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Drontal Plus (Small Dogs) (Canada)

This page contains information on Drontal Plus (Small Dogs) for veterinary use.
The information provided typically includes the following:
  • Drontal Plus (Small Dogs) Indications
  • Warnings and cautions for Drontal Plus (Small Dogs)
  • Direction and dosage information for Drontal Plus (Small Dogs)

Drontal Plus (Small Dogs)

This treatment applies to the following species:
Manufacturer: Bayer

(praziquantel/pyrantel pamoate/febantel)

Broad Spectrum Anthelmintic Tablets for Dogs

DIN 02169517 and DIN 02169525

FOR VETERINARY USE ONLY

Description

Drontal® Plus (praziquantel/pyrantel pamoate/febantel) Broad Spectrum Anthelmintic Tablets are available in two sizes. Each size is scored for convenient oral administration.

Each Drontal® Plus (praziquantel/pyrantel pamoate/febantel) Tablet for Small Dogs contains 22.7 mg praziquantel, 22.7 mg pyrantel base as pyrantel pamoate and 113.4 mg febantel.

Each Drontal® Plus (praziquantel/pyrantel pamoate/febantel) Tablet for Medium and Large Dogs contains 68.0 mg praziquantel, 68.0 mg pyrantel base as pyrantel pamoate and 340.2 mg febantel.

Drontal Plus (Small Dogs) Indications

Drontal® Plus (praziquantel/pyrantel pamoate/febantel) Broad Spectrum Anthelmintic Tablets are indicated for removal of tapeworms (Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus, and removal and control of Echinococcus multilocularis), Hookworms (Ancylostoma caninum, Uncinaria stenocephala), Ascarids (Toxocara canis, Toxascaris leonina), and Whipworms (Trichuris vulpis) in dogs.

Dosage and Administration

Dosage: The presence of parasites should be confirmed by laboratory fecal examination. Weigh the animal before treatment. Administer the proper dosage as specified in the following table, as a single oral treatment.

Drontal® Plus Tablets For Small Dogs

Body Weight

No. of Tablets

(kg)

(lbs)

1.0 - 2.2

2 - 4

0.5

2.3 - 3.2

5 - 7

1.0

3.3 - 5.5

8 - 12

1.5

5.6 - 8.2

13 - 18

2.0

8.3 - 11.4

19 - 25

2.5


Drontal® Plus Tablets For Medium and Large Dogs

Body Weight

No. of Tablets

(kg)

(lbs)

11.5 - 13.5

26 - 30

1.0

14.0 - 20.0

31 - 44

1.5

21.0 - 25.0

45 - 60

2.0

26.0 - 33.0

61 - 74

2.5

34.0 - 40.0

75 - 90

3.0

41.0 - 47.0

91 - 104

3.5

48.0 - 54.5

105 - 120

4.0

Administration: Drontal® Plus Tablets have been developed for oral administration. Tablets may be given directly or offered in a small amount of food. Fasting is neither necessary nor recommended prior to or after treatment.

A follow-up fecal examination should be conducted 2 to 4 weeks after treatment to determine the need for retreatment.

Retreatment: For those dogs living where reinfections are likely to occur, clients should be instructed in the steps to optimize prevention, otherwise treatment may be necessary. This is true in cases of Dipylidium caninum, where reinfection is almost certain to occur if fleas are not removed from the animal(s) and its environment. In addition, for control of Echinococcus multilocularis, a program of regular treatment every 21 to 26 days may be indicated (see Echinococcus multilocularis section below).

Echinococcus multilocularis: Echinococcus multilocularis is a tapeworm species ordinarily considered to be found in wild canids, including foxes, coyotes and wolves. The parasite has also been identified in domestic dogs and cats and potentially is a serious public health concern by involving humans as accidental intermediate hosts.

The life cycle of the parasite is based on a predator-prey relationship, as depicted.

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 (Alevolar 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

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.

® TM see www.bayer.ca/tm-mc

Bayer Inc., 2920 Matheson Blvd East, Mississauga, Ontario L4W 5R6

Last revised: July 2016

CPN: 1223015.3

BAYER
Animal Health

2920 MATHESON BOULEVARD EAST, MISSISSAUGA, ON, L4W 5R6
Telephone:   905-282-5550 or 800-62BAYER (800-622-2937)
Technical Service:   888-663-5326
Order Desk:   800-387-9179
Order Desk Fax:   800-361-3306
Fax:   905-282-5725
Website:   www.animalhealth.bayer.ca
    www.nobiteisright.ca
Every effort has been made to ensure the accuracy of the Drontal Plus (Small Dogs) information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.

Copyright © 2016 North American Compendiums. Updated: 2016-08-21

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