BENZTROPINE MESYLATE INJECTION, USP- benztropine mesylate injection

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Nexus Pharmaceuticals Inc

INN (Nome Internazionale):

BENZTROPINE MESYLATE

Composizione:

BENZTROPINE MESYLATE 1 mg in 1 mL

Via di somministrazione:

PARENTERAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Injection benztropine mesylate, 1 mg per mL, is a clear, colorless solution and is supplied in boxes of 5 x 2 mL vials. Store at 25°C (77°F): excursions permitted to 15° to 30°C (59 to 86°F) [see USP Controlled room temperature], protect from light, retain in carton until time of use. NDC Number 14789-300-02 Manufactured in the USA for: Nexus Pharmaceuticals, Inc., Lincolnshire, IL 60069                                May 2009        PM-30100 1 Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. 206:1963-1965, Nov.25, 1968 * Registered trademark of MERCK & CO., Inc.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

BENZTROPINE MESYLATE INJECTION, USP- BENZTROPINE MESYLATE INJECTION
NEXUS PHARMACEUTICALS 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 is supplied as a sterile injection for
intravenous and intramuscular use.
Each milliliter of the injection contains:
Benztropine mesylate 1 mg/mL
Sodium chloride 9 mg/mL
Water for injection q.s. 1 mL
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, it s 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).
21
25
4
3
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 may impair mental and/or physical abilities
required for performance of hazardous
tasks, such as operating m