Simparica For Dogs 88.1-132 lbs (40.1-60 kg)

Description

Simparica For Dogs 88.1-132 lbs (40.1-60 kg) contains 120 mg sarolaner per tablet, the highest single-tablet dose in the Simparica range, formulated to deliver no less than 0.91 mg/lb (2 mg/kg) across the full extent of this weight band. Sarolaner is an isoxazoline-class compound whose mechanism targets GABA receptor and glutamate receptor function in insects and acarines, producing fatal neuromuscular disruption without requiring direct external contact. Manufactured by Zoetis and registered under FDA NADA #141-452, this variant applies to dogs that have simultaneously attained 88.1 lbs (40.1 kg) and reached 6 months of age on the administration date.

Recommended for

Dogs weighing 88.1 to 132 lbs (40.1 to 60 kg), aged 6 months or older.

Indication/Coverage

For dogs suffering from, or at risk from, flea and tick infestations that require the highest-dose single-tablet sarolaner formulation:

• Flea treatment and prevention: Kills adult Ctenocephalides felis on contact with the treated host and prevents reinfestation; viable flea egg deposition is suppressed for a minimum of 35 days per dose, arresting larval development in the dog’s environment.
• Lone star tick treatment and control: Eliminates adult Amblyomma americanum with efficacy sustained across the complete 30-day dosing window.
• 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; additionally indicated for prevention of Borrelia burgdorferi infection by eliminating the tick vector 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 following attributes are grounded in Zoetis label data and clinical study results specific to the 120 mg sarolaner tablet used across the 88.1–132 lb range:

• Giant-breed dose accuracy: The 120 mg tablet delivers 1.36 mg/lb at 88.1 lbs , maintaining the full minimum therapeutic sarolaner concentration from the lower boundary through 132 lbs without underdosing at any point in the band.
• Comprehensive tick species coverage: A single monthly chewable addresses all six tick species of active regulatory and epidemiological concern in the U.S., including Haemaphysalis longicornis, whose geographic range continues to expand.
• Rapid flea elimination: Laboratory data confirm sarolaner begins killing adult fleas within 3 hours of oral administration, with 96.2% or greater flea reduction achieved within 8 hours of infestation at this dose.
• Environmental cycle disruption: Fleas on treated dogs are eliminated before egg deposition for at least 35 days per dose, preventing larval accumulation in bedding, flooring, and other high-contact areas rather than addressing only the adult flea burden on the host.
• Lyme disease vector elimination: Simparica is labeled for prevention of Borrelia burgdorferi infection through Ixodes scapularis kill before the bacterial transmission threshold is crossed, providing documented Lyme disease risk reduction across endemic U.S. zones.
• Demonstrated multi-month efficacy: In a 90-day U.S. field study, flea reduction reached 99.4% at Day 30, 99.8% at Day 60, and 100% at Day 90, confirming that cumulative monthly treatment produces progressively stronger environmental control.
• Coat- and water-independent delivery: Systemic distribution via gastrointestinal absorption means the 120 mg dose performs identically regardless of coat density, oiliness, water exposure frequency, or bathing schedule.

Caution

Hazards to Humans

Keep Simparica out of reach of children. If accidentally ingested by a person, seek immediate medical attention. Avoid contact with eyes when handling the tablet. Wash hands with soap and water after touching the product or a recently treated dog. Do not handle near food preparation areas or eating surfaces.

Hazards to Domestic Animals

Simparica is formulated for oral use in dogs only and must not be given to cats under any circumstances. Dogs in this variant must have reached a minimum body weight of 88.1 lbs (40.1 kg) and a minimum age of 6 months on the dosing day; Zoetis animal safety data identified neurologic signs in dogs administered sarolaner below 6 months of age, establishing this as a firm eligibility threshold. As an isoxazoline-class parasiticide, sarolaner carries a class-level risk of tremors, ataxia, and seizures, including in dogs with no documented neurological history. Obtain veterinary guidance before use in debilitated, aged, pregnant, or lactating animals, and observe for individual hypersensitivity following the initial dose.

Possible Side Effects

Monitor your dog for at least 24 hours after each dose, especially during the first 3  hours when sarolaner reaches its highest blood concentrations.

The reactions listed below are drawn from Zoetis controlled U.S. field trial data and post-approval FDA CVM adverse drug experience reports for sarolaner, ranked in decreasing order of documented frequency:

• Vomiting: Recorded in 0.95% of sarolaner-treated dogs in the controlled field study; observe for vomiting within the first 3 hours of administration when gastrointestinal absorption is still underway, then continue monitoring for any adverse reactions across the next 24 hours, contacting your veterinarian if either occurs.
• Diarrhea: Present in 0.63% of treated dogs during clinical evaluation; post-approval surveillance additionally documents cases involving blood in the stool.
• Lethargy: Observed in 0.32% of treated dogs in the field study, with further cases reported through post-market FDA adverse event submissions.
• Neurologic signs: Tremors, ataxia, diminished conscious proprioception, and seizures have been reported across the isoxazoline class in dogs of all neurological backgrounds; this class-level risk is not diminished by body size and applies fully to the 88.1–132 lb weight range.
• Additional post-approval events: Anorexia, pruritus, hypersalivation, and hyperactivity have been captured through ongoing FDA CVM surveillance for sarolaner across all weight variants.