Inspra

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Eplerenone 50mg; Eplerenone 50mg

Available from:

Viatris Limited

INN (International Name):

Eplerenone 50 mg

Dosage:

50 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Eplerenone 50mg Excipient: Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry Yellow Purified talc Purified water   Sodium laurilsulfate Active: Eplerenone 50mg Excipient: Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry Yellow Purified talc Purified water   Sodium laurilsulfate

Units in package:

Blister pack, PVC/Al Starter, 10 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Pharmacia & Upjohn Company LLC

Therapeutic indications:

Inspra is indicated to reduce the risk of cardiovascular death in combination with standard therapy in patients who have evidence of heart failure and left ventricular impairment within 3 to 14 days of an acute myocardial infarction.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al Starter - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 50 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 60 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2004-02-10

Patient Information leaflet

INSPRA
®
1
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.
_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 slowing the progression of heart
failure by reducing heart damage.
Inspra belongs to a group of
medicines called 'selective
aldosterone blockers' that stop th

Summary of Product characteristics

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NEW ZEALAND DATA SHEET
1. PRODUCT NAME
INSPRA
®
25 mg and 50 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 25 mg film-coated tablet contains 25 mg eplerenone.
Each 50 mg film-coated tablets contains 50 mg eplerenone.
Excipients with known effects:
•
Lactose monohydrate
For the full list of excipients, see section 6.1 – List of
excipients.
3. PHARMACEUTICAL FORM
INSPRA is supplied as yellow, arc diamond, film-coated tablets.
25 MG TABLET:
stylised with ‘NSR’ over ‘25’ on one side and ‘Pfizer’ on
the other.
50 MG TABLET:
stylised with ‘NSR’ over ‘50’ on one side and ‘Pfizer’ on
the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
INSPRA is indicated to reduce the risk of cardiovascular death in
combination with standard
therapy in patients who have evidence of heart failure and left
ventricular impairment within
3 to 14 days of an acute myocardial infarction.
4.2 DOSE AND METHOD OF ADMINISTRATION
INSPRA is usually administered in combination with standard therapies.
The recommended
dose of INSPRA is 50 mg once daily. Treatment should be initiated at
25 mg once daily and
titrated to the target dose of 50 mg once daily within 4 weeks as
tolerated by the patient.
In the pivotal clinical study, eplerenone was added to standard
medical therapy within
3-14 days after an acute qualifying myocardial infarction. There is
evidence that the reduction
in mortality occurred mostly within the first 12 months of INSPRA
treatment. Patients with
chronic heart failure should be reassessed no longer than 12 months
after commencing therapy
and options for the management of chronic heart failure considered.
Serum potassium should
be measured before initiating INSPRA therapy, within the first week
and at 1-month after the
start of treatment or dosage adjustment. Serum potassium should be
assessed periodically
thereafter, and the dose adjusted based on the serum potassium level
(refer table below).
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