Label: TRI-HEART PLUS- ivermectin and pyrantel pamoate tablet, chewable
TRIHEART PLUS- ivermectin and pyrantel pamoate tablet, chewable

  • NDC Code(s): 0061-1339-03, 0061-1346-04, 0061-1353-03
  • Packager: Intervet, Inc. a subsidiary of Merck and Company, Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated December 19, 2016

If you are a consumer or patient please visit this version.

  • 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.

  • VETERINARY INDICATIONS

    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 & ADMINISTRATION

    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.

  • SPL UNCLASSIFIED SECTION

    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

    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

    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.

  • SUMMARY OF SAFETY AND EFFECTIVENESS

    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.

  • STORAGE AND HANDLING

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

  • HOW SUPPLIED


    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

  • PRINCIPAL DISPLAY PANEL

    25 lb unit carton

    25

  • PRINCIPAL DISPLAY PANEL

    26-50 lb unit carton

    50

  • PRINCIPAL DISPLAY PANEL

    51-100 lb unit carton

    100

  • INGREDIENTS AND APPEARANCE
    TRI-HEART PLUS 
    ivermectin and pyrantel pamoate tablet, chewable
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:0061-1346
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D) IVERMECTIN68 ug
    PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7) PYRANTEL57 mg
    Product Characteristics
    Colorbrown (Light to dark brown) Scoreno score
    ShapeRECTANGLESize14mm
    FlavorMEAT (Artifical beeef) Imprint Code none
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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 AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D) IVERMECTIN136 ug
    PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7) PYRANTEL114 mg
    Product Characteristics
    Colorbrown (Light to dark brown) Scoreno score
    ShapeRECTANGLESize19mm
    FlavorMEAT (artifical beef) Imprint Code none
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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 AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D) IVERMECTIN272 ug
    PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7) PYRANTEL227 mg
    Product Characteristics
    Colorbrown (Light to dark brown) Scoreno score
    ShapeRECTANGLESize24mm
    FlavorMEAT (artifical beef) Imprint Code none
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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
    Shandong Qilu King-Phar Pharmaceutical Factory421524323api manufacture
    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