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Spironolactone information from DrugsUpdate  

See Available Brands of Spironolactone in India

P - Caution when used during pregnancy
L - Caution when used during lactation
FI - Food *
LI - Lab *

Spironolactone (marketed under the trade names Aldactone, Novo-Spiroton, Aldactazide, Spiractin, Spirotone, Verospiron or Berlactone) is a diuretic and is used as an antiandrogen.

Pharmacodynamics

Pharmacokinetics

Spironolactone acts on the distal renal tubules as a competitive antagonist of aldosterone. It increases the excretion of sodium chloride and water while conserving potassium and hydrogen ions.

Absorption
Well absorbed from the GI tract after oral admin with a bioavailability of 90%.

Distribution
About 90% bound to plasma proteins.

Metabolism

Extensively metabolised.

Excretion
Mainly excreted in the urine, some in the faeces, as metabolites.

Spironolactone Indications / Spironolactone Uses

Information Not Available

Spironolactone Adverse Reactions / Spironolactone Side Effects

Fluid or electrolyte imbalance, gynaecomastia, GI upset, drowsiness, headache, hyponatraemia; tachycardia, hypotension, oliguria, hyperkalaemia; confusion, weakness, paraesthesia, hirsutism, mental disturbances, menstrual irregularities, loss of libido and impotence.

Potentially Fatal: Fatal hyperkalaemia in combination with ACE inhibitors and previous renal impairment; agranulocytosis.

Precautions

Warnings
Spironolactone has been shown to be tumorogenic in chronic toxicity studies in rats. The drug should only be used for conditions included under indications and usage. Unnecessary use of the drug should be avoided. Monitor for evidence of fluid or electrolyte imbalance (eg, alkalosis, hyperkalemia, hypomagnesemia, hyponatremia). Monitoring serum and urine electrolytes are especially important when the patient is vomiting excessively or receiving parenteral fluids. Obtain ECG if hyperkalemia is suspected.

Monitor

Periodically measure serum electrolytes to detect possible electrolyte imbalance, particularly in the elderly and in patients with renal or hepatic impairment. It is critical to monitor serum potassium in patients with severe heart failure; monitor potassium and creatine 1 week after starting therapy, monthly for the first 3 months, then quarterly for a year, and then every 6 months.

Overdosage

Acute overdosage may result in drowsiness, mental confusion, maculopapular or erythematous rash, nausea, vomiting, dizziness or diarrhoea. Hyperkalemia may occur, especially in patients with impaired renal function. Induce vomiting or evacuate the stomach by lavage. Supportive treatment to maintain hydration, electrolyte balance and vital functions. For hyperkalaemia, cationic exchange resins such as sodium polystyrene sulfonate may be given orally or rectally. Persistent hyperkalemia may require dialysis.

Special Precautions

Patients at risk of developing hyperkalaemia and acidosis; monitor serum electrolytes; renal and hepatic impairment; DM; elderly; pregnancy.

Other Drug Interactions

Sodium excretion effect may be inhibited by aspirin. May reduce ulcer-healing properties of carbenoxolone. Increased risk of nephrotoxicity when used with NSAIDs or ciclosporin. Hyperkalaemia may occur if given with potassium supplements, ACE inhibitors, angiotensin II antagonists, NSAIDs, ciclosporin or trilostane. May increase risk of orthostatic hypotension when used with barbiturates, narcotics or alcohol. May reduce vascular responsiveness to pressor amines. May increase half-life of digoxin.

Potentially Fatal: Increased risk of lithium toxicity when used concurrently.

Other Interactions

Food Interaction
Improved absorption if taken after food.

Dosage

Oral
Oedema
Adult: Initially, 100 mg daily, may adjust dose according to response up to 400 mg daily.
Child: Neonates: 1–2 mg/kg daily; 1 month–12 years: 1–3 mg/kg daily; 12–18 years: 50–100 mg daily. To be given in 1–2 divided doses.
Elderly: Initially, 25-50 mg/day in 1-2 divided doses, may increase by 25-50 mg every 5 days when necessary.

