Simparica For Dogs 44.1-88 lbs (20.1-40 kg)

Description

Simparica For Dogs 44.1-88 lbs (20.1-40 kg) contains 80 mg sarolaner per tablet, the dose calibrated to sustain a minimum of 0.91 mg/lb (2 mg/kg) at every point across this weight span. Sarolaner is an isoxazoline-class parasiticide that achieves parasite kill by blocking GABA receptor and glutamate receptor activity, triggering uncontrolled neuromuscular excitation in target insects and acarines. Distributed by Zoetis and approved under FDA NADA #141-452, this variant is indicated for dogs that have reached both 44.1 lbs (20.1 kg) and 6 months of age on the day of administration.

Recommended for

Dogs weighing 44.1 to 88 lbs (20.1 to 40 kg), aged 6 months or older.

Indication/Coverage

For dogs suffering from, or at risk from, flea and tick infestations across the full range of U.S. vector species:

• Flea treatment and prevention: Kills adult Ctenocephalides felis on the host and suppresses reinfestation; treated dogs carry no viable flea eggs for a minimum of 35 days per dose, disrupting larval development in the surrounding environment.
• Lone star tick treatment and control: Eliminates adult Amblyomma americanum with protection sustained for the full 30-day dosing interval.
• Gulf Coast tick treatment and control: Eliminates adult Amblyomma maculatum infestations for one month per dose.
• American dog tick treatment and control: Eliminates adult Dermacentor variabilis infestations for one month per dose.
• Black-legged tick treatment and control: Eliminates adult Ixodes scapularis for one month; indicated concurrently for prevention of Borrelia burgdorferi infection by eliminating the vector tick before the bacterial transmission window is reached.
• Brown dog tick treatment and control: Eliminates adult Rhipicephalus sanguineus infestations for one month per dose.
• Asian longhorned tick treatment and control: Eliminates adult Haemaphysalis longicornis infestations for one month per dose.

Key Benefits

The properties below are substantiated by Zoetis clinical data and label specifications for the 80 mg sarolaner tablet applied to dogs in the 44.1–88 lb range:

• Large-dog dose calibration: The 80 mg tablet delivers exactly 2 mg/kg at a body weight of 88 lb (40 kg), maintaining the full minimum therapeutic concentration from the upper end of this weight range.
• Full U.S. tick vector coverage: One monthly chewable addresses all six tick species of current clinical and epidemiological concern in the United States, spanning both endemic and newly established geographic populations.
• Early-onset flea elimination: Sarolaner begins killing adult fleas within 3 hours of ingestion, with laboratory studies confirming 96.2% or greater flea reduction within 8 hours of infestation at this dose level.
• Reproductive cycle interruption: Fleas on treated dogs fail to deposit viable eggs for at least 35 days post-dose, preventing larval accumulation in home environments rather than managing only the adult parasite burden on the dog.
• Vector-borne disease prevention: Simparica eliminates Ixodes scapularis before Borrelia burgdorferi transmission can be established, providing documented Lyme disease risk reduction in endemic U.S. geographic zones.
• Compounding field efficacy: Across a 90-day U.S. multi-site field study, flea reduction reached 99.4% at Day 30, 99.8% at Day 60, and 100% at Day 90, indicating that repeated monthly dosing strengthens overall infestation control.
• Water-independent systemic action: Sarolaner circulates in plasma following gastrointestinal absorption, making the 80 mg dose entirely unaffected by swimming, rain, or bathing frequency, unlike residue-dependent topical formulations.

Caution

Hazards to Humans

Keep out of reach of children. If accidentally swallowed by a person, seek medical attention immediately. Wash hands thoroughly with soap and water after handling, and avoid contact with food, food preparation surfaces, or animal feed.

Hazards to Domestic Animals

Simparica is for oral use in dogs only and must not be given to cats. Dogs receiving this variant must have attained a minimum body weight of 44.1 lbs (20.1 kg) and reached 6 months of age; Zoetis safety studies identified neurologic signs in dogs dosed below this age threshold, making it a firm eligibility criterion. As a member of the isoxazoline class, sarolaner carries a documented risk of tremors, ataxia, and seizures, including in dogs without any prior neurological history. Consult a veterinarian before administering to debilitated, aged, pregnant, or lactating animals, and monitor for individual hypersensitivity reactions following the first dose.

Possible Side Effects

Monitor your dog for at least 24 hours following each monthly dose, with concentrated observation during the first 3 hours post-administration when sarolaner is ascending toward peak plasma concentration.

The adverse reactions below are compiled from Zoetis controlled field trial data and post-approval FDA CVM adverse drug experience reporting for sarolaner, presented in decreasing order of documented frequency:

• Vomiting: Recorded in 0.95% of sarolaner-treated dogs in the U.S. field study; observe for vomiting within the first 3 hours of administration when absorption remains active, then continue monitoring for adverse reactions across the subsequent 24 hours, contacting your veterinarian if either occurs.
• Diarrhea: Present in 0.63% of treated dogs during clinical evaluation; post-approval reports include cases with blood in the stool.
• Lethargy: Documented in 0.32% of treated dogs in the field study, with additional cases captured through post-market FDA adverse event submissions.
• Neurologic signs: Tremors, ataxia, reduced conscious proprioception, and seizures have been reported across the isoxazoline class, including in dogs without pre-existing neurological conditions; this class-level risk extends to dogs in the 44.1–88 lb range.
• Additional post-approval events: Anorexia, pruritus, hypersalivation, and hyperactivity have been identified through ongoing FDA CVM surveillance for sarolaner across all weight variants.