INSPRA TABLETS 50mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

EPLERENONE

Available from:

VIATRIS PRIVATE LIMITED

ATC code:

NIL

Dosage:

50 mg

Pharmaceutical form:

TABLET, COATED

Composition:

EPLERENONE 50 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Viatris Pharmaceuticals LLC

Authorization status:

ACTIVE

Authorization date:

2005-02-17

Patient Information leaflet

Page 1 of 14 
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 tablets 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

HYPERTENSION 
Eplerenone is indicated for the treatment of hypertension.
In these patients, eplerenone may be used 
alone or in combination with other antihypertensive agents. 

HEART FAILURE - POST MYOCARDIAL INFARCTION 
Eplerenone is indicated, in
addition to standard therapy, to reduce the risk
of cardiovascular mortality 
and cardiovascular hospitalization in stable patients
with left ventricular dysfunction (LVEF 
40%) 
and clinical evidence of heart failure
after recent myocardial infarction._ _

NYHA CLASS II (CHRONIC) HEART FAILURE 
Eplerenone is indicated,
in addition to standard optimal therapy to reduce the risk
of cardiovascular 
mortality and  hospitalization in heart failure 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 
>130msec). (see section 5.1)_ _

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 

For the individual adjustment of dose, the
strengths of 25 mg and 50 mg are available.

The maximum 
dose regimen is 50mg daily for heart failure and 100
mg daily for hypertension. 

FOR PATIENTS WITH HYPERTENSION: 

The recommended starting dose of eplerenone
is 50 mg administered once daily. The full therapeutic 
effect of eplerenone is apparent within 4
weeks. For patients with an inadequate blood pressure 
response to 50 mg once daily the dosage of eplerenone should
be increased to 50 mg twice daily. 
Higher do

Summary of Product characteristics

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 tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HYPERTENSION
Eplerenone is indicated for the treatment of hypertension. In these
patients, eplerenone may be used
alone or in combination with other antihypertensive agents.
HEART FAILURE - POST-MYOCARDIAL INFARCTION (MI)
Eplerenone is indicated, in addition to standard therapy, to reduce
the risk of cardiovascular mortality
and cardiovascular hospitalization in stable patients with left
ventricular dysfunction (left ventricular
ejection fraction [LVEF]

40%) and clinical evidence of heart failure after recent MI.
_ _
NEW YORK HEART ASSOCIATION (NYHA) CLASS II (CHRONIC) HEART FAILURE
Eplerenone is indicated, in addition to standard optimal therapy to
reduce the risk of cardiovascular
mortality and hospitalization in heart failure 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) (see section
5.1 PHARMACODYNAMIC PROPERTIES
).
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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 heart failure and 100 mg daily for
hypertension.
FOR PATIENTS WITH HYPERTENSION:
The recommended starting dose of eplerenone is 50 mg administered once
daily. The full therapeutic
effect of eplerenone is apparent within 4 weeks. For patients with an
inadequate blood pressure
response to 50 mg once daily the dosage of eplerenone should be
increased to 50 mg twice daily.
Higher dosages of eplerenone are not recommended because they have no
greater effect on blood
pressure than 100 mg and are associated with an increased risk of
hyperkalemia.
FOR POST-MYOCARDIAL INFARCTION HEART FAILURE PATIENTS:
Th