BENZTROPINE MESYLATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZTROPINE MESYLATE (UNII: WMJ8TL7510) (BENZTROPINE - UNII:1NHL2J4X8K)

Available from:

Bryant Ranch Prepack

INN (International Name):

BENZTROPINE MESYLATE

Composition:

BENZTROPINE MESYLATE 2 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BENZTROPINE MESYLATE- BENZTROPINE MESYLATE TABLET
BRYANT RANCH PREPACK
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BENZTROPINE MESYLATE TABLETS, USP 0.5 MG, 1 MG AND 2 MG
RX ONLY
DESCRIPTION
Benztropine mesylate is a synthetic compound containing structural
features found in atropine and
diphenhydramine.
It is a crystalline white powder, very soluble in water, designated as
3α-(Diphenylmethoxy)-1αH, 5αH-
tropane methanesulfonate, with the following structural formula:
Each tablet, for oral administration, contains 0.5 mg, 1 mg or 2 mg of
benztropine mesylate.
Each tablet contains the following inactive ingredients:
croscarmellose sodium, dibasic calcium
phosphate, lactose monohydrate, magnesium stearate and
microcrystalline cellulose.
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
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).
CONTRAINDICATIONS
Hypersensitivity to benztropine mesylate 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 operating machinery or driving a motor vehicle.
When benztropine mesylate is given concomitantly with phenothiazines,
haloperi