The 12-Month Laboratory Safety Study1 demonstrated capromorelin was well-tolerated in dogs at daily doses up to 40 mg/kg (17.5x labeled dose) for 12 months.
|Event, % of Dogs*||Placebo (n=8)||0.3 mg/kg (n=8)||7 mg/kg (n=8)||40 mg/kg (n=8)|
|Emesis||75% (1–3)||63% (1–2)||63% (1–4)||75% (1–6)|
|Loose stools||100% (1–41)||100% (5–32)||100% (2–220)||100% (1-46)|
|Excessive salivation||13% (4)||0||88% (1–104)||100% (34–354)|
*Results in parentheses are reported as the range of days on which the adverse events were observed.
- Beagle dogs (n=32) received either oral placebo or 0.3, 7, or 40 mg/kg capromorelin oral solution administered once-daily for 12 consecutive months
- Safety was evaluated by physical examinations, including electrocardiogram (ECG), ophthalmic examinations and comprehensive clinical pathology
Capromorelin was well-tolerated in dogs at daily doses up to 40 mg/kg for 12 months. The minimal toxicity observed across multiple body systems when capromorelin was administered at doses substantially higher than the labeled dose over an extended period of time supports the wide safety margin for the use of capromorelin in dogs.
1Zollers B, Huebner M, Armintrout G, Rausch-Derra LC, Rhodes L. Evaluation of the safety in dogs of long-term, daily oral administration of capromorelin (ENTYCE®), a novel drug for stimulation of appetite. J Vet Pharmacol Ther. 2016 Sep 25. Doi: 10.1111/jvp.12358.
IMPORTANT SAFETY INFORMATION: ENTYCE® (capromorelin oral solution) is for use in dogs only. Do not use in breeding, pregnant or lactating dogs. Use with caution in dogs with hepatic dysfunction or renal insufficiency. Adverse reactions in dogs may include diarrhea, vomiting, polydipsia, and hypersalivation. Should not be used in dogs that have a hypersensitivity to capromorelin. Please see the full Prescribing Information for more detail.
ENTYCE is Now Available
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