Betamethasone Acetate, Gentamicin Sulfate: what the FDA reviewed for dog products
1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Betamethasone Acetate, Gentamicin Sulfate, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs.
Products
- Gentocin® Durafilm® (NADA/ANADA 034-267)
Gentocin® Durafilm® NADA 034-267, Supplemental approval, November 10, 2014; sponsor Intervet, Inc.; species: Dogs; foi_id 299; FDA PDF
Indication
Treatment of external eye infections and inflammation in dogs (also cited as useful for some cases of pigmentary keratitis and pannus)
Dose regimen
One or two drops (3 mg/ml gentamicin base, 1 mg/ml betamethasone acetate), Topical ophthalmic (conjunctival sac), three or four times a day, frequency may thereafter be reduced; in chronic conditions withdraw by gradually decreasing frequency
3 mg/ml gentamicin base, 1 mg/ml betamethasone acetate H. How Supplied 5 mL plastic vials I. Dispensing Status Rx J. Dosage Regimen GENTOCIN DURAFILM Ophthalmic Solution should, in each instance, be administered to meet the specific needs of the individual case. One or two drops of the solution may be instilled into the conjunctival sac three or four times a day.
Target-animal safety
dose multiples 0X, 1X, 2X, 3X; duration 14 consecutive days, four times daily (Study S13074); animals 32 (4 males and 4 females per group).
Study Animals: 32 Beagle dogs which were 5 months old and weighed between 5.9 and 8.7 kg; 4 males and 4 females per group. b. Experimental Design: GENTOCIN DURAFILM was administered four times daily for 14 consecutive days at a dose of 2 drops/eye (1X maximum therapeutic daily dose), 4 drops/eye (2X maximum therapeutic daily dose), and 6 drops/eye (3X maximum therapeutic daily dose). The control group received 6 drops of sterile saline/eye four times daily (0X).
| Finding | Quote |
|---|---|
| Dose-related serous ocular discharge resolving within hours | A serous ocular discharge was observed in dogs administered GENTOCIN DURAFILM in a dose-related manner that resolved within a few hours of dosing. |
| Bilateral scleral redness in 1/8 (2X) and 5/8 (3X) dogs, Days 4-8, self-resolving | Bilateral scleral redness was seen in the 2X (1 of 8 dogs) and 3X (5 of 8 dogs) groups between Days 4-8; the redness spontaneously resolved. |
| Polyuria with decreased urine specific gravity, dose proportional (7/8 at 2X, 8/8 at 3X) | Most dogs in both the 2X (7 of 8 dogs) and 3X (8 of 8 dogs) groups exhibited polyuria. |
| Hematology: neutrophilia, lymphopenia, eosinopenia (corticosteroid pattern) | Changes in hematological parameters included neutrophilia, lymphopenia, and eosinopenia. |
| ALT, ALP and GGT increased after 14 days (attributed to steroid enzyme induction) | Alanine aminotransferase, alkaline phosphatase, and γ-glutamyl transferase were increased after 14 days of administration of GENTOCIN DURAFILM. |
| Clinical pathology changes of minimal severity without correlating clinical signs | The changes seen in the hematological and clinical chemistry parameters were of minimal severity and were not accompanied by any correlating clinical signs or complications during or after administration of GENTOCIN DURAFILM. |
Effectiveness
Supplemental approval for a new formulation (Cremophor ELP replacing Incrocas 30 as excipient); no effectiveness studies required; result: Excipient change not expected to impact effectiveness
CVM did not require effectiveness studies for this supplemental approval. The change in the formulation from Incrocas 30 (polyoxyl 32 castor oil) to Cremophor ELP (polyoxyl 35 castor oil) is not expected to impact the effectiveness of the product.
Extraction notes: Supplemental (formulation change) approval; safety supported by two margin-of-safety studies: pilot 5-day S13140 (16 beagles, 3X vs saline; ocular discharge in 7/8, scleral redness in 5/8) and pivotal 14-day S13074 captured above. No field study, so no adverse-reaction incidence table.
Reproduce: foi_structured_search(query="Betamethasone Acetate, Gentamicin Sulfate") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).