Enrofloxacin and sulfadiazine

Indications

Baytril Otic is indicated as a treatment for canine otitis externa complicated by bacterial and fungal organisms susceptible to enrofloxacin and/or silver sulfadiazine (see Microbiology section).

Dosage and Administration

Shake well before each use. Tilt head so that the affected ear is presented in an upward orientation. Administer a sufficient quantity of Baytril Otic to coat the aural lesions and the external auditory canal. As a general guide, administer 5-10 drops per treatment in dogs weighing 35 lbs. or less and 10-15 drops per treatment in dogs weighing more than 35 lbs. Following treatment, gently massage the ear so as to ensure complete and uniform distribution of the medication throughout the external ear canal. Apply twice daily for a duration of up to 14 days.

Contraindications

Baytril Otic is contraindicated in dogs with suspected or known hypersensitivity to quinolones and/or sulfonamides. HUMAN WARNINGS: Not for human use. Keep out of the reach of children. Avoid contact with eyes. In case of contact, immediately flush eyes with copious amounts of water for 15 minutes. In case of dermal contact, wash skin with soap and water. Consult a physician if irritation develops or persists following ocular or dermal exposures. Individuals with a history of hypersensitivity to quinolone compounds or antibacterials should avoid handling this product. In humans, there is a risk of user photosensitization within a few hours after excessive exposure to quinolones. If excessive accidental exposure occurs, avoid direct sunlight.

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 weightbearing 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. CONTACT INFORMATION: For product questions, to report adverse reactions, or for a copy of the Safety Data Sheet (SDS), call Elanco Product & Veterinary Support at 888-545-5973. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae . SAFETY: General Safety Study: In a target animal safety study, Baytril Otic was administered in both ears of 24 clinically normal beagle dogs at either recommended or exaggerated dosages: 10, 30 or 50 drops applied twice daily for 42 consecutive days. A control group of 8 beagle dogs was treated by administering 50 drops of vehicle in one ear twice daily for 42 consecutive days, with the contralateral ear untreated. Erythema was noted in all groups, including both treated and untreated ears in the controls, which resolved following termination of treatment. Oral Safety Study: In order to test safety in case of ingestion, Baytril Otic was administered, twice daily for 14 consecutive days, to the dorsum of the tongue and to the left buccal mucosa of 6 clinically normal dogs. No adverse local or systemic reactions were reported.

Storage

Store between 4° and 25°C (40 - 77°F). Store in an upright position. Do not store in direct sunlight.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming enrofloxacin and sulfadiazine as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.