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Simparica Trio for Dogs

Simparica Trio for Dogs

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Description

Simparica Trio is the first and only product that combines sarolaner, moxidectin, and pyrantel in one simple-to-give chewable-for protection against heartworm disease, ticks & fleas, roundworms & hookworms.

One chewable tablet provides month-long protection for all dogs over 8 weeks old and weighing 2.8 pounds or more. Simparica Trio is FDA-Approved and can be purchased with a prescription.

Animals Treated

Dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater.

Key Benefits

  • Pyrantel protects against intestinal parasites
  • In clinical studies, Simparica Trio was 99.2% effective for adult roundworm and reduction in fecal egg count5
  • Demonstrated >94% efficacy for hookworm, in studies4

Simparica Trio is designed for defense

Just one Simparica Trio chewable does the job of two or three parasiticides in a single chewable-the way pet owners prefer to give preventatives to their dogs.

Similar Products

Ingredients

Active Ingredients

Sarolaner, Moxidectin, and Pyrantel

Inactive Ingredients

Hydrolyzed Soy Protein, Starch, Corn, Wheat Germ, Anhydrous Dibasic Calcium Phosphate, Corn Syrup, Gelatin

Directions

Dosage

Simparica Trio is given orally once a month, at the recommended minimum dose of 0.54 mg/lb (1.2 mg/kg) sarolaner, 0.011 mg/lb (24 mg/kg) moxidectin, and 2.27 mg/lb (5 mg/kg) pyrantel (as pamoate salt).

View Simparica Trio Drug Facts Sheet.

Dosage Table

Body WeightSarolaner per Tablet (mg)Moxidectin per Tablet (mg)Pyrantel per Tablet (mg)Number of Tablets Administered
2.8 to 5.5 lbs.30.0612.5One (Yellow)
5.6 to 11.0 lbs.60.1225One (Purple)
11.1 to 22.0 lbs.120.2450One (Blue)
22.1 to 44.0 lbs.240.10050One (Blue)
44.1 to 88.0 lbs.480.96200One (Green)
88.1 to 132.0 lbs.721.44300One (Brown)
>132.1 lbs.Administer the appropriate combination of tablets

simparica trio table of tablet sizes with dog size


Administration

Simparica Trio 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 Trio and resume a monthly dosing schedule.

Simparica Trio should be administered at monthly intervals.

See the Simparica Trio difference

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Heartworm Prevention

Simparica Trio should be administered at monthly intervals year‑round or at least within one month of the animal's first seasonal exposure to mosquitoes and continuing until at least 1 month after the dog's last seasonal exposure. If a dose is missed, give Simparica Trio immediately and resume monthly dosing. When replacing a monthly heartworm preventive product, Simparica Trio should be given within one month of the last dose of the former medication.

Flea Treatment and Prevention

Treatment with Simparica Trio may begin at any time of the year. In areas where fleas are common year-round, monthly treatment with Simparica Trio 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 Trio can begin at any time of the year (see Effectivenes).

Intestinal Nematode Treatment and Control

For the treatment of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina) and adult hookworm (Ancylostoma caninum and Uncinaria stenocephala) infections, Simparica Trio should be administered once as a single dose. Monthly use of Simparica Trio will control any subsequent infections.

How to Store Simparica Trio

Store at or below 30°C (86°F). Keep away from children and pets.

Contraindications

There are no known containdications for the use of Simparica Trio.

Precautions

Sarolaner, one of the ingredients in Simparica Trio, 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.

Prior to administration of Simparica Trio, dogs should be tested for existing heartworm infections. Infected dogs should be treated with an adulticide to remove adult heartworms. Simparica Trio is not effective against adult D. immitis.

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

Just one Simparica Trio chewable delivered fully effective heartworm disease protection

In two well-controlled laboratory studies, a single oral dose of Simparica Trio was 100% effective in preventing the development of heartworm disease in dogs inoculated with infective larvae 30 days before treatment.

Simparica Trio was designed for balancing optimal effectiveness with safety to prevent heartworm disease

Possible Side Effects

In a field safety and effectiveness study, Simparica Trio was administered to dogs for the prevention of heartworm disease. The study included a total of 410 dogs treated once monthly for 11 treatments (272 treated with Simparica Trio and 138 treated with an active control). Over the 330 day study period, all observations of potential adverse reactions were recorded. The most frequent reactions reported in the Simparica Trio group are presented in the following table.

Dogs with Adverse Reactions
Clinical SignSimparica Trio n=272Active Controln=138
Vomiting14.3%10.9%
Diarrhea13.2%8.0%
Lethargy8.5%6.5%
Anorexia5.1%5.8%
Polyuria3.7%3.6%
Hyperactivity2.2%0.7%
Polydipsia2.2%2.9%

In a second field safety and effectiveness study, Simparica Trio was administered to 278 dogs with fleas. Adverse reactions in dogs treated with Simparica Trio included diarrhea.

