Simparica TRIO: Product Information

SIMPARICA TRIO- sarolaner, moxidectin and pyrantel pamoate tablet, chewable
Zoetis Inc.

Simparica TRIO®

(sarolaner, moxidectin, and pyrantel chewable tablets)

FOR ORAL USE IN DOGS ONLY

CAUTION

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

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.

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 adult hookworm (Ancylostoma caninum and Uncinaria stenocephala) infections. SIMPARICA TRIO kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, 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), and Rhipicephalus sanguineus (brown dog tick) 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 perTablet(mg) Moxidectinper Tablet(mg) PyrantelperTablet(mg) Numberof TabletsAdministered
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.

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