Simparica For Dogs 2.8-5.5 lbs (1.3-2.5 kg)

Description

Simparica For Dogs 2.8-5.5 lbs (1.3-2.5 kg) contain 5 mg sarolaner per tablet, formulated to deliver the labeled minimum dose of 0.91 mg/lb (2 mg/kg) across this weight band. Sarolaner belongs to the isoxazoline class of parasiticides and acts by inhibiting GABA receptor and glutamate receptor function in insects and acarines, producing lethal neuromuscular disruption. This variant covers six tick species alongside flea treatment and prevention, including the Asian longhorned tick (Haemaphysalis longicornis), and is approved for dogs that have reached both the minimum body weight of 2.8 lbs (1.3 kg) and the minimum age of 6 months.

Recommended for

Dogs weighing 2.8–5.5 lbs (1.3–2.5 kg), 6 months of age and older.

Indication/Coverage

For dogs weighing 2.8–5.5 lbs (1.3–2.5 kg) suffer from, or at risk from, mixed parasitic infections:

• Flea treatment and prevention: Kills adult Ctenocephalides felis and prevents reinfestation; flea egg production is eliminated for up to 35 days post-dosing.
• Lone star tick control: Treats and controls adult Amblyomma americanum infestations for one month.
• Gulf Coast tick control: Treats and controls adult Amblyomma maculatum infestations for one month.
• American dog tick control: Treats and controls adult Dermacentor variabilis infestations for one month.
• Black-legged tick control: Treats and controls adult Ixodes scapularis infestations for one month; also indicated for prevention of Borrelia burgdorferi infection through elimination of the vector tick.
• Brown dog tick control: Treats and controls adult Rhipicephalus sanguineus infestations for one month.
• Asian longhorned tick control: Treats and controls adult Haemaphysalis longicornis infestations for one month.

Key Benefits

The following characteristics apply specifically to the 2.8–5.5 lbs (1.3–2.5 kg) tablet based on labeled claims:

• Small-dog dosing accuracy: The 5 mg sarolaner tablet is calibrated to deliver no less than 0.91 mg/lb (2 mg/kg) across the full 2.8–5.5 lb range, preventing underdosing at the lower boundary.
• Broad tick spectrum: A single monthly chewable addresses six tick species including Haemaphysalis longicornis, covering both established and emerging vector populations across the U.S.
• Rapid flea kill: Laboratory data confirm that Simparica begins killing fleas within 3 hours of the first dose, reaching 96.2% or greater reduction within 8 hours post-infestation.
• Flea egg suppression: Fleas die before egg deposition for at least 35 days, interrupting the environmental reinfestation cycle rather than addressing only adult parasites on the host.
• Lyme disease prevention: By eliminating Ixodes scapularis before transmission can occur, Simparica provides a documented reduction in Borrelia burgdorferi infection risk in endemic regions.
• Oral delivery: Chewable tablet administration bypasses coat-condition variables that affect topical spot-on absorption, making it appropriate for dogs with dense or double-layered coats.
• Sustained monthly efficacy: In a 90-day U.S. field study, Simparica achieved 99.4% flea reduction at Day 30, 99.8% at Day 60, and 100% at Day 90, confirming consistent performance across consecutive monthly doses.

Caution

Hazards to Humans

Keep out of reach of children. In the event of accidental ingestion by a person, contact a physician immediately. Wash hands with soap and water after handling the tablet. Do not use near food, food preparation surfaces, or animal feed.

Hazards to Domestic Animals

Simparica Chewables are formulated for oral administration in dogs only; do not administer to cats. This variant is indicated for dogs that have reached a minimum body weight of 2.8 lbs (1.3 kg) and a minimum age of 6 months. Dogs under 6 months of age should not receive this product, as the animal safety study identified neurologic signs in dogs dosed below this age threshold. Use with caution in dogs with a history of seizures or neurological disorders, as sarolaner is an isoxazoline-class compound associated with tremors, ataxia, and seizures. Individual hypersensitivity reactions occur rarely; monitor the animal after the first dose. Consult a veterinarian before administering to debilitated, aged, pregnant, or lactating dogs.

Possible Side Effects

Monitor your dog for at least 24 hours after each monthly dose, with particular attention during the first 3 hours following administration when sarolaner plasma concentrations are rising toward peak levels. The following adverse reactions have been reported in association with sarolaner use, listed in decreasing order of post-approval reporting frequency:

• Vomiting: Observed in 0.95% of Simparica-treated dogs in the controlled U.S. field study; also among the most frequently reported events in post-approval surveillance.
• Diarrhea: Recorded in 0.63% of treated dogs in the field study, with and without blood noted in post-approval reports.
• Lethargy: Reported in 0.32% of treated dogs during clinical trials; also documented in post-market experience.
• Neurologic signs: Tremors, ataxia, decreased conscious proprioception, and seizures have been reported across the isoxazoline class, including in dogs without prior seizure history.
• Additional post-approval events: Anorexia, pruritus, hypersalivation, and hyperactivity have been identified through FDA CVM adverse drug experience reporting.

If any of these signs occur or persist, discontinue administration and consult a veterinarian.