INSPRA eplerenone 50 mg tablet blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

eplerenone, Quantity: 50 mg

Disponível em:

Viatris Pty Ltd

DCI (Denominação Comum Internacional):

Eplerenone

Forma farmacêutica:

Tablet, film coated

Composição:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; hypromellose; sodium lauryl sulfate; purified talc; magnesium stearate; titanium dioxide; polysorbate 80; iron oxide yellow; iron oxide red; macrogol 400

Via de administração:

Oral

Unidades em pacote:

10, 30, 50, 60

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

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 3-14 days of an acute myocardial infarction (see CLINICAL TRIALS and DOSAGE AND ADMINISTRATION). To reduce the risk of cardiovascular mortality and morbidity in adult patients with NYHA class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF less than or equal to 30% or LVEF less than or equal to 35% in addition to QRS duration of greater than 130 msec), in addition to standard optimal therapy (see CLINICAL TRIALS).

Resumo do produto:

Visual Identification: Arc-diamond shape, yellow, film-coated tablet with the following debossing: 'Pfizer' on one side of the tablet, 'NSR' over '50' on the other; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status de autorização:

Licence status A

Data de autorização:

2005-06-22

Folheto informativo - Bula

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 slowing the progress

Características técnicas

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AUSTRALIAN PRODUCT
INFORMATION –
INSPRA
® (EPLERENONE)
1.
NAME OF THE MEDICINE
Eplerenone
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each INSPRA tablet contains 25 or 50 mg eplerenone.
EXCIPIENT(S) WITH KNOWN EFFECT
lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Tablet, film coated
INSPRA is supplied as yellow, arc diamond, film-coated tablets
containing 25 or 50 mg
eplerenone.
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 3-14 days of an
acute myocardial infarction (see Section 4.2 Dose and method of
administration and
Section 5.1 Pharmacodynamic properties - Clinical trials).
•
to reduce the risk of cardiovascular mortality and morbidity in adult
patients with NYHA
Class II (chronic) heart failure and left ventricular systolic
dysfunction (LVEF ≤30% or
LVEF ≤35% in addition to QRS duration of > 130 msec), in addition to
standard optimal
therapy (see Section 5.1 Pharmacodynamic properties - Clinical
trials).
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4.2 DOSE AND METHOD OF ADMINISTRATION
FOR POST-MYOCARDIAL INFARCTION HEART FAILURE PATIENTS
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 EPHESUS, eplerenone was added to
standard medical therapy
within 3-14 days after an acute qualifying myocardial infarction.
There is evidence that t