HEARTGARD (ivermectin 165 ug) Dailymed

Chewables for Cats

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:

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

Administration:

Remove only one chewable at a time from the foil-backed buler 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.

To report suspected adverse drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS), contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth.

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.