Simparica (sarolaner) Chewables Tablets for Dogs | On Sale | EntirelyPets Rx
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Simparica (sarolaner) Chewables Tablets for Dogs

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  • Description
  • Ingredients
  • Directions
  • FAQ
  • Reviews

Description

Simparica is a fast-acting oral flea and tick preventative that begins killing fleas and ticks within hours of administration and remains effective for one month to prevent re-infestations. It is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations [Amblyomma americanum (Lone Star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (deer tick/black-legged tick), and Rhipicephalus sanguineus (brown dog tick)]. Simparica begins to kill adult fleas within 3 hours and ticks within 8 hours of administration. Treatment with Simparica may begin at any time of the year and is safe to use year-round without interruption. Simparica is given monthly and requires a prescription from your veterinarian.

Key Benefits

  • Each tablet provides a full month of protection against fleas and ticks
  • Tasty, liver-flavored chewable tablet is easy to administer
  • Chewable tablets can be given directly to your dog or broken up and mixed with food
  • Kills over 95% of adult fleas within 8 hours
  • Available in six weight categories: 2.8-5.5 lbs, 5.6-11 lbs, 11.1-22.0 lbs, 22.1-40 lbs, 44.1-88.0 lbs and 88.1-132 lbs

Indication:

Simparica kills adult fleas, and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations [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)] for one month in dogs 6 months of age or older and weighing 2.8 pounds or greater.

How It Works

Simparica contains the active ingredient sarolaner, which 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. Simparica is administered once a month directly by mouth or can be crumbled and mixed with food. 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.

Prescription Required

Ingredients

Simparica for Dogs 2.8-5.5 lbs:
Active Ingredient (per tablet) Amount
Sarolaner 5 mg
Simparica for Dogs 5.6-11 lbs:
Active Ingredient (per tablet) Amount
Sarolaner 10 mg
Simparica for Dogs 11.1-22.0 lbs:
Active Ingredient (per tablet) Amount
Sarolaner 20 mg
Simparica for Dogs 22.1-44.0 lbs:
Active Ingredient (per tablet) Amount
Sarolaner 40 mg
Simparica for Dogs 44.1-88.0 lbs:
Active Ingredient (per tablet) Amount
Sarolaner 80 mg
Simparica for Dogs 88.1-132.0 lbs:
Active Ingredient (per tablet) Amount
Sarolaner 120 mg

Directions

View Simparica Drug Facts Sheet.

Simparica is given orally once a month at the recommended minimum dosage of 0.91 mg/lb (2 mg/kg).

Body Weight Sarolaner per Tablet (mg) Number of Tablets Administered
2.8 to 5.5 lbs 5 1 (Yellow)
5.6 to 11.0 lbs 10 1 (Purple)
11.1 to 22.0 lbs 20 1 (Orange)
22.1 to 44.0 lbs 40 1 (Blue)
44.1 to 88.0 lbs 80 1 (Green)
88.1 to 132.0 lbs 120 1 (Brown)
> 132.1 lbs Administer the appropriate combination of tablets

Simparica 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 refuse. If a dose is missed, administer Simparica and resume a monthly dosing schedule.

Simparica should be administered at monthly intervals.

Flea Treatment and Prevention:

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

Contraindications:

There are no known contraindications for the use of Simparica.

Warnings:

Not for use in humans. Keep this and all drugs out of reach of children and pets. For use in dogs only. Do not use Simparica in cats.

Simparica should not be used in dogs less than 6 months of age (see Animal Safety).

Precautions:

Simparica may cause abnormal neurologic signs such as tremors, decreased conscious proprioception, ataxia, decreased or absent menace, and/or seizures (see Animal Safety). The safe use of Simparica has not been evaluated in breeding, pregnant, or lactating dogs.

Adverse Reactions:

Simparica was administered in a well-controlled US field study, which included a total of 479 dogs (315 dogs treated with Simparica and 164 dogs treated with active control once monthly for three treatments).

