Description

IVERHART MAX Tablets

Ivermectin/Pyrantel/Praziquantel Flavored Chewable for Dogs

Manufactured by: Virbac AH

Dosage form: Tablets

Presentation: 

Available in 4 dosage strengths in colour coded packages for different weights of dogs.
Box of 6 tablets (packed 10 boxes per display box).
4 convenient weight ranges:
• Toy, 6-12 lbs.
• Small, 12.1-25 lbs.
• Medium, 25.1-50 lbs.
• Large, 50.1-100 lbs.
Use the appropriate combination for dogs over 100 lbs

Ingredients & Composition:

Large (50.1 – 100 lbs)
Each Chew contains:
Ivermectin     272 mcg,
pyrantel as pamoate salt     228 mg and
Praziquantel  228 mg

Medium  (25.1 – 50 lbs)
Each Chew contains:
Ivermectin     136 mcg,
Pyrantel as pamoate salt     114 mg and
Praziquantel 114 mg

Small (12.1 – 25 lbs)
Each Chew contains:
Ivermectin     68 mcg,
Pyrantel as pamoate salt     57 mg and
Praziquantel 57 mg

Toy (6.0 – 12 lbs)
Each Chew contains
Ivermectin     34 mcg,
Pyrantel as pamoate salt     28.5 mg and
Praziquantel 28.5 mg

Ingredients:
• Ivermectin—protects against heartworms
• Pyrantel pamoate—treats and controls roundworms and hookworms
• Praziquantel—treats and controls tapeworms
Contains hydrolyzed poultry liver as part of the bacon flavor palatability enticer
Highly palatable (96%), pork liver flavoured chewable tablet

Description / Action: 

IVERHART MAX (ivermectin/pyrantel pamoate/praziquantel) prevents heartworm disease caused by Dirofilaria immitis, treats and controls 3 common parasites – roundworms (Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense) and tapeworms (Dipylidium caninum, Taenia pisiformis). It is in a bacon-flavored chew that has a 96% acceptance rate.

Class: Dewormer / Parasiticide

Indication / Uses:

Indicated for use in dogs to
• Prevent canine heartworm disease (eliminates tissue stage of Dirofilaria immitis larvae for 30 days after infection)
• Treatment and control of round worms or ascarids (Toxascaris leonina, Toxocara canis) and
• Treatment and control of hookworms (Ancylostoma braziliense, Uncinaria stenocephala, Ancylostoma caninum etc).
• Treatment and control of tapeworms (Dipylidium caninum, Taenia pisiformis).

Dosage and administration:

For oral administration at monthly intervals at the recommended minimum 6 mcg/kg or 2.72 mcg/lb of ivermectin, 5 mg/kg or 2.27 mg/lb of pyrantel and 5 mg/kg or 2.27 mg/lb of praziquantel.

Recommended dosing schedule:

Dog Weight Pounds	Chew per Month	Chew Size	Ivermectin Content	Pyrantel Pamoate Content	Praziquantel Content
6.0 to 12	1	Toy	34 mcg	28.5 mg	28.5 mg
12.1 to 25	1	Small	68 mcg	57 mg	57 mg
25.1 to 50	1	Medium	136 mcg	114 mg	114 mg
50.1 to 100	1	Large	272 mcg	228 mg	228 mg

Use the appropriate combination for dogs over 100 lbs.

This schedule is helpful in both prevention of Dirofilaria or canine heartworm disease and for the treatment + control of intestinal roundworms, hookworms and tapeworms.

Directions for use:

Only one tablet at a time should be removed from the foil-backed blister card. It can either be offered to the dog by hand or may be added intact to a small amount of dog food. It can also be placed in the back of the dog’s mouth for forced swallowing.

Take care of complete consumption 0f dose, and after administration treated animals should be observed for a few minutes to ensure if part of the dose is not lost or rejected. In case of suspected loss of the dose, redosing is recommended.

Frequency:

During the period of the year when mosquitoes (vectors) are active and potentially carrying infective heartworm larvae; it should be given at monthly intervals.

Within 30 days after the dog’s first exposure to mosquitoes give the initial dose and final dose within a month after the last exposure.

In case if you are replacing another heartworm preventive medicine then first dose must be given within 30 days of the last dose of the former medication.

Efficacy of ivermectin can be reduced in case administration gap exceeds 30 days. To maintain optimal performance, administer once in a month on or about the same day of the month. If the treatment is delayed, whether by a few days or many, immediate treatment and resumption of the recommended dosing regimen minimizes the opportunity for the development of adult heartworms. Clients should be advised to take measures to prevent reinfestation with intestinal parasites.

EFFICACY:

Oral administration of the recommended dose and regimen is effective against the larval stage of Dirofilaria immitis for a period of 30 days after infection and the elimination of adult stages of hookworm (Ancylostoma caninum, Uncinaria stenocephala, Anyclostoma braziliense), roundworm (Toxocara canis, Toxascaris leonina), and tapeworm (Dipylidium caninum, Taenia pisiformis) infections in dogs was demonstrated in well-controlled laboratory studies.

Species: For Oral Use in Dogs Only.

