Credelio Chewable Tablets (900 mg) (Canada)

Company: Elanco

(lotilaner chewable tablets)

FOR VETERINARY USE ONLY

Description

CREDELIO (lotilaner) is an oral, once-a-month, flavoured chewable tablet for dogs and puppies. CREDELIO are white to beige round biconvex chewable tablets with brownish spots and beveled edges.

Therapeutic Classification

Lotilaner is a member of the isoxazoline family, a class of parasiticides that are inhibitors of gamma-aminobutyric acid (GABA)-gated chloride channels (GABACls). Lotilaner has the chemical composition of 5 - [(5S) - 4,5 - dihydro - 5 - (3,4,5 - trichlorophenyl) - 5 - (trifluoromethyl) - 3 - isoxazolyl] - 3 - methyl - N - [2 - oxo - 2 - [(2,2,2 - trifluoroethyl)amino]ethyl] - 2-thiophenecarboxamide.

Credelio Chewable Tablets (900 mg) Indication

CREDELIO is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Amblyomma americanum (Lone Star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged or deer tick) and Rhipicephalus sanguineus (brown dog tick)] for one month in dogs and puppies.

Credelio Chewable Tablets (900 mg) Dosage And Administration

CREDELIO chewable tablets are given orally once a month, at the minimum dosage of 20 mg/kg (9 mg/lb) and a maximum dose of 43 mg/kg (20 mg/lb).

Use the table to find the right dose for the dog’s weight.

Dosage Schedule

Administer CREDELIO with food.

Flea Treatment And Prevention

Treatment with CREDELIO may begin at any time of the year, preferably starting one month before fleas become active and continuing monthly through the end of flea season.

To minimize the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved flea protection product.

Tick Treatment And Control

Treatment with CREDELIO may begin at any time of the year.

Contraindications

Do not give to puppies younger than 8 weeks of age or to dogs weighing less than 1.4 kg.

Credelio Chewable Tablets (900 mg) Cautions

The safe use of CREDELIO in breeding, pregnant or lactating dogs has not been evaluated.

Lotilaner is a member of the isoxazoline class. This class has been associated with neurological adverse reactions including tremors, ataxia, and seizures. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurological disorders.

Warnings

Not for use in humans. Wash hands after handling the product. Keep out of reach of children.

Adverse Reactions

Three hundred and twelve dogs were enrolled in a multi-centred pivotal field study to evaluate the effectiveness of lotilaner against natural infestations with fleas; 197 of the dogs were treated with CREDELIO. Over the 90-day study period, all observations of potential adverse reactions were recorded. Reactions that occurred at an incidence greater than 1% are presented in the following table.

Percentage of Dogs (%) with Adverse Reactions

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

Pharmacology

Mode Of Action

The primary target of action of the active ingredient of CREDELIO, lotilaner, in insects and acarines is an influx of GABA-mediated chloride, which leads to hyperpolarization of the cellular membrane and generates an inhibitory postsynaptic potential. GABACls are not able to open upon GABA stimulation, defining this molecule as an antagonist of GABACls. Parasites exposed to lotilaner will endure a spastic paralysis leading to their starvation and eventually death.

Pharmacokinetics

Following oral administration in adult dogs, lotilaner is readily absorbed and peak blood concentration is reached within 2 hours. Food enhances the absorption; the bioavailability is 82% in fed dogs and 24% in fasted dogs. The terminal half-life is approximately 4 weeks in adult dogs. Pharmacokinetics change as young puppies grow to adults dogs. The terminal half-life is approximately 10 days in puppies at 2 months of age.

The major route of elimination (approximately 90% of the dose) is biliary excretion and renal excretion is the minor route of elimination (less than 10% of the dose). Lotilaner is metabolized to a small extent into more hydrophilic compounds, which are observed in feces and urine.

Safety

In a margin of safety study, CREDELIO was administered orally to 24, 8-week-old Beagle puppies at average doses of 1, 3, and 5 times the maximum recommended dose at 28-day intervals over an 8-month period. There were also 8 control dogs in the study that were not treated. The average daily and total weight gains of dogs in the 1X male group were less than control dogs and were considered incidental. CREDELIO was not associated with clinically significant changes in daily observations, body weights and food consumption data; electrocardiograms; ophthalmoscopic, physical and neurological examinations; and hematology, clinical chemistry, coagulation or urinalysis parameters. Treatment with CREDELIO was not associated with any other clinically significant adverse clinical observations, gross pathology or histopathological changes except for significantly decreased kidney weights in the animals in the 5x group.

Efficacy

In a well-controlled laboratory study, CREDELIO killed 56.7% of a European strain of flea within 4 hours. In another laboratory study, greater than 99% of fleas were killed within 8 hours and 100% were killed within 12 hours through day 35. CREDELIO kills fleas before they can lay eggs, therefore it breaks the flea life cycle and prevents environmental flea contamination in areas to which the dog has access.

In well controlled laboratory studies, CREDELIO was effective against Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged or deer tick) and Rhipicephalus sanguineus (brown dog tick) with >97% effectiveness 48 hours post-infestation for up to 37 days, and against Amblyomma americanum (Lone Star tick) with >97% effectiveness 48 hours post-infestation up to end of study (30 days post-treatment). In another well-controlled laboratory study, CREDELIO started killing Ixodes ricinus, a European tick within 4 hours of administration.

Lotilaner acts systemically to kill fleas and ticks. Ticks and fleas must attach to or bite the host and feed in order to be exposed to lotilaner.

In a 90-day well-controlled U.S. field study conducted in households with existing flea infestations of varying severity, the effectiveness of CREDELIO against fleas on days 30, 60 and 90 compared to baseline was 99.5%,100% and 100%, respectively. Fifty-two of fifty-five dogs with signs of flea allergy dermatitis showed improvement by day 30 in all signs assessed: erythema, papules, scaling, alopecia, dermatitis/pyodermatitis and pruritus as a direct result of eliminating the fleas; by day 90, fifty-four of the fifty-five dogs showed improvement. CREDELIO was also used concurrently with other medications, such as vaccines, anthelmintics, antibiotics, steroids, NSAIDs, anesthetics, and antihistamines. No adverse reactions were attributed to the concomitant use of CREDELIO with other medications.

Palatability

In the same U.S. field study with client owned dogs, 573 doses of CREDELIO were given to 197 dogs with 100% administration success by dog owners. There were no reports of unsuccessful dosing. Ninety-four percent of the doses were offered by hand, in an empty food bowl or with food. Just 6% of owners placed the tablet in the back of the dog’s mouth.

Storage Conditions

Store at 15°C to 25°C. Excursions permitted between 5°C and 40°C.

HOW SUPPLIED

The product is available in five sizes: 56.25, 112.5, 225, 450, or 900 mg lotilaner per tablet. Each chewable tablet size is available in colour-coded packages of 1, 3 or 6 flavoured chewable tablets. Not all package sizes may be marketed.

DIN 02471205 (56.25 mg), 02471213 (112.5 mg), 02471248 (225 mg), 02471221 (450 mg), 02471256 (900 mg)

MANUFACTURED FOR

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

DATE: April 2022

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

© 2022 Elanco or its affiliates.

30May2022

CPN: 1231175.2