Drontal Plus (Medium and Large Dogs) (Canada)

The adult tapeworm is small (1-4 mm) and resides in the intestinal tract of the definitive host (wild or domestic canids). Eggs from the adult tapeworm are shed in the feces of the infected canid. Rodents such as mice and voles serve as the intermediate host for E. multilocularis. Eggs ingested by rodents develop in the liver, lungs and other organs to form multilocular cysts. The life cycle is completed after a canid consumes a rodent infected with cysts. After ingestion of an infected rodent, larvae within the cyst develop to adult tapeworms in the intestinal tract of the canid. Eggs may begin to be passed in the feces of the canid approximately 28 days later.

This parasite poses a serious public health problem because of the possibility for human involvement in the life cycle. If eggs shed by an infected canid are accidentally ingested, they develop into the cyst stage in humans and cause a highly pathogenic condition (Alveolar Hydatid Disease).

The original geographic distribution of E. multilocularis was primarily confined to northern areas of North America. Current evidence indicates migration of the parasite well into the continental United States.

Domestic dogs living in E. multilocularis endemic areas, who roam freely with the opportunity to catch wild rodents, are at risk for infection. Pet owners should be advised on how to minimize this risk. Proper restraint of roaming dogs should be encouraged, along with regular treatment with Drontal Plus Tablets, following the dosing schedule and precautions indicated above.

Additional information on the life cycle and epidemiology of this parasite is available in veterinary parasitology texts.

Diagnosis: Diagnosis of E. multilocularis in canids is difficult. The adult tapeworm produces no clinical signs of infection. Tapeworm segments (proglottids) are usually not observed in the feces. E. multilocularis eggs, observed using microscopic fecal examination procedures, are similar in appearance to the common taenid species of canids such as Taenia pisiformis.

Assistance in the diagnosis of E. multilocularis may be available from a provincial veterinary diagnostic laboratory. Additional information regarding areas where E. multilocularis is suspected or has been confirmed may be obtained from area veterinary schools.

Treatment: Dogs infected with E. multilocularis should be treated to prevent exposure of humans to infective eggs and to reduce perpetuation of the parasite’s life cycle.

The dosage of Drontal Plus Tablets for removal of E. multilocularis is the same as that indicated for the removal of the other tapeworm species listed on the label. Laboratory efficacy studies have demonstrated the recommended dosage is 100% effective for removal of this tapeworm.

Under condition of continual exposure to wild rodents, treatment of dogs at 21-26 day intervals is recommended to prevent the shedding of infectious eggs.

Contraindications

Not for use in dogs weighing less than 1 kg (2 lbs). Do not administer this drug to breeding animals or to animals kept for breeding purposes.

CAUTIONS:

Strict hygienic precautions should be taken when handling dogs or feces suspected of harbouring E. multilocularis. Infected dogs treated for the first time with Drontal Plus Tablets and dogs treated at intervals greater than 28 days may shed eggs in the feces after treatment. These dogs should be held in the clinic during this interval and all feces should be incinerated or autoclaved. If these procedures are not possible, the eggs can be destroyed by soaking the feces in a sodium hypochlorite (bleach) solution of 3.75% or greater. All areas where a dog was maintained or in contact with should be thoroughly cleaned with sodium hypochlorite and allowed to dry completely before re-use.

Clients should be instructed in the measures to be taken to prevent reinfection with intestinal cestodes and nematodes.

Warnings

Keep out of reach of children.

ADVERSES REACTIONS:

Although all adverse reactions are not reported, the following information is based on voluntary post-approval drug experience reporting. It is generally recognized that this results in significant under-reporting. The adverse events listed here reflect reporting and not necessarily causality. Adverse events are listed by body system, in decreasing order of frequency:

Digestive tract disorders: vomiting, diarrhea

Systemic disorders: lethargy

Behavioural disorders: hyperactivity

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

Clinical Pharmacology

Drontal Plus Tablets contain three active ingredients having different modes of action and spectra of activity. Praziquantel is active against cestodes (tapeworms). Praziquantel is absorbed, metabolized in the liver and excreted in the bile. Upon entering the digestive tract from the bile, cestocidal activity is exhibited. Following exposure to praziquantel, the tapeworm loses its ability to resist digestion by the mammalian host. Because of this, whole tapeworms, including the scolices, are very rarely passed after administration of praziquantel. In many instances, only disintegrated and partially digested pieces of tapeworms will be seen in the stools. The majority of tapeworms are digested and are not found in the feces.

Pyrantel pamoate is active against hookworms and ascarids. Pyrantel pamoate acts upon the nematode’s cholinergic receptors to result in spastic paralysis. Peristaltic action in the intestinal tract is then able to eliminate the parasite.

Febantel is active against nematode parasites including whipworms. Febantel is rapidly absorbed and metabolized in the animal. Available information suggests that the parasite’s energy metabolism is blocked, leading to energy exchange breakdown and inhibited glucose uptake.

Laboratory efficacy and clinical studies conducted with Drontal Plus Tablets demonstrate that each of the three active ingredients act independently of one another without interference. The combined tablet formulation provides a wide spectrum of activity against the indicated species of intestinal helminths.

SAFETY AND EFFICACY STUDIES:

Animal Safety: Controlled safety evaluation have been conducted in dogs with Drontal Plus (praziquantel/pyrantel pamoate/febantel) Tablets. Dogs receiving up to 5 times the label dosage (35 mg praziquantel, 35 mg pyrantel pamoate and 179 mg febantel per kg of body weight) for 3 consecutive days (3 times the label duration) showed clinical signs of vomiting. No adverse trends were observed in hematology/clinical chemistry parameters nor were there any treatment-related abnormal histological findings. Vomiting was also the only adverse event observed when dogs received a single treatment of 61 mg praziquantel, 61 mg pyrantel pamoate and 305 mg febantel/kg.

Efficacy: Drontal Plus (praziquantel/pyrantel pamoate/febantel) Tablets eliminates the adult stage of the following parasites occurring in the intestinal tract when administered orally according to the recommended dosage schedule: Tapeworms (Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus, Echinococcus multilocularis), Hookworms (Ancylostoma caninum, Uncinaria stenocephala), Ascarids (Toxocara canis, Toxascaris leonina), and Whipworms (Trichuris vulpis).

Results obtained in the laboratory and clinical studies indicate small numbers of hookworm or roundworm eggs may be passed in the feces for up to 7 days after treatment although the worms themselves were eliminated.

STORAGE INFORMATION: Store at temperatures between 4-30°C.

How Supplied

Each tablet size is available in bottles of 50 tablets.

MANUFACTURED FOR:

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

DATE: September 2022

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

© 2022 Elanco or its affiliates.

18Oct2022

CPN: 1231214.1