SPIRIDON TABLETS 100MG

País: Singapur

Idioma: anglès

Font: HSA (Health Sciences Authority)

ingredients actius:

Spironolactone

Disponible des:

ORION PHARMA (SG) PTE. LTD.

Codi ATC:

C03DA01

formulario farmacéutico:

TABLET

Composición:

Spironolactone 100.0mg

Vía de administración:

ORAL

tipo de receta:

Prescription Only

Fabricat per:

Orion Corporation, Orion Pharma (Turku)

Estat d'Autorització:

ACTIVE

Data d'autorització:

2023-02-23

Fitxa tècnica

1
1.
NAME OF THE MEDICINAL PRODUCT
Spiridon tablets 25 mg
Spiridon tablets 50 mg
Spiridon tablets 100 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: spironolactone.
_25 mg tablets_: Each tablet contains 25 mg spironolactone.
_50 mg tablets_: Each tablet contains 50 mg spironolactone.
_100 mg tablets_: Each tablet contains 100 mg spironolactone.
3.
PHARMACEUTICAL FORM
Tablets are for oral administration.
Spironolactone tablet 25 mg is an almost white tablet with a diameter
of 7 mm and a flat bevelled
edge. It contains 25 mg spironolactone as drug substance and there is
a code ORN 85 and a score on
the tablet.
Spironolactone tablet 50 mg is an almost white tablet with a diameter
of 9 mm and a flat bevelled
edge. It contains 50 mg spironolactone as drug substance and there is
a code ORN 213 and a score on
the tablet
.
Spironolactone tablet 100 mg is an almost white, biconvex tablet with
a diameter of 11 mm. It
contains 100 mg spironolactone as drug substance and there is a code
ORN 352 and a score on the
tablet.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Spironolactone is indicated for the following:
•
Congestive cardiac failure
•
Hepatic cirrhosis with ascites and oedema
•
Malignant ascites
•
Nephrotic syndrome
•
Diagnosis and treatment of primary aldosteronism.
Children should only be treated under guidance of a paediatrician.
There is limited paediatric data
available (see section 5.1 and 5.2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Administration of spironolactone once daily with a meal is
recommended.
ADULTS
CONGESTIVE CARDIAC FAILURE
2
The usual dosage is 100 mg/day. In difficult or severe cases, the
dosage may be gradually increased up
to 400 mg/day. When oedema is controlled, the usual maintenance level
is 75 mg/day to 200 mg/day.
HEPATIC CIRRHOSIS WITH ASCITES AND OEDEMA
If urinary Na+/K+ ratio is greater than 1.0, the usual adult dose is
100 mg/day. If the ratio is less than
1.0, the usual adult dose is 200 mg/day