DRONTAL PLUS- praziquantel/pyrantel pamoate/febantel tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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) 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. 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.

Product summary:

Each tablet size is available in bottles of 50 (puppies and small dogs, medium sized dogs) or 30 (large dogs). Code 08713130-176099    50 Tablets/Bottle       (Puppies and Small Dogs) Code 08713149-177099    50 Tablets/Bottle       (Medium Sized Dogs) Code 08724639                 30 Tablets/Bottle       (Large Dogs)

Authorization status:

New Animal Drug Application

Summary of Product characteristics

DRONTAL PLUS- PRAZIQUANTEL/PYRANTEL PAMOATE/FEBANTEL TABLET
BAYER HEALTHCARE LLC ANIMAL HEALTH DIVISION
----------
DRONTAL PLUS
(PRAZIQUANTEL/PYRANTEL PAMOATE/FEBANTEL)
TABLETS
BROAD SPECTRUM ANTHELMINTIC 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 (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.
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 inf