Interceptor Plus: Product Information

INTERCEPTOR PLUS- milbemycin oxime and praziquantel tablet, chewable
Elanco US Inc.

PLUS

(milbemycin oxime/praziquantel)

PA102961X

Caution

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Description

INTERCEPTOR PLUS is available in four strengths in color-coded packages for oral administration to dogs and puppies according to their weight. Each chewable flavored tablet is formulated to provide a minimum of 0.23 mg/pound (0.5 mg/kg) of milbemycin oxime and 2.28 mg/pound (5 mg/kg) of praziquantel.

Milbemycin oxime consists of the oxime derivatives of 5-didehydromilbemycins in the ratio of approximately 80% A4 (C32 H45 NO7 , MW 555.71) and 20% A3 (C31 H43 NO7 , MW 541.68). Milbemycin oxime is classified as a macrocyclic anthelmintic.

Praziquantel is an isoquinolone anthelmintic with the chemical name 2-(Cyclohexylcarbonyl)-1,2,3,6,7,-11b-hexahydro-4H-pyrazino [2,1-a]isoquinolin-4-one.

Indications

INTERCEPTOR PLUS is indicated for the prevention of heartworm disease caused by Dirofilaria immitis ; and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm (Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult tapeworm (Taenia pisiformis, Echinococcus multilocularis, Echinococcus granulosus, and Dipylidium caninum) infections in dogs and puppies two pounds of body weight or greater and six weeks of age and older.

Dosage and Administration

INTERCEPTOR PLUS should be administered orally, once every month, at the minimum dosage of 0.23 mg/lb (0.5 mg/kg) milbemycin oxime, and 2.28 mg/lb (5 mg/kg) praziquantel. For heartworm prevention, give once monthly for at least 6 months after exposure to mosquitoes (see EFFECTIVENESS).

Dosage Schedule
Body Weight Milbemycin Oxime per chewable Praziquantel per chewable Number of chewables
2 to 8 lbs. 2.3 mg 22.8 mg One
8.1 to 25 lbs. 5.75 mg 57 mg One
25.1 to 50 lbs. 11.5 mg 114 mg One
50.1 to 100 lbs. 23 mg 228 mg One
Over 100 lbs. Administer the appropriate combination of chewables.

INTERCEPTOR PLUS may be offered to the dog by hand or added to a small amount of dog food. The chewables 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 no part of the dose is lost or rejected. If it is suspected that any of the dose has been lost, redosing is recommended.

Heartworm Prevention:

INTERCEPTOR PLUS should be administered at monthly intervals beginning within 1 month of the dog’s first seasonal exposure to mosquitoes and continuing until at least 6 months after the dog’s last seasonal exposure (see EFFECTIVENESS). INTERCEPTOR PLUS may be administered year-round without interruption. When switching from another heartworm preventative product to INTERCEPTOR PLUS, the first dose of INTERCEPTOR PLUS should be given within a month of the last dose of the former product.

Intestinal Nematode and Cestode Treatment and Control:

Dogs may be exposed to and can become infected with roundworms, whipworms, hookworms, and tapeworms throughout the year, regardless of season or climate. Clients should be advised of appropriate measures to prevent reinfection of their dog with intestinal parasites. Because the prepatent period for E. multilocularis may be as short as 26 days, dogs treated at the labeled monthly intervals may become reinfected and shed eggs between treatments.

Contraindications

There are no known contraindications to the use of INTERCEPTOR PLUS.

Warnings

Not for use in humans. Keep this and all drugs out of the reach of children.

Precautions

Treatment with fewer than 6 monthly doses after the last exposure to mosquitoes may not provide complete heartworm prevention (see EFFECTIVENESS).

Prior to administration of INTERCEPTOR PLUS, dogs should be tested for existing heartworm infections. At the discretion of the veterinarian, infected dogs should be treated to remove adult heartworms. INTERCEPTOR PLUS is not effective against adult D. immitis.

Mild, transient hypersensitivity reactions, such as labored breathing, vomiting, hypersalivation, and lethargy, have been noted in some dogs treated with milbemycin oxime carrying a high number of circulating microfilariae. These reactions are presumably caused by release of protein from dead or dying microfilariae.

Do not use in puppies less than six weeks of age.

Do not use in dogs or puppies less than two pounds of body weight.

The safety of INTERCEPTOR PLUS has not been evaluated in dogs used for breeding or in lactating females. Studies have been performed with milbemycin oxime alone (see ANIMAL SAFETY).

Adverse Reactions

The following adverse reactions have been reported in dogs after administration of milbemycin oxime or praziquantel: vomiting, diarrhea, depression/lethargy, ataxia, anorexia, convulsions, weakness, and salivation.

To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Elanco US, Inc. at 1-888-545-5973. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

Information for Owner or Person Treating Animal:

Echinococcus multilocularis and Echinococcus granulosus are tapeworms found in wild canids and domestic dogs. E. multilocularis and E. granulosus can infect humans and cause serious disease (alveolar hydatid disease and hydatid disease, respectively).

Owners of dogs living in areas where E. multilocularis or E. granulosus are endemic should be instructed on how to minimize their risk of exposure to these parasites, as well as their dog’s risk of exposure. Although INTERCEPTOR PLUS (milbemycine oxime/praziquantel) was 100% effective in laboratory studies in dogs against E. multilocularis and E. granulosus , no studies have been conducted to show that the use of this product will decrease the incidence of alveolar hydatid disease or hydatid disease in humans. Because the prepatent period for E. multilocularis may be as short as 26 days, dogs treated at the labeled monthly intervals may become reinfected and shed eggs between treatments.

Effectiveness

Heartworm Prevention:

In a well-controlled laboratory study, INTERCEPTOR PLUS was 100% effective against induced heartworm infections when administered once monthly for 6 consecutive months. In well-controlled laboratory studies, neither one dose nor two consecutive doses of INTERCEPTOR PLUS provided 100% effectiveness against induced heartworm infections.

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