Dog Heartgard® (ivermectin) Chewables

Ivermectin (Rx)

Trade Names:

HEARTGARD® Chewables for Cats

HEARTGARD® Chewables for Dogs

HEARTGARD® Tablets for Dogs

General Description:

Ivermectin is an anti-parasitic drug used monthly in dogs and cats to prevent heartworm infection and for the treatment and control of hookworms and some forms of mange. This medication is available as regular tablets, chewable tablets and also as a topical solution.

What is this product?

• Ivermectin is an anti-parasite drug
• Ivermectin is given by mouth

Reasons for prescribing:

• For heartworm prevention in dogs and cats
• For treatment and control of adult and immature hookworm infections in cats
• For treatment of some types of mange

What dogs/cats should not take this medication?

• Puppies and kittens less than 6 weeks of age
• Use with caution in Collies, Australian shepherds, Old English sheepdogs, Shelties and any of these crossbreed dogs
• Considered safe for use in young cats at the regular heartworm preventive doses
• Pets known to have had an allergic reaction to ivermectin or like products

Directions:

Give this medication with or without food. Ivermectin is bitter, so some pets may need the taste masked with food.

Ensure that your pet consumes the entire dose.

Give medication as directed by your veterinarian. This medication is often given seasonally.

As a heartworm preventative, this medication is given once a month, beginning within a month after the pet's first exposure to mosquitoes. The medication kills the parasites acquired during the previous month. The final dose should be given within a month of the last exposure to mosquitoes. Ideally, give the medication on or about the same day each month.

If this product replaces another type of heartworm preventive, the first dose must be given within 30 days after the last dose of the previous product.

What if dose is missed?

If a dose is missed, give it as soon as you can. If it is time already for the next dose, skip the missed dose and go back to the normal schedule. Do not give two doses at the same time. If you miss more than 8 weeks in a row, give the drug as soon as you remember, but you should have your pet's blood tested for heartworms within 6 months (as infection may have occurred).

What to tell/ask veterinarian before giving medication?

Talk to your veterinarian about:

• When will your pet need to be rechecked
• Whether a blood test will need to be performed prior to treatment with this drug
• Risks and benefits of using this drug

Tell your veterinarian about:

• If your pet has experienced side-effects on other drugs/products
• If your pet has experienced digestive upset now or ever
• If your pet has experienced liver or kidney disease now or ever
• If your pet has experienced any other medical problems or allergies now or ever
• All medicines and supplements that you are giving your pet or plan to give your pet, including those you can get without a prescription. Your veterinarian may want to check that all of your pet's medicines can be given together.

Storage and Warnings:

Store in a tight, light resistant, childproof container in a cool, dry place at room temperature away from heat and direct sunlight.

Dispose of this product properly as it is very toxic to fish, turtles and other wildlife.

People should not take this product. Keep this and all medication out of reach of children and pets. Call your physician immediately if you accidentally take this product.

Potential side effects:

• Side effects are rare for ivermectin given at heartworm preventive doses
• Considered to be safe in pregnant and nursing animals
• Problems may arise at high doses in some dogs, especially Collies, Australian Shepherds, Old English Sheepdogs, Shelties and any of these crossbreed dogs. If your dog is one of these breeds, observe your pet for at least 8 hours after treatment for any signs of weakness, staggering, dilated pupils, trembling, etc. Take your pet to your veterinary clinic if s/he exhibits these symptoms.
• When the parasite begin to die off, the animal may experience swelling, irritation and pain at the sites where the parasites are located. Dogs with a large number of heartworm larvae (immature heartworm) may experience a shock-like reaction as the parasites die all at once.
• It is important to stop therapy and contact your veterinarian immediately if you think your pet has a medical problem or side effect from this product's therapy

Can this drug be given with other drugs?

• Yes, when ivermectin is used at heartworm preventive doses, there are no contraindicated drugs. When higher doses are used (ie. for skin mites), interactions may occur with amitraz dips and collars (Mitaban®, Preventic®), spinosad (Comfortis™) or diazepam or related tranquilizers.
• If your pet experiences any unusual reactions when taking multiple medications, contact your veterinarian

Overdosing?

Contact your veterinarian immediately if pet consumes more than the prescribed amount.

What else should I know?

Notify your veterinarian if your animal's condition does not improve or worsens despite this treatment.

As with all prescribed medicines, ivermectin should only be given to the dog/cat for which it was prescribed. It should be given only for the condition for which it was prescribed.

This is just a summary of information about ivermectin. If you have any questions or concerns about ivermectin or for the condition it was prescribed, contact your veterinarian.

HEARTGARD^® CHEWABLES FOR DOGS

Merial

(ivermectin)

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:

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.

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.

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

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

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

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.

U.S. Pat. 4,199,569

© 2008 Merial. All Rights Reserved.

Made in U.S.A.

May 2008

1051-2594-00