GLYCOPYRROLATE INJECTION MULTIDOSE SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

GLYCOPYRROLATE

Tilgjengelig fra:

JUNO PHARMACEUTICALS CORP.

ATC-kode:

A03AB02

INN (International Name):

GLYCOPYRRONIUM

Dosering :

0.2MG

Legemiddelform:

SOLUTION

Sammensetning:

GLYCOPYRROLATE 0.2MG

Administreringsrute:

INTRAMUSCULAR

Enheter i pakken:

100

Resept typen:

Ethical

Produkt oppsummering:

Active ingredient group (AIG) number: 0102396002; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2023-07-05

Preparatomtale

PRODUCT MONOGRAPH
GLYCOPYRROLATE INJECTION MULTIDOSE
0.2 MG / ML
(CONTAINS BENZYL ALCOHOL)
ANTICHOLINERGIC
FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION
STERILE SOLUTION FOR INJECTION
HOUSE STANDARD
Juno Pharmaceuticals Corp.
402-2233 Argentia Road
Mississauga, Ontario
L5N 2X7
Submission Control No.
275408
Date
of
Preparation:
JUL
05, 2023
- 2 -
GLYCOPYRROLATE INJECTION MULTIDOSE
0.2 MG / ML
THERAPEUTIC CLASSIFICATION
Anticholinergic
ACTION AND CLINICAL PHARMACOLOGY
Glycopyrrolate, like other anticholinergic (antimuscarinic) agents,
competitively antagonizes the
action of acetylcholine on structures innervated by postganglionic
cholinergic nerves and on
smooth muscles that respond to acetylcholine but lack cholinergic
innervation.
Glycopyrrolate antagonizes muscarinic symptoms (e.g., bronchorrhea,
bronchospasm, bradycardia
and intestinal hypermotility) induced by cholinergic drugs such as
anticholinesterases.
As a premedicant, Glycopyrrolate Injection reduces excessive
pharyngeal, tracheal and bronchial
secretions and, during anesthesia, it appears to protect the heart
against excessive vagal stimulation.
The polar ammonium moiety of glycopyrrolate limits its passage across
lipid membranes such as
the blood-brain barrier, in contrast to the belladonna alkaloids (such
as atropine), which are
nonpolar tertiary amines.
Consequently, Glycopyrrolate Injection does not cause the central
nervous system effects seen with the belladonna alkaloids.
The onset of action following intramuscular injection of injectable
glycopyrrolate is 20 to 40
minutes. Peak effects occur approximately 30 to 45 minutes after
administration and the duration
of action ranges from 4 to 6 hours. With intravenous injection, the
onset of action is generally
evident within one minute; the duration of action varies, as does that
of all other anticholinergics.
Following intravenous glycopyrrolate, the vagal blocking effects
persist for 2 to 3 hours and the
antisialagogue effects persist up to 7 hours.
- 3 -
INDICATIONS
GASTROINTESTINAL DISORDERS:
Gl