Description:
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:
IVERHART™ Plus (ivermectin/pyrantel) Flavored Chewables 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
|
Flavored
Chewable
Per Month
|
Ivermectin Content
|
Pyrantel Content
|
Color
Coding
on Foil-Backing
and Carton
|
|
Up to 25 lbs
|
1
|
68
mcg
|
57
mg
|
blue
|
|
26 to 50 lbs
|
1
|
136
mcg
|
114
mg
|
green
|
|
51 to 100 lbs
|
1
|
272
mcg
|
227
mg
|
brown
|
IVERHART
Plus Flavored Chewables are recommended for dogs 6 weeks of age and older.
For dogs over 100 lbs
use the appropriate combination of these flavored chewables.
ADMINISTRATION:
Remove only one flavored chewable at a time from the foil-backed blister card.
Because most dogs find IVERHART Plus Flavored Chewables palatable, the
product can be offered to the dog by hand. Alternatively, it may be added intact
to a small amount of dog food or placed in the back of the dog's mouth for
forced swallowing. 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.
IVERHART
Plus Flavored Chewables 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 prevention program, the
first dose of IVERHART Plus Flavored Chewables 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 IVERHART Plus Flavored
Chewables and resumption of the recommended dosing regimen will minimize the
opportunity for the development of adult heartworms.
Monthly treatment with
IVERHART Plus Flavored Chewables 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:
IVERHART Plus Flavored 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. IVERHART Plus Flavored Chewables are also effective
against canine ascarids (T. canis, T. leonina) and hookworms (A.
caninum, U. stenocephala, A. braziliense).
ACCEPTABILITY:
In a trial in client-owned dogs, IVERHART Plus Flavored Chewables were
shown to be a palatable oral dosage form consumed at first offering by the
majority of dogs.
PRECAUTIONS:
All dogs should be tested for existing heartworm infection before starting
treatment with IVERHART Plus Flavored Chewables which are not effective
against adult D. immitis. Infected dogs must be treated to remove adult
heartworms and microfilariae before initiating a program with IVERHART
Plus Flavored Chewables.
While some
microfilariae may be killed by the ivermectin in IVERHART Plus Flavored
Chewables at the recommended dose level, IVERHART Plus Flavored Chewables
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
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 at controlled
room temperature of 59°-86°F (15°-30°C).
Warnings: Use
product on or before expiration date. Discard or return unused tablets.
Protect product from
light.
ADVERSE REACTIONS:
In clinical trials with ivermectin, 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.
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. Ivermectin 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
ivermectin products in dogs, including Collies, when used as recommended.
Ivermectin 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
ivermectin/pyrantel in a heartworm disease prevention 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.
HOW SUPPLIED:
IVERHART Plus Flavored Chewables are available in three dosage strengths
(see Dosage section) for dogs of different weights. Each strength comes in a box
of 6 tablets, packed 10 boxes per display box and in a bulk dispenser carton
containing 20 cards of 6 tablets per card.
Manufactured for:
Vibrac AH, Inc.
Fort Worth, TX
76137, USA
For technical
assistance or to report adverse drug reactions, please call 1-800-338-3659.
© 2001 VibracAH, Inc.
All rights reserved.
LR-IVH2-085-022
|
Recommended
for dogs
|
|
|
up to 25 lbs
body weight
|
500384-01
|
|
26 to 50 lbs
body weight
|
500383-01
|
|
51 to 100 lbs
body weight
|
500382-01
|
|