Benefits:

• Cost-effective formula and Affordable heartworm and internal parasite protection against hookworms, roundworms, and tapeworms
• Easy Dosing: 96.3% acceptance rate
• Bacon flavor that dogs love
• Beef-free—safe for dogs with beef allergies
• The only ivermectin-based, bacon-flavored chew
• Can be given to puppies 8 weeks or older

Over-dosage / Side effects / Contraindications /Warnings:

In safety studies in some dogs testicular hypoplasia was observed. These dogs received 3 and 5 times of the maximum recommended dose monthly for 6 months. Use with caution in dogs weighing less than 10 lbs, debilitated or underweight and sick animals and dogs.

Six months before and after starting a preventive program, all dogs should be tested for heartworm infestation because Iverhart Max is not effective against adult heartworms and infected dogs must be treated to remove adult heartworms before starting preventive dosing.

Clinical trials have rarely shown vomiting or diarrhoea within 24 hours of dosing with ivermectin/pyrantel/praziquantel. At recommended dose levels Iverhart Max is not effective against microfilariae clearance. Some dogs that have circulating microfilariae a mild hypersensitivity-type reaction, presumably due to dead or dying heartworm larvae and particularly involving a transient diarrhea, has been observed in clinical trials with ivermectin alone after treatment.

Commonly encountered self-limiting adverse reactions following the Iverhart Max administration include difficulty swallowing, diarrhea, vomiting, excessive salivation, lethargy, increased water consumption, and coughing. Other self-limiting adverse reactions with ivermectin/pyrantel pamoate/praziquantel tablets observed were lethargy, limpness, salivation, shaking, diarrhea, decreased appetite, licking lips, and belching between 20 minutes and 72 hours following treatment in a field study.

Adverse reactions like depression/lethargy, vomiting, anorexia, diarrhea, mydriasis, ataxia, staggering, convulsions, and hypersalivation have been reported in dogs following the use of ivermectin products.

Pharmaceutical precautions / Instructions: 

Keep out of the reach of kids/children. Contact a medical professional immediately in case of accidental ingestion by human beings.

Store at 20°C – 25°C, excursions permitted between 15°C – 30°C. Protect product from light. Use product on or prior to its expiry date. Dispose of or return unused tablets.

Safety: Age / Pregnancy/ Withdrawal:

The safety in pregnant or lactating bitches hasn’t been evaluated. Research studies with ivermectin demonstrates that certain Collie breed dogs are more sensitive at elevated dose levels of greater than 16 times of the normal level of 6 mcg/kg in comparison to the dogs of other breeds. Sensitive dogs at these elevated dose levels showed adverse reactions like mydriasis, tremors, depression, ataxia, excitability, paresis, recumbency, drooling, stupor, coma and death. lvermectin showed no signs of poisoning at ten times (60 mcg/kg) of the recommended dose (6 mcg/kg) in sensitive Collies. Outcome of these trials and bioequivalency studies, supports the safety of ivermectin products in dogs, including Collie breed, when used as recommended.

IVERHART MAX is well tolerated and rare digestive or neurological side effects are reported in healthy dogs.

The margin of safety is narrower than reported in these studies because ivermectin and praziquantel are approximately 30% more bioavailable in the IVERHART MAX Chew than in the ivermectin/pyrantel pamoate/praziquantel tablets used in the following target animal safety studies.

Individual dogs given IVERHART MAX Chew may experience more adverse events than dogs given ivermectin/ pyrantel/praziquantel pills.

In a target animal safety study employing ivermectin/pyrantel/praziquantel tablets, dosages of 1, 3, and 5 times the maximum recommended dose of 12.5 mcg/kg ivermectin, 10.47 mg/kg pyrantel, and 10.47 mg/kg praziquantel, respectively were given to 8-week-old Beagle pups.

 For six months, the dogs were treated every 30 days. Within 6 hours of dose, there was vomiting, and within 24 hours after dosing, there was soft or watery faeces.

Ano-genital swelling, sleepiness/lethargy, head movements, shallow, audible or difficult breathing, and salivation were also seen during the study. Tremors and decreased activity were observed in one of the dogs in the 5X group.

12-week old Beagle puppies were given 3 and 5 times the recommended dose once weekly for 1 weeks in a laboratory safety trial utilising ivermectin/ pyrantel pamoate/ praziquantel tablets.

12-week-old Beagle puppies receiving 3 and 5 times the recommended dose once weekly for 13 weeks showed a dose-related reduction in testicular maturation compared to controls in a laboratory safety trial using ivermectin/pyrantel pamoate/praziquantel tablets. When compared to untreated controls, all treated puppies had considerably elevated cholesterol levels.

Adult males were given 31.4 mg/kg pyrantel, 37.5 mcg/kg ivermectin, and 31.4 mg/kg praziquantel every 14 days during two full spermatogenic cycles in a reproductive safety study (112 days). Treatment had no effect on the quality of sperm or reproductive health. During this trial, dogs experienced vomiting and soft faeces as a result of their treatment.

One 8.1 pound, 72-day-old dog died 6 days after receiving the label dose of ivermectin/pyrantel pamoate/praziquantel tablets for the treatment of Toxocara canis in a trial. This puppy, like many others in the research, had a high worm burden and was frequently reported to have diarrhoea before and after treatment, which was sometimes bloody.

The only aberrant gross necropsy findings were dehydration and symptoms of anaemia (pale mucous membranes). There was no conclusive cause found. The most serious adverse reactions (lethargy, limpness, and salivation) were found in dogs weighing less than 10 pounds in a 90-day field study employing ivermectin/pyrantel pamoate/praziquantel chews.

Substitute: Updating Soon

Also See KIWOF HART Tablets, Interceptor Plus