BENZTROPINE MESYLATE injection

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Navinta LLC

Spôsob podávania:

INTRAMUSCULAR

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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.

Prehľad produktov:

Benztropine mesylate injection, USP, 2 mg per 2 mL (1 mg/mL), is a clear, colorless solution and is supplied as follows:- (NDC 68475-512-01) 2 mL vial (NDC 68475-512-02) Carton of 5 X 2 mL vials Recommended Storage: Store at 20° to 25°C (68 to 77°F). [See USP controlled room temperature].

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

BENZTROPINE MESYLATE - BENZTROPINE MESYLATE INJECTION
NAVINTA LLC
----------
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
USP---------------------------------------------------------------------------------
-1 mg
Sodium chloride
USP----------------------------------------------------------------------------------------
9 mg
Water for injection USP
q.s.-------------------------------------------------------------------------------
-1 mL
ACTIONS
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.
21
25
4
3
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
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 effects, this drug is
contraindicated in pediatric patients
under three y