Merial
(ivermectin/pyrantel)
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:
|
Dog
Weight |
Chewables Per Month |
Ivermectin
Content |
Pyrantel Content |
Color Coding
on Foil-Backing
and Carton |
|
Up to 25 lb |
1 |
68 mcg |
57 mg |
Blue |
|
26 - 50 lb |
1 |
136 mcg |
114 mg |
Green |
|
51 - 100 lb |
1 |
272 mcg |
227 mg |
Brown |
HEARTGARD Plus is recommended for dogs 6 weeks of age and
older.
For dogs over 100 lb use the appropriate combination of
these chewables.
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°- 77°F (20°- 25°C). Excursions between 59°
- 86°F (15° - 30°C) are permitted. Protect product from light.
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.