Simparica Trio 40-60 kg (3 tablets)

FOR ORAL USE IN DOGS ONLY
CAUTION
Federal (USA) law restricts this drug to use by or on the order of a licensed
veterinarian.
DESCRIPTION
SIMPARICA TRIO (sarolaner, moxidectin, and pyrantel chewable tablets)
is a flavored, chewable tablet for administration to dogs 8 weeks of age and
older. Each tablet is formulated to provide minimum dosages of 0.54 mg/lb
(1.2 mg/kg) sarolaner, 0.011 mg/lb (24 µg/kg) moxidectin, and 2.27 mg/lb
(5 mg/kg) pyrantel (as pamoate salt).
Sarolaner is a member of the isoxazoline class of parasiticides and the
chemical name is 1‑(5’‑((5S)‑5‑(3,5‑Dichloro‑4‑fluorophenyl)‑5‑
(trifluoromethyl)‑4,5‑dihydroisoxazol‑3‑yl)‑3’‑H‑spiro(azetidine‑3,1’‑(2)
benzofuran)‑1‑yl)‑2‑(methylsulfonyl)ethanone. SIMPARICA TRIO contains
the S‑enantiomer of sarolaner.
Moxidectin is a semi‑synthetic methoxime derivative of nemadectin which
is a fermentation product of Streptomyces cyaneogriseus subspecies
noncyanogenus. Moxidectin is a pentacyclic 16-membered lactone macrolide.
The chemical name for moxidectin is (6R,23E,25S)-5-O-Demethyl-28-deoxy25-[(1E)-1,3-dimethyl-1-buten-1-yl]-6,28-epoxy-23-(methoxyimino)
milbemycin B.
Pyrantel belongs to a family classified chemically as tetrahydropyrimidines
and the chemical name is (E)-1,4,5,6-Tetrahydro-1-methyl-2-[2-(2-thienyl)
vinyl] pyrimidine 4,4’ methylenebis [3-hydroxy-2-naphthoate](1:1). It is a
yellow, water-insoluble crystalline salt of the tetrahydropyrimidine base and
pamoic acid containing 34.7% base activity.
INDICATIONS
SIMPARICA TRIO prevents heartworm disease caused by Dirofilaria immitis,
kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and
prevention of flea infestations, the treatment and control of tick infestations
with 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), and the
treatment and control of roundworm (immature adult and adult Toxocara
canis and adult Toxascaris leonina) and adult hookworm (Ancylostoma
caninum and Uncinaria stenocephala) infections for one month in dogs and
puppies 8 weeks of age and older, and weighing 2.8 pounds or greater.
DOSAGE AND ADMINISTRATION
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 µg/kg)
moxidectin, and 2.27 mg/lb (5 mg/kg) pyrantel (as pamoate salt).
Dosage Schedule
Body Weight
(lbs)
Sarolaner per
Tablet
(mg)
Moxidectin
per Tablet
(mg)
Pyrantel
per
Tablet
(mg)
Number
of Tablets
Administered
2.8 to 5.5 3 0.06 12.5 One
5.6 to 11.0 6 0.12 25 One
11.1 to 22.0 12 0.24 50 One
22.1 to 44.0 24 0.48 100 One
44.1 to 88.0 48 0.96 200 One
88.1 to 132.0 72 1.44 300 One
>132.0 Administer the appropriate combination of tablets
SIMPARICA TRIO can be offered to the dog with or without food.
Care should be taken to ensure that the dog consumes the complete dose
and that part of the dose is not lost or refused. If a dose is missed, give
SIMPARICA TRIO immediately and resume monthly dosing.
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.
SIMPARICA TRIO should be administered year‑round at monthly intervals
or started at least one month before fleas become active.
To minimize the likelihood of flea re‑infestation, it is important to treat all
dogs and cats within a household with a flea control product.
Tick Treatment and Control:
Treatment with SIMPARICA TRIO can begin at any time of the year.
SIMPARICA TRIO should be administered year‑round at monthly intervals
or started at least one month before ticks become active.
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.
CONTRAINDICATIONS
There are no known contraindications for the use of SIMPARICA TRIO.
WARNINGS