Risk and Warning Statements

Caution: Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian.

Federal Law prohibits  the extralabel use of this drug in food-producing animals.

CONTRAINDICATIONS:
Baytril® Otic is contraindicated in dogs with suspected or known hypersensitivity to quinolones and/or sulfonamides.


PRECAUTIONS:
The use of Baytril® Otic in dogs with perforated tympanic membranes has not been evaluated. Therefore, the integrity of the tympanic membrane should be evaluated before administering this product. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of Baytril® Otic.
Quinolone-class drugs should be used with caution in animals with known or suspected Central Nervous System (CNS) disorders. In such animals, quinolones have, in rare instances, been associated with CNS stimulation which may lead to convulsive seizures.
Quinolone-class drugs have been associated with cartilage erosions in weight-bearing joints and other forms of arthropathy in immature animals of various species.
The safe use of Baytril® Otic in dogs used for breeding purposes, during pregnancy, or in lactating bitches, has not been evaluated.


ADVERSE REACTIONS:
During clinical trials, 2 of 113 (1.7%) dogs exhibited reactions that may have resulted from treatment with Baytril® Otic. Both cases displayed local hypersensitivity responses of the aural epithelium to some component within the Baytril® Otic formulation. The reactions were characterized by acute inflammation of the ear canal and pinna.