DRONTAL PLUS TASTE TABS- praziquantel/pyrantel pamoate/febantel tablet, chewable

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457), PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7), FEBANTEL (UNII: S75C401OS1) (FEBANTEL - UNII:S75C401OS1)
Available from:
Bayer HealthCare LLC Animal Health Division
INN (International Name):
PRAZIQUANTEL
Composition:
PRAZIQUANTEL 22.7 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION
Therapeutic indications:
Drontal® Plus (praziquantel/pyrantel pamoate/febantel) Taste Tabs® Broad Spectrum Chewable Anthelmintic Tablets are indicated for removal of Tapeworms (Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus, and removal and control of Echinococcus multilocularis ) and for removal of Hookworms (Ancylostoma caninum, Uncinaria stenocephala ), Ascarids (Toxocara canis, Toxascaris leonina ), and Whipworms (Trichuris vulpis ) in dogs. 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 Anthelmintic Tablets on pregnant animals have not been determined. There are no known contraindications against the use of praziquantel or pyrantel pamoate in dogs.
Product summary:
Drontal® Plus Taste Tabs® Tablets are available in three tablet sizes: Code    08758428: 40 tabs/box for Puppies and Small Dogs Code    08892051: 40 tabs/box for Medium Sized Dogs Code    08892078: 30 tabs /box for Large Dogs
Authorization status:
New Animal Drug Application
Authorization number:
0859-2180-01, 0859-2181-01, 0859-2182-01

DRONTAL PLUS TASTE TABS- praziquantel/pyrantel pamoate/febantel tablet, chewable

Bayer HealthCare LLC Animal Health Division

----------

Drontal

Plus

(praziquantel/pyrantel pamoate/febantel)

Taste Tabs

Broad Spectrum Chewable Anthelmintic Tablets for Dogs

CAUTION:

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

DESCRIPTION:

Drontal

Plus Taste Tabs

(praziquantel/pyrantel pamoate/febantel) Broad Spectrum Chewable

Anthelmintic Tablets for Dogs are available in three tablet sizes. Each size is scored for convenient

oral administration.

Each Drontal Plus Taste Tabs 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 Taste Tabs 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 Taste Tabs 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 Taste Tabs

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 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.

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 Anthelmintic 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) Taste Tabs

Broad Spectrum Chewable

Anthelmintic Tablets are indicated for removal of Tapeworms (Dipylidium caninum, Taenia pisiformis,

Echinococcus granulosus, and removal and control of Echinococcus multilocularis) and 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.

The effects of Drontal

Plus

Anthelmintic Tablets on pregnant animals have not been determined.

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

PRECAUTIONS:

Strict hygienic precautions should be taken when handling dogs or feces suspected of harboring E.

multilocularis. Infected dogs treated for the first time with Drontal

Plus Taste Tabs

Tablets and dogs

treated at intervals greater than 28 days may shed eggs in the feces after treatment. The animal 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 the animal was maintained or in contact with

should be thoroughly cleaned with sodium hypochlorite and allowed to dry completely before reuse.

WARNING:

KEEP OUT OF REACH OF CHILDREN.

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.

DRONTAL PLUS TASTE TABS TABLETS DOSAGE CHARTS

for Puppies and Small Dogs

(2 - 25 lbs.)

for Medium Sized Dogs

(26 - 60 lbs.)

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

26 – 30

45 – 60

5 – 7

31 – 44

61 – 90

8 – 12

45 – 60

91 – 120

13 – 18

19 – 25

ADMINISTRATION:

Most dogs find Drontal

Plus Taste Tabs

Tablets palatable. The tablets may be offered to the dog by

hand. Alternatively 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.

®

®

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

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 is 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.

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.

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 Taste Tabs

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.

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 those of

common species such as Taenia pisiformis.

Assistance in the diagnosis of E. multilocularis may be available from a state veterinary diagnostic

laboratory. Additional information regarding areas where E. multilocularis is suspected or has been

confirmed may be obtained from area veterinary schools or the Centers for Disease Control in Atlanta,

TREATMENT:

Dogs infected with E. multilocularis should be treated to prevent exposure of humans to infective eggs

and to break the parasite’s life cycle.

The dosage of Drontal

Plus Taste Tabs

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

conducted with Drontal Plus tablets have demonstrated the recommended dosage is 100% effective.

Under condition of continual exposure to wild rodents, retreatment of the dog at 21-26 day intervals is

recommended to prevent the shedding of infectious eggs.

EFFICACY:

A total of 176 dogs and puppies with naturally acquired or experimental parasite infections were

included in 4 well-controlled laboratory studies to establish the efficacy of Drontal

Plus Anthelmintic

Tablets. In addition, 103 dogs and puppies were included in clinical field studies conducted in 5

veterinary clinics at different geographic locations throughout the United States to further evaluate

safety and efficacy. These studies included dogs of various sizes, ages and breeds. Data from these

studies demonstrated Drontal Plus Anthelmintic Tablets are safe and efficacious for the removal of the

parasite species indicated on the label when used as directed.

