APO-EPLERENONE eplerenone 25 mg tablet blister pack

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

eplerenone, Quantity: 25 mg

Tersedia dari:

Arrotex Pharmaceuticals Pty Ltd

Bentuk farmasi:

Tablet, film coated

Komposisi:

Excipient Ingredients: titanium dioxide; hypromellose; croscarmellose sodium; magnesium stearate; iron oxide yellow; microcrystalline cellulose; iron oxide red; purified talc; lactose monohydrate; macrogol 6000

Rute administrasi :

Oral

Unit dalam paket:

30

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

Eplerenone 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). - 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 CLINICAL TRIALS).

Ringkasan produk:

Visual Identification: Yellow, round, biconvex film coated tablet, engraved with "E25" on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Status otorisasi:

Registered

Tanggal Otorisasi:

2018-08-08

Selebaran informasi

APO-EPLERENONE TABLETS
1
APO-EPLERENONE
TABLETS
_Eplerenone _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about eplerenone. 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 this medicine
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 THIS MEDICINE IS
USED FOR
APO-Eplerenone tablets are used to:
•
treat heart failure in patients who
have experienced a heart attack.
•
reduce the risk of death or need
for hospitalisations due to heart
failure in patients with chronic
heart failure.
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 IT WORKS _
Eplerenone belongs to a group of
medicines called 'selective
aldosterone blockers' that stop the
action of aldosterone, a substance
made by your body.
Aldosterone is important for
regulating blood pressure and is one
of the factors involved

Karakteristik produk

1
AUSTRALIAN PRODUCT INFORMATION
APO-EPLERENONE (EPLERENONE) TABLET
1
NAME OF THE MEDICINE
Eplerenone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg or 50 mg eplerenone, as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
APO-EPLERENONE TABLETS
25 MG:
Yellow, round, biconvex film coated tablet, engraved with “E25” on
one side.
50 MG:
Yellow, round, biconvex film coated tablet, engraved with “E50” on
one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Eplerenone 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 sections 5.1 PHARMACODYNAMIC PROPERTIES -
CLINICAL TRIALS
and 4.2 DOSE AND METHOD OF ADMINISTRATION).
•
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).
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Eplerenone tablets are intended for oral administration.
DOSAGE
FOR POST-MYOCARDIAL INFARCTION HEART FAILURE PATIENTS
Eplerenone is usually administered in combination with standard
therapies. The recommended
dose of eplerenone 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 the
reduction in mortality occurred mostly within the first 12 months of
eplerenone treatment.
Patients with chronic heart failure should be reassessed n