Formulary
Spironolactone: Indications, Dosing, Side Effects and Interactions
Spironolactone clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 3 min read
Spironolactone: Indications, Dosing, Side Effects and Interactions
Spironolactone clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Oedema in cirrhosis of the liver,Ascites in cirrhosis of the liver**
- **Adult** (By Mouth): 100-400 mg once daily, to be adjusted according to response.
**Malignant ascites**
- **Adult** (By Mouth): Initially 100-200 mg once daily, then increased if necessary up to 400 mg once daily, maintenance dose adjusted according to response.
**Nephrotic syndrome**
- **Adult** (By Mouth): 100-200 mg once daily.
**Oedema in congestive heart failure**
- **Adult** (By Mouth): Initially 100 mg once daily, dose may also be taken as divided doses, maintenance dose adjusted according to response, alternatively initially 25-200 mg once daily, dose may also be taken as divided doses, maintenance dose adjusted according to response.
**Moderate to severe heart failure (adjunct)**
- **Adult** (By Mouth): Initially 25 mg once daily, then adjusted according to response to 50 mg once daily.
**Resistant hypertension (adjunct)**
- **Adult** (By Mouth): 25 mg once daily.
**Primary hyperaldosteronism in patients awaiting surgery**
- **Adult** (By Mouth): 100-400 mg once daily, may be used for long-term maintenance if surgery inappropriate, use lowest effective dose.
**Oedema in heart failure and in ascites, Nephrotic syndrome for spironolactone**
- **Neonate** (By mouth): Initially 1-2 mg/kg daily in 1-2 divided doses, dose increased if necessary up to 7 mg/kg per day in resistant ascites.
- **Child 1 month-11 years** (By mouth): Initially 1-3 mg/kg daily in 1-2 divided doses, dose increased if necessary up to 9 mg/kg per day in resistant ascites.
- **Child 12-17 years** (By mouth): Initially 50-100 mg daily in 1-2 divided doses, dose increased if necessary up to 9 mg/kg per day in resistant ascites; maximum 400 mg per day.
**Reduction of hypokalaemia induced by diuretics or amphotericin B for spironolactone**
- **Neonate** (By mouth): Initially 1-2 mg/kg daily in 1-2 divided doses.
- **Child 1 month-11 years** (By mouth): Initially 1-3 mg/kg daily in 1-2 divided doses.
- **Child 12-17 years** (By mouth): Initially 50-100 mg daily in 1-2 divided doses.
Cautions
Acute porphyrias ; elderly; rodent studies indicate potential carcinogenic risk Cautions, further information Elderly For mineralocorticoid receptor antagonists, Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) criteria to aid medication reviews (see Prescribing in the elderly for information): potentially inappropriate with concurrent potassium-conserving drugs without monitoring of serum potassium (risk of dangerous hyperkalaemia).
Contraindications
Addison's disease; anuria; hyperkalaemia
Side effects
Frequency not known Acidosis hyperchloraemic; acute kidney injury; agranulocytosis; alopecia; breast neoplasm benign; breast pain; confusion; dizziness; electrolyte imbalance; gastrointestinal disorder; gynaecomastia; hepatic function abnormal; hyperkalaemia (discontinue); hypertrichosis; leg cramps; leucopenia; libido disorder; malaise; menstrual disorder; nausea; severe cutaneous adverse reactions (SCARs); skin reactions; thrombocytopenia
Interactions
**Severe interactions:**
- Concomitant use of drugs known to cause hyperkalaemia with spironolactone may result in severe hyperkalaemia.
**Other interactions (12):**
- In addition, concomitant use of trimethoprim/sulfamethoxazole (co-trimoxazole) with spironolactone may result in clinically relevant hyperkalaemia.
- Spironolactone has been reported to increase serum digoxin concentration and to interfere with certain serum digoxin assays.
- In patients receiving digoxin and spironolactone the digoxin response should be monitored by means other than serum digoxin concentrations, unless the digoxin assay used has been proven not to be...
- If it proves necessary to adjust the dose of digoxin patients should be carefully monitored for evidence of enhanced or reduced digoxin effect.
- Non-steroidal anti-inflammatory drugs such as aspirin, indomethacin and mefenamic acid may attenuate the natriuretic efficacy of diuretics due to inhibition of intrarenal synthesis of prostaglandins...
- Spironolactone reduces vascular responsiveness to noradrenaline.
Pregnancy
Use only if potential benefit outweighs risk-feminisation of male fetus in animal studies.
Breast feeding
Metabolites present in milk, but amount probably too small to be harmful.
Renal impairment
Avoid in acute renal insufficiency or severe impairment. Monitoring Monitor plasma-potassium concentration (high risk of hyperkalaemia in renal impairment).
Medicinal forms
Solution,Tablet,Suspension,Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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