SIMPARICA for DOGS - TABLETS against FLEAS, TICKS and MITES - ZOETIS - sarolaner - isoxazoline

Brand: SIMPARICA

Company: ZOETIS

FORMULATION: «tablets» for oral administration; may be chewable, flavored, coated, etc., depending on the country

ACTIVE INGREDIENT(S): SAROLANER

CHEMICAL CLASS of the active ingredient(s): ISOXAZOLINE

INDICATIONS: DOGS

PARASITES CONTROLLED* (spectrum of activity)

  • In addition, in laboratory studies, sarolaner was shown to be active against other tick species Ixodes scapularis, as well as the mite species Demodex canis (demodectic mange) and Otodectes cynotis (ear mites).

RECOMMENDED DOSE*

USA:

  • Dogs, 2.8 to 5.5 lbs bw: 1 tablet with 5 mg sarolaner (equivalent to 3.8 to 2.0 mg/kg)
  • Dogs, 5.6 to 11.0 lbs bw: 1 tablet with 10 mg sarolaner (equivalent to 3.8 to 2.0 mg/kg)
  • Dogs, 11.1 to 22.0 lbs bw: 1 tablet with 20 mg sarolaner (equivalent to 3.9 to 2.0 mg/kg)
  • Dogs, 22.1 to 44.0 lbs bw: 1 tablet with 40 mg sarolaner (equivalent to 4.0 to 2.0 mg/kg)
  • Dogs, 44.1 to 88.0 lbs bw: 1 tablet with 80 mg sarolaner (equivalent to 4.0 to 2.0 mg/kg)
  • Dogs, 88.1 to 132.0 lbs bw: 1 tablet with 120 mg sarolaner (equivalent to 3.0 to 2.0 mg/kg)
  • Dogs, >132.1 lbs bw: Administer the appropriate combination of tablets

EU:

  • Dogs, 1.3 to 2.5 kg bw: 1 tablet with 5 mg sarolaner (equivalent to 3.8 to 2.0 mg/kg)
  • Dogs, >2.5 to 5 kg bw: 1 tablet with 10 mg sarolaner (equivalent to 3.8 to 2.0 mg/kg) 
  • Dogs, >5 to 10 kg bw: 1 tablet with 20 mg sarolaner (equivalent to 3.9 to 2.0 mg/kg) 
  • Dogs, >10 to 20 kg bw: 1 tablet with 40 mg sarolaner (equivalent to 4.0 to 2.0 mg/kg) 
  • Dogs, >20 - 40 kg bw: 1 tablet with 80 mg sarolaner (equivalent to 4.0 to 2.0 mg/kg)
  • Dogs, >40 - 60 kg bw: 1 tablet with 120 mg sarolaner (equivalent to 3.0 to 2.0 mg/kg)

 

SAFETY

  • LD50 (acute oral) in rats: n.a. for the tablets.
    • 783 mg/kg for the a.i. sarolaner
  • Estimated Hazard Class according to the WHO: not applicable for veterinary medicines

In September 2018 the FDA of the USA has alerted pet owners and veterinarians about potential neurological adverse events following the use of products containing isoxazolines. Some treated animals have experienced adverse events such as muscle tremors, ataxia (lack of voluntary coordination of muscle movements), and seizures. This regards all products containing isoxazolines. Most treated animals will not show such adverse drug reactions, but some may be affected.

Suspected poisoning? Read the articles on sarolaner safety in this site.

WARNING !!!: Never use on cats tablets approved only for use on dogs, and vice-versa. Never use on cats or small dogs tablets approved for large dogs. Learn more about tablets and their safety.

General information on the safety of veterinary antiparasitics is available in specific articles in this site (click to visit):

RESISTANCE PREVENTION

Risk of resistance development?

Sarolaner has been introduced in 2016. It is the third isoxazoline to be introduced, two years after afoxolaner (the a.i. of NEXGARD) and fluralaner (the a.i. of BRAVECTO). Isoxazolines are a new chemical class of insecticides recently discovered, from which this three mentioned active ingredients used in dogs are the first commercial products at all. Isoxazolines have a mode of action that is different from all other insecticides currently used against fleas or ticks, and shows no cross-resistance with them. Consequently there are no reports on flea, tick or mite resistance to isoxazolines yet. However, fleas have developed resistance to several other insecticides (e.g. carbamates, organophosphates and synthetic pyrethroids) and are certainly capable of becoming resistant to isoxazolines as well. Experience shows that prolonged and uninterrupted use of any insecticide on fleas bears the risk of resistance development.

