BENZTROPINE MESYLATE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Par Pharmaceutical, Inc.

INN (Nama Internasional):

BENZTROPINE MESYLATE

Komposisi:

BENZTROPINE MESYLATE 0.5 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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.

Ringkasan produk:

Benztropine Mesylate Tablets, USP are available as follows: 0.5 mg: white, round, flat-faced beveled edge, scored tablets, debossed "2325" on one side and debossed "V" on the reverse side, supplied in bottles of 10, 100 and 1000. 1 mg: white, oval, scored tablets, debossed "2326" on one side and debossed "V" on the reverse side, supplied in bottles of 10, 100 and 1000. 2 mg: white, round, flat-faced beveled edge, scored tablets, debossed "2327" on one side and debossed "V" on the reverse side, supplied in bottles of 10, 100 and 1000. Dispense in a well-closed container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. *Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. 206:1963–1965, Nov. 25, 1968.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

BENZTROPINE MESYLATE- BENZTROPINE MESYLATE TABLET
PAR PHARMACEUTICAL, INC.
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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,
halo