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. A follow-up fecal examination should be conducted 2 to 4 weeks after

treatment to determine the need for retreatment.

Palatability: Palatability studies with Drontal

Plus Taste Tabs

Tablets were conducted at 3 different

veterinary clinics in the United States. These studies included a total of 151 dogs (65 males / 86

females) representing 34 different breeds with body weights ranging from 3.8 – 190 lbs. The tablets

were offered free-choice to the dogs by their owners and over 89% of the dogs willingly consumed

the tablets.

ADVERSE REACTIONS:

None of the 103 dogs treated with Drontal

Plus Anthelmintic Tablets in the clinical field studies

exhibited drug-related side effects. Of the 40 dogs treated with Drontal Plus Taste Tabs

Tablets in

laboratory studies, two dogs exhibited vomiting, one puppy exhibited bloody/mucoid stool and one

puppy exhibited watery/profuse stool.

For customer service or to obtain product information, including Material Safety Data Sheet, call 1-

800-633-3796. For medical emergencies or to report adverse reactions, call 1-800-422-9874.

ANIMAL SAFETY:

Controlled safety evaluations have been conducted in dogs with Drontal

Plus (praziquantel/pyrantel

pamoate/febantel) Anthelmintic 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 vomition and non-formed stools. One dog receiving

a 3 times labeled dose had elevated SGPT, SGOT, CPK and GGT readings (outside of normal range) at

6 days post-treatment. No additional findings were noted in hematology/clinical chemistry parameters

nor were there any treatment-related histological lesions. Vomition was the only side effect observed

when dogs received a single treatment of 61 mg praziquantel, 61 mg pyrantel pamoate and 305 mg

febantel/kg with one dog having an elevated SGPT reading (outside of normal range) at 24 hours post-

treatment which had returned to normal by 7 days.

STORAGE CONDITIONS:

Drontal

Plus Taste Tabs

Tablets should be stored at or below 77 °F (25 °C).

Un-blistered whole or partial tablets should be stored in a tightly sealed container.

HOW SUPPLIED:

Drontal

Plus Taste Tabs

Tablets are available in three tablet sizes:

Code 08758428: 40 tabs/box for Puppies and Small Dogs

Code 08892051: 40 tabs/box for Medium Sized Dogs

Code 08892078: 30 tabs /box for Large Dogs

REFERENCES:

Andrews P. 1976. Pharmacokinetic Studies with DRONCIT in Animals Using a Biological Assay.

Veterinary Medical Review. 2:154-165.

Campbell WC. 1986. The Chemotherapy of Parasitic Infections. J. Parasit. 72(1):45-61.

Hildreth MB Johnson MD and Kazacos KR. 1991. A Zoonosis of Increasing Concern in the United

States. Compendium for Cont. Ed. 13(5): 727-740.

Lieby PD Carney WP and Woods CE. 1970. Studies on Sylvatic Echinococcosis, Ill. Host

Occurrence and Geographic Distribution of Echinococcus multilocularis in the North Central United

States. J. Parasit. 56(6): 1141-1150.

Georgi JR and Georgi ME. 1990. Parasitology for Veterinarians. W.B. Saunders Co. 118-138.

Soulsby EJL. 1982. Helminths, Arthropods and Protozoa of Domesticated Animals. 7th Edition. Lea &

Febiger. 118-138.

Craig PS and McPharson CNL. 1988. Sodium Hypochlorite as an Ovicide for Echinococcus. Ann

Trop Med. and Parasit. 82(2): 211-213.

Freedom of Information Summary (FOI) NADA 133-953 Vercom Paste (febantel and praziquantel).

U.S. Patent No. 7,348,027

October, 2013

18492

©2013 Bayer HealthCare LLC

Bayer, the Bayer Cross, Drontal, and Taste Tabs are registered trademarks of Bayer

Bayer HealthCare LLC

Animal Health Division

Shawnee Mission, Kansas 66201 USA

NADA 141-007, Approved by FDA

PRINCIPAL DISPLAY PANEL - Puppies and Small Dogs (2-25 lbs.):

40 Taste Tabs

(4 strips of 10 Tablets)

Drontal

Plus Taste Tabs

(praziquantel/pyrantel pamoate/febantel)

Broad Spectrum Chewable Anthelmintic

For Puppies and Small Dogs (2-25 lbs.)

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

Each Drontal

Plus Taste Tabs

Tablet contains:

22.7 mg praziquantel, 22.7 mg pyrantel base as pyrantel pamoate, and 113.4 mg febantel

Bayer HealthCare LLC, Animal Health Division

Shawnee Mission, Kansas 66201 USA

NADA 141-007, Approved by FDA

WARNING: KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL - Medium Sized Dogs (26-60 lbs.):

40 Taste Tabs

(4 strips of 10 Tablets)

Drontal

Plus Taste Tabs

(praziquantel/pyrantel pamoate/febantel)

Broad Spectrum Chewable Anthelmintic

For Medium Sized Dogs (26-60 lbs.)