Over the 90-day study period, all observations of potential adverse reaction were recorded.

Table 1. Dogs with adverse reactions
Adverse reaction Sarolaner Sarolaner Active control Active control
N % (n=315) N % (n=164)
Vomiting 3 0.95% 9 5.50%
Diarrhea 2 0.63% 2 1.20%
Lethargy 1 0.32% 2 1.20%
Inappetence 0 0% 3 1.80%

Additionally, one female dog aged 8.6 years exhibited lethargy, ataxia while posturing to eliminate, elevated third eyelids, and inappetence one day after receiving Simparica concurrently with a heartworm preventative (ivermectin/pyrantel pamoate). The signs resolved one day later. After the day 14 visit, the owner elected to withdraw the dog from the study. For a copy of the Safety Data Sheet (SDS) or to report adverse reactions call Zoetis Inc. at 1-888-963-8471. Additional information can be found at www.Simparica.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/AnimalVeterinary/SafetyHealth.

Clinical Pharmacology:

Sarolaner is rapidly and well absorbed following oral administration of Simparica. In a study of 12 Beagle dogs the mean maximum plasma concentration (Cmax) was 1100 mg/mL and the mean time to maximum concentration (Tmax) occurred at 3 hours following a single oral dose of 2 mg/kg to fasted animals. The mean oral bioavailability was 86% and 107% in fasted and fed dogs, 2 mg/kg to fasted animals. The mean oral T½ values for fasted and fed animals was 10 and 12 days respectively. Sarolaner is distributed widely; the mean volume of distribution (Vdss) was 2.81 L/kg bodyweight following at 2 mg/kg intravenous dose of sarolaner. Sarolaner is highly bound (≥99.9%) to plasma proteins. The metabolism of sarolaner appears to be minimal in the dog. The primary route of sarolaner elimination from dogs is biliary excretion with elimination via the feces.

Following repeat administration of Simparica once every 28 days for 10 doses to Beagle dogs at 1X, 3X, and 5X the maximum intended clinical dose of 4 mg/kg, stead-state plasma concentrations were reached after the 6th dose. Following treatment at 1X, 3X, and 5X the maximum intended clinical dose of 4 mg/kg, sarolaner systemic exposure was dose proportional over the range 1X to 5X.

Mode of Action:

The active substance of simparica, 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 result in uncontrolled neuromuscular activity leading to death in insects or acarines.

Effectiveness:

In a well-controlled laboratory study, Simparica began to kill fleas 3 hours after initial administration and reduce the number of live fleas by ≥96.2% within 8 hours after flea infestation through Day 35.

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

In a study to explore flea egg production and viability, Simparica killed fleas before they could lay eggs for 35 days. In a study to simulate a flea-infested home environment, with flea infestation established prior to the start of treatment and re-infestations on Days 7, 37 and 67, Simparica administered monthly for three months demonstrated >95.6% reduction in adult fleas within 14 days after treatment and reached 100% on Day 60.

In well-controlled laboratory studies, Simparica demonstrated ≥99% effectiveness against an initial infestation of Amblyomma americanum, Amblyomma maculatum, Dermacentor variabilis, Ixodes scapularis, and Rhipicephalus sanguineus 48 hours post-administration and maintained >96% effectiveness 48 hours post re-infestation for 30 days.

In a well-controlled 90-day US field study conducted in households with existing flea infestations of varying severity, the effectiveness of Simparica against fleas on Day 30, 60 and 90 visits compared to baseline was 99.4%, 99.8%, and 100%, respectively. Dogs with signs of flea allergy dermatitis and pruritus as a direct result of eliminating fleas.

