Regulatory product record
BAYTRIL OTIC
Product identity, ingredients and source provenance from the regulatory catalogue. Linked clinical evidence has a separate review status.
Owner information handout
Plain-language medication information to review with the owner. Open the handout to print it or download a PDF.
Product identity
- Brand name
- BAYTRIL OTIC
- DIN
- 02246715
- DPD drug code
- 70910
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- OTIC
- Pharmaceutical form(s)
- EMULSION
- Ingredients
- ENROFLOXACIN (5 MG), SILVER SULFADIAZINE (10 MG)
- Species (DPD record)
- DOGS
- Company
- ELANCO CANADA LIMITED (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 70910
- Archive fingerprint (SHA-256)
- 85cc3ce208af3aa57018c3d14d83f90220c436baef7455384b6d48d9774e1c88
Linked clinical reference
Clinical entries are linked through the active molecule. Check their species, formulation, source and review status separately from this product record.
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.
Indications10
Susceptible bacterial infections (gram-negative predominant) — skin, UTI, respiratory
DogCatOn-label (ON_LABEL)2 source records · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Susceptible bacterial infections (gram-negative predominant) — skin, UTI, respiratory — Authorized (FDA — oral only in dogs/cats)
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Susceptible bacterial infections (gram-negative predominant) — skin, UTI, respiratory — Authorized (FDA — oral only in dogs/cats)
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Indications table · Not applicable · 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 States2 source records · View provenance
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Cattle - Single-Dose Therapy: Mannheimia haemolytica, Pasteurella multocida, Histophilus somni Mycoplasma bovis M. haemolytica, P. multocida, H. somni M. bovis Baytril 100 is indicated for the treatment of bovine respiratory disease (BRD) associated withandin beef and non-lactating dairy cattle; and for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated withand. Cattle - Multiple-Day Therapy: Mannheimia haemolytica, Pasteurella multocida Histophilus somni Baytril 100 is indicated for the treatment of bovine respiratory disease (BRD) associated withandin beef and non-lactating dairy cattle. Swine: Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica Mycoplasma hyopneumoniae. Escherichia coli Baytril 100 is indicated for the treatment and control of swine respiratory disease (SRD) associated withandBaytril 100 is indicated for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated withhas been diagnosed.
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
Fluroxin (brand of enrofloxacin) Injectable Solution is indicated for the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.
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
™ Enrosite(brand of enrofloxacin) Injectable Solution is indicated for the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.
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 regimens15
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.
Select a species above to calculate a dose.
Adverse effects411
Cartilage/articular damage — Young, rapidly growing dogs (esp. large/giant breeds) — bubble-like cartilage lesions
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Retinal degeneration/blindness — Dose-related, seen at >15–20 mg/kg — can be irreversible
CatNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
GI distress, CNS stimulation, crystalluria — Occasional
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · 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 States2 source records · View provenance
- Species not recorded · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
- Species not recorded · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
No adverse reactions were observed during clinical trials. To report suspected adverse drug experiences, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Elanco at 1-800-428-4441. 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
- Vomiting816 reports
- Lethargy (see also Central nervous system depression in 'Neurological')496 reports
- Anorexia427 reports
- Death by euthanasia397 reports
- Other abnormal test result NOS348 reports
- Death339 reports
- Diarrhoea318 reports
- Ataxia253 reports
- Elevated alanine aminotransferase (ALT)249 reports
- Seizure NOS248 reports
- Lack of efficacy - NOS239 reports
- Fever234 reports
Cat
- Mydriasis454 reports
- Blindness400 reports
- Retinal disorder NOS244 reports
- Death by euthanasia163 reports
- Anorexia153 reports
- Peripheral nervous system disorder NOS132 reports
- Ataxia123 reports
- Vomiting123 reports
- Behavioural disorder NOS115 reports
- Death114 reports
- Partial blindness111 reports
- Impaired vision109 reports
Monitoring1
Clinical efficacy; ocular signs in cats; hydration status
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Monitoring Parameters · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Contraindications8
Small/medium breed dogs 2–8 months old (label); food-producing animals (extra-label use prohibited); do not exceed 5 mg/kg/day in cats
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · 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 States2 source records · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Enrofloxacin is contraindicated in dogs known to be hypersensitive to quinolones. Based on the studies discussed under the section on Animal Safety Summary, the use of enrofloxacin is contraindicated in small and medium breeds of dogs during the rapid growth phase (between 2 and 8 months of age). The safe use of enrofloxacin has not been established in large and giant breeds during the rapid growth phase. Large breeds may be in this phase for up to one year of age and the giant breeds for up to 18 months. In clinical field trials utilizing a daily oral dose of 5.0 mg/kg, there were no reports of lameness or joint problems in any breed. However, controlled studies with histological examination of the articular cartilage have not been conducted in the large or giant breeds.
Species not recordedOn-label (ON_LABEL)United States4 source records · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
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
Precautions20
Seizure disorders (CNS stimulation risk); hepatic/renal impairment; dehydration (crystalluria risk)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Never exceed 5 mg/kg/day in cats — this is a hard, well-documented ceiling to prevent irreversible retinal blindness.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Avoid in growing dogs (2–8 months for small/medium breeds; larger breeds need longer windows since growth continues past 8 months) — cartilage damage risk.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
The injectable large-animal product (100 mg/mL) should not be diluted/used in small animals — reserve the correctly concentrated small-animal product.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Should not be used by humans handling it — can cause hallucinations/vivid dreams/headache.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Interactions10
Antacids/dairy (cations) — ↓ absorption — separate by ≥2h
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Theophylline — ↑ theophylline levels 30–50%
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Cyclosporine — ↑ nephrotoxicity, ↓ cyclosporine metabolism
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
NSAIDs (flunixin specifically studied) — Bidirectional ↑ AUC/half-life of both drugs
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Sucralfate — ↓ enrofloxacin absorption — separate by ≥2h
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics5
Bioavailability — ~80% PO (dog) — about 2x ciprofloxacin
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Protein binding — ~27% (dog)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Half-life — 4–5h (dog); 6h (cat)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Metabolism — Partial conversion to active ciprofloxacin (~10–40%)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Elimination — Renal + hepatic/fecal
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pregnancy / lactation considerations1
No treatment-related effects in breeding/pregnant/lactating dogs up to 15 mg/kg/day, but generally avoided in pregnancy due to cartilage-injury class concern. Safety in pregnant/lactating cats not established.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 463–465; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 287–289 — Pregnancy & Lactation · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Literature references36
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.
- Antibacterial Efficacy of 6-Gingerol Alone and in Combination With Enrofloxacin Against Multidrug-Resistant Staphylococcus aureus Isolated From Goats.
Study summary not available in the imported record. Open the original citation to review the study.
- A label-free and highly sensitive fluorescence aptasensor for enrofloxacin detection based on G-triplex-mediated signal amplification.
Study summary not available in the imported record. Open the original citation to review the study.
- Tissue-specific molecular responses to salinomycin and their modulation by ionophore-antibiotic interactions in turkeys.
Study summary not available in the imported record. Open the original citation to review the study.
- Phenotypic antimicrobial susceptibility and genomic resistance determinants in canine otitis-associated Pseudomonas aeruginosa isolates.
Study summary not available in the imported record. Open the original citation to review the study.
- Health risk assessment of enrofloxacin, oxytetracycline, and sulfadimidine residues in broiler chicken carcasses marketed in Mit Ghamr, Egypt.
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; Plumb DC. Plumb's Veterinary Drug Handbook. 7th ed. PharmaVet Inc; 2011.