Alternatives to prevent flea resistance through product rotation:

*F = effective against fleas; T = effective against ticks.

These alternative products may not be available in all countries, or may not be available as tablets. Resistance of fleas to carbamates, organophosphates and synthetic pyrethroids is not uncommon in several countries, including the USA.

Learn more about resistance and how it develops.

MARKETING

Are the active ingredients of this product ORIGINAL* or GENERICS**? ORIGINAL (introduced in 2016 by ZOETIS)

*Meaning that they are still patent protected and generics are not yet available
**Meaning that they have lost patent protection and may be acquired from manufacturers of generic active ingredients other than the holder of the original patent.

COUNTRIES where this product is marketed: USA and EU
GENERIC BRANDS available? NO

Click here to learn more about GENERIC vs. ORIGINAL drugs.

COMMENTS

SIMPARICA from ZOETIS is another once-a-month chewable tablet for flea + tick + mange mite control in dogs. Compared with the other isoxazoline tablets (NEXGARD with afoxolaner, BRAVECTO with fluralaner), SIMPARICA controls not only ticks and fleas, but also mange mites (Sarcoptes scabiei) after two consecutive monthly treatments.

It must be considered that there are other tick species in Europe and in the USA that can infect dogs in addition to the ones controlled by this product, e.g. Dermacentor marginatus, Dermacentor pictus, Haemaphysalis spp, Hyalomma spp, Rhipicephalus bursa, etc. It is not known whether SIMPARICA controls such tick species as well.

Sarolaner is a broad-spectrum insecticide and acaricide belonging to the isoxazolines introduced in 2015 (by ZOETIS). It has a systemic mode of action, i.e. after oral administration it gets into the blood of the pet and reaches fleas and ticks during their blood meal. More than 95% of the fleas are killed within 8 hours after exposure, and this effect (>95% kill within 8 hours) lasts for about 4 weeks. Administered about every 5 weeks SIMPARICA controls established flea infestations and prevents flea population development in the pets environment, but only if all the dogs and cats in the same household are treated against fleas.

For ticks (Ixodes ricinus ) the onset of efficacy is within 12 hours of attachment during the 28 day period after product administration. Ticks on the animal prior to administration are killed within 24 hours. Other tick species may be less susceptible to sarolaner and the onset of efficacy may take longer. Ticks are killed during about 4 weeks after treatment.

Systemic products (e.g. tablets for oral administration or injectables) have several general advantages over topical products (spot-ons, insecticide-impregnated collars, shampoos, soaps, sprays, powders, etc):

  • They do not contaminate the pet's hair coat: avoiding contact with the pets after administration is not necessary for children or adults.
  • The active ingredient reaches the parasites through the blood, everywhere in the pet's body, whereas topical products may leave some body parts (e.g. the ears, between the legs, etc.) insufficiently protected.
  • Efficacy is independent from exposure to dirt, sun, shampooing, washings, rain, baths, etc., whereas topical products can be washed away, or broken down by sunlight, etc.

But they have also a few disadvantages:

  • External parasites have to bite and suck blood first before they are killed or sterilized, i.e. they may transmit several diseases before they are killed.
  • Orally administered products (tablets, suspensions, pastes, etc.) may be vomited and treatment needs to be repeated.
  • Administration of tablets may be less convenient than administration of spot-ons.
  • The choice of products for oral or injectable administration is smaller than for topical administration.

For an overview and a list of the most popular pet antiparasitics for flea, tick, lice and/or mite control click here.

DISCLAIMER

This article IS NOT A PRODUCT LABEL. It offers complementary information that may be useful to veterinary professionals and users that are not familiar with veterinary antiparasitics. 

Information offered in this article has been extracted from publications issued by manufacturers, government agencies (e.g. EMEA, FDA, USDA, etc.) or in the scientific literature. No guarantee is given on its accuracy, integrity, sufficiency, actuality and opportunity, and any liability is denied. Read the site's DISCLAIMER.

In case of doubt contact the manufacturer or a veterinary professional.

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