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Source overview
Recorded excerpts for one species. Each dose remains a separate source entry; no regimen is selected.
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View full clinical evidence and sources ↓Clinical evidence
Pending clinical review (PROPOSED)Rule-based (RULE_BASED)— applies to the facts and dose entries in this species selection; individual source records retain their own status.
Indications2
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).
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Microbiology Baytril Otic is indicated as a treatment for canine otitis externa complicated by bacterial and fungal organisms susceptible to enrofloxacin and/or silver sulfadiazine (seesection).
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dose regimens2
This calculator performs arithmetic only on the sourced dosing field shown for each result — it does not verify the field's accuracy, does not select which field to use for a patient, and does not replace a veterinarian's order. Not for clinical use. Confirm every result against the primary source before dispensing.
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Adverse effects202
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 CovetrusNorth America at (855) 724-3461. 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.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
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. http://www.fda.gov/reportanimalae For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
These are counts of spontaneously reported events, not proven adverse effects, causal relationships, or incidence rates.
Bars compare report counts within each species; they do not show incidence.
More reportsFewer reportsDog
- Pinnal erythema54 reports
- Deafness42 reports
- Lack of efficacy - NOS42 reports
- Vomiting42 reports
- Application site erythema39 reports
- Pinnal irritation31 reports
- Other abnormal test result NOS27 reports
- Pruritus25 reports
- Ear discharge23 reports
- Loss of hearing22 reports
- Lethargy (see also Central nervous system depression in 'Neurological')20 reports
- Decreased appetite18 reports
Cat
- Lethargy (see also Central nervous system depression in 'Neurological')10 reports
- Behavioural disorder NOS9 reports
- Ear discharge9 reports
- Application site scab8 reports
- Lack of efficacy - NOS8 reports
- Application site alopecia7 reports
- Application site erythema7 reports
- Pinnal erythema7 reports
- Anorexia6 reports
- Ataxia6 reports
- Dermatitis6 reports
- Head shake - ear disorder6 reports
Contraindications2
Enrofloxacin and Silver Sulfadiazine Otic Emulsion is contraindicated in dogs with suspected or known hypersensitivity to quinolones and/or sulfonamides.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Baytril Otic is contraindicated in dogs with suspected or known hypersensitivity to quinolones and/or sulfonamides.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Precautions3
The use of Enrofloxacin and Silver Sulfadiazine Otic Emulsion 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 Enrofloxacin and Silver Sulfadiazine Otic Emulsion. 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 Enrofloxacin and Silver Sulfadiazine Otic Emulsion in dogs used for breeding purposes, during pregnancy, or in lactating bitches, has not been evaluated.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 42232-9 (PRECAUTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
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.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34071-1 (WARNINGS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
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.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 42232-9 (PRECAUTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Literature references20
References are linked to this drug. Species applicability is not recorded here, so the species filter does not narrow this list. Imported dates do not retain their original precision; confirm dates in the original citation.
- Castanea sativa Flower Extract Accelerates Burn Wound Healing via Antioxidant and Anti-Inflammatory Mechanisms in Juvenile Rats.
Study summary not available in the imported record. Open the original citation to review the study.
- Evaluation of Functional Electrospun Chitosan-Based Nanofibers Loaded with Norfloxacin for Enhanced Burn Wound Healing Response.
Study summary not available in the imported record. Open the original citation to review the study.
- Therapeutic effects of skin repair plus ointment on molecular and morphological changes in burn wounds: A rat model.
Study summary not available in the imported record. Open the original citation to review the study.
- Repurposing amlexanox as a topical anti-inflammatory and antioxidant intervention for diabetic foot ulcers: insights from in-silico and in-vivo studies.
Study summary not available in the imported record. Open the original citation to review the study.
- From Vineyard to Hydrogel: Antioxidant, Anti-Inflammatory, and Regenerative Potential of Grape Skin Extract in Diabetic Wound Repair.
Study summary not available in the imported record. Open the original citation to review the study.
Sources: DailyMed, U.S. National Library of Medicine; PubMed, National Library of Medicine; openFDA, U.S. Food and Drug Administration.
Available products
Products listed in the Health Canada Drug Product Database for this active ingredient. A listing does not establish that a product is authorized for the clinical uses described on this page.