Baytril Otic 15 ml is a broad-spectrum antibiotic for dogs that treats bacterial ear infection in dogs. The enrofloxacin in Baytril is a fluoroquinolone antibiotic that is effective against Gram positive and Gram negative bacteria.
Baytril Otic pet meds also contain silver sulfadiazine which is an effective antimycotic. This quinolone class antibiotic is effective against a wide variety of bacterial ear infection in dogs.
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Ototopical Use in Dogs
- Topical solution approved by the FDA for treatment of canine otitis externa
- Water-based emulsion soothes ear infection in dogs
- Two powerful ingredients (enrofloxacin and silver sulfadiazine) kill bacteria and fungus
Federal (U.S.A.) Law restricts this pet meds 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.
Each milliliter of Baytril Otic dog medicine contains: enrofloxacin 5 mg (0.5% w/v), silver sulfadiazine (SSD) 10 mg (1.0% w/v), benzyl alcohol (as a preservative) and cetylstearyl alcohol (as a stabilizer) in a neutral oil and purified water emulsion. The active ingredients are delivered via a physiological carrier (a nonirritating emulsion).
CHEMICAL NOMENCLATURE AND STRUCTURE:
Enrofloxacin1-Cyclopropyl-7-(4-ethyl-1-piperazinyl)-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid. Silver SulfadiazineBenzenesulfonamide, 4-amino-N-2-pyrimidinyl-monosilver
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).
The ultimate outcome of the fluoroquinolone intervention is DNA fragmentation and bacterial cell death.
Silver sulfadiazine (SSD) is synthesized from silver nitrate and sodium sulfadiazine.
This compound has a wide spectrum of antimicrobial activity against Gram negative and Gram positive bacteria and is also an effective antimycotic. SSD suppresses microbial growth through inhibition of DNA replication and modification of the cell membrane.
In clinical field trials, Baytril Otic pet meds demonstrated elimination or reduction of clinical signs associated with otitis externa in dogs and in vitro activity against cultured organisms. Baytril® Otic is effective when used as a treatment for canine otitis externa associated with one or more of the following organisms: Malassezia pachydermatis, coagulase-positive Staphylococcus spp., Pseudomonas aeruginosa, Enterobacter spp., Proteus mirabilis, Streptococci spp., Aeromonas hydrophila, Aspergillus spp., Klebsiella pneumoniae, and Candida albicans.
In vitro assays, such as disk-diffusion and agar/broth-dilution, are used to determine the susceptibilities of microbes to antimicrobial therapies. Results of agar/broth-dilution assays are reported as a Minimal Inhibitory Concentration (MIC) which represents the lowest antimicrobial concentration, expressed in μg/mL, capable of inhibiting the growth of a pathogenic microorganism. MICs are used in conjunction with pharmacokinetics to predict the in vivo efficacy of systemically administered antimicrobials. Topical administration of Baytril Otic dog medicine to an exudate and debris-free canal, however, will generally result in local antimicrobial concentrations that greatly exceed serum and tissue levels resulting from systemic therapy. Therefore, when using Baytril® Otic as a treatment for canine otitis externa, interpret susceptibility data cautiously.
Baytril Otic 15 ml 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).
Due to its combination of active ingredients, Baytril® Otic, a broad-spectrum antibiotic for dogs provide antimicrobial therapy against bacteria and fungi (which includes yeast) commonly encountered in cases of canine otitis externa.
The effectiveness of this dog ear medicine was evaluated in a controlled, double-blind, multi-site clinical trial. One hundred and sixty-nine dogs (n=169), with naturally occurring active otitis externa participated in the study.
The presence of active disease was verified by aural cytology, microbial culture and otoscopy/clinical scoring.
Qualified cases were randomly assigned to either Baytril Otic treatment (n=113) or to a comparable placebo-based regimen (n=56). Treatments were administered twice daily for up to 14 days. Assessment of effectiveness was based on continued resolution of clinical signs 3 to 4 days following administration of the last dose.
At study conclusion, Baytril Otic for dogs was found to be a significantly more effective treatment for canine otitis externa than the placebo regimen. Based on the scoring system used to assess treatment response, therapeutic success occurred in 67% of Baytril® Otic-treated infections compared to 14% with placebo (r-value2 0.001) after 14 days of treatment.
Baytril Otic pet meds is contraindicated in dogs with suspected or known hypersensitivity to quinolones and/or sulfonamides.
This dog ear medicine is 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 antibacterial 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 pet medicine 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 for dogs.
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 this pet medication 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 for dogs. Both cases displayed local hypersensitivity responses of the aural epithelium to some component within this dog ear medicine 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.
General Safety Study:
In a target animal safety study, Baytril Otic pet medication 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 contra lateral 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 for dogs 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.
DOSAGE AND ADMINISTRATION:
Shake well before each use of this pet medicine.
Tilt head so that the affected ear is presented in an upward orientation. Administer a sufficient quantity of Baytril Otic for dogs 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.
Store this pet medicine to treat bacterial ear infection in dogs, between 4° and 25°C (40 – 77°F). Store this ear drops for dogs in an upright position. Do not store in direct sunlight.
Baytril® Otic (enrofloxacin/silver sulfadiazine)
|08711529-042099||15 mL||Oval plastic bottle with dropper tip and extended tip closure|
|08711537-042199||30 mL||Oval plastic bottle with dropper tip and extended tip closure|
Bayer HealthCare LLC, Animal Health Division, Shawnee Mission, Kansas, 66201 U.S.A.
U.S. Patent No: 5,753,269
©2003 Bayer HealthCare LLC
NADA # 141-176, Approved by FDA
Regulations for product use are established by country. Information contained on this site pertains only to the United States of America, and is not intended to provide adequate information for product use. Before using or dispensing any product, read and carefully observe the label directions.