INSPRA 50MG FILM-COATED TABLETS

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

EPLERENONE

Boleh didapati daripada:

VIATRIS SDN. BHD.

INN (Nama Antarabangsa):

EPLERENONE

Unit dalam pakej:

50Tablet Tablets; 30Tablet Tablets

Dikeluarkan oleh:

VIATRIS PHARMACEUTICALS LLC

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
INSPRA
™ FILM-COATED TABLET
Eplerenone (25 mg, 50 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Inspra is used for
2.
How Inspra works
3.
Before you use Inspra
4.
How to use Inspra
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Inspra
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT INSPRA IS USED FOR
Inspra is used in combination with
other drugs to help prevent worsening
of dysfunction of the left lower
chamber of the heart. It is also used
when there is clinical evidence of
heart failure after a recent heart
attack.
HOW INSPRA WORKS
Inspra belongs to a group of
medicines known as selective
aldosterone blocking agents. These
blocking agents inhibit the action of
aldosterone, a substance produced
within the body, which controls your
blood pressure and heart function.
High levels of aldosterone can cause
changes in your body that lead to
heart failure.
BEFORE YOU USE INSPRA
-
_When you must not use it_
Do not take Inspra
•
if you are allergic
(hypersensitive) to eplerenone or
any of the other ingredients of
Inspra.
•
if you have high levels of
potassium in your blood
(hyperkalemia) or any other
conditions associated with high
potassium levels.
•
if you are taking groups of drugs
which help you to excrete
excessive body fluid (potassium
sparing diuretics) or potent
inhibitors of CYP450 3A4 such
as ketoconazole, itraconazole,
and ritonavir.
•
if you have moderate to severe
kidney disease.
•
if you have severe liver disease.
_Pregnancy and lactation_
Ask your doctor or pharmacist for
advice before taking any medicine.
The effect of Inspra has not been
evaluated during pregnancy in
humans.
It is not known if eplerenone is
excreted in human breast milk. A
decision should be made with your
doctor, whether to discontinue
breast-feeding or to discontinue the
drug.
-
_Before you start to use it_
Take special care with Inspra
•
if you have high potassium levels
in your blood
•
if

Ciri produk

1
INSPRA*
EPLERENONE
1.
NAME OF THE MEDICINAL PRODUCT
INSPRA
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: eplerenone.
The tablets for oral administration contain either 25 mg or 50 mg of
eplerenone.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
25 mg tablet: yellow tablet with stylized “Pfizer” on one side of
tablet, “NSR” over “25” on
the other side of tablet.
50 mg tablet: yellow tablet with stylized “Pfizer” on one side of
tablet, “NSR” over “50” on
the other side of tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HEART FAILURE - POST MYOCARDIAL INFARCTION (MI)
Eplerenone is indicated, in addition to standard therapy, to reduce
the risk of cardiovascular
(CV) mortality and morbidity in stable patients with left ventricular
dysfunction (left
ventricular ejection fraction [LVEF] <40%) and clinical evidence of
heart failure after recent
myocardial infarction (MI).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
For the individual adjustment of dose, the strengths of 25 mg and 50
mg are available. The
maximum dose regimen is 50 mg daily.
_For post-MI heart failure patients:_
The recommended maintenance dose of eplerenone is 50 mg once daily
(OD). Treatment
should be initiated at 25 mg once daily and titrated to the target
dose of 50 mg once daily
preferably within 4 weeks, taking into account the serum potassium
level (see Table 1).
Eplerenone therapy should usually be started within 3-14 days after an
acute MI.
Patients with a serum potassium of >5.0 mmol/L should not be started
on eplerenone (see
section
4.3 CONTRAINDICATIONS
).
2
Serum potassium should be measured before initiating eplerenone
therapy, within the first
week and at one month after the start of treatment or dose adjustment.
Serum potassium
should be assessed as needed periodically thereafter.
After initiation, the dose should be adjusted based on the serum
potassium level as shown in
Table 1.
TABLE 1: DOSE ADJUSTMENT IN HEART FAILURE - POST-MI
SERUM POTASSIUM (MMOL/L
OR MEQ/L)
ACTION
DOSE ADJ