Epsiprantel: what the FDA reviewed for dog products
1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Epsiprantel, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Cats and Dogs.
Products
- Cestex® (NADA/ANADA 140-893)
Cestex® NADA 140-893, Original approval, December 01, 1989; sponsor Zoetis Inc.; species: Cats and Dogs; foi_id 522; FDA PDF
Indication
Removal of canine cestodes Dipylidium caninum and Taenia pisiformis in dogs (and feline cestodes D. caninum and Taenia taeniaeformis in cats)
Dose regimen
2.5 mg/lb of body weight (dog); 1.25 mg/lb (cat), Oral, Single treatment (the field study describes the drugs as 'administered as a single treatment'), Fasting is not necessary or recommended; reinfection likely unless exposure to intermediate hosts (fleas for D. caninum) is controlled
CESTEX® (epsiprantel) tablets should be administered orally. The recommended dosage of epsiprantel is: · Cat - 1.25 mg/lb of body weight · Dog - 2.5 mg/lb of body weight Fasting is not necessary or recommended.
Target-animal safety
dose multiples 1X (2.5 mg/lb), 3X (7.5 mg/lb), 5X (12.5 mg/lb); duration 3 consecutive days (necropsy 24 h or 48 h after the third dose).
Twelve male and twelve female 5-6 month old beagles were used. Prior to treatment, the dogs were randomized into four groups, each consisting of three males and three females. This study was an open evaluation of epsiprantel tablets utilizing three dosage levels and a control group. The drug was administered orally for three days at a dose rate of 2.5, 7.5 and 12.5 mg/lb.
| Finding | Quote |
|---|---|
| No test-drug-related abnormalities in body temperature, heart rate, respiratory rate, body weight, food consumption or general appearance (pivotal 3-day study at 2.5, 7.5 and 12.5 mg/lb) | No abnormal values considered related to the test drug were obtained in regard to body temperature, heart rate, respiratory rate, body weight, food consumption and general appearance. |
| No drug-related hematology or blood chemistry differences; no gross or microscopic lesions related to epsiprantel | Hematology and blood chemistries did not reveal any drug related differences between the test and control dogs. No gross or microscopic lesions related to epsiprantel were detected. |
| 14-day repeat-dose study at 10, 100 and 500 mg/kg/day: physical signs limited to isolated emesis at all dose levels | Epsiprantel was administered orally to dogs at dose levels of 10, 100, and 500 mg/kg/day for 14 days. Physical symptoms were limited to isolated occurrence of emesis at all dose levels. |
| 14-day repeat-dose study: increased alkaline phosphatase and reduced total WBC at the high dose (500 mg/kg/day); reduced lymphocytes in females at 100 and 500 mg/kg/day | changes consisted of increased alkaline phosphatase activity and reduced total white blood cell counts at the high dose level. Reduced lymphocyte counts in females only were noted in the 100 and 500 mg/kg/day group. |
| Single-dose tolerance: 100 mg/kg (7-10 week puppies, adult collie) and 200 mg/kg (adult dogs) produced no overt toxicity | A single oral dose of 100 mg/kg produced no overt toxicity in 7 to 10 week old beagle puppies, nor in an adult collie. Similarly, no toxic side effects were detected in adult dogs given a single oral dose of 200 mg/kg. |
Effectiveness
Blind, parallel-group, multicenter clinical field study in dogs with confirmed tapeworm infection (17 investigators, 11 states): epsiprantel 2.5 mg/lb single oral treatment vs active control praziquantel (Droncit) at label dose; post-treatment examination 7 to 30 days later; n = 252; primary endpoint: Elimination of tapeworms (both clinical observation and fecal flotation negative at the 7-30 day post-treatment examination); result: Epsiprantel eliminated 106/108 (98%) of D. caninum infections vs 120/120 (100%) for praziquantel; both drugs eliminated 100% of T. pisiformis. Pivotal dose titration (0, 1.25, 2.5, 3.75 mg/lb; 4 studies) and dose confirmation (2.5 mg/lb; 4 studies) necropsy studies gave 99.6-100% efficacy at 2.5 mg/lb against D. caninum and T. pisiformis
A total of 252 evaluable cases was enrolled. A total of 255 tapeworms was identified during the pre-treatment examination in these 252 cases. Epsiprantel eliminated 106/108 (98%) of the D. caninum versus 120/120 (100%) for DRONCIT (praziquantel). Both drugs eliminated 100% of the Taenia pisiformis.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Adverse reactions (dose titration study, experimentally induced T. pisiformis) | There was no evidence of any adverse reactions in the treated dogs. | ||
| Adverse effects (dose confirmation study, natural D. caninum) | Epsiprantel was effective at a dose of 2.5 mg/lb. No adverse effects were noted in this study. |
Extraction notes: Original NADA (1989) for cats and dogs; the record captures the canine studies. Summary text lacks an approval date and file uses a 508-reformatted layout. TAS n_animals left null because the pivotal study gives group sizes in words ('Twelve male and twelve female', i.e. 24 dogs, 6 per group); dose multiples (1X/3X/5X) are derived from the 2.5 mg/lb label dose and are not stated as multiples in the summary. Dose-titration tables were flattened by PDF extraction (column order: treatment group mg/lb, No. dogs, No. parasites, No. dogs cleared, % dogs cleared, % efficacy). The field study reports no adverse reaction counts; adverse_reactions rows are the negative statements from the laboratory studies. Feline data (dose titration/confirmation, field study of 225 cats, feline TAS at 1.25/3.75/6.25 mg/lb) are not extracted.
Reproduce: foi_structured_search(query="Epsiprantel") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).