국가: 싱가포르
언어: 영어
출처: HSA (Health Sciences Authority)
Spironolactone
ORION PHARMA (SG) PTE. LTD.
C03DA01
TABLET
Spironolactone 25.0mg
ORAL
Prescription Only
Orion Corporation, Orion Pharma (Turku)
ACTIVE
2023-02-23
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 전체 문서 읽기