EPOPROSTENOL FOR INJECTION POWDER FOR SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

EPOPROSTENOL (EPOPROSTENOL SODIUM)

から入手可能:

SANDOZ CANADA INCORPORATED

ATCコード:

B01AC09

INN（国際名）:

EPOPROSTENOL

投薬量:

1.5MG

医薬品形態:

POWDER FOR SOLUTION

構図:

EPOPROSTENOL (EPOPROSTENOL SODIUM) 1.5MG

投与経路:

INTRAVENOUS

パッケージ内のユニット:

100

処方タイプ:

Prescription

治療領域:

VASODILATING AGENTS

製品概要:

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

認証ステータス:

CANCELLED PRE MARKET

承認日:

2021-04-21

製品の特徴

_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