Drontal Plus: Product Information

DRONTAL PLUS- praziquantel, pyrantel pamoate and febantel tablet
Bayer HealthCare LLC Animal Health Division

CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION:

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

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

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

Each Drontal® Plus Tablet for Large Dogs contains 136.0 mg praziquantel, 136.0 mg pyrantel base as pyrantel pamoate, and 680.4 mg febantel.

ACTION:

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.1 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 stool. The majority of tapeworms are digested and are not found in the feces.

Pyrantel pamoate is active against hookworms and ascarids. Pyrantel pamoate acts on the cholinergic receptors of the nematode resulting in spastic paralysis. Peristaltic action of the intestinal tract then eliminates the parasite. 2

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 without interference. The combined tablet formulation provides a wide spectrum of activity against the indicated species of intestinal helminths.

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 Echincoccus multilocularis). For removal of Hookworms (Ancylostoma caninum,Uncinaria stenocephala), Ascarids (Toxocara canis, Toxascaris leonina), and Whipworms (Trichuris vulpis) in dogs.

CONTRAINDICATIONS:

DO NOT USE IN PREGNANT ANIMALS. Dogs treated with elevated levels (6 consecutive days with 3 times the labeled dosage rate) of the combination of febantel and praziquantel in early pregnancy demonstrated an increased incidence of abortion and fetal abnormalities.8 The effects of Drontal® Plus on pregnant animals have not been determined.

There are no known contraindications against the use of praziquantel or pyrantel pamoate in dogs.

USE DIRECTIONS 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.

DOSAGE CHARTS
*
NOT FOR USE IN PUPPIES LESS THAN 3 WEEKS OF AGE OR DOGS WEIGHING LESS THAN 2 LBS.

Drontal® Plus

Tablets

for Puppies and

Small Dogs *

(2 — 25 lbs.)

Drontal® Plus

Tablets

for Medium

Sized Dogs

(26 — 60 lbs.)

Drontal® Plus

Tablets

for Large Dogs

(45 lbs.

and greater)

Body Wt. (lbs.)

No. of Tablets

Body Wt. (lbs.)

No. of Tablets

Body Wt. (lbs.)

No. of Tablets

2 – 4

5 – 7

8 – 12

13 – 18

19 – 25

0.5

1.0

1.5

2.0

2.5

26 – 30

31 – 44

45 – 60

1.0

1.5

2.0

45 – 60

61 – 90

91 – 120

1.0

1.5

2.0

ADMINISTRATION:

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

RETREATMENT:

For those animals living where reinfections are likely to occur, clients should be instructed in the steps to optimize prevention; otherwise, retreatment 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 and its environment. In addition, for control of Echinococcus multilocularis , a program of regular treatment every 21 to 26 days may be indicated (see E. multilocularis section below).

ECHINOCOCCUS MULTILOCULARIS:

Echinococcus multilocularis a tapeworm species usually found in wild canids, including foxes, coyotes and wolves. The parasite has also been identified in domestic dogs and cats and is potentially a serious public health concern because it may infect humans.

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

Tapeworm Lifecycle

The adult tapeworm is small (1-4mm) and resides in the intestinal tract of the definitive host (wild or domestic canids). Eggs from the adult tapeworm are shed in the feces. Rodents such as mice and voles serve as the intermediate host. 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. Larvae within the cyst develop into adult tapeworms in the intestinal tract of the canid. Eggs may 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, a highly pathogenic condition (Alveolar Hydatid Disease) results from development of the cyst stage in humans.

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. 3,4

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

Additional information on the life cycle and epidemiology of this parasite is available in veterinary parasitology texts. 5,6

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