Monodur

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

Isosorbide mononitrate

Tilgængelig fra:

AstraZeneca Pty Ltd

Klasse:

Medicine Registered

Indlægsseddel

MONODUR(R)
1
MONODUR(R)
_Isosorbide mononitrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
Monodur.  It does not contain all the
information that is known about
Monodur.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and
benefits.  Your doctor has weighed
the risks of you taking Monodur
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MONODUR IS FOR
Monodur is used to prevent angina.
Angina is a pain or uncomfortable
feeling in the chest, often spreading
to the arms or the neck and
sometimes to the shoulders and back.
This is caused by too little blood and
oxygen getting to the heart.
The pain of angina is usually brought
on by exercise or stress.
Monodur belongs to a group of
medicines called nitrates.
Monodur works by relaxing the
blood vessels, letting more blood and
oxygen reach the heart.
Your doctor will have explained why
you are being treated with Monodur
and told you what dose to take.
Follow all directions given to you by
your doctor carefully.  They may
differ from the information contained
in this leaflet.
However, your doctor may prescribe
this medicine for another use.  Ask
your doctor if you want more
information.
Monodur is not addictive.
BEFORE YOU USE
MONODUR
_WHEN YOU MUST NOT USE IT_
DO NOT USE MONODUR IF YOU ARE
ALLERGIC TO IT OR FOOD CONTAINING
NITRATES OR NITRITES OR ANY
INGREDIENTS LISTED AT THE END OF THE
LEAFLET.
DO NOT USE MONODUR IF YOU HAVE
ANY OF THE FOLLOWING MEDICAL
CONDITIONS:
*
Low blood pressure
*
Shock including those caused by
low blood pressure or failing
heart
*
Pericarditis (swelling around the
heart)
*
Weakened muscle of the heart
YOU MUST NOT USE MONODUR WHILST
TAKING

Produktets egenskaber

Monodur
®
 Durules
®
 Product Information 
1 (7) 
MONODUR

®
 DURULES
®
 PRODUCT INFORMATION 
(isosorbide mononitrate) 

DESCRIPTION 

MONODUR DURULES contain isosorbide mononitrate (AAN) in a sustained
release 
formulation. 

The chemical name is 1,4:3,6-Dianhydro-D-glucitol 5-nitrate.
 Molecular formula 
C6H9NO6; m.w. 191.14.  Isosorbide mononitrate is a white to pale
yellow crystalline 
powder and is freely soluble in water.  CAS 16051-77-7. 

The chemical structure of isosorbide mononitrate is: 
O
O
H
H
OH
ONO
2

MONODUR DURULES contain the active drug embedded in a porous inert
matrix 
consisting of paraffin-synthetic, aluminium sodium silicate, magnesium
stearate, 
hydroxypropylcellulose and silica - colloidal anhydrous.  In
addition the tablet coating 
contains hypromellose, macrogol, titanium dioxide, hydrogen peroxide,
paraffin- 
synthetic and water-purified. 

PHARMACOLOGY 

Isosorbide mononitrate is an active metabolite of isosorbide dinitrate
and exerts 
qualitatively similar effects.  Isosorbide mononitrate reduces the
workload of the heart 
by producing venous and arterial dilatation.  By reducing the end
diastolic pressure 
and volume, isosorbide mononitrate lowers the intramural pressure,
hence leading to 
an improvement in the subendocardial blood flow.  The net effect when
administering 
isosorbide mononitrate is therefore a reduced workload for the heart
and an 
improvement in the oxygen supply/demand balance of the myocardium. 

Nitrates are highly effective in the prophylaxis of symptomatic and
asymptomatic 
myocardial ischaemia.  Nitrates dilate coronary arteries not only in
pre- and post-
stenotic vessels, but also in eccentric lesions.  The natural
initiator of vascular 
relaxation is thought to be endothelium-derived relaxing factor
(EDRF), which has 
both the clinical and biological characteristics of nitric oxide (NO).
 Organic nitrates 
are metabolised to NO in the muscle cell via a sulfhydryl dependent
mecha