In a third field safety and effectiveness study, Simparica Trio was administered to 120 dogs with roundworms. Adverse reactions in dogs treated with Simparica Trio included diarrhea and vomiting.

Simparica Trio Important Safety Information

Use with caution in dogs with a history of seizures. Simparica Trio contains sarolaner, a member of the isoxazoline class, which has been associated with neurologic adverse reactions including tremors, ataxia, and seizures in dogs with or without a history of neurologic disorders. The safe use of Simparica Trio has not been evaluated in breeding, pregnant, or lactating dogs. The most frequently reported adverse reactions in clinical trials were vomiting and diarrhea. See full Prescribing Information, attached.

Effectiveness

Heartworm Prevention

In two well controlled laboratory studies, a single oral dose of Simparica Trio was 100% effective in preventing the development of adult D. immitis in dogs inoculated with infective larvae 30 days before treatment.

In a well controlled US field study consisting of 246 dogs administered Simparica Trio and 119 administered an active control, no dogs treated with Simparica Trio tested positive for heartworm disease. All dogs treated with Simparica Trio were negative for D. immitis antigen and blood microfilariae at study completion on day 330.

Flea Treatment and Prevention

In a well controlled laboratory study, Simparica Trio began to kill fleas at 4 hours and demonstrated 100% effectiveness at 8 hours after initial administration. After weekly re-infestations, Simparica Trio reduced the number of live fleas by 97.8% within 12 hours of infestation for 28 days.

In a separate well controlled laboratory study, Simparica Trio demonstrated 100% effectiveness against adult fleas within 24 hours following treatment and maintained 99.7% effectiveness against weekly re-infestations for 35 days.

In a study to explore flea egg production and viability, Simparica Trio killed fleas before they could lay eggs for 35 days.

In a well-controlled 60-day US field study conducted in dogs with existing flea infestations of varying severity, the effectiveness of Simparica Trio against fleas on Day 30 and 60 visits was 99.0% and 99.7%, respectively, compared to baseline. Dogs with signs of flea allergy dermatitis showed improvement in erythema, papules, scaling, alopecia, dermatitis/pyodermatitis and pruritus as a direct result of eliminating fleas.

Tick Treatment and Control

In a well controlled laboratory study, Simparica Trio began to kill existing I. scapularis within 8 hours, Simparica Trio reduced the number of live ticks by 94.2% within 24 hours of infestation for 28 days.

In well controlled laboratory studies, Simparica Trio demonstrated 98.9% effectiveness against an existing infestation of Amblyomma maculatum, Ixodes scapularis, Rhipicephalus sanguineus, and Dermacentor variabilis 48 hours postadministration and maintained 90.4% effectiveness 48 hours after re-infestation for at least 28 days. Against Amblyomma americanum, Simparica Trio demonstrated 99.4% effectiveness 72 hours after treatment of existing infestations, and maintained 98.4% effectiveness 72 hours after re-infestation for at least 28 days.

Intestinal Nematode Treatment and Control

Elimination of roundworms (immature adult and adult Toxocara canis and adult Toxascaris leonina) and adult hookworms (Ancylostoma caninum and Uncinaria stenocephala) was demonstrated in well controlled laboratory studies.

In a 10-day multi-center field study, Simparica Trio was effective against Toxocara canis and reduced fecal egg counts 99.2%.

Animal Safety

Margin of Safety

Simparica Trio was administered orally to 8 week old Beagle puppies at doses of 1, 3, and 5X the maximum labeled dose (2.4 mg/kg sarolaner, 48 g/kg moxidectin, and 10 mg/kg pyrantel) at 28 day intervals for 7 treatments. Dogs in the control group received placebo. There were no clinically relevant, treatment related effects on clinical observations, body weights, food consumption, clinical pathology (hematology, coagulation, serum chemistry, and urinalysis), gross pathology, histopathology, or organ weights. During the end of study ophthalmic examination, the following change was found: one 1X dog had retinal dysplasia (OS folds).

Ivermectin-sensitive Collie Safety

Simparica Trio was administered orally once at 1, 3 and 5X the maximum labeled dose to Collies that had been pre-screened for avermectin sensitivity. Dogs in the control group received placebo. Clinical signs (ataxia, muscle fasciculations, mydriasis) associated with avermectin sensitivity were observed in the 5X group. All dogs were completely recovered by the third day of the study.

Heartworm-Positive Safety

Simparica Trio was administered orally at 1 and 3X the maximum labeled dose at 28 day intervals for 3 treatments to Beagle dogs with patent adult heartworm infections and circulating microfilariae. Dogs in the control group received placebo. Diarrhea occurred more commonly in the treated dogs and also more often in the 3X group compared with the 1X group. Two dogs (1 each in 1X and 3X) developed a fever less than 24 hours after the first dose. The fever may have been a transient reaction to a rapid microfilaria reduction. Both dogs recovered without treatment.

