Heartgard® (ivermectin) Chewables for Cats

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 CATS

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 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).

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:

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.

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).

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.

STABILITY: HEARTGARD Chewables for Cats are stable for 2 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.

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.

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

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.

U.S. Pat. 4,199,569

© 2008 Merial. All Rights Reserved.

Rev. 12-2008

1050-2169-02