Animal Safety:

In a margin of safety study, Simparica was administered orally to 8 week old Beagle puppies at doses of 0, 1X, 3X, and 5X the maximum recommended dose 94 mg/kg) at 28 day intervals for 10 doses (8 dogs per group). The control group received placebo tablets. No neurologic signs were observed in the 1X group. In the 3X group, one male dog exhibited tremors and ataxia post-dose on Day 0; one female dog exhibited tremors on Days 1, 2, 3, and 5; and one female dog exhibited tremors on Day 1. In the 5C group, one female dog has a seizure on Day 61 (5 days after third dose); one female dog had tremors post-dose on Day 0 and abnormal head coordination after dosing on Day 140; and one female dog exhibited seizures associated with the second and fourth doses and tremors associated with the second and third doses. All dogs recovered without treatment. Except for the observation of abnormal head coordination in one dog in the 5X group two hours after dosing on Day 140 (dose 6). There were no treatment-related neurological signs observed once the dogs reached the age of 6 months.

In a separate exploratory pharmacokinetic study, one female dog dose at 12 mg/kg 93X the maximum recommended dose) exhibited lethargy, anorexia, and multiple neurological signs including ataxia, tremors, disorientation, hypersalivation, diminished proprioception, and absent menace, approximately 2 days after a third monthly dose. The dog was not treated, and was ultimately euthanized. The first two doses resulted in plasma concentrations that were consistent with those of the other dogs in the treatment group. Starting at 7 hours after the third dose, there was a rapid 2.5 fold increase in plasma concentrations within 41 hours, resulting in a Cmax more than 7 fold higher than the mean Cmax at the maximum recommended use dose. No cause for the sudden increase in sarolaner plasma concentrations was identified.

Storage:

Store at or below 30°C (86°F) with excursions permitted up to 40°C (104°F).

FAQ

Simparica works fast. It starts killing fleas within 3 hours and ticks within 8 hours and it keeps killing them for the full month.
The great thing about Simparica is that your dog is covered for an extra 4-5 days if you are a few days late with your monthly treatment date. Simparica has continuous killing activity for 35 days so it keeps going strong between doses, unlike some of the other products available. This extra coverage keeps the dog protected for the 4 out of 5 owners who admit to giving the treatment late. See how it compares against other popular treatments in our competitor section.
Yes. Simparica can be given to your dog any time of the day as it can be given with or without food.
Fleas can live in a variety of areas outside of your home as well as on other dogs that your dog may encounter. Simparica provides flea protection that works fast and lasts for a full month, so any newly arrived fleas will be killed. There’s no need to re-treat your dog until the next monthly dose is due.
As fleas begin to die they will start to move around erratically as they start to lose their coordination, resulting in a transient increase in scratching behavior of your dog. Simparica starts killing fleas within 3 hours with 100% eliminated within 8 hours providing a fast resolution for your dog.
Immediately. Simparica can be given directly before or after bathing or swimming. Bathing, shampooing or swimming will not affect how well Simparica works.
Simparica is used for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations [Amblyomma americanum (Lone Star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (deer tick/black-legged tick), and Rhipicephalus sanguineus (brown dog tick)] in dogs over 6 months of age weighing 2.8 lbs and over. Simparica is available as a liver-flavored, chewable tablet. Simparica requires a prescription from your veterinarian.
Tell your veterinarian if your pet is breeding, pregnant, or lactating.

Simparica should be administered orally, once every month, at the minimum dosage of 0.91 mg/lb (2 mg/kg) sarolaner. Dogs weighing 2.8 to 5.5 lbs should be given one 5 mg Simparica chewable tablet monthly. Dogs weighing 5.6 to 11.0 lbs should be given one 10 mg Simparica chewable tablet monthly. Dogs weighing 11.1 to 22.0 lbs should be given one 20 mg Simparica chewable tablet monthly. Dogs weighing 22.1 to 44.0 lbs should be given one 40 mg Simparica chewable tablet monthly. Dogs weighing 44.1 to 88.0 lbs should be given one 80 mg Simparica chewable tablet monthly. Dogs weighing 88.1 to 132.0 lbs should be given one 120 mg Simparica chewable tablet monthly. Dogs weighing more than 132.0 lbs should be given appropriate combination of Simparica tablets monthly. Care should be taken that your dog consumes the complete dose, and treated pets should be observed for a few minutes to ensure that part of the dose is not lost or refused.

