Enrofloxacin, Silver sulfadiazine: what the FDA reviewed for dog products
2 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Enrofloxacin, Silver sulfadiazine, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs.
Products
- Baytril™ Otic (NADA/ANADA 141-176)
- EnroPro™ Silver Otic (NADA/ANADA 200-782)
EnroPro™ Silver Otic NADA 200-782, Original approval, May 09, 2024; sponsor Cronus Pharma Specialities India Private Ltd.; species: Dogs; foi_id 15424; FDA PDF
Indication
Treatment of canine otitis externa complicated by bacterial and fungal organisms susceptible to enrofloxacin and/or silver sulfadiazine
Dose regimen
5-10 drops per treatment (dogs 35 lbs or less); 10-15 drops per treatment (dogs more than 35 lbs), Otic, Twice daily, Up to 14 days; massage the ear after each treatment to distribute the medication through the external ear 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.
Extraction notes: Generic ANADA approved on a biowaiver (otic emulsion with the same active ingredients, concentrations and dosage form as the RLNAD Baytril Otic, NADA 141-176). Each mL contains enrofloxacin 5 mg (0.5%) and silver sulfadiazine 10 mg (1.0%). No in vivo bioequivalence, PK, target animal safety, effectiveness or adverse reaction data in the summary; the validator warning 'no PK, safety or effectiveness content' is expected.
Baytril™ Otic NADA 141-176, Original approval, September 29, 2000; sponsor Elanco US Inc.; species: Dogs; foi_id 686; FDA PDF
Indication
Treatment of canine otitis externa complicated by bacterial and fungal organisms susceptible to enrofloxacin and/or silver sulfadiazine.
Dose regimen
5-10 drops per treatment (dogs 35 lbs or less); 10-15 drops per treatment (dogs over 35 lbs); each mL contains 5 mg enrofloxacin and 10 mg silver sulfadiazine, topical, into the ear canal, twice daily, up to 14 days
Each mL contains 5 mg enrofloxacin and 10 mg silver sulfadiazine. Route of Administration: Baytril® Otic is topically applied to the ear canal. Recommended Dosage: Shake well before each use. Tilt head so that the affected ear is presented in an upward orientation. Administer a sufficient quantity of Baytril® Otic 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.
Target-animal safety
dose multiples 1X, 3X, 5X; duration 42 consecutive days (3X the labeled duration); 60-day study; animals twelve male and twelve female beagle dogs (four per sex per dose group) plus four male and four female vehicle controls.
To determine the safety of Baytril® Otic when 10 (1X), 30 (3X), or 50 (5X) drops are administered into the ear canals of dogs twice a day for 42 consecutive days.
| Finding | Quote |
|---|---|
| Mild aural erythema in all dogs of all groups (including controls), onset day 1-2, resolved within 2 days of stopping treatment; no edema | The most notable clinical abnormality was aural erythema. This affected all dogs in the study, and occurred to the same extent in all treatment groups. |
| No changes in hearing | No changes in hearing were reported. |
| No clinically significant hematology or clinical chemistry changes | No clinically significant changes were reported for hematology or clinical chemistry values. |
| Up to 5X dose volume for 42 days produced only reversible ear erythema; no other adverse effects | Twice daily administration of Baytril® Otic at doses up to five times the recommended dose volume and for as long as 42 days produced reversible erythema of the ears. No other adverse effects or signs of toxicity were reported. |
Effectiveness
Controlled, double-blind, multi-site (7 veterinary hospitals) placebo-controlled clinical field study in dogs with naturally occurring otitis externa (clinical score >= 6); ototopical treatment twice daily for 7-14 days, ~2:1 active:placebo randomization; n = 113 Baytril Otic, 56 placebo; primary endpoint: clinical success: final composite otic clinical score of 2 or less, assessed 3-4 days after the last dose; result: Therapeutic success in 67% of aural infections treated with active formulation vs 14% with placebo (p = 0.0143) after 14 days; odds of success 14.78 times greater with active product
By study conclusion, 113 (67%) and 56 (33%) cases had been randomly assigned to the Baytril® Otic and placebo treatment groups, respectively (approximately a 2:1 active: placebo ratio).
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| local hypersensitivity-type reaction (aural erythema, swelling, vesicles, pain or pruritus after 2-3 days; resolved on withdrawal) | 1.8% of 113 cases | Two of 113 cases (1.8%) treated with Baytril® Otic displayed responses compatible with a local hypersensitivity reaction to one of the components within the formulation. |
Extraction notes: Original NADA 141-176 (2000). No systemic PK study in the summary (only in vitro MIC and FICI data), so pharmacokinetics left empty. Field study enrolled 169 dogs in total ('One hundred and sixty-nine dogs qualified for study enrollment'); n_dogs gives the 113/56 randomization split. Success rates per site are per ear (122/183 ears active vs 13/93 placebo). Target animal safety n given in words because the summary spells the numbers out ('Twelve male and twelve female beagle dogs'); adverse-reaction 'treated' expressed as 1.8% of 113 cases since 'Two' is spelled out in the quote.
Reproduce: foi_structured_search(query="Enrofloxacin, Silver sulfadiazine") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).