HEARTGARD- ivermectin tablet, chewable

HEARTGARD by

Drug Labeling and Warnings

HEARTGARD by is a Animal medication manufactured, distributed, or labeled by Merial, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Chewables

1051-2594-02

Caution

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

INDICATION

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.

DOSAGE

HEARTGARD® Chewables should be administered orally at monthly intervals at the recommended minimum dose level of 6.0 mcg of ivermectin per kilogram (2.72 mcg/lb) of body weight. (See ADMINISTRATION). The recommended dosage schedule for prevention of canine heartworm disease is as follows:

Dog Weight	Chewables Per Month	Ivermectin Content	Color Coding on Foil Backing and Carton
Give dogs over 100 lb the appropriate combination of these chewables.; HEARTGARD Chewables are recommended for use in dogs 6 weeks of age and older.
Up to 25 lb	1	68 mcg	Blue
26 to 50 lb	1	136 mcg	Green
51 to 100 lb	1	272 mcg	Brown

ADMINISTRATION

Remove only one chewable at a time from the foil-backed blister card. Return the card with the remaining chewables to the box to protect the product from light. Because most dogs find HEARTGARD Chewables palatable, the product can be offered to the dog by hand. Alternatively, it may be added 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 to see 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 Chewables 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 in a heartworm disease preventive program, the first dose of HEARTGARD must be given within a month (30 days) after the last dose of the former medication.

If the interval between doses exceeds a month (30 days), the efficacy of ivermectin can be reduced. 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 and resumption of the recommended dosing regimen minimizes the opportunity for the development of adult heartworms.

EFFICACY

HEARTGARD® (ivermectin) Chewables, given orally using the recommended dose and regimen, are effective against the tissue larval stage of Dirofilaria immitis for a month (30 days) after infection and, as a result, prevent the development of the adult stage.

ACCEPTABILITY

In acceptability and field trials, HEARTGARD Chewables were shown to be an acceptable oral dosage form that was consumed at the first offering by the majority of dogs.

PRECAUTIONS

All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD which is not effective against adult D. immitis. Infected dogs must be treated to remove adult heartworms and microfilariae prior to initiating a program with HEARTGARD.

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

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 has shown a wide margin of safety at the recommended dose level in dogs (See PRECAUTIONS for exceptions) 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 Chewables in a heartworm disease preventive program.

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 support the safety of HEARTGARD products in dogs, including Collies, when used as recommended.

HOW SUPPLIED

HEARTGARD Chewables are available in three dosage strengths (See DOSAGE section) for dogs of different weights. Each strength comes in convenient cartons of 6 chewables, packed 10 cartons per tray.

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

Marketed by
Merial Inc.
Duluth, GA 30096-4640, U.S.A.

Merial is the Animal Health Division of sanofi.

©2015 Merial, Inc. All Rights Reserved.
Made in U.S.A.
April 2015

PRINCIPAL DISPLAY PANEL - 6 Tablet Carton (For DOGS UP TO 25 lbs)

Heartgard®
(ivermectin)

Treat once a month to prevent
heartworm disease in dogs.

For
DOGS
UP TO 25 lbs

6 Chewables
Each chewable contains 68 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 Carton (For DOGS 26-50 lbs)

Heartgard®
(ivermectin)

Treat once a month to prevent
heartworm disease in dogs.

For
DOGS
26-50 lbs

6 Chewables
Each chewable contains 136 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 Carton (For DOGS 51-100 lbs)

Heartgard®
(ivermectin)

Treat once a month to prevent
heartworm disease in dogs.

For
DOGS
51-100 lbs

6 Chewables
Each chewable contains 272 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

INGREDIENTS AND APPEARANCE

HEARTGARD 
ivermectin tablet, chewable

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 50604-4003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ivermectin (UNII: 8883YP2R6D) (ivermectin - UNII:8883YP2R6D)	ivermectin	68 ug

Product Characteristics
Color	RED (red to red-brown)	Score	no score
Shape	RECTANGLE	Size	20mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50604-4003-1	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	NADA140886	08/01/1989

HEARTGARD 
ivermectin tablet, chewable

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 50604-4004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ivermectin (UNII: 8883YP2R6D) (ivermectin - UNII:8883YP2R6D)	ivermectin	136 ug

Product Characteristics
Color	RED (red to red-brown)	Score	no score
Shape	RECTANGLE	Size	27mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50604-4004-1	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	NADA140886	08/01/1989

HEARTGARD 
ivermectin tablet, chewable

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 50604-4005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ivermectin (UNII: 8883YP2R6D) (ivermectin - UNII:8883YP2R6D)	ivermectin	272 ug

Product Characteristics
Color	RED (red to red-brown)	Score	no score
Shape	RECTANGLE	Size	33mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50604-4005-1	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	NADA140886	08/01/1989

Labeler - Merial, Inc. (799641006)