For flea treatment and prevention: Treatment may begin at any time of the year. In areas where fleas are common year-round, monthly treatment with Simparica 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.

For tick treatment and control: Treatment with Simparica can begin at any time of the year.

The most frequently reported adverse reactions were vomiting and diarrhea. Simparica may cause abnormal neurologic signs such as tremors, decreased conscious proprioception [awareness of body position and movement], ataxia [loss of full control of bodily movements], decreased or absent menace [blinking reflex], and/or seizures.
If a dose is missed, administer Simparica and resume a monthly dosing schedule.
Contact your veterinarian immediately.
Do not use Simparica in cats. Simparica should not be used in dogs less than 6 months of age. The safe use of Simparica has not been evaluated in breeding, pregnant, or lactating dogs.
There are no known contraindications for the use of Simparica.

Reviews

Review Summary
4.6
9 Reviews
5
89% (8)
4
0% (0)
3
0% (0)
2
0% (0)
1
11% (1)
89% Recommend this product (8 of 9 responses)
By barbara
Conyers, GA
herding breed flea prevention
March 2, 2020
We are very careful about what our rare breed, Entlebucher Mountain Dog is given for routine medications. She has had no problems with Simparica and we have had no fleas.
By Joanne
MS gulf coast
Happy Pup
August 22, 2019
We adopted a heartworm positive dog. Following 3 months of treatment, our vet recommended the heartworm prevention shots & Simparica for monthly flea & tick prevention. Our dog loves Simparica & eats it from our hands like a treat.
ProsPup likes the product & it isn't a topical treatment that rubs off on our hands or other items. No fleas nor ticks bothering us or the pup.
By Allison
Michigan
Excellent!
August 18, 2019
Arrived timely. Excellent price! They contacted my vet! It’s the same medication we receive from the vet but cheaper!!!!
By Gudrun B.
SAN FRANCISCO
Simparica oral flea treatment for dogs
October 17, 2018
This prescription oral flea treatment works great for my dog, no more messy ointments. She has not had any adverse reactions to the medication.

It's not cheap but it's worth it.

Good product.

By Annie
Columbia,SC
Simparica
June 10, 2018
Chewables are so easy to use. This is also an excellent price.
Merchant Response:Dear Annie, It's great to hear that the Simparica chewables are easy to use and to your satisfaction. EntirelyPets Pharmacy appreciates your business.
ProsEasy to use.
ConsNone
By Patty M.
Fairfield,Ca
Very satisfied
May 16, 2018
I like using a chewable flea medication instead of a tropical one. I was using Nexguard until my Vet told me about Simparica. She said it’s as safe and as effective as Nexguard, and it’s less expensive.
That really helps especially when you have multiple dogs!
By Rich
OH
Awesome
March 7, 2018
Entirelypets Pharmacy is a great place to get your meds for your pet. Great communication and customer service is awesome!
ProsGreat communication, awesome customer service, and great prices
ConsNone!
By JuicyJ
CA
Shipping is SLOW!
February 21, 2018
I've ordered from them 3-4 times now and their ordering processing is terribly slow. It took 2 weeks for this order to ship for a Rx that has unlimited refills! Seeking another company to order my dog's Rx from as they continue to disappoint.
ConsSLOW shipping
By Lisa J.
Galveston TX
Great product
July 2, 2017
I have tried them all and this works the best for my dogs. We have a lot of fleas here and the summer time it's brutal. Simperica works great and works all month. I have a finicky chi and the Simperica is small enough and doesn't have a foul odor..
ProsSmall, no foul odor
ConsNone

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