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

Each Drontal

Plus Taste Tabs

Tablet contains:

68.0 mg praziquantel, 68.0 mg pyrantel base as pyrantel pamoate, and 340.2 mg febantel

Bayer HealthCare LLC, Animal Health Division

Shawnee Mission, Kansas 66201 USA

NADA 141-007, Approved by FDA

WARNING: KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL - Large Dogs (45 lbs. and greater):

30 Taste Tabs

(3 strips of 10 Tablets)

Drontal

Plus Taste Tabs

(praziquantel/pyrantel pamoate/febantel)

Broad Spectrum Chewable Anthelmintic

For Large Dogs (45 lbs. and greater)

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

Each Drontal

Plus Taste Tabs

Tablet contains:

136.0 mg praziquantel, 136.0 mg pyrantel base as pyrantel pamoate, and 680.4 mg febantel

Bayer HealthCare LLC, Animal Health Division

Shawnee Mission, Kansas 66201 USA

NADA 141-007, Approved by FDA

WARNING: KEEP OUT OF REACH OF CHILDREN

DRONTAL PLUS TASTE TABS

praziquantel/pyrantel pamoate/febantel tablet, chewable

Product Information

Product T ype

PRESCRIPTION ANIMAL DRUG

Ite m Code (Source )

NDC:0 8 59 -218 0

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PRAZIQ UANTEL (UNII: 6 49 0 C9 U457) (PRAZIQUANTEL - UNII:6 49 0 C9 U457)

PRAZIQUANTEL

22.7 mg

PYRANTEL PAMO ATE (UNII: 8 1BK19 4Z5M) (PYRANTEL - UNII:4QIH0 N49 E7)

PYRANTEL

22.7 mg

FEBANTEL (UNII: S75C40 1OS1) (FEBANTEL - UNII:S75C40 1OS1)

FEBANTEL

113.4 mg

Product Characteristics

Color

BROWN

S core

2 pieces

S hap e

FREEFORM (Bo ne)

S iz e

20 mm

Flavor

MEAT (Artificial Beef)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 8 59 -218 0 -0 1

4 in 1 BOX

1

10 in 1 BLISTER PACK

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NADA

NADA1410 0 7

0 1/12/20 0 6

DRONTAL PLUS TASTE TABS

praziquantel/pyrantel pamoate/febantel tablet, chewable

Product Information

Product T ype

PRESCRIPTION ANIMAL DRUG

Ite m Code (Source )

NDC:0 8 59 -218 1

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PRAZIQ UANTEL (UNII: 6 49 0 C9 U457) (PRAZIQUANTEL - UNII:6 49 0 C9 U457)

PRAZIQUANTEL

6 8 mg

PYRANTEL PAMO ATE (UNII: 8 1BK19 4Z5M) (PYRANTEL - UNII:4QIH0 N49 E7)

PYRANTEL

6 8 mg

FEBANTEL (UNII: S75C40 1OS1) (FEBANTEL - UNII:S75C40 1OS1)

FEBANTEL

340 .2 mg

Product Characteristics

Color

BROWN

S core

2 pieces

S hap e

FREEFORM (Bo ne)

S iz e

25mm

Flavor

MEAT (Artificial Beef)

Imprint Code

DP30

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 8 59 -218 1-0 1

4 in 1 BOX

1

10 in 1 BLISTER PACK

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NADA

NADA1410 0 7

0 1/12/20 0 6

DRONTAL PLUS TASTE TABS

praziquantel/pyrantel pamoate/febantel tablet, chewable

Product Information

Product T ype

PRESCRIPTION ANIMAL DRUG

Ite m Code (Source )

NDC:0 8 59 -218 2

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PRAZIQ UANTEL (UNII: 6 49 0 C9 U457) (PRAZIQUANTEL - UNII:6 49 0 C9 U457)

PRAZIQUANTEL

136 mg

PYRANTEL PAMO ATE (UNII: 8 1BK19 4Z5M) (PYRANTEL - UNII:4QIH0 N49 E7)

PYRANTEL

136 mg

FEBANTEL (UNII: S75C40 1OS1) (FEBANTEL - UNII:S75C40 1OS1)

FEBANTEL

6 8 0 .4 mg

Product Characteristics

Color

BROWN

S core

2 pieces

S hap e

FREEFORM (Bo ne)

S iz e

32mm

Bayer HealthCare LLC Animal Health Division

Flavor

MEAT (Artificial Beef)

Imprint Code

DP6 0

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 8 59 -218 2-0 1

3 in 1 BOX

1

10 in 1 BLISTER PACK

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NADA

NADA1410 0 7

0 1/12/20 0 6

Labeler -

Bayer HealthCare LLC Animal Health Division (152266193)

Revised: 3/2020

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