Monopril

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

Fosinopril sodium

Tilgængelig fra:

Bristol-Myers Squibb Australia Pty Ltd

Klasse:

Medicine Registered

Indlægsseddel

MONOPRIL
®

_Fosinopril Sodium (FOS-in-O-pril)_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING MONOPRIL.*
This leaflet answers some common
questions about MONOPRIL. It does
not contain all the available
information. Some of the information
it contains may not apply to you. It
does not take the place of talking to
your doctor or pharmacist.
KEEP THIS LEAFLET.
You may need to refer to it again
later.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING MONOPRIL, ASK YOUR
DOCTOR OR PHARMACIST.
WHAT IS MONOPRIL
USED FOR
MONOPRIL is used for treating high
blood pressure (hypertension) or
heart failure. Both of these are long
term (chronic) diseases so it is
important that you continue to take
your MONOPRIL every day.
HIGH BLOOD PRESSURE
(HYPERTENSION):
Everyone has blood pressure. This
pressure helps get your blood all
around your body. Your blood
pressure may be different at different
times of the day, depending on how
busy or worried you are. If you have
hypertension (high blood pressure),
this means that your blood pressure
stays higher than is needed, even
when you are relaxed.
There are usually no symptoms of
hypertension. The only way of
knowing that you have hypertension
is to have your blood pressure
checked on a regular basis. If high
blood pressure is not treated it can
lead to serious health problems,
including stroke, heart disease and
kidney failure.
HEART FAILURE:
Heart failure means that the heart
muscle cannot pump blood strongly
enough to supply all the blood
needed throughout the body. Heart
failure is not the same as heart attack
and does not mean that the heart
stops. Heart failure may start off with
no symptoms, but as the condition
progresses, patients feel short of
breath or may get tired easily after
light physical activity such as
walking. Some patients may wake up
short of breath at night. Fluid may
collect in different parts of the body,
often first noticed as swollen ankles
and feet.
HOW MONOPRIL
WORKS
MONOPRIL contains fosinopril
sodium. Fo

Produktets egenskaber

Monopril V5.0 
1 November 2012 
1 

PRODUCT INFORMATION 

MONOPRIL
® 

(FOSINOPRIL SODIUM) 

NAME OF THE MEDICINE 

Fosinopril 
sodium 
is 
designated 
chemically 
as: 
_L_-proline, 
4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy)  propoxy]  (4-phenylbutyl)  phosphinyl]acetyl]-, 
sodium salt,_ trans-_. 

DESCRIPTION 

MONOPRIL
®
  (fosinopril  sodium)  is  the  sodium  salt  of  fosinopril,  the  ester  prodrug  of  a 
long-acting angiotensin converting enzyme (ACE) inhibitor,
fosinopril diacid. 

Fosinopril is a sub-class of ACE inhibitors.  It contains a phosphinate group which makes it 
different from other marketed ACE inhibitors. 

Its structural formula is: 

Fosinopril  sodium  is  a 
white 
to 
off-white 
crystalline powder.  It is soluble in water (100 mg/mL) methanol, and ethanol and slightly soluble 
in hexane. 

Its empiric formula is C
30
H
45
NNaO
7
P, and its molecular weight is 585.65. 

MONOPRIL tablets consist of the active ingredient and the following excipients: anhydrous 
lactose, microcrystalline cellulose, crospovidone, povidone and
sodium stearylfumarate. 

PHARMACOLOGY 

In  humans  and  animals,  fosinopril  sodium  following  absorption  is  hydrolyzed  to  the 
pharmacologically  active  fosinopril  diacid,  a  specific  competitive  inhibitor  of  angiotensin 
converting enzyme (ACE). 

Monopril V5.0 
1 November 2012 
2 

ACE, a peptidyldipeptidase, catalyzes the conversion of the decapeptide angiotensin I to the 
octapeptide  angiotensin  II.    Angiotensin  II  is  a  potent  vasoconstrictor  and  it  also  stimulates 
aldosterone secretion by the adrenal cortex, thereby contributing to sodium and fluid retention.

The effects of fosinopril in hypertension appear to result