROTROPHIC EFFECT OF TOPICALLY APPLIED ESTRADIOL-17β BENZOATE 1967 Acta Derm-Venereol 47, 435-439.

7. Tjan, I. D. and Gunberg, D. L., PERCUTANEOUS ABSORPTION OF TWO STEROIDS DISSOLVED IN DIMETHYL SULFOXIDE IN THE IMMATURE FEMALE RAT 1967 N. Y. Acad. Sci. 141, 406–413 Mar. 1967.

Approved by FDA under NADA # 045-512
zoetis
Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007
Revised: May 2019
50981700

PRINCIPAL DISPLAY PANEL — 8 mL Vial Label

8 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 60 mL Vial Label

60 mL Vial Label
(click image for full-size original)
SYNOTIC OTIC OTIC
fluocinolone acetonide and dimethyl sulfoxide solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-0120
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE 0.1 mg in 1 mL
DIMETHYL SULFOXIDE (DIMETHYL SULFOXIDE) DIMETHYL SULFOXIDE 600 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
CITRIC ACID MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-0120-1 1 VIAL, PLASTIC in 1 CARTON contains a VIAL, PLASTIC
1 8 mL in 1 VIAL, PLASTIC This package is contained within the CARTON (54771-0120-1)
2 NDC:54771-0120-2 1 VIAL, PLASTIC in 1 CARTON contains a VIAL, PLASTIC
2 60 mL in 1 VIAL, PLASTIC This package is contained within the CARTON (54771-0120-2)
3 NDC:54771-0120-3 12 VIAL, PLASTIC in 1 CARTON contains a VIAL, PLASTIC
3 8 mL in 1 VIAL, PLASTIC This package is contained within the CARTON (54771-0120-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA045512 07/20/1972
Labeler — Zoetis Inc. (828851555)

Revised: 09/2021 Zoetis Inc.

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