Interceptor Flavor Tabs for Dogs (5.75 mg) (Canada)

(milbemycin oxime)

DOGS

DIN 02141434 (2.3 mg), 02141426 (5.75 mg), 02141418 (11.5 mg), 02141396 (23.0 mg)

Interceptor Flavor Tabs for Dogs (5.75 mg) Indications

INTERCEPTOR Flavor Tabs are recommended for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of parasitic infections due to adult hookworm (Ancylostoma caninum), adult roundworms (Toxocara canis and Toxascaris leonina), and adult whipworm (Trichuris vulpis) in dogs two weeks of age or greater.

Dosage

Available in four sizes for convenient dosing of dogs of various weights.

The minimum dosage level is 0.5 mg/kg of body weight. Dogs weighing over 45 kg should receive the appropriate combination of Flavor Tabs.

For heartworm prevention, administer INTERCEPTOR Flavor Tabs once per month on the same day.

Reminder stickers are provided for use on a calendar.

The initial dose must be given within a month after the first indication of mosquito activity and regular dosing should continue until at least one month after the end of the mosquito season. If the interval between doses exceeds 30 days, the efficacy of INTERCEPTOR may be reduced. If regular monthly treatment is delayed, it is essential to immediately recommence treatment at the recommended dosage rate. If treatment has been delayed beyond two months, the advice of a veterinarian should be sought. When replacing an existing diethylcarbamazine citrate (DEC) or ivermectin based product, the initial dose of INTERCEPTOR may be given at any time within 30 days of the last treatment with that product.

For hookworm, roundworm and whipworm, control will be obtained in conjunction with heartworm prevention, or by separate administration of INTERCEPTOR Flavor Tabs. INTERCEPTOR should be given to puppies at 2, 4, 6, 8, 10 and 12 weeks of age, then monthly to 6 months of age. In non-heartworm endemic areas, adult dogs should be treated a minimum of 4 times per year, or as directed by the veterinarian.

Administration

INTERCEPTOR Flavor Tabs are highly palatable and may be given by hand. They may also be added to dog food or administered as a regular tablet. The tablet(s) should be placed into the dog’s mouth on the back of the tongue, or can be hidden in food. The dog should be watched closely for several minutes following administration of the INTERCEPTOR Flavor Tab to ensure that the entire dose has been swallowed. If it is suspected that any of the dose has been lost, dosing should be repeated.

Interceptor Flavor Tabs for Dogs (5.75 mg) Cautions

Prior to initiation of INTERCEPTOR Flavor Tab treatment for the first time, dogs 6 months of age or older should be tested for existing heartworm infections. Dogs on preventive medication should be retested at the start of the following season. Thereafter, testing is performed at the veterinarian’s discretion. If positive, dogs should be converted to negative status by the use of appropriate heartworm adulticides prior to INTERCEPTOR use.

Mild, transient 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 events.

Warnings

Keep out of reach of children. If accidentally swallowed, call a physician.

Adverse Reactions

Although all adverse events are not reported, the following information is based on voluntary post-approval drug experience reporting. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data.

The post marketing adverse events reports for INTERCEPTOR have shown suspected lack of efficacy*, emesis/vomiting to be rarely reported¹. Signs of lethargy, diarrhea, anorexia/decreased appetite, convulsion, and ataxia were very rare².

*Product efficacy requires that testing, dosing and administration instructions be carefully followed. Failure to follow label directions could result in a real or perceived lack of efficacy. Several factors, including local parasite prevalence, coprophagia, consistent and compliant administration, as well as timing and frequency of testing, can contribute to a perceived inefficacy. The majority of reports received related to suspected heartworm inefficacy originate from areas of high heartworm prevalence outside Canada.

Very rarely, death has been reported as an outcome of the reported adverse events.

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.

Signs most frequently seen following overdose of INTERCEPTOR include lethargy, ataxia, muscle tremor and emesis.

¹Reported in at least 1 but not more than 10 animals in 10,000 animals.

²Reported in less than 1 in 10,000 animals.

Safety Studies

In safety studies INTERCEPTOR was tested and found to have no adverse reactions in over 75 dog breeds, pregnant females, breeding males and females, and puppies greater than 2 weeks of age and one (1) kilogram body weight when administered at the recommended monthly dosage.

Five pivotal target animal studies provided evidence that milbemycin oxime could be used safely in dogs. Milbemycin was administered daily to reproducing dogs, prior to mating and during gestation, without detectable adverse effects.

In a chronic study (10 months) milbemycin was given to dogs at rates up to 5X the monthly use rate, on three consecutive days. The only adverse effects found were transient ataxia and trembling in some 8-week old puppies. An additional study in 8-week old puppies demonstrated no adverse effects when milbemycin was given for 3 days at the proposed rate and only minor effects in a few animals at the 5X rate given daily for 3 days.

Two specifically designed target animal safety studies in puppies 2 weeks of age were conducted. These studies demonstrated a very adequate margin of safety for the use of milbemycin in young puppies between 2 and 8 weeks of age.

Seven supportive animal safety studies provided evidence that milbemycin oxime would not be expected to have adverse effects in dogs under normal use conditions and up to 3X the recommended use rate.

Presentation

INTERCEPTOR is available in four Flavor Tab sizes, formulated and package colour coded according to the weight range of the dog.

Available in the following package sizes: 6 INTERCEPTOR Flavor Tabs packaged 10 per display carton.

Storage Conditions

INTERCEPTOR Flavor Tabs should be stored at room temperature, 15 - 30°C.

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

Date: April 2022

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

© 2022 Elanco or its affiliates

17May2022

CPN: 1231010.10