Inspra

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

Eplerenone

थमां उपलब्ध:

Pfizer Australia Pty Ltd

वर्ग:

Medicine Registered

सूचना पत्रक

INSPRA
®

(IN-SPRA)
_Eplerenone_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Inspra.
It does not contain all the available
information. 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 Inspra against
the benefits it is expected to 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 INSPRA IS USED
FOR
_WHAT INSPRA DOES_
•
THIS MEDICINE IS USED TO TREAT
HEART FAILURE IN PATIENTS WHO
HAVE EXPERIENCED A HEART
ATTACK.
A heart attack occurs when one of
the major blood vessels supplying
blood to your heart becomes blocked.
This means that your heart cannot
receive the oxygen it needs and
becomes damaged. This may lead to
further problems, such as heart
failure, irregular heart rhythms and
blood clots.
Heart failure means that the heart
muscle is weak and cannot pump
blood strongly enough to supply all
the blood needed throughout the
body. Heart failure is not the same as
heart attack, and may start off with
mild or no symptoms, but as the
condition progresses, patients may
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, or
have to prop their heads up during
sleep to avoid this problem. Fluid
may collect in different parts of the
body, often first noticed as swollen
ankles and feet.
•
THIS MEDICINE IS ALSO USED TO
REDUCE THE RISK OF DEATH OR NEED
FOR HOSPITALISATIONS DUE TO HEART
FAILURE IN PATIENTS WITH CHRONIC
HEART FAILURE.
_HOW INSPRA WORKS_
Your body makes a substance called
aldosterone. It is important for
regulating blood pressure and is one
of the factors involved in heart
function. Sometimes aldosterone can
cause changes in our body that lead
to heart failure. Inspra works by
blocking the action of aldosterone,
and slow

उत्पाद विशेषताएं

Version: pfpinspt10513 

Supersedes: pfpinspt11109 

Page 1 of 23 
PRODUCT INFORMATION 
INSPRA


(EPLERENONE)  
NAME OF THE MEDICINE

Eplerenone  (CAS  107724-20-9)  is  Pregn-4-ene-7,21-dicarboxylic  acid,  9,11-epoxy-17-
hydroxy-3-oxo, γ-lactone, methyl ester, (7α,11α,17α).  The empirical formula of eplerenone is 
C
24
H
30
O
6
  and  its  molecular  weight  414.50.    The  structural  formula  of  eplerenone  is  shown 
below:

DESCRIPTION

Eplerenone is an odourless, white to off-white crystalline powder.  It
is very slightly soluble in 
water, with  its  solubility essentially pH independent.   The octanol/water partition coefficient 
of eplerenone is approximately 7.1 at pH 7.0.

Each INSPRA tablet contains 25 or 50 mg eplerenone and the following inactive ingredients: 
lactose,  microcrystalline  cellulose,  croscarmellose  sodium,  hypromellose,  sodium  lauryl 
sulfate,  talc-purified,  magnesium  stearate,  titanium  dioxide,  macrogol 400,  polysorbate 80, 
iron oxide yellow (CI77492), and iron oxide red (CI77491). 
PHARMACOLOGY

PHARMACODYNAMICS

Eplerenone is a relatively selective mineralocorticoid receptor
antagonist with weak binding to 
androgen,  glucocorticoid  and  progesterone  receptors.    Eplerenone  prevents  the  binding  of 
aldosterone,  a  key  hormone  in  the  renin-angiotensin-aldosterone-system  (RAAS),  which  is 
involved  in  the  regulation  of  blood  pressure  and  the  pathophysiology  of  cardiovascular 
disease.

Eplerenone  has  been  shown  to  produce  sustained  increases  in  plasma  renin  and  serum 
aldosterone,  consistent  with  inhibition  of the negative regulatory feedback of aldosterone on 
renin  secretion.    The  resulting  increased  plasma  renin