Simparica for Dogs - 2.8-5.5 lbs (1 Chew Tab) - [Flea & Tick]

Simparica is a fast-acting, prescription-strength oral flea and tick preventative for dogs that begins working within hours of administration. It provides a full 30 days of protection, helping prevent reinfestation and keeping your dog comfortable, itch-free, and protected all month long.

Simparica is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and for the treatment and control of several common tick species, including: 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).

Simparica starts killing adult fleas within just 3 hours and eliminates ticks within 8 hours. It can be safely used year-round with no break in coverage, making it a reliable choice for consistent protection.

Key Benefits

• One chewable tablet provides full-month protection against fleas and ticks
• Starts killing fleas within 3 hours and ticks within 8 hours
• Easy-to-give, liver-flavored chewable dogs love
• Can be given directly or crumbled and mixed with food
• Protects against 5 common tick species
• Available in six size options for dogs from 2.8 to 132 lbs: 2.8–5.5 lbs, 5.6–11 lbs, 11.1–22 lbs, 22.1–40 lbs, 44.1–88 lbs, 88.1–132 lbs

Indications

Simparica is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and for the treatment and control of tick infestations caused by: 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).

Approved for use in dogs 6 months of age or older, weighing 2.8 pounds or more.

How It Works

Simparica contains sarolaner, an advanced ingredient that targets the nervous systems of fleas and ticks. It works by blocking neurotransmitter receptors (GABA and glutamate) in the parasites, causing overstimulation, paralysis, and death.

The chewable is administered monthly and can be given directly or mixed with food. For best results and to prevent reinfestation, all pets in the household should be treated with an approved flea and tick product.

View Simparica Drug Facts Sheet.

Dosage: Simparica is administered orally once a month at a minimum dosage of 0.91 mg/lb (2 mg/kg).

Simparica can be given by hand, with food, or administered like a standard oral medication. Ensure your dog consumes the full dose and monitor briefly to prevent any part from being lost or refused. If a dose is missed, give Simparica as soon as possible and continue monthly dosing.

Flea Treatment and Prevention

Simparica can be started any time of year. In areas where fleas are active year-round, monthly use is recommended without interruption to maintain protection. All pets in the household should be treated to prevent re-infestation.

Tick Treatment and Control

Simparica may be started at any time (see Effectiveness).

Contraindications

There are no known contraindications for Simparica.

Warnings

Not for human use. Keep out of reach of children and pets. For canine use only. Do not use Simparica in cats. Not recommended for dogs under 6 months of age (see Animal Safety).

Precautions

Simparica may cause neurologic signs such as tremors, ataxia, or seizures (see Animal Safety). The safety of Simparica has not been evaluated in breeding, pregnant, or lactating dogs.

Adverse Reactions

In a U.S. field study with 479 dogs (315 treated with Simparica, 164 with active control), potential adverse effects were monitored over 90 days.

Additional adverse events were reported, including one female dog who experienced neurological symptoms after concurrent administration with a heartworm preventative. Symptoms resolved without treatment.

For Safety Data Sheets or to report adverse events, contact Zoetis at 1-888-963-8471 or visit www.Simparica.com. You may also contact the FDA at 1-888-FDA-VETS or visit FDA Animal Veterinary Safety.

Clinical Pharmacology

Sarolaner is well-absorbed following oral administration. In a study on Beagle dogs, the mean maximum plasma concentration (C_max) was 1100 ng/mL, with a mean time to max concentration (T_max) of 3 hours. Bioavailability was 86% (fasted) and 107% (fed). The half-life was 10–12 days. Sarolaner is highly protein-bound (≥99.9%), minimally metabolized, and eliminated primarily via feces through biliary excretion.

Repeated monthly doses for 10 months at 1X–5X levels showed dose-proportional exposure and consistent pharmacokinetics. One dog at 12 mg/kg (3X) exhibited serious neurological effects after a third dose and was euthanized. No sudden cause for increased plasma levels was found.

Mode of Action

Sarolaner, the active ingredient in Simparica, is an insecticide and acaricide from the isoxazoline class. It inhibits GABA and glutamate receptor function in the nervous system of fleas and ticks, resulting in their death due to overstimulation and paralysis.

Effectiveness

Simparica starts killing fleas within 3 hours and achieves ≥96.2% reduction within 8 hours post-infestation. Studies show 100% effectiveness within 24 hours and consistent weekly protection for 35 days.

Simparica kills fleas before they lay eggs and has been shown to control infestations in real-world home environments. Tick control studies show ≥99% effectiveness within 48 hours and >96% effectiveness for up to 30 days.

In a 90-day U.S. field study, Simparica showed 99.4% effectiveness at Day 30, 99.8% at Day 60, and 100% at Day 90. Dogs with flea allergy dermatitis showed clear relief due to effective flea elimination.

Animal Safety

In a margin of safety study on 8-week-old Beagle puppies, Simparica was administered at up to 5X the maximum dose. Mild, transient neurologic signs were observed in a few dogs at 3X and 5X doses. No long-term adverse effects occurred. Dogs over 6 months of age showed no neurologic signs.

In a pharmacokinetic study, one dog at 12 mg/kg (3X) experienced severe neurological reactions and was euthanized. Plasma levels spiked unusually after the third dose, with no identified cause.

Storage

Store below 30°C (86°F). Temporary excursions up to 40°C (104°F) are permitted.