- Approval Id
- 10435c8e75f36500
- Drug Name
- SPIRIDON TABLETS 25MG
- Product Name
- SPIRIDON TABLETS 25MG
- Approval Number
- SIN16711P
- Approval Date
- 2023-02-23
- Registrant
- ORION PHARMA (SG) PTE. LTD.
- Licence Holder
- ORION PHARMA (SG) PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET
- Dosage
- **4.2 Posology and method of administration**
Posology
Administration of spironolactone once daily with a meal is recommended.
**Adults**
**Congestive cardiac failure**
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 to 400 mg/day. Maintenance dosage should be individually determined.
**Malignant ascites**
Initial dose is usually 100 mg/day to 200 mg/day. In severe cases the dosage may be gradually increased up to 400 mg/day. When oedema is controlled, maintenance dosage should be individually determined.
**Nephrotic syndrome**
The usual adult dose is 100 mg/day to 200 mg/day. Spironolactone has not been shown to be anti-inflammatory, or to affect the basic pathological process. Its use is only advised if glucocorticoids by themselves are insufficiently effective.
**Diagnosis and treatment of primary aldosteronism**
Spironolactone may be employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.
_Long test_: Daily adult dose of 400 mg for 3 to 4 weeks. Correction of hypokalaemia and hypotension provides presumptive evidence for the diagnosis of primary hyperaldosteronism.
_Short test_: Daily dosage of 400 mg for 4 days. If serum potassium increases during spironolactone administration, but drops when spironolactone is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered.
**Short-term preoperative treatment of primary hyperaldosteronism**
After the diagnosis of hyperaldosteronism has been established by more definitive testing procedures, spironolactone may be administered at doses of 100 mg to 400 mg daily in preparation of surgery. For patients who are considered unsuitable candidates for surgery, Spiridon may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient.
**Elderly**
It is recommended that treatment is started with the lowest dose and titrated upwards as required to achieve maximum benefit. Care should be taken with severe hepatic and renal impairment which may alter drug metabolism and excretion.
**Children**
Initial dosage is 3 mg/kg body weight daily in divided doses. Dosage should be adjusted on the basis of response and tolerance (see sections 4.3 and 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Children should only be treated under guidance of a paediatrician. There is limited paediatric data available (see sections 5.1 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Method of administration
Oral use.
- Route Of Administration
- ORAL
- Indication Info
- **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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Contraindications
- **4.3 Contraindications**
Spironolactone is contraindicated in adults and children in the following cases:
- acute renal insufficiency, significant renal compromise, anuria
- Addison’s disease
- hyperkalaemia
- hypersensitivity to spironolactone
- concomitant use of eplerenone.
Spironolactone is contraindicated in children with moderate to severe renal insufficiency.
- Atc Code
- C03DA01
- Atc Item Name
- spironolactone
- Pharma Manufacturer Name
- ORION PHARMA (SG) PTE. LTD.
- Company Detail Path
- /organization/9fc8178ac4c510b0/orion-pharma-sg-pte-ltd
