Simparica Chewables: Product Information

SIMPARICA CHEWABLES- sarolaner tablet, chewable
Zoetis Inc.

Simparica®

(sarolaner) Chewables

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 is a flavored, chewable tablet for administration to dogs over 6 months of age according to their weight. Each tablet is formulated to provide a minimum sarolaner dosage of 0.91 mg/lb (2 mg/kg ) body weight.

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 contains the S-enantiomer of sarolaner.

Indications

SIMPARICA kills adult fleas, and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations [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 6 months of age or older and weighing 2.8 pounds or greater.

Dosage and Administration

SIMPARICA is given orally once a month at the recommended minimum dosage of 0.91 mg/lb (2 mg/kg).

Dosage Schedule:

Body Weight

SAROLANER per Tablet (mg)

Number of Tablets Administered

2.8 to 5.5 lbs

5

One

5.6 to 11.0 lbs

10

One

11.1 to 22.0 lbs

20

One

22.1 to 44.0 lbs

40

One

44.1 to 88.0 lbs

80

One

88.1 to 132.0 lbs

120

One

>132.1 lbs

Administer the appropriate combination of tablets

SIMPARICA can be offered by hand, in the food, or administered like other tablet medications.

Care should be taken that the dog consumes the complete dose, and treated animals should be observed for a few minutes to ensure that part of the dose is not lost or refused. If a dose is missed, administer SIMPARICA and resume a monthly dosing schedule.

SIMPARICA should be administered at monthly intervals.

Flea Treatment and Prevention:

Treatment with SIMPARICA may begin at any time of the year. In areas where fleas are common year-round, monthly treatment with SIMPARICA can continue the entire year without interruption.

To minimize the likelihood of flea re-infestation, it is important to treat all dogs and cats within a household with an approved flea control product.

Tick Treatment and Control:

Treatment with SIMPARICA can begin at any time of the year (see Effectiveness).

Contraindications

There are no known contraindications for the use of SIMPARICA.

Warnings

Not for use in humans. Keep this and all drugs out of reach of children. For use in dogs only. Do not use SIMPARICA in cats.
SIMPARICA should not be used in dogs less than 6 months of age (see Animal Safety).
Keep SIMPARICA in a secure location out of reach of dogs, cats and other animals to prevent accidental ingestion or overdose.

Precautions

Sarolaner 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.
The safe use of SIMPARICA has not been evaluated in breeding, pregnant, or lactating dogs.

Adverse Reactions

SIMPARICA was administered in a well-controlled US field study, which included a total of 479 dogs (315 dogs treated with SIMPARICA and 164 dogs treated with active control once monthly for three treatments).Over the 90-day study period, all observations of potential adverse reactions were recorded.

Table 1. Dogs with adverse reactions

Adverse reaction

sarolaner

sarolaner

active control

active control

N

% (n = 315)

N

# (n =164)

Vomiting

3

0.95%

9

5.50%

Diarrhea

2

0.63%

2

1.20%

Lethargy

1

0.32%

2

1.20%

Inappetence

0

0%

3

1.80%

Additionally, one female dog aged 8.6 years exhibited lethargy, ataxia while posturing to eliminate, elevated third eyelids, and inappetence one day after receiving SIMPARICA concurrently with a heartworm preventative (ivermectin/pyrantel pamoate). The signs resolved one day later. After the day 14 visit, the owner elected to withdraw the dog from the study.
Abnormal neurologic signs such as tremors, decreased conscious proprioception, ataxia, decreased or absent menace, and/or seizures were reported in dogs receiving SIMPARICA (see Animal Safety).
Post Approval Experience (2019):
The following adverse events are based on post-approval adverse drug experience reporting for SIMPARICA. 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 for dogs are listed in decreasing order of reporting frequency:
Vomiting, tremors, lethargy, seizure, diarrhea (with and without blood), anorexia, ataxia, pruritus, hypersalivation and hyperactivity.
For a copy of the Safety Data Sheet (SDS) or to report adverse reactions call Zoetis Inc. at 1-888-963-8471. Additional information can be found at www.SIMPARICA.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.

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