N-EPI® 1mgml Concentrate for Solution for Infusion

国: マレーシア

言語: 英語

ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有効成分:

Norepinephrine Bitartrate

から入手可能:

AVERROES PHARMACEUTICALS SDN. BHD.

INN（国際名）:

Norepinephrine Bitartrate

パッケージ内のユニット:

5x4ml Ampoules

製:

PT NOVELL PHARMACEUTICAL LABORATORIES.

製品の特徴

N-EPI
® 1MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
NOREPINEPHRINE BITARTRATE 1 MG
PRODUCT DESCRIPTION
Clear solution, colourless to pale yellow colour and negative
precipitate.
After reconstitution with 5% Glucose solution, and with 0.9% Sodium
chloride solution and 5%
Dextrose solution, the solutions of product remain clear, colourless
and negative of precipitate until 24
hours.
COMPOSITION
Each ml Concentrate for solution for infusion contains Norepinephrine
Bitartrate equivalent to 1mg of
Noradrenaline.
PHARMACODYNAMICS
The vascular effects in the doses normally used clinically result from
the simultaneous stimulation of
alpha and beta adrenergic receptors in the heart and vascular system.
Except in the heart, its action is
predominantly on the alpha receptors. This results in an increase in
the force (and in the absence of vagal
inhibition, in the rate) of myocardial contraction. Peripheral
resistance increases and diastolic and
systolic pressures are raised.
The increase in blood pressure may cause a reflex decrease in heart
rate. Vasoconstriction may result
in decreased blood flow in kidneys, liver, skin and smooth muscles.
Local vasoconstriction may cause
haemostasis and/or necrosis. The effect on blood pressure disappears
1-2 minutes after stopping the
infusion.
PHARMACOKINETICS
Up to 16% of an intravenous dose is excreted unchanged in the urine
with methylated and deaminated
metabolites in free and conjugated forms.
INDICATION
For
blood
pressure
control
in
certain
acute
hypotensive
states
(e.g.,
pheochromocytomectomy,
sympathectomy, poliomyelitis, spinal anaesthesia, myocardial
infarction, septicemia, blood transfusion,
and drug reactions).
As an adjunct in the treatment of cardiac arrest and profound
hypotension.
RECOMMENDED DOSAGE
Norepinephrine Bitartrate Injection is a concentrated, potent drug
which must be diluted in dextrose-
containing solutions prior to infusion. An infusion of N-EPI should be
given into a large vein (see
Warnings and Precautions).
RESTORATION OF BLOOD PRESSURE IN THE ACUTE H