BENZTROPINE MESYLATE tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Leading Pharma, LLC

INN（国际名称）:

BENZTROPINE MESYLATE

组成:

BENZTROPINE MESYLATE 0.5 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Benztropine mesylate tablets, USP 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 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. Because of the atropine-like side effects, benztropine mesylate should be used with caution in pediatric patients over three years of age (see CONTRAINDICATIONS ).

產品總結:

Benztropine Mesylate Tablets, USP, for oral use, are supplied in the following forms: As 0.5 mg: White color, round, flat face beveled edge, bisected, compressed tablets, debossed "EP” above the bisect and "136" below the bisect, on one side and plain on the other side, in bottles of 100 (NDC 69315-136-01), and 1000 (NDC 69315-136-10) tablets. As 1 mg: White color, oval, bisected, compressed tablets, debossed "EP" on the left side and "137" on the right side of the bisect, on one side and plain on the other side, in bottles of 100 (NDC 69315-137-01) and 1000 (NDC 69315-137-10) tablets. As 2 mg: White color, round, flat face beveled edge, bisected, compressed tablets, debossed "EP" above bisect and "138" below bisect on one side and plain on the other side, in bottles of 100 (NDC 69315-138-01) and 1000 (NDC 69315-138-10) tablets. 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. * Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. 206:1963-1965, Nov. 25, 1968. Manufactured and Distributed by: Leading Pharma, LLC 3 Oak Road Fairfield, NJ 07004 USA Rev 04 12/20

授权状态:

Abbreviated New Drug Application

产品特点

BENZTROPINE MESYLATE- BENZTROPINE MESYLATE TABLET
LEADING PHARMA, LLC
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BENZTROPINE MESYLATE TABLETS USP
0.5 MG, 1 MG AND 2 MG
DESCRIPTION
Benztropine mesylate, USP is a synthetic compound containing
structural features
found in atropine and diphenhydramine.
It is designated chemically as 3α-(Diphenylmethoxy) -1α-H,5 α
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: corn starch, dicalcium phosphate anhydrous,
hydrogenated
vegetable oil, lactose anhydrous, lactose monohydrate,
microcrystalline cellulose, talc.
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.
21
25
4
3
INDICATIONS AND USAGE
Benztropine mesylate tablets, USP 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).
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.
WARNINGS
Safe use in pregnancy has not been established.
Benztropine mesylate may impair me