Field Safety

In three well-controlled field studies, Simparica Trio was used concurrently with other medications such as vaccines, antimicrobials, anthelmintics, antiprotozoals, steroidal and non-steroidal anti-inflammatory agents, anesthetic agents and analgesics. No adverse reactions were associated with the concurrent use of Simparica Trio and other medications.

FAQ

  • Moxidectin provides monthly protection from heartworm disease.
  • Sarolaner treats & controls tick infestations, and treats & prevents flea infestations.
  • Pyrantel treats & controls roundworms and hookworms.
  • Heartworm disease prevention - In two well-controlled laboratory studies, a single oral dose of Simparica Trio was 100% effective in preventing the development of heartworm disease in dogs.
  • Tick treatment and control - In a well-controlled laboratory study, Simparica Trio began to kill deer ticks within 8 hours.
  • Flea treatment and prevention - In a well-controlled laboratory study, Simparica Trio began to kill fleas at 4 hours and demonstrated 100% effectiveness at 8 hours after initial administration.
  • Intestinal parasite treatment and control - In a 10-day multi-center field study, Simparica Trio was 99.2% effective against adult roundworm and reduction in fecal egg count.1,2† It also demonstrated >94% effective against hookworm, in studies.4

Dosage and Administration

  • Can be given with or without food
  • Available in 6-packs
  • Store at or below 30°C (86°F)

Sarolaner is an acaricide and insecticide belonging to the isoxazoline group. Sarolaner inhibits the function of the neurotransmitter gamma aminobutyric acid (GABA) receptor and glutamate receptor and works at the neuromuscular junction in insects. This results in uncontrolled neuromuscular activity leading to death in insects or acarines.

Moxidectin is an endectocide in the macrocyclic lactone class. Moxidectin acts by interfering with the chloride channel-mediated neurotransmission in the parasite. This results in paralysis and death of the parasite.

Pyrantel pamoate is a nematocide belonging to the tetrahydropyrimidine class. Pyrantel acts as a depolarizing, neuromuscular-blocking agent in susceptible parasites, which causes paralysis and death or expulsion of the organism.

Safety demonstrated in:

  • 8 week old puppies
  • Ivermectin-sensitive dogs
  • Heartworm-positive dogs*
  • Dogs concurrently receiving other medications†

The three most common adverse events:

  • Vomiting
  • Diarrhea
  • Lethargy

*Infected dogs should be treated with an adulticide to remove adult heartworms. Simparica Trio is not effective against adult D. immitis.

†While dogs received concurrent medications during field studies, no specific studies to demonstrate safety with concurrent use of other drugs were performed.

In clinical trials, Simparica Trio:

  • Was 100% effective against heartworm disease in dogs after one dose
  • Started killing fleas within 4 hours and achieved 100% efficacy 8 hours after treatment
  • Was ≥98.9% effective against tick infestations in 48 hours‡
  • Resulted in 99.2% efficacy for adult roundworm and reduction in fecal egg count, and >94% efficacy for hookworm1,2,4

‡Against Amblyomma americanum, Simparica Trio demonstrated 99.4% effectiveness 72 hours after treatment of existing infestations.

If a dose is missed, a new dose should be given immediately. If a dose is vomited or spit out, a new dose should be given again. Then, continue on the prescribed monthly dosing schedule
Both are highly palatable chews that protect against ticks and fleas in dogs, but Simparica Trio has the added benefit of moxidectin and pyrantel to protect dogs against heartworms disease, roundworms and hookworms.

Sarolaner is an acaricide and insecticide belonging to the isoxazoline group. Sarolaner inhibits the function of the neurotransmitter gamma aminobutyric acid (GABA) receptor and glutamate receptor and works at the neuromuscular junction in insects. This results in uncontrolled neuromuscular activity leading to death in insects or acarines.

Moxidectin is an endectocide in the macrocyclic lactone class. Moxidectin acts by interfering with the chloride channel-mediated neurotransmission in the parasite. This results in paralysis and death of the parasite.

Pyrantel pamoate is a nematocide belonging to the tetrahydropyrimidine class. Pyrantel acts as a depolarizing, neuromuscular-blocking agent in susceptible parasites, which causes paralysis and death or expulsion of the organism.

Simparica Trio has been demonstrated safe for puppies as young as 8 weeks, weighing at least 2.8 lbs.
No. Simparica Trio chewables are not scored, and are not meant to be divided.
No studies have been conducted at this time to evaluate Simparica Trio administered concurrently with other medications, but Simparica Trio has demonstrated efficacy against heartworm disease, ticks and fleas in one chewable so there is no need to administer another product.
No. Simparica Trio has only been approved for dogs.

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