Lufenuron, Milbemycin Oxime, Nitenpyram: what the FDA reviewed for dog products
1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Lufenuron, Milbemycin Oxime, Nitenpyram, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs.
Products
- Sentinel® Flavor Tabs® and Capstar® Flea Management System™ (NADA/ANADA 141-204)
Sentinel® Flavor Tabs® and Capstar® Flea Management System™ NADA 141-204, Original approval, June 11, 2003; sponsor Intervet, Inc.; species: Dogs; foi_id 722; FDA PDF
Indication
Concurrent use of SENTINEL Flavor Tabs and CAPSTAR Tablets in dogs and puppies to kill adult fleas and prevent flea eggs from hatching.
Dose regimen
1 tablet of each by body-weight band: CAPSTAR 11.4 mg or 57.0 mg nitenpyram; SENTINEL 46 mg/2.3 mg up to 460 mg/23.0 mg lufenuron/milbemycin oxime, oral, CAPSTAR once or twice weekly (only if adult fleas are seen); SENTINEL once per month, products are not co-packaged; dogs over 100 lb receive the appropriate combination of SENTINEL tablets
Body Wt. In Pounds Dose CAPSTAR® (nitenpyram) Once or twice weekly* SENTINEL® (lufenuron/milbemycin oxime) Once per month 2 to 10 1 tablet 11.4 mg 46 mg/2.3 mg 11 to 25 1 tablet 11.4 mg 115 mg/5.75 mg 26 to 50 1 tablet 57.0 mg 230 mg/11.5 mg 51 to 100 1 tablet 57.0 mg 460 mg/23.0 mg 101 to 125 1 tablet 57.0 mg Dogs > 100 lbs are provided the appropriate combination of tablets. *CAPSTAR® is administered only if adult fleas are seen.
Target-animal safety
dose multiples 5X; duration 90 days (nitenpyram 5X once daily; milbemycin oxime/lufenuron 5X once every two weeks, 7 treatments); animals 16.
Animals: 16 beagle dogs (8 male and 8 female), 10 to 11 weeks of age at start of dosing
| Finding | Quote |
|---|---|
| Treated group had a higher incidence of soft stool and fecal mucus than control. | Both groups had soft stool, fecal mucus, and the occasional appearance of blood in the feces and diarrhea. The treated group had a higher incidence of soft stool and fecal mucus when compared to control. |
| Body weights and rate of weight gain significantly lower (p < .10) in treated dogs on several days. | Body weights in treated dogs were significantly lower (p < .10) than control dogs on Days 42, 49, 63, 77, and 84. Rate of weight gain for the treated dogs was significantly lower (p < .10) than for control dogs. |
| Creatinine and serum sodium significantly higher in treated dogs but within normal range; no hematology differences. | Creatinine values were significantly higher (p < 0.05) for treated dogs than for controls. Serum sodium was higher (p < 0.01) for treated dogs than for controls. All of these values remained within the normal range. |
| Lymphoid hyperplasia of the stomach in treated and control dogs; cecal mucosal congestion in 3 treated dogs. | There was lymphoid hyperplasia in the stomach of treated and control dogs. The severity was possibly greater in treated female dogs when compared to control females. Congestion of the cecal mucosa was noted in the 3 treated dogs that had reddened mucosa on the gross exam. |
| Conclusion: concurrent 5X dosing for 90 days well tolerated in beagles from 10-11 weeks of age. | Concurrent administration of CAPSTAR ® Tablets daily for 90 days, and SENTINEL® Flavor Tabs® biweekly for 7 trea tments at 5X the recommended dosage rates was well tolerated by beagle dogs beginning at 10-11 weeks of age. |
Effectiveness
Laboratory non-interference / confirmation study in a simulated home environment: 72 Beagle dogs in eight groups of nine (untreated control, CAPSTAR twice weekly, CAPSTAR once weekly, SENTINEL only on days 0/30/58, SENTINEL + CAPSTAR once weekly; three Program groups reported under NADA 141-205); weekly flea counts days 14-63.; n = 72; primary endpoint: Percent effectiveness (reduction in adult flea counts vs untreated control) by day; result: CAPSTAR twice weekly >90% from Day 14; CAPSTAR once weekly >90% from Day 21; SENTINEL + CAPSTAR once weekly >90% from Day 28; SENTINEL alone >90% from Day 35. Concurrent use gave greater reduction in adult fleas than SENTINEL alone.
Animals : 72 Beagle dogs (41 males and 31 females), adults, > 6 months of age, between 14.1 and 35.2 pounds.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Swollen eyes and fever (one dog, CAPSTAR twice-weekly group, simulated home environment study) | One dog in the CAPSTAR® twice weekly group developed swollen eyes and a fever of 103.5 degrees F on Day 36 (one day after CAPSTAR® administration). | ||
| No adverse reactions (flea mortality/reproduction non-interference study) | There were no adverse reactions reported for these treatment groups. | ||
| No adverse reactions (hookworm non-interference study) | Adverse Reactions: None reported |
Extraction notes: Concurrent-use NADA; heartworm/nematode claims are not addressed in this summary (refers to NADA 141-084). No field study; effectiveness consists of three laboratory non-interference studies (simulated home environment, flea reproduction with 48 dogs, hookworm removal with 32 dogs showing 100% efficacy). Table 2 percent-effectiveness values are flattened in the PDF text and summarised in the result field. The general information section is unparsed, so indication and dosage quotes were taken from the raw text; the indication quote contains the PDF artifact 'a nd'.
Reproduce: foi_structured_search(query="Lufenuron, Milbemycin Oxime, Nitenpyram") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).