BENZTROPINE MESYLATE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

benztropine mesylate (UNII: WMJ8TL7510) (benztropine - UNII:1NHL2J4X8K)

Disponible des:

Upsher-Smith Laboratories, LLC

Designació comuna internacional (DCI):

benztropine mesylate

Composición:

benztropine mesylate 0.5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Benztropine mesylate tablets are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders [ except tardive dyskinesia - see PRECAUTIONS] due to neuroleptic drugs (e.g., phenothiazines). Hypersensitivity to benztropine mesylate or to any component of the tablets. Because of its atropine-like side effects, this drug is contraindicated in pediatric patients under three years of age, and should be used with caution in older pediatric patients.

Resumen del producto:

Benztropine Mesylate Tablets, USP, for oral use, are supplied in the following forms: 0.5 mg : Compressed tablet, white, 1/4" diameter, flat beveled edge; one side scored and debossed 832 and BM05 and the other side plain. They are supplied as follows. 1 mg : Compressed tablet, white, 0.231" x 0.420", oval; one side scored and debossed 832 and BM1 and the other side plain. They are supplied as follows. 2 mg : Compressed tablet, white, 9/32" diameter, flat beveled edge; one side scored and debossed 832 and BM2 and the other side plain. They are supplied as follows. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in well-closed containers as defined in the USP. Keep out of reach of children.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

BENZTROPINE MESYLATE- BENZTROPINE MESYLATE TABLET
UPSHER-SMITH LABORATORIES, LLC
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BENZTROPINE MESYLATE TABLETS, USP
RX ONLY
DESCRIPTION
Benztropine mesylate, USP is a synthetic compound containing
structural features found in atropine and
diphenhydramine.
It is designated chemically as 3 -(Diphenylmethoxy)-1 H, 5 H-tropane
methanesulfonate. Its molecular
formula is C
H NO•CH O S, and its structural formula is:
Benztropine mesylate, USP is a crystalline white powder, very soluble
in water, and has a molecular
weight of 403.54.
Each benztropine mesylate tablet, USP for oral administration contains
benztropine mesylate 0.5 mg, 1
mg or 2 mg.
Inactive ingredients: croscarmellose sodium, anhydrous lactose,
magnesium stearate, povidone.
CLINICAL PHARMACOLOGY
Benztropine mesylate possesses both anticholinergic and antihistaminic
effects, although only the
former have been established as therapeutically significant in the
management of parkinsonism.
In the isolated guinea pig ileum, the anticholinergic activity of this
drug is about equal to that of
atropine; however, when administered orally to unanesthetized cats, it
is only about half as active as
atropine.
In laboratory animals, its antihistaminic activity and duration of
action approach those of pyrilamine
maleate.
INDICATIONS AND USAGE
Benztropine mesylate tablets are indicated for use as an adjunct in
the therapy of all forms of
parkinsonism.
Useful also in the control of extrapyramidal disorders _[_except
tardive dyskinesia - _see PRECAUTIONS]_
due to neuroleptic drugs (e.g., phenothiazines).
21
25
4
3
CONTRAINDICATIONS
Hypersensitivity to benztropine mesylate or to any component of the
tablets.
Because of its atropine-like side effects, this drug is
contraindicated in pediatric patients under three
years of age, and should be used with caution in older pediatric
patients.
WARNINGS
Safe use in pregnancy has not been established.
Benztropine mesylate may impair mental and/or physical abilities
required for performance of hazardous
tasks, such as operati