HEARTGARD

Merial Limited

Heartgard Plus (ivermectin/pyrantel)

FULL PRESCRIBING INFORMATION: CONTENTS*

• Caution
• INDICATIONS
• DOSAGE
• ADMINISTRATION
• EFFICACY
• ACCEPTABILITY
• PRECAUTIONS
• HEARTGARD ADVERSE REACTIONS
• SAFETY
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 12 Tablet Carton (For Dogs Up To 25 lbs)
• PRINCIPAL DISPLAY PANEL - 12 Tablet Carton (For Dogs 26-50 lbs)
• PRINCIPAL DISPLAY PANEL - 12 Tablet Carton (For Dogs 51-100 lbs)

FULL PRESCRIBING INFORMATION

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:

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.

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.

HEARTGARD 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.

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

Marketed by
Merial Limited
Duluth, GA 30096-4640

Merial Limited, a company limited by 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, with a place of business at 3239 Satellite Blvd., Duluth, GA 30096-4640 USA.

Made in U.S.A.

©2010 Merial. All Rights Reserved.

Rev. April 2010
1050-1999-02

®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 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 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