BENZTROPINE MESYLATE injection

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

Benztropine Mesylate (UNII: WMJ8TL7510) (Benztropine - UNII:1NHL2J4X8K)

Disponibil de la:

Akorn

INN (nume internaţional):

Benztropine Mesylate

Compoziție:

Benztropine Mesylate 1 mg in 1 mL

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

For use as an adjunct in the therapy of all forms of parkinsonism (see DOSAGE AND ADMINISTRATION). 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, USP. 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.

Rezumat produs:

Benztropine Mesylate Injection, USP 1 mg per mL, is a clear, colorless solution and is supplied as follows: NDC 17478-012-02 in boxes of 5 x 2 mL ampuls. Storage: Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Akorn Distributed by: Akorn, Inc. Lake Forest, IL 60045 BZ00N Rev. 09/16

Statutul autorizaţiei:

New Drug Application Authorized Generic

Caracteristicilor produsului

BENZTROPINE MESYLATE- BENZTROPINE MESYLATE INJECTION
AKORN
----------
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, USP 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.
21
25
4
3
In laboratory animals, its antihistaminic activity and duration of
action approach those of
pyrilamine maleate.
INDICATIONS
For use as an adjunct in the therapy of all forms of parkinsonism (see
DOSAGE AND
ADMINISTRATION).
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,
USP.
Because of its atropine-like side effec