EPOPROSTENOL FOR INJECTION POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

EPOPROSTENOL (EPOPROSTENOL SODIUM)

Διαθέσιμο από:

SANDOZ CANADA INCORPORATED

Φαρμακολογική κατηγορία (ATC):

B01AC09

INN (Διεθνής Όνομα):

EPOPROSTENOL

Δοσολογία:

1.5MG

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

EPOPROSTENOL (EPOPROSTENOL SODIUM) 1.5MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

VASODILATING AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0133040002; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED PRE MARKET

Ημερομηνία της άδειας:

2021-04-21

Αρχείο Π.Χ.Π.

_Epoprostenol for Injection Page 1 of 35_
PRODUCT MONOGRAPH
PR
EPOPROSTENOL FOR INJECTION
Epoprostenol Sodium
0.5 mg or 1.5 mg per vial
VASODILATOR
Sandoz Canada Inc.
Date of Revision: December 6, 2018
110 rue de Lauzon
Boucherville, QC, Canada
J4B 1E6
Control Number: 221995
_Epoprostenol for Injection Page 2 of 35_
PR
EPOPROSTENOL FOR INJECTION
Epoprostenol Sodium
0.5 mg or 1.5 mg per vial
ACTION AND CLINICAL PHARMACOLOGY
Epoprostenol sodium, also known as prostacyclin, PGI
2
or PGX, a metabolite of arachidonic
acid, is a naturally occurring prostaglandin. Epoprostenol has two
major pharmacological
actions: (1) direct vasodilation of pulmonary and systemic arterial
vascular beds, and (2)
inhibition of platelet aggregation. In animals, the vasodilatory
effects of epoprostenol reduce
right and left ventricular afterload and increase cardiac output and
stroke volume. The effect of
epoprostenol on heart rate in animals varies with dose. At low doses,
there is vagally mediated
bradycardia, but at higher doses, epoprostenol causes reflex
tachycardia in response to direct
vasodilation and hypotension. No major effects on cardiac conduction
have been observed.
Additional pharmacologic effects of epoprostenol in animals include
bronchodilation, inhibition
of gastric acid secretion, and decreased gastric emptying.
PHARMACOKINETICS
ABSORPTION/DISTRIBUTION:
Epoprostenol is rapidly hydrolyzed at neutral blood pH and is also
subject to enzymatic degradation. No available chemical assay is
sufficiently sensitive and
specific to assess the
_in vivo_
human pharmacokinetics of epoprostenol. Animal studies using
tritium-labelled epoprostenol have indicated a high clearance (93
mL/min/kg), small volume of
distribution (357 mL/kg), and a short half-life (2.7 minutes). During
infusions in animals, steady-
state plasma concentrations of tritium-labelled epoprostenol were
reached within 15 minutes and
were proportional to infusion rates.
METABOLISM:
Tritium-labelled epoprostenol has been administered to humans in order
to identify
the