Companion Animal Product & Promotions Guide

May 2020

Animal Health Solution - a Henry Schein Animal Health magazine for veterinary professionals

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FOR ORAL USE IN DOGS ONLY CAUTION Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. INDICATIONS SIMPARICA TRIO prevents heartworm disease caused by Dirofilaria immitis, kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog tick), and the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina) and adult hookworm (Ancylostoma caninum and Uncinaria stenocephala) infections for one month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater. DOSAGE AND ADMINISTRATION SIMPARICA TRIO is given orally once a month, at the recommended minimum dose of 0.54 mg/lb (1.2 mg/kg) sarolaner, 0.011 mg/lb (24 µg/kg) moxidectin, and 2.27 mg/lb (5 mg/kg) pyrantel (as pamoate salt). Dosage Schedule Body Weight (lbs) Sarolaner per Tablet (mg) Moxidectin per Tablet (mg) Pyrantel per Tablet (mg) Number of Tablets Administered 2.8 to 5.5 3 0.06 12.5 One 5.6 to 11.0 6 0.12 25 One 11.1 to 22.0 12 0.24 50 One 22.1 to 44.0 24 0.48 100 One 44.1 to 88.0 48 0.96 200 One 88.1 to 132.0 72 1.44 300 One >132.0 Administer the appropriate combination of tablets SIMPARICA TRIO can be offered to the dog with or without food. Care should be taken to ensure that the dog consumes the complete dose and that part of the dose is not lost or refused. If a dose is missed, give SIMPARICA TRIO immediately and resume monthly dosing. Heartworm Prevention: SIMPARICA TRIO should be administered at monthly intervals year-round or at least within one month of the animal's first seasonal exposure to mosquitoes and continuing until at least 1 month after the dog's last seasonal exposure. If a dose is missed, give SIMPARICA TRIO immediately and resume monthly dosing. When replacing a monthly heartworm preventive product, SIMPARICA TRIO should be given within one month of the last dose of the former medication. Flea Treatment and Prevention: Treatment with SIMPARICA TRIO may begin at any time of the year. SIMPARICA TRIO should be administered year-round at monthly intervals or started at least one month before fleas become active. To minimize the likelihood of flea re-infestation, it is important to treat all dogs and cats within a household with a flea control product. Tick Treatment and Control: Treatment with SIMPARICA TRIO can begin at any time of the year. SIMPARICA TRIO should be administered year-round at monthly intervals or started at least one month before ticks become active. Intestinal Nematode Treatment and Control: For the treatment of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina) and adult hookworm (Ancylostoma caninum and Uncinaria stenocephala) infections, SIMPARICA TRIO should be administered once as a single dose. Monthly use of SIMPARICA TRIO will control any subsequent infections. CONTRAINDICATIONS There are no known contraindications for the use of SIMPARICA TRIO. WARNINGS Not for use in humans. Keep this and all drugs out of reach of children. Keep SIMPARICA TRIO in a secure location out of reach of dogs, cats and other animals to prevent accidental ingestion or overdose. PRECAUTIONS Sarolaner, one of the ingredients in SIMPARICA TRIO, is a member of the isoxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. Prior to administration of SIMPARICA TRIO, dogs should be tested for existing heartworm infections. Infected dogs should be treated with an adulticide to remove adult heartworms. SIMPARICA TRIO is not effective against adult D. immitis. The safe use of SIMPARICA TRIO has not been evaluated in breeding, pregnant, or lactating dogs. ADVERSE REACTIONS In a field safety and effectiveness study, SIMPARICA TRIO was administered to dogs for the prevention of heartworm disease. The study included a total of 410 dogs treated once monthly for 11 treatments (272 treated with SIMPARICA TRIO and 138 treated with an active control). Over the 330-day study period, all observations of potential adverse reactions were recorded. The most frequent reactions reported in the SIMPARICA TRIO group are presented in the following table. Table 1. Dogs with Adverse Reactions Clinical Sign SIMPARICA TRIO n = 272 Active Control n = 138 Vomiting 14.3% 10.9% Diarrhea 13.2% 8.0% Lethargy 8.5% 6.5% Anorexia 5.1% 5.8% Polyuria 3.7% 3.6% Hyperactivity 2.2% 0.7% Polydipsia 2.2% 2.9% In a second field safety and effectiveness study, SIMPARICA TRIO was administered to 278 dogs with fleas. Adverse reactions in dogs treated with SIMPARICA TRIO included diarrhea. In a third field safety and effectiveness study, SIMPARICA TRIO was administered to 120 dogs with roundworms. Adverse reactions in dogs treated with SIMPARICA TRIO included diarrhea and vomiting. For a copy of the Safety Data Sheet or to report adverse reactions, call Zoetis Inc. at 1-888-963-8471. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae. STORAGE CONDITIONS Store at or below 30°C (86°F). HOW SUPPLIED SIMPARICA TRIO is available in six flavored tablet sizes (see DOSAGE AND ADMINISTRATION). Each tablet size is available in packages of one, three, or six tablets. Approved by FDA under NADA # 141-521 Distributed by: Zoetis Inc. Kalamazoo, MI 49007 September 2019 51000400A&P Brief Summary of full Prescribing Information

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