Baytril Otic

For Ototopical Use In Dogs

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.

Enrofloxacin, a 4-fluoroquinolone compound, is bactericidal with activity against a broad spectrum of both Gram negative and Gram positive bacteria. Fluoroquinolones elicit their bactericidal activities through interactions with two intracellular enzymes, DNA gyrase (DNA topoisomerase II) and DNA topoisomerase IV, which are essential for bacterial DNA transcription, synthesis and replication. It is believed that fluoroquinolones actively bind with bacterial DNA:ENZYME complexes and thereby inhibit the essential processes catalyzed by the enzymes (DNA supercoiling and chromosomal decatenation).1 The ultimate outcome of the fluoroquinolone intervention is DNA fragmentation and bacterial cell death.2,3

Silver sulfadiazine (SSD) is synthesized from silver nitrate and sodium sulfadiazine.4 This compound has a wide spectrum of antimicrobial activity against Gram negative and Gram positive bacteria and is also an effective antimycotic.5,6 SSD suppresses microbial growth through inhibition of DNA replication and modification of the cell membrane.

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.

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.

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.

For medical emergencies or to report adverse reactions, call 1-800-422-9874. For customer service or to obtain product information, including Material Safety Data Sheet, call 1-800-633-3796.

1. Hooper DC and Wolfson JS. Mechanisms of quinolone action and bacterial killing in quinolone antimicrobial agents. Washington DC, American Society for Microbiology, 2nd ed., 1993: 53-75.
2. Gootz TD and Brightly KE. Fluoroquinolone antibacterial: mechanism of action, resistance and clinical aspects. Medicinal Research Reviews 1996: 16 (5): 433-486.
3. Drlica K and Zhoa X. DNA gyrase, topoisomerase IV and the 4-quinolones. Microbiology and Molecular Biology Reviews 1997: 61(3): 377-392.
4. Fox CL. Silver sulfadiazine: a new topical therapy for Pseudomonas in burns. Archives of Surgery 1968: 96:184- 188.
5. Wlodkowski TJ and Rosenkranz HS. Antifungal activity of silver sulfadiazine. Lancet 1973: 2:739-740.
6. Schmidt A. In vitro activity of climbazole, clotrimazole and silver sulfadiazine against isolates of Malassezia pachydermatis. J of Vet Medicine Series B 1997: 44: 193-197.

Bayer HealthCare LLC

Animal Health Division

Shawnee Mission, Kansas
66201 U.S.A.

U.S. Patent No: 5,753,269 08715591-80004200 R.1

©2003 Bayer HealthCare LLC                      October, 2003

NADA # 141-176, Approved by FDA