For oral use in dogs only.
Caution: Federal (U.S.A.) law restricts this
drug to use by or on the order of a licensed veterinarian.
Description: IVERHART MAX®
Chewable Tablets is a combination of three anthelmintics (ivermectin/pyrantel
pamoate/praziquantel). The tablets are available in four sizes in color-coded
packages for oral administration to dogs according to their weight (see
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 roundworms (Toxocara canis,
Toxascaris leonina), hookworms (Ancylostoma caninum,
Uncinaria stenocephala, Ancylostoma braziliense), and tapeworms
(Dipylidium caninum, Taenia pisiformis).
Dosage: IVERHART MAX (ivermectin/pyrantel
pamoate/praziquantel) Chewable Tablets should be administered orally at monthly
intervals at the recommended minimum dose level of 6 mcg of ivermectin per
kilogram (2.72 mcg/lb), 5 mg of pyrantel (as pamoate salt) per kg (2.27 mg/lb)
and 5 mg of praziquantel per kg (2.27 mg/lb) of body weight, as follows:
Dog Weight Lbs.
Chewable Tablet Per Month
Pyrantel Pamoate Content
6.0 to 12
12.1 to 25
25.1 to 50
50.1 to 100
IVERHART MAX Chewable Tablets are recommended for dogs 8 weeks
of age and older. For dogs over 100 lbs, use the appropriate combination of
these Chewable Tablets.
Administration: Remove only one tablet at a
time from the foil-backed blister card. Return the remaining tablets to their
box to protect the product from light. IVERHART MAX Chewable Tablets can be
offered to the dog by hand or be added intact to a small amount of dog food.
Care should be taken that the dog consumes the complete dose, and the dog 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.
IVERHART MAX Chewable Tablets 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
When replacing another heartworm preventive product in a
heartworm disease prevention program, the first dose of IVERHART MAX Chewable
Tablets must be given within a month (30 days) of the last dose of the former
medication. A heartworm test should be performed prior to switching heartworm
If the interval between doses exceeds a month (30 days), the
efficacy of ivermectin can be reduced. Therefore, for optimal performance, the
tablet 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
IVERHART MAX Chewable Tablets and resumption of the recommended dosing regimen
will minimize the opportunity for the development of adult heartworms.
For use in dogs only. Keep this and all drugs
out of reach of children. In safety studies, testicular hypoplasia was observed
in some dogs receiving 3 and 5 times the maximum recommended dose monthly for 6
months (see Animal Safety).
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.
For a copy of the Material Safety Data Sheet (MSDS), or to
report adverse reactions, call 1-800-338-3659.
Precautions: Use with caution in sick,
debilitated, or underweight animals and dogs weighing less than 10 lbs (see
Animal Safety). The safe use of this drug has not been evaluated in pregnant or
All dogs should be tested for existing heartworm infection
before starting treatment with IVERHART MAX Chewable Tablets, which are not
effective against adult D. immitis. Infected dogs
should be treated to remove adult heartworms and microfilariae before initiating
a heartworm prevention program.
While some microfilariae may be killed by the ivermectin in
IVERHART MAX Chewable Tablets at the recommended dose level, IVERHART MAX
Chewable Tablets are 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
Adverse Reactions: Self-limiting adverse
reactions including lethargy, limpness, salivation, shaking, diarrhea, decreased
appetite, licking lips, and belching were reported between 20 minutes and 72
hours following treatment in a field study with IVERHART MAX Chewable Tablets.
In clinical field trials with ivermectin/pyrantel pamoate,
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 ivermectin: depression/lethargy, vomiting, anorexia,
diarrhea, mydriasis, ataxia, staggering, convulsions and hypersalivation.
Effectiveness: IVERHART MAX Chewable
Tablets, 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. IVERHART MAX Chewable Tablets are also effective against canine
roundworms (T. canis, T. leonina), hookworms
(A. caninum, U. stenocephala, A. braziliense), and tapeworms
(T. pisiformis, D. caninum).
A total of 61 dogs and puppies with naturally acquired or
experimental parasite infections treated with IVERHART MAX Chewable Tablets were
enrolled in 7 well-controlled laboratory studies to establish effectiveness.
These studies included dogs of various sizes, ages and breeds. Data from these
studies demonstrated IVERHART MAX Chewable Tablets are safe and effective for
the removal of the parasite species indicated on the label when used as
Palatability: In a field trial, IVERHART MAX
was shown to be a palatable oral dosage form for dogs.
Animal Safety: 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 of 6 mcg/kg) 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. No signs of toxicity were seen at 10 times the recommended dose (27.2
mcg/lb) in sensitive Collies. Results of these studies and bioequivalence
studies support the safety of ivermectin products in dogs, including Collies,
when used as recommended by the label.
In a target animal safety study, IVERHART MAX Chewable Tablets
were administered to 8-week-old Beagle puppies at one, three and five times the
maximum recommended dose of 12.5 mcg/kg ivermectin, 10.47 mg/kg pyrantel and
10.47 mg/kg praziquantel. The dogs were treated every 30 days for 6 months.
Vomiting within 6 hours of dosing and soft or watery feces within 24 hours of
dosing were observed. Other observations during the study were: anogenital
swelling, lethargy, head movements, shallow, audible or difficult breathing, and
salivation. One dog in the 5X group had tremors and decreased activity. All
these signs were transient. No treatment was required. Pathology showed
testicular hypoplasia in the 3 and 5X groups (see Warnings).
In a laboratory safety study, 12-week-old Beagle puppies
receiving 3 and 5 times the recommended dose once weekly for 13 weeks
demonstrated a dose-related decrease in testicular maturation compared to
controls. In this study, all treated puppies had significantly higher
cholesterol levels compared to untreated controls.
In a reproductive safety study, adult males were treated at 37.5
mcg/kg ivermectin, 31.4 mg/kg pyrantel and 31.4 mg/kg praziquantel every 14 days
during two full spermatogenic cycles (112 days). The quality of semen and
reproductive health were not affected by treatment. Treatment-related vomiting
and soft feces were reported during this study.
In a study of the effectiveness of IVERHART MAX Chewable Tablets
for treatment of T. canis, one 8.1 lb, 72-day-old puppy
died 6 days after administration of IVERHART MAX Chewable Tablets at the label
dose. This puppy and many of the other puppies in the study had high worm
burdens and were reported to have diarrhea, sometimes bloody, frequently before
and after treatment with IVERHART MAX Chewable Tablets or the placebo.
Dehydration and signs of anemia (pale mucous membranes) were the only abnormal
gross necropsy findings observed. No definitive cause of death was determined.
In a 90-day field study, the most serious ADEs (lethargy, limpness, and
salivation) were seen in dogs weighing less than 10 lbs (see
Storage Information: Store at controlled
room temperature of 59°-86°F (15°-30°C). Protect product from light.
How Supplied: IVERHART MAX Chewable Tablets
are available in four dosage strengths (see dosage section) for dogs of
different weights. Each strength comes in a box of 6 chewable tablets and in a
box of 12 chewable tablets, packed 10 boxes per display box.
NADA 141-257, Approved by FDA.
Manufactured by: Virbac Animal Health, Inc., Fort Worth, TX
IVERHART MAX is a registered trademark of Virbac Corporation.
NAC No.: 10230981