Label: HEARTGARD PLUS- ivermectin and pyrantel pamoate tablet, chewable

  • NDC Code(s): 50604-4012-1, 50604-4012-2, 50604-4012-3, 50604-4013-1, view more
    50604-4013-2, 50604-4014-1, 50604-4014-2
  • Packager: Merial, Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated December 13, 2018

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

  • SPL UNCLASSIFIED SECTION

    Chewables

    NADA 140-971, Approved by the FDA

  • 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, Toxascaris leonina) and hookworms (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense).

  • DOSAGE

    HEARTGARD® Plus 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/lb) 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:

    HEARTGARD Plus is recommended for dogs 6 weeks of age and older.
    For dogs over 100 lb use the appropriate combination of these chewables.

    Dog Weight

    Chewables Per Month

    Ivermectin Content

    Pyrantel Content

    Color Coding on Foil Backing and Carton

    Up to 25 lb

    1

    68 mcg

    57 mg

    Blue

    26 to 50 lb

    1

    136 mcg

    114 mg

    Green

    51 to 100 lb

    1

    272 mcg

    227 mg

    Brown

  • ADMINISTRATION

    Remove only one chewable at a time from the foil-backed blister card. Return the card with the remaining chewables to its box to protect the product from light. Because most dogs find HEARTGARD Plus palatable, the product can be offered to the dog by hand. Alternatively, it may be added intact to a small amount of dog food. The chewable should be administered in a manner that encourages the dog to chew, rather than to swallow without chewing. Chewables may be broken into pieces and fed to dogs that normally swallow treats whole.

    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.

    HEARTGARD Plus 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 HEARTGARD Plus 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 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 HEARTGARD Plus and resumption of the recommended dosing regimen minimizes the opportunity for the development of adult heartworms.

    Monthly treatment with HEARTGARD Plus 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

    HEARTGARD® Plus (ivermectin/pyrantel) Chewables, 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. HEARTGARD Plus Chewables are also effective against canine ascarids (T. canis, T. leonina) and hookworms (A. caninum, U. stenocephala, A. braziliense).

  • ACCEPTABILITY

    In acceptability and field trials, HEARTGARD Plus was shown to be an acceptable 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 HEARTGARD Plus which is not effective against adult D. immitis. Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with HEARTGARD Plus.

    While some microfilariae may be killed by the ivermectin in HEARTGARD Plus at the recommended dose level, HEARTGARD Plus is 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.

  • STORAGE AND HANDLING

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

    Store between 68°F° - 77°F (20° - 25°C). Excursions between 59°F - 86°F (15° - 30°C) are permitted. Protect product from light.

  • ADVERSE REACTIONS

    In clinical field trials with HEARTGARD Plus, 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 HEARTGARD: Depression/lethargy, vomiting, anorexia, diarrhea, mydriasis, ataxia, staggering, convulsions and hypersalivation.

  • SAFETY

    HEARTGARD Plus has been shown to be bioequivalent to HEARTGARD, with respect to the bioavailability of ivermectin. The dose regimens of HEARTGARD Plus and HEARTGARD are the same with regard to ivermectin (6 mcg/kg). 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) 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. HEARTGARD 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 HEARTGARD products in dogs, including Collies, when used as recommended.

    HEARTGARD Plus 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 HEARTGARD Plus 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.

  • HOW SUPPLIED

    HEARTGARD Plus is available in three dosage strengths (See DOSAGE section) for dogs of different weights. Each strength comes in convenient cartons of 6 and 12 chewables.

  • SPL UNCLASSIFIED SECTION

    For customer assistance, please contact Merial at 1-888-637-4251.

    Marketed by
    Merial, Inc.
    Duluth, GA 30096-4640

    Merial is the Animal Health Division of sanofi.

    Made in U.S.A.

    ©2015 Merial, Inc. All Rights Reserved.

    Rev. May 2015
    1050-1999-03

    ®HEARTGARD and the Dog & Hand logo are registered trademarks of Merial.

  • PRINCIPAL DISPLAY PANEL - 12 Tablet Carton (For Dogs Up To 25 lbs)

    Heartgard®
    Plus
    (ivermectin/pyrantel)

    Administer once a month to prevent
    heartworm disease and to treat and control
    ascarid and hookworm infections in dogs.

    For
    DOGS
    UP TO 25 lbs

    12 Chewables
    Each chewable contains 68 mcg ivermectin
    and 57 mg pyrantel as pamoate salt.

    Keep this and all drugs out
    of the reach of children.

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

    MERIAL

    PRINCIPAL DISPLAY PANEL - 12 Tablet Carton (For Dogs Up to 25 lbs)
  • PRINCIPAL DISPLAY PANEL - 12 Tablet Carton (For Dogs 26-50 lbs)

    Heartgard®
    Plus
    (ivermectin/pyrantel)

    Administer once a month to prevent
    heartworm disease and to treat and control
    ascarid and hookworm infections in dogs.

    For
    DOGS
    26-50 lbs

    12 Chewables
    Each chewable contains 136 mcg ivermectin
    and 114 mg pyrantel as pamoate salt.

    Keep this and all drugs out
    of the reach of children.

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

    MERIAL

    PRINCIPAL DISPLAY PANEL - 12 Tablet Carton (For Dogs 26-50 lbs)
  • PRINCIPAL DISPLAY PANEL - 12 Tablet Carton (For Dogs 51-100 lbs)

    Heartgard®
    Plus
    (ivermectin/pyrantel)

    Administer once a month to prevent
    heartworm disease and to treat and control
    ascarid and hookworm infections in dogs.

    For
    DOGS
    51-100 lbs

    12 Chewables
    Each chewable contains 272 mcg ivermectin
    and 227 mg pyrantel as pamoate salt.

    Keep this and all drugs out
    of the reach of children.

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

    MERIAL

    PRINICPAL DISPLAY PANEL - 12 Tablet Carton (For Dogs 51-100 lbs)
  • INGREDIENTS AND APPEARANCE
    HEARTGARD  PLUS
    ivermectin and pyrantel pamoate tablet, chewable
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:50604-4012
    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
    ColorRED (red to red-brown) Scoreno score
    ShapeRECTANGLESize25mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50604-4012-11 in 1 CARTON
    16 in 1 BLISTER PACK
    2NDC:50604-4012-22 in 1 CARTON
    26 in 1 BLISTER PACK
    3NDC:50604-4012-31 in 1 CARTON
    31 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14097101/15/1993
    HEARTGARD  PLUS
    ivermectin and pyrantel pamoate tablet, chewable
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:50604-4013
    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
    ColorRED (red to red-brown) Scoreno score
    ShapeRECTANGLESize32mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50604-4013-11 in 1 CARTON
    16 in 1 BLISTER PACK
    2NDC:50604-4013-22 in 1 CARTON
    26 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14097101/15/1993
    HEARTGARD  PLUS
    ivermectin and pyrantel pamoate tablet, chewable
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:50604-4014
    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) pyrantel228 mg
    Product Characteristics
    ColorRED (red to red-brown) Scoreno score
    ShapeRECTANGLESize38mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50604-4014-11 in 1 CARTON
    16 in 1 BLISTER PACK
    2NDC:50604-4014-22 in 1 CARTON
    26 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14097101/15/1993
    Labeler - Merial, Inc. (799641006)