Label: HEARTGARD- ivermectin tablet, chewable

  • NDC Code(s): 50604-4040-1, 50604-4040-3, 50604-4041-1
  • Packager: Merial Limited
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated 08/10

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  • SPL UNCLASSIFIED SECTION

    Chewables for Cats

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  • Caution

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

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  • INDICATION

    For use in cats to prevent feline heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection, and for the removal and control of adult and immature hookworms (Ancylostoma tubaeforme and A. braziliense).

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  • DOSAGE

    HEARTGARD for Cats should be administered orally at monthly intervals at the recommended minimum dose level of 24 mcg of ivermectin per kg (10.9 mcg/lb) of body weight. The recommended dosage schedule for prevention of feline heartworm disease and control of hookworm is as follows:

    Cat Weight lb HEARTGARD for Cats Chewables per Month Ivermectin content
    For cats over 15 lb, use the appropriate combination of chewables.
    HEARTGARD for Cats is recommended for use in cats 6 weeks of age and older.
    Up to 5 lb 1 55 mcg
    5 to 15 lb 1 165 mcg
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  • 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. HEARTGARD for Cats can be offered to the cat by hand or may be added to a small amount of cat food. If manual dosing is required, the chewable should be broken into pieces for administration. Food should be routinely available during the day of treatment administration. If cats are fasted, or if the chewable is not broken into pieces for manual dosing, then reduced absorption may result. A relationship between reduced absorption and reduced efficacy has not been established.

    Care should be taken to see that the cat consumes the complete dose. 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 with a new chewable is recommended. Fragments of chewables have occasionally been observed in the feces of some cats; efficacy of the product was not adversely affected.

    HEARTGARD for Cats should be given at monthly intervals when mosquitoes potentially carrying infective heartworm larvae are active. The initial dose must be given within a month (30 days) after the cat's first exposure to mosquitoes. The final dose must be given within a month (30 days) after the cat's last exposure to mosquitoes. For optimal performance, HEARTGARD for Cats must be given once a month on or about the same date. If treatment is delayed, whether by a few days or many, immediate treatment with HEARTGARD for Cats and resumption of the recommended dosing regimen will minimize the opportunity for development of adult heartworm.

    It is recommended that cats should be tested for existing heartworm infection prior to starting treatment with HEARTGARD for Cats. Cats already infected with adult heartworms can be given HEARTGARD for Cats monthly to prevent further infections.

    Monthly treatment with HEARTGARD® (ivermectin) for Cats also provides effective removal and control of adult and immature hookworms (A. tubaeforme and A. braziliense).

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  • SAFETY

    In the clinical studies involving more than 3000 doses of HEARTGARD for Cats, observations reported within 24 hours of treatment included vomition in ≤ 0.3% and diarrhea in ≤ 0.2% of the doses administered. There were no statistical differences between HEARTGARD for Cats and the product vehicle (control) for these observations.

    A wide margin of safety was demonstrated in clinical trials at the recommended dose level in cats and kittens 6 weeks of age and older and in laboratory studies in cats with circulating microfilariae of D. immitis. A wide margin of safety has also been demonstrated at 3 times the recommended dose in pregnant or breeding queens and breeding toms. No adverse effects were observed in either male or female cats or their offspring in breeding studies. A 30-fold safety margin over the minimum recommended dosage was established in a single dose tolerance study. In growing kittens dosed monthly for 8 consecutive doses, one cat given 5 times the market dose vomited and a second cat in this group experienced diarrhea within 24 hours of the initial treatment. In clinical trials, many commonly used flea control products, anthelmintics, vaccines, antibiotics and steroid preparations were administered with HEARTGARD for Cats without incident.

    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.

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  • STABILITY

    HEARTGARD Chewables for Cats are stable for 3 years when stored below 77°F (25°C) and protected from light. Store at controlled room temperature of 68°F-77°F (20°C-25°C). Excursions between 59°F-86°F (15°C-30°C) are permitted.

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  • HOW SUPPLIED

    HEARTGARD for Cats is available in two dosage strengths (see DOSAGE section) for cats of different weights. Each strength comes in a convenient carton of 6 chewables, packed 10 cartons per tray.

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  • SPL UNCLASSIFIED SECTION

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

    Marketed by
    Merial Limited
    3239 Satellite Blvd.
    Duluth, GA 30096
    Made in USA

    Merial Limited, a company limited in shares registered in England and Wales (registered number 3332751) with a registered office at PO Box 327, Sandringham House, Sandringham Avenue, Harlow Business Park, Harlow, Essex CM19 5QA, England, and domesticated in Delaware, USA as Merial LLC.

    NADA 141-078, Approved by the FDA.

    ©2010 Merial. All Rights Reserved.

    Rev. 04-2010

    1050-2169-03

    ©HEARTGARD and the Cat & Hand logo are registered trademarks of Merial.

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  • PRINCIPAL DISPLAY PANEL - 6 tablet blisterpack

    Heartgard®
    (ivermectin)

    Chewables
    for Cats

    Administer once a month to prevent
    heartworm disease and to remove and
    control infections of hookworms in cats.

    For
    CATS
    UP TO 5 lbs

    6 Chewables
    Each chewable contains 55 mcg of ivermectin.

    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 - 6 tablet blisterpack
    Close
  • PRINCIPAL DISPLAY PANEL - 6 tablet blisterpack

    Heartgard®
    (ivermectin)

    Chewables
    for Cats

    Administer once a month to prevent
    heartworm disease and to remove and
    control infections of hookworms in cats.

    For
    CATS
    5 TO 15 lbs

    6 Chewables
    Each chewable contains 165 mcg of ivermectin.

    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 - 6 tablet blisterpack
    Close
  • INGREDIENTS AND APPEARANCE
    HEARTGARD 
    ivermectin tablet, chewable
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:50604-4040
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ivermectin (ivermectin) ivermectin 55 ug
    Product Characteristics
    Color RED (red to red-brown) Score no score
    Shape ROUND Size 13mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50604-4040-1 1 in 1 CARTON
    1 6 in 1 BLISTER PACK
    2 NDC:50604-4040-3 1 in 1 CARTON
    2 1 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA141078 12/23/1996
    HEARTGARD 
    ivermectin tablet, chewable
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:50604-4041
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ivermectin (ivermectin) ivermectin 165 ug
    Product Characteristics
    Color RED (red to red-brown) Score no score
    Shape ROUND Size 14mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50604-4041-1 1 in 1 CARTON
    1 6 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA141078 12/23/1996
    Labeler - Merial Limited (034393582)
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