BENZTROPINE MESYLATE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

American Health Packaging

INN (Mezinárodní Name):

BENZTROPINE MESYLATE

Složení:

BENZTROPINE MESYLATE 0.5 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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.

Přehled produktů:

Benztropine Mesylate Tablets USP, for oral use, are supplied in the following forms: 0.5 mg: Compressed tablet, white, round, flat-faced beveled edge tablets debossed “N” left of bisect “9” on one side and plain on other side, in Unit dose packages of 100 (10 x 10) NDC 60687-356-01. 1 mg: Compressed tablet, white oval tablets debossed “N” left of bisect “10” on one side and plain on other side, in Unit dose packages of 100 (10 x 10) NDC 60687-368-01. 2 mg: Compressed tablet, white, round, flat-faced beveled edge tablets debossed “N” left of bisect “11” on one side and plain on other side, in Unit dose packages of 100 (10 x 10) NDC 60687-379-01. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. Keep out of reach of children. *Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. 206 : 1963–1965, Nov. 25, 1968.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

BENZTROPINE MESYLATE- BENZTROPINE MESYLATE TABLET
AMERICAN HEALTH PACKAGING
----------
BENZTROPINE MESYLATE TABLETS, USP
8435601/0322
RX ONLY
DESCRIPTION
Benztropine mesylate is a synthetic compound containing structural
features found in
atropine and diphenhydramine.
It is designated chemically as 3α-(Diphenylmethoxy)-1αH,
5αH-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 USP for oral administration contains
benztropine
mesylate USP 0.5 mg, 1 mg or 2 mg.
Inactive ingredients: colloidal silicon dioxide, magnesium stearate,
microcrystalline
cellulose, pregelatinized starch.
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
21
25
4
3
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 mental and/or physical abilities
required for
perform