BENZTROPINE MESYLATE- benztropine tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Cipla USA Inc.

DCI (Denominação Comum Internacional):

BENZTROPINE MESYLATE

Composição:

BENZTROPINE MESYLATE 0.5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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. 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.

Resumo do produto:

Benztropine Mesylate Tablets, USP are available as follows: 0.5 mg white, capsule shaped biconvex tablets de-bossed with 'I' on the left side of bisect and 'G'on the right side of the bisect and "318" on the other side, supplied in bottles of 30 (NDC 69097-826-02), 100 (NDC 69097-826-07) and 1000 (NDC 69097-826-15). 1 mg white, modified oval biconvex tablets de-bossed with "I" on the left side of bisect and "G" on the right side of the bisect on one side and "319" on the other side, supplied in bottles of 30 (NDC 69097-827-02), 100 (NDC 69097-827-07) and 1000 (NDC 69097-827-15). 2 mg white, round, flat faced beveled edged tablets de-bossed with 'I' on the left side of bisect and 'G' on the right side of the bisect and "320" on the other side, supplied in bottles of 30 (NDC 69097-832-02), 100 (NDC 69097-832-07) and 1000 (NDC 69097-832-15). Dispense in a well-closed container as defined in the USP. Store at 20° to 25°C (68° to77°F) [See USP Controlled Room Temperature]. *Duvoisin, R.C.; Katz, R.J.; Amer. Med.Ass. 206:1963-1965, Nov. 25, 1968. Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 Revised: 02/2020

Status de autorização:

Abbreviated New Drug Application

Características técnicas

BENZTROPINE MESYLATE- BENZTROPINE TABLET
CIPLA USA INC.
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BENZTROPINE MESYLATE TABLETS, USP
DESCRIPTION
Benztropine mesylate, USP 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:
C
H NO•CH O S MW 403.55
Each tablet, for oral administration, contains 0.5 mg, 1 mg or 2 mg of
benztropine mesylate USP.
Each tablet contains the following inactive ingredients: lactose
anhydrous, micro-crystalline cellulose,
colloidal silicon dioxide, sodium starch glycolate and magnesium
stearate.
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
21
25
4
3
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,
haloper