GLYCOPYRROLATE INJECTION USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

GLYCOPYRROLATE

Available from:

STERIMAX INC

ATC code:

A03AB02

INN (International Name):

GLYCOPYRRONIUM

Dosage:

0.2MG

Pharmaceutical form:

SOLUTION

Composition:

GLYCOPYRROLATE 0.2MG

Administration route:

INTRAMUSCULAR

Units in package:

10X1ML

Prescription type:

Ethical

Therapeutic area:

ANTIMUSCARINICS ANTISPASMODICS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2018-03-12

Summary of Product characteristics

1
PRODUCT MONOGRAPH
GLYCOPYRROLATE INJECTION USP
0.2 MG / ML
FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION
ANTICHOLINERGIC
SteriMax Inc.
2770 Portland Drive
Oakville, Ontario
L6H 6R4
Control no.: 205682
Date of Preparation:
March 9, 2018
2
PRODUCT MONOGRAPH
GLYCOPYRROLATE INJECTION USP
0.2 MG / ML
ANTICHOLINERGIC
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, Glycopytrolate Injection USP 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 USP
does not cause the
central nervous system effects seen with the belladonna alkaloids.
The onset of action following intramuscular injection of
Glycopyrrolate Injection USP 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
: Glycopyrrolate Injection USP may be used in the management
of gastrointestinal disorders amenable to anticholinergic therapy wh