GLYCOPYRROLATE INJECTION MULTIDOSE SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

GLYCOPYRROLATE

Disponible des:

MONT-PHARMA INC

Codi ATC:

A03AB02

Designació comuna internacional (DCI):

GLYCOPYRRONIUM

Dosis:

4MG

formulario farmacéutico:

SOLUTION

Composición:

GLYCOPYRROLATE 4MG

Vía de administración:

INTRAMUSCULAR

Unidades en paquete:

1X20 ML

tipo de receta:

Ethical

Área terapéutica:

ANTIMUSCARINICS ANTISPASMODICS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2018-07-23

Fitxa tècnica

PRODUCT MONOGRAPH
GLYCOPYRROLATE INJECTION MULTIDOSE
0.2 MG / ML
HOUSE STANDARD
(Medicinal Ingredient: Each mL contains: Glycopyrrolate 0.2 mg.)
(CONTAINS BENZYL ALCOHOL)
ANTICHOLINERGIC
FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION
STERILE SOLUTION FOR INJECTION
Mont-Pharma Inc.
2379 Rue Guénette
Saint Laurent, Québec
H4R 2E9
Control # 216942
Date of preparation:
July 23, 2018
- 2 -
GLYCOPYRROLATE INJECTION MULTIDOSE
0.2 MG / ML
HOUSE STANDARD
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