Ivermectin + Pyrantel pamoate + Praziquantel (Rx)

Trade Names:

Iverhart Max® Chewable Tablets

General Description:

Ivermectin + pyrantel pamoate + praziquantel is a combination of 3 anti-parasitic drugs used monthly in dogs to prevent heartworm infection and for the treatment and control of tapeworms, roundworms and hookworms. This product may be given with or without food. Chewable tablets are available in different strengths.

What is this product?

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

Reasons for prescribing:

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

What dogs/cats should not take this medication?

• For use in dogs only
• Puppies less than 8 weeks of age
• Use with caution in sick, debilitated or underweight animals and dogs weighing less than 10 pounds
• This product has not been evaluated in pregnant or nursing animals
• 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
• Pets known to have had an allergic reaction to ivermectin, pyrantel pamoate or praziquantel or like products

Directions:

Give this medication with or without food. 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, hookworms and whipworms.

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, limpness, salivation, shaking, vomiting, diarrhea, decreased appetite, staggering, licking lips and belching 20 minutes to 72 hours following 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 this product is 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, pyrantel pamoate and praziquantel. If you have any questions or concerns about this product or for the condition it was prescribed, contact your veterinarian.

IVERHART MAX^® CHEWABLE TABLETS

Virbac

(ivermectin/pyrantel pamoate/praziquantel)

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 Dosage).

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:

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 mosquitoes.

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 preventive products.

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.

WARNING:

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 lactating bitches.

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 microfilariae.

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 directed.

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 Precautions).

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 76137 USA

IVERHART MAX is a registered trademark of Virbac Corporation.

301733-02, 301734-02