GLYCOPYRROLATE INJECTION USP SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

GLYCOPYRROLATE

Διαθέσιμο από:

JAMP PHARMA CORPORATION

Φαρμακολογική κατηγορία (ATC):

A03AB02

INN (Διεθνής Όνομα):

GLYCOPYRRONIUM

Δοσολογία:

0.2MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

GLYCOPYRROLATE 0.2MG

Οδός χορήγησης:

INTRAMUSCULAR

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Ethical

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2022-10-31

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
GLYCOPYRROLATE INJECTION USP
SOLUTION: 0.2 MG / ML
FOR INTRAMUSCULAR (IM) OR INTRAVENOUS (IV) ADMINISTRATION
ANTICHOLINERGIC
JAMP Pharma Corporation
1310 rue Nobel
Boucherville,
Québec
J4B 5H3
Date of Revision:
October 27, 2022
Control # 262480
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PRODUCT MONOGRAPH
GLYCOPYRROLATE INJECTION USP
0.2 MG/ML
THERAPEUTIC CLASSIFICATION
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, Glycopyrrolate 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.
INDICATIONS
GASTROINTESTINAL DISORDERS: Glycopyrrolate Injection USP may be used
in the management of
gas