Tri-Heart Plus (Ivermectin and Pyrantel)

TRI-HEART PLUS - ivermectin and pyrantel pamoate tablet, chewable 
TRIHEART PLUS - ivermectin and pyrantel pamoate tablet, chewable 
Intervet, Inc. a subsidiary of Merck and Company, Inc.

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Package Insert Top

Tri-Heaart Plus

(Ivermectin and Pyrantel)

Chewable Tablets

Caution: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

INDICATIONS: For use in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection and for the treatment and control of ascarids (Toxocara canis, Toxoscaris leonina) and hookworms (Ancylostoma caninum, Uncinaria stenocephala, Ancyclostoma braziliense).

DOSAGE: Tri-Heart® Plus ivermectin/pyrantel chewable tablets should be administered orally at monthly intervals at the
recommended minimum dose level of 6 mcg of ivermectin per kilogram (2.72 mcg/lb) and 5 mg of pyrantel (as
pamoate salt) per kg (2.27 mg/Ib) of body weight. The recommended dosing schedule for prevention of canine
heartworm disease and for the treatment and control of ascarids and hookworms is as follows:

Dog Weight
Chewable Tablets
per Month
Ivermectin
Content
Pyrantel
Content
Color Coding on
Blister Card and Carton
Up  to 25 lbs.168 mcg57 mgBlue
26 to 50 lbs.1136 mcg114 mgGreen
51 to 100 lbs.1272 mcg227 mgBrown

Tri-Heart® Plus ivermectin/pyrantel chewable tablets are recommended for dogs 6 weeks of
age and older. For dogs over 100 lbs, use the appropriate combination of these tablets.

ADMINISTRATION: Remove only one chewable tablet at a time from the blister card.
Because most dogs find Tri-Heart®t Plus chewable tablets palatable, the product can be
offered to the dog by hand. Alternatively, it may be added intact to a small amount of dry food
or placed in the back of the dog’s mouth for forced swallowing.

Care should be taken that the dog consumes the complete dose, and treated animals should
be observed for a few minutes after administration to ensure that part of the dose is not lost
or rejected. If it is suspected that any of the dose has been lost, redosing is recommended.

Tri-Heart® Plus chewable tablets should be given at monthly intervals during the period of the
year when mosquitoes (vectors), potentially carrying infective heartworm larvae, are active.
The initial dose must be given within a month (30 days) after the dog’s first exposure to mosquitoes.
The final dose must be given within a month (30 days) after the dog’s last exposure
to mosquitoes.

When replacing another heartworm preventive product in a heartworm disease preventive
program, the first dose of Tri-Heart® Plus chewable tablets must be given within a month (30
days) of the last dose of the former medication.

If the interval between doses exceeds a month (30 days), the efficacy of ivermectin can be
reduced. Therefore, for optimal performance, the chewable tablet must be given once a
month on or about the same day of the month. If treatment is delayed, whether by a few days
or many, immediate treatment with Tri-Heart® Plus chewable tablets and resumption of the
recommended dosing regimen minimizes the opportunity for the development of adult
heartworms.

Monthly treatment with Tri-Heart® Plus chewable tablets also provides effective treatment
and control of ascarids (T. canis, T. leonina) and hookworms (A. caninum, U. stenocephala,
A. braziliense
). Clients should be advised of measures to be taken to prevent reinfection with
intestinal parasites.

EFFICACY: Tri-Heart® Plus chewable tablets given orally using the recommended dose and
regimen, are effective against the tissue larval stage of D. immitis for a month (30 days)
after infection and, as a result, prevent the development of the adult stage. Tri-Heart®
Plus chewable tablets are also effective against canine ascarids (T. canis, T. leonina)
and hookworms (A. caninum, U. stenocephala, A. braziliense).

ACCEPTABILITY: In acceptability trials, Tri-Heart® Plus chewable tablets were shown to be
a palatable oral dosage form that was consumed at first offering by the majority of dogs.

PRECAUTIONS: All dogs should be tested for existing heartworm infection before starting
treatment with Tri-Heart® Plus chewable tablets which are not effective against adult
D. immitis. Infected dogs must be treated to remove adult heartworms and microfilariae
before initiating a program with Tri-Heart® Plus chewable tablets.

While some microfilariae may be killed by the ivermectin in Tri-Heart® Plus chewable
tablets at the recommended dose level, Tri-Heart® Plus chewable tablets are not effective
for microfilariae clearance. A mild hypersensitivity-type reaction, presumably due to
dead or dying microfilariae and particularly involving a transient diarrhea has been
observed in clinical trials with ivermectin alone after treatment of some dogs that have
circulating microfilariae.


Keep this and all drugs out of the reach of children. In case of ingestion by humans, clients
should be advised to consult a physician immediately. Physicians may contact a Poison Control Center for
advice concerning cases of ingestion by humans.

