Heartgard Plus (ivermectin/pyrantel) Chewables for Dogs to prevent canine heartworm disease and for the treatment and control of ascarids and hookworms.  

Why has my veterinarian prescribed Heartgard Plus (ivermectin/pyrantel) Chewables for Dogs?

Ivermectin is used as an intestinal de-wormer and as a preventative for heartworm. It may also be used to treat various types of mites.

Pyrantel pamoate is an anthelmintic. Anthelmintics are used to treat infections with intestinal worms.

How do I give Heartgard Plus (ivermectin/pyrantel) Chewables for Dogs?

• Give this medication to your pet as directed by your veterinarian. READ THE LABEL CAREFULLY.
• If the medicine is a liquid, measure the dose with reasonable care.
• Try to give this medication at about the same time each day.
• DO NOT give the pet more medicine than directed
• DO NOT give more often than directed.
• Try not to miss giving any doses.

What if I miss giving a dose?

Give the dose as soon as possible. If it is almost time for the next dose, skip the missed dose, and continue with the regular schedule. Do not give the pet two doses at once.

How do I store Heartgard Plus (ivermectin/pyrantel) Chewables for Dogs?

• Keep this medicine out of reach of children.
• Store this medicine in a cool, dry place at room temperature. Store away from heat and direct sunlight.
• Do not store this medicine in the bathroom, near the kitchen sink or in damp places. The medicine may break down if exposed to heat or moisture.

What are the potential side effects on ivermectin?

"Use this medication with caution in collie or collie-cross breeds and observe for adverse effects."

• There are very few side effects when the drug is given at the usual dose.
• Ivermectin may cause a shock like reaction in dogs. If this occurs, notify your veterinarian.
• Use this medication with caution in collie or collie-cross breeds and observe for adverse effects.
• Other side effects may occur. If you notice anything unusual, contact your veterinarian.

What are the potential side effects of Pyrantel Pamoate?

"There are very few side effects when the drug is given at the usual dose."

• There are very few side effects when the drug is given at the usual dose.
• Vomiting has been reported.
• Other side effects may occur. If you notice anything unusual, contact your veterinarian.

Are there any possible drug interactions?

• Make sure to tell your veterinarian what other medication you are giving to your pet.
• Quite often, your veterinarian may prescribe two different medications, and sometimes a drug interaction may be anticipated. In this case, your veterinarian may vary the dose and/or monitor your pet more closely.
• Contact your veterinarian if your pet experiences any unusual reactions when different medications are given together.

Ivermectin + Pyrantel pamoate (Rx)

Trade Names:

HEARTGARD® Plus Chewables for Dogs

Iverhart™ Plus Flavored Chewables

Tri-Heart® Plus Chewable Tablets

Worm Shield™ Flavored Chewables

General Description:

Ivermectin + pyrantel pamoate is a combination of 2 anti-parasitic drugs used monthly in dogs and cats to prevent heartworm infection and for the treatment and control of roundworms and hookworms. This product may be given with or without food. Chewable tablets are available in different strengths.

What is this product?

• Ivermectin and pyrantel pamoate is a combination of two anti-parasite drugs
• Ivermectin and pyrantel pamoate is given by mouth

Reasons for prescribing:

• For heartworm prevention in dogs
• For treatment and control of roundworms and hookworms

What dogs/cats should not take this medication?

• For use in dogs only
• Puppies less than 6 weeks of age
• Safe for use in Collies, Australian shepherds, Old English sheepdogs, Shelties and any of these crossbreed dogs if given the regular monthly heartworm preventative dosing level
• Safe for use in breeding, pregnant and nursing animals
• Pets known to have had an allergic reaction to ivermectin or pyrantel pamoate or like products

Directions:

Give this medication with or without food. The medication is meant to be chewed before swallowing. It may be necessary to break the chewable into smaller pieces and hand feed as treats. Ensure that your pet consumes the entire dose.

