Tri-Heart® Plus

(ivermectin/pyrantel)

Chewable Tablets

Caution: Federal 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 roundworms (Toxocara canis, Toxascaris leonina) and hookworms (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense).

DOSAGE: Tri-Heart® 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 roundworms and hookworms is as follows:

Tri-Heart® Plus is recommended for dogs 6 weeks of
age and older. For dogs over 100 lbs, use the appropriate combination of these tablets.

ADMINISTRATION: Remove only one chewable tablet at a time from the blister card.
Because most dogs find Tri-Heart® Plus palatable, the product can be
offered to the dog by hand. Alternatively, it may be added intact to a small amount of dry 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.

Tri-Heart® 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 Tri-Heart® 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 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 Tri-Heart® Plus and resumption of the
recommended dosing regimen minimizes the opportunity for the development of adult
heartworms.

Monthly treatment with Tri-Heart® Plus also provides effective treatment
and control of roundworms (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: Tri-Heart® Plus (ivermectin/pyrantel) 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. Tri-Heart®
Plus chewable tablets are also effective against canine roundworms (T. canis, T. leonina)
and hookworms (A. caninum, U. stenocephala, A. braziliense).

ACCEPTABILITY: In acceptability trials, Tri-Heart® Plus is shown to be
a palatable 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 Tri-Heart® 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 Tri-Heart® Plus.

While some microfilariae may be killed by the ivermectin in Tri-Heart® Plus 
at the recommended dose level, Tri-Heart® 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.

Choking or intestinal obstruction has been reported after dosing with ivermectin/pyrantel. For dogs that normally swallow treats whole, chewables may be broken into pieces (​see Post-Approval Experience).​

Keep this and all drugs out of the reach of children. In case of ingestion by humans, clients
should be advised to consult a physician immediately. Physicians may contact a Poison Control Center for
advice concerning cases of ingestion by humans.

Keep Tri-Heart Plus in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Store at controlled room temperature of 59-86​o F (15-30​o C). Protect product from light.

ADVERSE REACTIONS: In clinical field trials with ivermectin/pyrantel, vomiting or diarrhea
within 24 hours of dosing was observed (1.1% of administered doses). 

​POST-APPROVAL EXPERIENCE:​ The following adverse events are based on post-approval adverse
drug experience reporting for ivermectin/pyrantel. Not all adverse events are reported to FDA/CVM.
It is not always possible to reliably estimate the adverse event frequency or establish a causal
relationship to product exposure using these data.

The following adverse events reported in dogs are listed in decreasing order of reporting frequency:
Vomiting, diarrhea, lethargy, anorexia, seizures, ataxia, muscle tremors, hypersalivation, pruritus.

In some cases, choking or intestinal obstruction has been reported after administration of
ivermectin/pyrantel.

Contact Information: Contact Merck Animal Health at 1-800-224-5318 or www.TriHeartPlus.com.
To report suspected adverse drug experiences, contact Merck Animal Health at 1-800-224-5318.
For additional information about reporting adverse drug experiences for animal drugs, contact FDA
at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae To obtain a Safety Data Sheet(s), contact
Merck Animal Health at 1-800-224-5318 or www.Tri-HeartPlus.com.

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/pyrantel 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 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.

HOW SUPPLIED: Tri-Heart® Plus is available in three dosage strengths (See
DOSAGE section) for dogs of different weights. Each strength comes in convenient packs of 6
chewable tablets.

Manufactured for: Intervet Inc. a subsidiary of Merck & Co. Inc., 126 E. Lincoln Avenue, Rahway, NJ 07065
Manufactured by: Diamond Animal Health, Inc., Des Moines, IA 50327

©2024 Diamond Animal Health. All rights reserved.

02356

Approved by FDA under ANADA # 200-338

www.TriHeartPlus.com

25 lb unit carton

26-50 lb unit carton

51-100 lb unit carton