Lufenuron, Nitenpyram: what the FDA reviewed for dog products
1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Lufenuron, Nitenpyram, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs and Cats.
Products
- Program® Flavor Tabs® and Capstar® Flea Management System™ (NADA/ANADA 141-205)
Program® Flavor Tabs® and Capstar® Flea Management System™ NADA 141-205, Original approval, June 11, 2003; sponsor Elanco US Inc.; species: Dogs and Cats; foi_id 723; FDA PDF
Indication
Concurrent use of PROGRAM Flavor Tabs and CAPSTAR Tablets in dogs and puppies (and in cats and kittens) to kill adult fleas and prevent flea eggs from hatching.
Dose regimen
Dogs: 1 tablet each by body-weight band: CAPSTAR 11.4 mg (2-25 lb) or 57.0 mg (26-125 lb) nitenpyram; PROGRAM 45.0, 90.0, 204.9 or 409.8 mg lufenuron, oral, CAPSTAR once or twice weekly (if adult fleas are seen); PROGRAM once per month, dogs over 90 lb receive the appropriate combination of PROGRAM Flavor Tabs; separate cat table (2-6 lb 90 mg, 7-15 lb 204.9 mg lufenuron with 11.4 mg nitenpyram)
Table 1: Dog Dosage Body Weight Dose CAPSTAR® Once o r twice weekly* (nitenpyram/ tablet) PROGRAM® Flavor Tabs ® Once per month (lufenuron/tablet) 2 to 10 lbs 1 tablet 11.4 mg 45.0 mg 11 to 20 lbs 1 tablet 11.4 mg 90.0 mg 21 to 25 lbs 1 tablet 11.4 mg 204.9 mg 26 to 45 lbs 1 tablet 57.0 mg 204.9 mg 46 to 90 lbs 1 tablet 57.0 mg 409.8 mg 91 to 125 lbs 1 tablet 57.0 mg **
Effectiveness
Three-group, multi-center, masked, placebo-controlled field study (11 sites) of nitenpyram tablets alone or with PROGRAM Flavor Tabs for rapid flea removal in 273 dogs and 265 cats; live/dead/moribund fleas counted 4-6 hours after dosing at two visits 7-14 days apart.; n = 113; primary endpoint: Percent dead and moribund fleas within six hours of administration; result: Dogs visit 1: nitenpyram 98.6% (n=108), nitenpyram + PROGRAM 98.5% (n=113) vs placebo 6.2% (n=52); visit 2: 99.1% and 99.3% vs 13.1%. Cats: 98.4%/98.7% vs 5.7% at visit 1; 99.9%/99.7% at visit 2. Conclusion: nitenpyram alone or with PROGRAM >98% effective within 6 hours.
Nitenpyram + PROGRAM® 98.5% (n=113) 99.3% (n=82) 98.7% (n=108) 99.7% (n=44)
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Vomiting (dog non-interference study, PROGRAM + CAPSTAR group) | Two dogs in the PROGRAM® Flavor Tabs® + CAPSTAR® group vomited on Day 30, 24 hours after administration of both drugs. One of those dogs also vomited on Day 1, 24 hours after administration of both products. | ||
| Diarrhea (dog non-interference study, PROGRAM + CAPSTAR group) | One dog in the PROGRAM® Flavor Tabs® + CAPSTAR® group experienced a bout of diarrhea 24 hours after administration of both products on Day 0. | ||
| 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). | ||
| Transient ocular discharge (cats receiving CAPSTAR, simulated home environment study) | 12 | Transient, uncomplicated ocular discharge was noted in 12 cats receiving CAPSTAR® Tablets, with or without PROGRAM® Flavor Tabs® . | |
| No adverse reactions (field study, dogs and cats) | Adverse Reactions: None reported. Conclusions: Nitenpyram, alone or in combination with PROGRAM® Flavor Tabs®, is safe and effective for the treatment of flea infestations in dogs and cats. |
Extraction notes: Summary covers dogs and cats (species_class 'Dogs and Cats'); OTC product. Target animal safety is not presented (refers to the CAPSTAR NADA 141-175 summary). Effectiveness quote is the flattened Table 14 row for the nitenpyram + PROGRAM group (columns: dogs visit 1, dogs visit 2, cats visit 1, cats visit 2); n_dogs 113 is the dog visit-1 count for that group, of 273 dogs enrolled. Laboratory non-interference studies (72 and 48 dogs; 36 and 32 cats) are summarised only in notes. Two cat deaths in the cat simulated-home study were not considered drug related / of unclear relationship.
Reproduce: foi_structured_search(query="Lufenuron, Nitenpyram") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).