Febantel, Praziquantel: what the FDA reviewed for dog products
1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Febantel, Praziquantel, 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
- Vercom Paste Anthelmintic (NADA/ANADA 133-953)
Vercom Paste Anthelmintic NADA 133-953, Supplemental approval, September 12, 1991; sponsor Elanco US Inc.; species: Dogs and Cats; foi_id 1635; FDA PDF
Indication
Removal of nematode (and cestode) parasites: in dogs and puppies hookworms (Ancylostoma caninum, Uncinaria stenocephala), ascarids (Toxocara canis, Toxocara leonina), whipworms (Trichuris vulpis) and tapeworms (Dipylidium caninum, Taenia pisiformis); in cats and kittens hookworms (A. tubaeforme), ascarids (T. cati) and tapeworms (D. caninum, T. taeniaeformis) - unchanged by this supplement
Dose regimen
10 mg febantel and 1.0 mg praziquantel/kg BW (1 g paste per 7.5 lb) for mature dogs and cats, Oral; directly into the mouth or, for mature animals, mixed with food, Daily, 3 consecutive days. Puppies and kittens younger than 6 months: 1 g/5 lb (15 mg febantel and 1.5 mg praziquantel/kg) daily for 3 consecutive days on a full stomach
Dogs and Cats: 1 g/7.5 lb body weight (BW) given to mature dogs and cats (10 mg febantel and 1.0 mg praziquantel/kg BW) given daily for 3 consecutive days.
Target-animal safety
The addition of this warning is based on data gathered during the safety evaluation of febantel alone for Rintal Tabs, NADA 140-912.
| Finding | Quote |
|---|---|
| At elevated doses, toxicity may be increased in animals with pre-existing hepatic or renal disease (basis for the new label warning; data from the Rintal Tabs febantel-alone safety evaluation in cats) | It was shown in this study, that, at elevated doses, toxicity may be increased in the animal already compromised by hepatic or renal disease. |
Extraction notes: Supplemental NADA (September 12, 1991; Category II) that only adds the label warning 'Consider alternative therapy or use with caution in animals with pre-existing liver or kidney dysfunction'. No new studies: effectiveness refers to the original Vercom Paste FOI (50 FR 19167) and the spectrum-extension supplement (53 FR 48533); the safety basis is the febantel tablet (Rintal Tabs, NADA 140-912) General Safety Evaluation in cats, so the target_animal_safety entry is a cross-reference rather than a study in this summary. Summary has no explicit Species/Class field; species taken from the dosage regimen headings (Dogs and Cats; Puppies and Kittens). Sponsor: Mobay Corporation.
Reproduce: foi_structured_search(query="Febantel, Praziquantel") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).