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:
|
Cat Weight
lb |
HEARTGARD for Cats
Chewables per month |
Ivermectin
content |
|
Up to 5 lb |
1 |
55 mcg |
|
5 to 15 lb |
1 |
165 mcg |
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 safely 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.