Sarolaner, moxidectin and pyrantel

Indications

SIMPARICA TRIO is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina ) and hookworm (L4, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala ) infections. SIMPARICA TRIO kills adult fleas ( Ctenocephalides felis ) and is indicated for the treatment and prevention of flea infestations, the prevention of Dipylidium caninum (tapeworm) infections as a direct result of killing Ctenocephalides felis vector fleas on the treated dog, and 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), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick) for one month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater. SIMPARICA TRIO is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

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. Tapeworm 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. SIMPARICA TRIO will only prevent D. caninum infections by killing the fleas on the treated dog. Dogs may also become infected with D. caninum by ingesting fleas from untreated animals, it is therefore recommended that all pets in a household are treated for fleas. 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 hookworm (L4, immature adult, and adult Ancylostoma caninum and adult 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. In one well-controlled laboratory study, one dog had a seizure 16 days after administration of SIMPARICA TRIO. Post-Approval Experience (2024) The following adverse events are based on post-approval adverse drug experience reporting for SIMPARICA TRIO. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events reported in dogs are listed in decreasing order of reporting frequency: Vomiting, diarrhea (with and without blood), seizure, lethargy, anorexia, muscle tremor, ataxia, non-specific behavioral changes, and pruritus.

Description

SIMPARICA TRIO (sarolaner, moxidectin, and pyrantel chewable tablets) is a flavored, chewable tablet for administration to dogs 8 weeks of age and older. Each tablet is formulated to provide minimum dosages 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). Sarolaner is a member of the isoxazoline class of parasiticides and the chemical name is 1‑(5’-((5S)-5-(3,5-Dichloro-4-fluorophenyl)-5-trifluoromethyl)-4,5-dihydroisoxazol-3-yl)-3’-H-spiro(azetidine-3,1’-(2)benzofuran)-1-yl)-2-(methylsulfonyl)ethanone. SIMPARICA TRIO contains the S-enantiomer of sarolaner. Moxidectin is a semi-synthetic methoxime derivative of nemadectin which is a fermentation product of Streptomyces cyaneogriseus subspecies noncyanogenus. Moxidectin is a pentacyclic 16-membered lactone macrolide. The chemical name for moxidectin is (6R,23E,25S)-5-O-Demethyl-28-deoxy-25-[(1E)-1,3-dimethyl-1-buten-1-yl]-6,28-epoxy-23-(methoxyimino)milbemycin B. Pyrantel belongs to a family classified chemically as tetrahydropyrimidines and the chemical name is (E)‑1,4,5,6-Tetrahydro-1-methyl-2-[2-(2-thienyl) vinyl] pyrimidine 4,4’ methylenebis [3-hydroxy-2-naphthoate] (1:1). It is a yellow, water-insoluble crystalline salt of the tetrahydropyrimidine base and pamoic acid containing 34.7% base activity.

Storage

Store at or below 30°C (86°F).

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming sarolaner and moxidectin and pyrantel as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.