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Drug Information for COMFORTIS (spinosad) Chewable Tablets (Elanco Animal Health Co): Animal Safety:
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- Post Approval Experience (June 2009):
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COMFORTIS chewable tablets were tested in pure and mixed breeds of healthy dogs in well-controlled clinical and laboratory studies. No dogs were withdrawn from the field studies due to treatment-related adverse reactions.
In a dose tolerance study, COMFORTIS chewable tablets were administered orally to adult Beagle dogs at average doses of up to 100 mg/kg once daily for 10 consecutive days (16.7 times the maximum recommended monthly dose). Vomiting was seen in 5 of 6 treated dogs during the first 6 days of treatment, usually within 2.5 hours of dosing. Treated females lost weight early in the treatment period, but their weights were similar to control dogs by the end of the 24-day study. COMFORTIS chewable tablets were not associated with any clinically significant changes in hematology, blood coagulation or urinalysis parameters; however, mild elevations in ALT occurred in all dogs treated with COMFORTIS chewable tablets. By day 24, ALT values had returned to near baseline levels. Phospholipidosis (vacuolation) of the lymphoid tissue was seen in all dogs treated with COMFORTIS chewable tablets, the long-term effects of which are unknown.
In a margin of safety study, COMFORTIS chewable tablets were administered orally to 6-week-old Beagle puppies at average doses of 1.5, 4.4, and 7.4 times the maximum recommended dose at 28-day intervals over a 6-month period. Vomiting was observed across all groups, including the control. Increased vomiting was observed at elevated doses, usually within 1 hour following administration. Vomiting at all doses decreased over time and stabilized when puppies were 14 weeks of age. The average daily and total weight gains of treated dogs were smaller than control dogs and were dose dependent. COMFORTIS chewable tablets were not associated with clinically significant changes in hematology, clinical chemistry, coagulation or urinalysis parameters. Phospholipidosis (vacuolation) of the lymphoid tissue was seen in some dogs in the 4.4X group and all dogs in the 7.4X group. The long term effects of phospholipidosis are unknown. Treatment with COMFORTIS chewable tablets was not associated with any other clinically significant adverse clinical observations, gross necropsy or histopathological changes.
In a reproductive safety study, COMFORTIS chewable tablets were administered orally to female Beagles at 1.3 and 4.4 times the maximum recommended therapeutic dose every 28 days prior to mating, during gestation, and during a six-week lactation period. No treatment-related adverse effects were noted for conception rates in the dams, or for mortality, body temperature, necropsy, or histopathology findings for the dams or puppies. One dam from each treatment group experienced early pregnancy loss and one additional high dose dam aborted late term. The treated dams experienced more vomiting, especially at one hour post-dose, than the control dams. Puppies from dams treated at 1.3 times the maximum recommended therapeutic dose had lower body weights than puppies from control dams. Although puppy mortality between treated and control dams was not different, the puppies from the treated dams experienced more lethargy (4.4X group only), dehydration, weakness and felt cold to the touch (4.4X group only) than puppies from control dams.
A pilot study without a control group was conducted to analyze milk from three lactating dogs treated with an experimental formulation of spinosad at 1.5 times the maximum recommended dose administered at day 28 of gestation and 24 hours prior to parturition. The data demonstrated that spinosyns were excreted in the milk of these dogs. Mortality and morbidity were greatest in puppies from the dam with the highest spinosyns level in milk. The spinosad milk: reference plasma exposure ratio calculated from this study ranged from 2.2 to 3.5.
In well-controlled field studies, COMFORTIS chewable tablets were administered safely in conjunction with other frequently used veterinary products, such as vaccines, anthelmintics, antibiotics, steroids, flea and tick control products, anesthetics, NSAIDs, antihistamines, alternative/herbal remedies, shampoos, and prescription diets. Changes in hematology, clinical chemistry and urinalysis values were compared pre-and post-study and were unremarkable.
- Drug Information Provided by National Library of Medicine (NLM).