PANACUR- fenbendazole paste

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Fenbendazole (UNII: 621BVT9M36) (Fenbendazole - UNII:621BVT9M36)

Available from:

Schering Corporation

INN (International Name):

Fenbendazole

Composition:

Fenbendazole 100 mg in 1 g

Administration route:

ORAL

Prescription type:

OTC

Therapeutic indications:

Panacur® Paste 10% is indicated for the treatment and control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris ), encysted early 3rd stage (hypobiotic), late 3rd stage and 4th stage cyathostome larvae, small strongyles, pinworms (Oxyuris equi ), ascarids (Parascaris equorum ), and for the control of arteritis caused by 4th stage larvae of Strongylus vulgaris in horses.

Product summary:

Panacur® Paste 10% Equine Dewormer is supplied in 25 gram syringes. Store at or below 25°C (77°F). HOW SUPPLIED: Panacur® Paste 10% Equine Dewormer is supplied in 57 gram syringes, 5 per carton. Store at or below 25°C (77°F).

Authorization status:

New Animal Drug Application

Summary of Product characteristics

PANACUR- FENBENDAZOLE PASTE
SCHERING CORPORATION
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PANACUR
(FENBENDAZOLE)
PASTE 10% (100 MG/G) EQUINE DEWORMER
DESCRIPTION:
Panacur
(fenbendazole) Paste 10% contains the active anthelmintic,
fenbendazole. The
chemical name of fenbendazole is methyl 5-(phenylthio)-2-benzimidazole
carbamate.
The chemical structure is:
Each gram of Panacur
Paste 10% contains 100 mg of fenbendazole and is flavored
with artificial apple-cinnamon liquid.
ACTIONS:
The antiparasitic action of Panacur
Paste 10% is believed to be due to the inhibition of
energy metabolism in the parasite.
INDICATIONS:
Panacur
Paste 10% is indicated for the treatment and control of large
strongyles
(_Strongylus edentatus, S. equinus, S. vulgaris_), encysted early 3rd
stage (hypobiotic),
late 3rd stage and 4th stage cyathostome larvae, small strongyles,
pinworms (_Oxyuris_
_equi_), ascarids (_Parascaris equorum_), and for the control of
arteritis caused by 4th stage
larvae of _Strongylus vulgaris_ in horses.
PRECAUTIONS:
Side effects associated with Panacur
Paste 10% could not be established in well-
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controlled safety studies in horses with single doses as high as 454
mg/lb (1,000 mg/kg)
and 15 consecutive daily doses of 22.7 mg/lb (50 mg/kg). Particularly
with higher doses,
the lethal action of fenbendazole may cause the release of antigens by
the dying
parasites. This phenomenon may result in either a local or systemic
hypersensitivity
reaction. As with any drug, these reactions should be treated
symptomatically.
Panacur
Paste 10% has been evaluated for safety in pregnant mares during all
stages
of gestation with doses as high as 11.4 mg/lb (25 mg/kg) and in
stallions with doses as
high as 11.4 mg/lb (25 mg/kg). No adverse effects on reproduction were
detected. The
recommended dose for control of 4th stage _Strongylus vulgaris_
larvae, 4.6 mg/lb (10
mg/kg) daily for 5 consecutive days, has not been evaluated for safety
in stallions or
pregnant mares.
WARNINGS:
NOT FOR USE IN HUMANS. KEEP OUT OF REACH OF CHILDREN. The Safety Data