silver sulfadiazine

As a treatment for canine otitis externa complicated by bacterial and fungal organisms susceptible to enrofloxacin and/or silver sulfadiazine.

EnroPro™ Silver Otic

Enrofloxacin and Silver Sulfadiazine Otic Emulsion 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).

Enrofloxacin and Silver Sulfadiazine Otic Emulsion(enrofloxacin/silver sulfadiazine)Antibacterial-Antimycotic Emulsion

Enrosite™ Silver 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).

VET one ® Enrosite™ Silver Otic(enrofloxacin/silver sulfadiazine)Antibacterial-Antimycotic Emulsion

Enrofloxacin and Silver Sulfadiazine Otic Emulsion is contraindicated in dogs with suspected or known hypersensitivity to quinolones and/or sulfonamides.

Enrofloxacin and Silver Sulfadiazine Otic Emulsion(enrofloxacin/silver sulfadiazine)Antibacterial-Antimycotic Emulsion

Enrosite™ Silver Otic is contraindicated in dogs with suspected or known hypersensitivity to quinolones and/or sulfonamides.

VET one ® Enrosite™ Silver Otic(enrofloxacin/silver sulfadiazine)Antibacterial-Antimycotic Emulsion

General Safety Study: In a target animal safety study, enrofloxacin/silver sulfadiazine 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, enrofloxacin/silver sulfadiazine 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.

VET one ® Enrosite™ Silver Otic(enrofloxacin/silver sulfadiazine)Antibacterial-Antimycotic Emulsion

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.

VET one ® Enrosite™ Silver Otic(enrofloxacin/silver sulfadiazine)Antibacterial-Antimycotic Emulsion

During clinical trials, 2 of 113 (1.7%) dogs exhibited reactions that may have resulted from treatment with enrofloxacin/silver sulfadiazine otic. Both cases displayed local hypersensitivity responses of the aural epithelium to some component within the enrofloxacin/silver sulfadiazine otic formulation. The reactions were characterized by acute inflammation of the ear canal and pinna. To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Cronus Pharma LLC at 1-844-227-6687 or 1-844-2-CRONUS. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

VET one ® Enrosite™ Silver Otic(enrofloxacin/silver sulfadiazine)Antibacterial-Antimycotic Emulsion

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.

BaytrilTM Otic (enrofloxacin/silver sulfadiazine) Antibacterial-Antimycotic Emulsion

Administer 5 to 10 drops per treatment in dogs weighing 35 pounds or less and 10 to 15 drops per treatment in dogs weighing more than 35 pounds. Apply twice daily for a duration of up to 14 days.

Otic

EnroPro™ Silver Otic

5 to 10 drops for dogs weighing 35 pounds or less and 10 to 15 drops for dogs weighing more than 35 pounds; applied twice daily for up to 14 days.

Topical

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra- label use of this drug in food-producing animals.

Baytril™ Otic

Shake well before each use. Tilt head so that the affected ear is presented in an upward orientation. Administer a sufficient quantity of Enrofloxacin and Silver Sulfadiazine Otic Emulsion 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.

AURICULAR (OTIC)

Enrofloxacin and Silver Sulfadiazine Otic Emulsion(enrofloxacin/silver sulfadiazine)Antibacterial-Antimycotic Emulsion