BENZTROPINE MESYLATE tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

McKesson Contract Packaging

INN (Tên quốc tế):

benztropine mesylate

Thành phần:

benztropine mesylate 1 mg

Loại thuốc theo toa:

PRESCRIPTION DRUG

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

BENZTROPINE MESYLATE- BENZTROPINE MESYLATE TABLET
MCKESSON CONTRACT PACKAGING
----------
BENZTROPINE
MESYLATE TABLETS, USP
RX ONLY
DESCRIPTION
Benztropine mesylate 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 is a crystalline white powder, very soluble in
water, and has a molecular weight
of 403.54.
Each benztropine mesylate tablet 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
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 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.
21
25
4
3
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