Give medication as directed by your veterinarian. This medication is often given seasonally.

As a heartworm preventative, this medication is given once a month, beginning within a month after the pet's first exposure to mosquitoes. The medication kills the parasites acquired during the previous month. The final dose should be given within a month of the last exposure to mosquitoes.

Monthly treatment also provides effective treatment and control of roundworms and hookworms.

Ideally, give the medication on or about the same day each month.

What if dose is missed?

If a dose is missed, give it as soon as you can. If it is time already for the next dose, skip the missed dose and go back to the normal schedule. Do not give two doses at the same time. If you miss more than 8 weeks in a row, give the drug as soon as you remember, but you should have your pet's blood tested for heartworms within 6 months (as infection may have occurred).

What to tell/ask veterinarian before giving medication?

Talk to your veterinarian about:

• When will your pet need to be rechecked
• Whether a blood test will need to be performed prior to treatment with this drug
• Risks and benefits of using this drug

Tell your veterinarian about:

• If your pet has experienced side-effects on other drugs/products
• If your pet has experienced digestive upset now or ever
• If your pet has experienced liver or kidney disease now or ever
• If your pet has experienced any other medical problems or allergies now or ever
• All medicines and supplements that you are giving your pet or plan to give your pet, including those you can get without a prescription. Your veterinarian may want to check that all of your pet's medicines can be given together.

Storage and Warnings:

Store in a tight, light resistant, childproof container in a cool, dry place at room temperature away from heat and direct sunlight.

People should not take this product. Keep this and all medication out of reach of children and pets. Call your physician immediately if you accidentally take this product.

Potential side effects:

• When the parasites begin to die off, the animal may experience a mild hypersensitivity reaction including diarrhea
• Self-limiting reactions may include lethargy, vomiting, diarrhea, decreased appetite, staggering, hypersalivation, convulsions within 24 hours of treatment
• It is important to stop therapy and contact your veterinarian immediately if you think your pet has a medical problem or side effect from this product's therapy

Can this drug be given with other drugs?

• Yes, when ivermectin and pyrantel are used at the recommended dose, there are no contraindicated drugs. When higher doses are used, interactions may occur with amitraz dips and collars (Mitaban®, Preventic®), spinosad (Comfortis™) or diazepam or related tranquilizers.
• If your pet experiences any unusual reactions when taking multiple medications, contact your veterinarian

Overdosing?

Contact your veterinarian immediately if pet consumes more than the prescribed amount.

What else should I know?

Notify your veterinarian if your animal's condition does not improve or worsens despite this treatment.

As with all prescribed medicines, this product should only be given to the dog/cat for which it was prescribed. It should be given only for the condition for which it was prescribed.

This is just a summary of information about ivermectin and pyrantel pamoate. If you have any questions or concerns about this product or for the condition it was prescribed, contact your veterinarian.

HEARTGARD^® PLUS CHEWABLES FOR DOGS

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:

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°F - 77°F (20° - 25°C). Excursions between 59°F - 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.

HOW SUPPLIED: HEARTGARD Plus is available in three dosage strengths (See DOSAGE section) for dogs of different weights. Each strength comes in convenient cartons of 6 and 12 chewables.

HEARTGARD and the Dog & Hand logo are registered trademarks of Merial.

For customer assistance, please contact Merial at 1-888-637-4251.

Marketed by Merial Limited, Duluth, GA 30096-4640

Merial Limited, a company limited by shares registered in England and Wales [registered number 3332751] with a registered office at PO Box 327, Sandringham House, Sandringham Avenue, Harlow Business Park, Harlow Essex CM19 5QA, England, and domesticated in Delaware, USA as Merial LLC, with a place of business at 3239 Satellite Blvd., Duluth, GA 30096-4640 USA.

U.S. Pat. 4,199,569

Made in U.S.A.

© 2008 Merial. All Rights Reserved.

Rev. May 2008

1050-1999-01