IVERHART PLUS- ivermectin/pyrantel tablet, chewable

Iverhart Plus by

Drug Labeling and Warnings

Iverhart Plus by is a Animal medication manufactured, distributed, or labeled by Virbac AH, Inc, Virbac Corporation, Zhejiang Hisun Pharma, Cosma S.p.A. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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See your veterinarian for more IVERHART PLUS® Chewable Tablets

IVERHART PLUS®
(ivermectin/pyrantel)
Flavored Chewables

PRECAUTIONS

Caution: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

INDICATIONS & USAGE

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 & ADMINISTRATION

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
Up to 25 lbs	1	68 mcg	57 mcg
26 to 50 lbs	1	136 mcg	114 mcg
51 to 100 lbs	1	272 mcg	227 mcg

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 preventive 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 flavored 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 minimizes 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.

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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).

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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

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.

STORAGE AND HANDLING

Store at 20°C – 25°C (68°F – 77°F), excursions permitted between 15°C – 30°C (59°F – 86°F).

Protect product from light.

WARNINGS

Warnings: Use product on or before its expiration date.
Discard or return unused tablets.

ADVERSE REACTIONS

ADVERSE REACTIONS: In clinical trials with ivermectin/pyrantel, 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.

OTHER SAFETY INFORMATION

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

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.

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ANADA 200-302, Approved by FDA.

Manufactured by: Virbac AH, Inc.
Fort Worth, TX 76137, USA

For technical assistance or to report adverse drug reactions, please call 1-800-338-3659.

Package Label Principal Display Panel

Virbac
Animal Health

IVERHART PLUS®
(ivermectin/pyrantel)
Flavored Chewables

26-50 lbs.

Administer once a month to prevent heartworm disease and to treat and control ascarid and hookworm infections in dogs

Each flavored chewable contains 136 mcg ivermectin and 114 mg pyrantel as pamoate salt.

CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

6 | Contains 6 Flavored Chewables

ANADA 200-302                                                    Keep this and all drugs out of the
Approved by FDA                                                          reach of children.

Recommended for dogs up to 26 - 50 lbs. body weight

6 | Contains 6 Flavored Chewables

Manufactured by: Virbac AH, Inc. Fort Worth, TX 76137, USA

For technical assistance or to report adverse drug reactions, please call 1-800-338-3659
ANADA 200-302, Approved by FDA

Store at 20ºC-25ºC (68ºF-77ºF), excursions permitted between 15ºC-30ºC (59ºF-86ºF). Protect product from light.

MADE IN THE USA
www.iverhart.com

INGREDIENTS AND APPEARANCE

IVERHART PLUS 
ivermectin/pyrantel tablet, chewable

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 51311-171
Route of Administration	oral

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D)	IVERMECTIN	0.136 mg
PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7)	PYRANTEL	114 mg

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51311-171-20	1 in 1 BOX
1		6 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200302	12/03/2001

Labeler - Virbac AH, Inc (131568396)

Registrant - Virbac AH, Inc (131568396)

Establishment
Name	Address	ID/FEI	Business Operations
Virbac Corporation		829166276	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Hisun Pharma		654211754	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Cosma S.p.A		428655732	api manufacture