BENZTROPINE MESYLATE - benztropine mesylate injection, solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

American Regent, Inc.

INN (Medzinárodný Name):

BENZTROPINE MESYLATE

Zloženie:

BENZTROPINE MESYLATE 1 mg in 1 mL

Spôsob podávania:

INTRAMUSCULAR

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 any component of benztropine mesylate injection. 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.

Prehľad produktov:

Benztropine Mesylate Injection, USP 1 mg per mL, is a clear, colorless solution and is supplied in boxes of 5 x 2 mL vials. NDC 0517-0785-05. Recommended Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. 1 Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. 206:1963-1965, Nov. 25, 1968. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Revised: December 2009

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

BENZTROPINE MESYLATE - BENZTROPINE MESYLATE INJECTION, SOLUTION
AMERICAN REGENT, INC.
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BENZTROPINE MESYLATE INJECTION, USP
RX ONLY
DESCRIPTION
Benztropine mesylate is a synthetic compound containing structural
features found in atropine and
diphenhydramine.
It is designated chemically as 8-azabicyclo[3.2.1] octane,
3-(diphenylmethoxy)-, _endo_,
methanesulfonate. Its empirical 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.
Benztropine Mesylate Injection, USP is supplied as a sterile injection
for intravenous and intramuscular
use. Each milliliter of the injection contains:
Benztropine Mesylate: ……….1 mg
Sodium Chloride: .……………9 mg
Water for Injection q.s.: ………1 mL
CLINICAL PHARMACOLOGY
Benztropine mesylate injection 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.
21
25
4
3
Useful also in the control of extrapyramidal disorders (except tardive
dyskinesia — see
PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).
CONTRAINDICATIONS
Hypersensitivity to any component of benztropine mesylate injection.
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 injection may impair mental and/or physical
abilities required for per