Interceptor Plus (2.3 mg/22.8 mg) (Canada)

Company: Elanco

(milbemycin oxime and praziquantel)

For Veterinary Use Only

Chewable Tablets

For Use in Dogs Only

DIN 02468344 (2.3 mg), 02468352 (5.75 mg), 02468360 (11.5 mg), 02468379 (23 mg)

Description

Each chewable flavoured tablet of INTERCEPTOR PLUS is formulated to provide a minimum of 0.5 mg/kg of milbemycin oxime and 5 mg/kg of praziquantel.

Milbemycin oxime is classified as a macrocyclic anthelmintic.

Praziquantel is classified as an isoquinolone anthelmintic.

Interceptor Plus (2.3 mg/22.8 mg) Indications

INTERCEPTOR PLUS is indicated for the prevention of heartworm disease caused by Dirofilaria immitis; and for the treatment and control of adult roundworms (Toxocara canis, Toxascaris leonina), adult hookworm (Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult tapeworms (Taenia pisiformis, Echinococcus multilocularis, Echinococcus granulosus and Dipylidium caninum) infections in dogs and puppies.

Interceptor Plus (2.3 mg/22.8 mg) Dosage And Administration

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

Dosage Schedule

INTERCEPTOR PLUS may be offered to the dog by hand or added to a small amount of dog food. The chewable tablets should be administered in a manner that encourages the dog to chew, rather than to swallow without chewing. Chewable tablets 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 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.

Interceptor Plus (2.3 mg/22.8 mg) Cautions

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

Do not use in dogs or puppies less than 0.9 kg of body weight.

Treatment with fewer than 6 monthly doses after the last exposure to mosquitoes may not provide complete heartworm prevention. INTERCEPTOR PLUS may not be 100% effective for the prevention of all strains of heartworm infection because as a class, macrocyclic lactone resistance to some strains of Dirofilaria immitis are known to occur.

Prior to administration of INTERCEPTOR PLUS, dogs greater than 6 months of age should be tested for existing heartworm infections. INTERCEPTOR PLUS is not effective against adult D. immitis.

Infected dogs should be treated with labelled adulticides and microfilaricides (if microfilaria are present) as soon after diagnosis as medically practical.

Annual testing of all dogs for heartworm should be done.

Hypersensitivity reactions manifested as laboured respiration, lethargy, vomiting, and salivation 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. In some cases, death has been reported as an outcome of the adverse event.

Puppies 6 to 10 weeks of age may develop mild neurological signs following administration of INTERCEPTOR PLUS.

Use with caution in dogs with a history of seizures.

The safety of INTERCEPTOR PLUS has not been evaluated in dogs used for breeding, pregnant or in lactating females.

Some Collies and other P-glycoprotein-deficient dogs (e.g. with MDR or ABCB1-1-delta gene mutation) are known to be more sensitive to the macrocyclic lactone class of medications. Such dogs may be susceptible to macrocyclic lactone toxicity with over-dosing or when used in combination with other macrocyclic lactone drugs. Signs of depression, hypersalivation, tremor and ataxia have been associated with macrocyclic lactone toxicity.

Warnings

Not for use in humans. Keep out of reach of children.

Adverse Reactions

Based on case reports received under a voluntary reporting system by veterinarians or pet owners/caregivers, the common adverse reactions reported are provided. Case reports often did not provide sufficient information to establish the cause of the signs.

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

To report suspected adverse drug events or for technical assistance, contact Elanco Canada Limited at 1-800-265-5475.

Efficacy Studies

Heartworm Prevention:

In a well-controlled laboratory study, INTERCEPTOR PLUS was 100% effective against a susceptible strain of induced heartworm infections when administered once monthly for 6 consecutive months after the infection.

Intestinal Nematodes and Cestodes Treatment and Control:

Elimination of the adult stage of hookworm (Ancylostoma caninum) the dose limiting parasite for milbemycin oxime, and tapeworms (Echinococcus multilocularis, Echinococcus granulosus, Taenia pisiformis and Dipylidium caninum) infections in dogs was demonstrated in well-controlled laboratory studies.

Palatability:

In a field study of 115 dogs offered INTERCEPTOR PLUS, 108 dogs (94%) accepted the product when offered from the hand as if a treat, 1 dog (0.9%) accepted it from the bowl with food, 2 dogs (1.7%) accepted it when it was placed in the dog’s mouth, and 4 dogs (3.5%) refused it.

ANIMAL SAFETY

INTERCEPTOR PLUS:

In a repeated dose safety study, 40 ten-week-old puppies (10 per group) were dosed with either a sham dose (0X) or 1, 3, or 5X the maximum label exposure of INTERCEPTOR PLUS every 14 days for a total of seven treatments. Ataxia, lethargy, and salivation were seen in the 3X and 5X treated dogs following each of the seven doses. Vomiting was seen in all treatment groups but had a higher incidence in the 3X and 5X treatment groups.

In a repeated dose safety study, 64 six-week-old puppies (16 per group) were dosed with either a sham dose (0X) or 1, 3, or 5X the maximum label exposure of INTERCEPTOR PLUS every 14 days for a total of four treatments. Lethargy was observed in all groups. Ataxia was observed in the three treated groups, including one dog in the 1X treated group. For both lethargy and ataxia the incidence and duration increased in the 3X and 5X groups. These signs were observed during the first 24 hours following treatment. Salivation and tremors were observed in the 3X and 5X treated dogs beginning immediately after dosing and up to six hours post-dose. Vomiting was only observed in the 5X treatment group on most, but not all, treatment days.

STORAGE CONDITIONS

Store at room temperature, between 15°C and 25°C.

HOW SUPPLIED

INTERCEPTOR PLUS is available in four strengths, formulated according to the weight of the dog. Each strength is available in colour-coded packages of one or six chewable tablets each.

MANUFACTURED FOR

Elanco Canada Limited, 1919 Minnesota Court, Suite 401, Mississauga, Ontario L5N 0C9

DATE: March 2022

Interceptor, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

©2022 Elanco or its affiliates.

31Mar2022

CPN: 1231165.3