ADVERSE REACTIONS: In clinical field trials with ivermectin/pyrantel, vomiting or diarrhea
within 24 hours of dosing was rarely observed (1.1% of administered doses). The following
adverse reactions have been reported following the use of ivermectin at the recommended
dose: depression/lethargy, vomiting, anorexia, diarrhea, mydriasis, ataxia, staggering,
convulsions and hypersalivation.

SAFETY: Studies with ivermectin indicate that certain dogs of the Collie breed are more
sensitive to the effects of ivermectin administered at elevated dose levels (more than 16
times the target use level of 6 mcg/kg) than dogs of other breeds. At elevated doses,
sensitive dogs showed adverse reactions which included mydriasis, depression, ataxia,
tremors, drooling, paresis, recumbency, excitability, stupor, coma and death. Ivermectin
demonstrated no signs of toxicity at 10 times the recommended dose (60 mcg/kg) in sensitive
Collies. Results of these trials and bioequivalency studies support the safety of
ivermectin products in dogs, including Collies, when used as recommended.

Ivermectin/pyrantel has shown a wide margin of safety at the recommended dose level in
dogs, including pregnant or breeding bitches, stud dogs and puppies aged 6 or more
weeks. In clinical trials, many commonly used flea collars, dips, shampoos,
anthelmintics, antibiotics, vaccines and steroid preparations have been administered
with ivermectin/pyrantel in a heartworm disease preventive program.

In one trial, where some pups had parvovirus, there was a marginal reduction in efficacy
against intestinal nematodes, possibly due to a change in intestinal transit time.

Store at controlled room temperature of 59·860 F (15·300 C). Protect product from light


HOW SUPPLIED:
Tri-Heart® Plus chewable tablets are available in three dosage strengths (See
DOSAGE section) for dogs of different weights. Each strength comes in convenient packs of 6
chewable tablets.

For Technical Assistance, call Merck Animal Health: 1-800-224-5318

Manufactured for: Intervet Inc. a subsidiary of Merck and Co. Inc., Summit, NJ 07901
Manufactured by: Diamond Animal Health, Inc., a wholly owned subsidiary of Heska Corporation,
Des Moines, IA 50327

©2013 Heska Corporation. All rights reserved.

02260-1

ANADA 200-338, Approved by FDA

www.TriHeartPlus.com

25 lb unit carton

25 lb unit carton

25 lb display carton

25 lb display carton

26-50 lb unit carton

26-50 lb unit carton

26-50 lb display carton

26-50 lb display carton

51-100 lb unit carton

51-100 lb unit carton

51-100 lb display carton

51-100 lb display carton

TRI-HEART PLUS 
ivermectin and pyrantel pamoate tablet, chewable
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:0061-1346
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IVERMECTIN (IVERMECTIN) IVERMECTIN68 ug
PYRANTEL PAMOATE (PYRANTEL) PYRANTEL57 mg
Product Characteristics
Colorbrown (Light to dark brown) Scoreno score
ShapeRECTANGLESize14mm
FlavorMEAT (Artifical beeef) Imprint Code none
Contains    
Packaging
#Item CodePackage Description
1NDC:0061-1346-041 in 1 CARTON
16 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20033805/10/2013
TRIHEART PLUS 
ivermectin and pyrantel pamoate tablet, chewable
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:0061-1339
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IVERMECTIN (IVERMECTIN) IVERMECTIN136 ug
PYRANTEL PAMOATE (PYRANTEL) PYRANTEL114 mg
Product Characteristics
Colorbrown (Light to dark brown) Scoreno score
ShapeRECTANGLESize19mm
FlavorMEAT (artifical beef) Imprint Code none
Contains    
Packaging
#Item CodePackage Description
1NDC:0061-1339-031 in 1 CARTON
16 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20033805/10/2013
TRIHEART PLUS 
ivermectin and pyrantel pamoate tablet, chewable
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:0061-1353
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IVERMECTIN (IVERMECTIN) IVERMECTIN272 ug
PYRANTEL PAMOATE (PYRANTEL) PYRANTEL227 mg
Product Characteristics
Colorbrown (Light to dark brown) Scoreno score
ShapeRECTANGLESize24mm
FlavorMEAT (artifical beef) Imprint Code none
Contains    
Packaging
#Item CodePackage Description
1NDC:0061-1353-031 in 1 CARTON
16 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20033805/10/2013
Labeler - Intervet, Inc. a subsidiary of Merck and Company, Inc. (001317601)
Registrant - Heska Corp (603631326)
Establishment
NameAddressID/FEIBusiness Operations
Diamond Animal Health, Inc.102913878manufacture
Establishment
NameAddressID/FEIBusiness Operations
Moehs Catalana SL460021629api manufacture
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Hisun Pharmaceutical Co., Ltd.654211754api manufacture
Establishment
NameAddressID/FEIBusiness Operations
Hangzhou Minsheng Pharmaceutical Co., Ltd.420559965api manufacture

Revised: 05/2013
 
Intervet, Inc. a subsidiary of Merck and Company, Inc.