CrCl (ml/min)    Dosage Recommendation
10-50        Recommended dosing interval: Every 12-24 hours.
<10        Avoid use.

Oral

Hepatic Cirrhosis with Ascites and Oedema
Adult: Depending on urinary sodium/potassium ratio: If >1: Initially, 100 mg daily and if <1: Initially, 200-400 mg daily.
Child: Neonate: 1–2 mg/kg daily (Max: 7 mg/kg daily in resistant ascites); 1 month–12 years: 1–3 mg/kg daily (Max: 9 mg/kg daily in resistant ascites); 12–18 years: 50–100 mg daily (Max: 400 mg daily in resistant ascites). To be given in 2 divided doses.
Elderly: Dosing adjustment may be required.

CrCl (ml/min)    Dosage Recommendation
10-50        Recommended dosing interval: Every 12-24 hours.
<10        Avoid use.

Oral
Diagnosis of primary hyperaldosteronism
Adult: 400 mg daily for 3-4 weeks. Correction of serum potassium levels and hypertension gives the presumptive evidence for the diagnosis of primary aldosteronism.
Elderly: Dosing adjustment may be required.

CrCl (ml/min)    Dosage Recommendation
10-50        Recommended dosing interval: Every 12-24 hours.
<10        Avoid use.

Oral
Preoperative Management of Hyperaldosteronism
Adult: 100-400 mg daily. Long term maintenance in the absence of surgery: May initiate at 400 mg daily and maintain at 100-300 mg daily; lowest effective dose should be used.
Elderly: Dosing adjustment may be required.

CrCl (ml/min)    Dosage Recommendation
10-50        Recommended dosing interval: Every 12-24 hours.
<10        Avoid use.

Oral

Hypertension
Adult: As monotherapy: Usual dose range: 25-50 mg daily, may increase up to 100 mg daily if needed.
Elderly: Initially, 25-50 mg/day in 1-2 divided doses, may increase by 25-50 mg every 5 days when necessary.

CrCl (ml/min)    Dosage Recommendation
10-50        Recommended dosing interval: Every 12-24 hours.
<10        Avoid use.

Oral
Severe congestive heart failure
Adult: For patients receiving an ACE inhibitor and a loop diuretic with or without a cardiac glycoside: Initially, 12.5-25 mg daily. May increase to 50 mg daily after 8 weeks of treatment depending on response.
Child: Neonates: 1–2 mg/kg daily; 1 month–12 years: 1–3 mg/kg daily; 12–18 years: 50–100 mg daily. To be given in 1–2 divided doses.
Elderly: Dosing adjustment may be required.

CrCl (ml/min)    Dosage Recommendation
10-50        Recommended dosing interval: Every 12-24 hours.
<10        Avoid use.

Oral
Diuretic-induced hypokalaemia
Adult: 25-100 mg daily.
Child: Neonates: 1–2 mg/kg daily; 1 month–12 years: 1–3 mg/kg daily; 12–18 years: 50–100 mg daily. To be given in 1–2 divided doses.
Elderly: Dosing adjustment may be required.

CrCl (ml/min)    Dosage Recommendation
10-50        Recommended dosing interval: Every 12-24 hours.
<10        Avoid use.

Oral

Hirsutism
Adult: 50-200 mg daily.
Elderly: Dosing adjustment may be required.

CrCl (ml/min)    Dosage Recommendation
10-50        Recommended dosing interval: Every 12-24 hours.
<10        Avoid use.

Food(before/after)

Should be taken with food.

List of Contraindications

Spironolactone and Pregnancy

Caution when used during pregnancy

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

If used in pregnancy-induced hypertension.

Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Spironolactone and Lactation

Caution when used during lactation

Excreted in breast milk

Spironolactone and Children

Safety and efficacy not established

Spironolactone and Geriatic

Information Not Available

Spironolactone and Other Contraindications

Anuria, hyperkalaemia, acute or progressive renal insufficiency. Addison's disease.

Storage

Oral
Store <25°C

Lab interference

Oral
Store <25°C

Spironolactone brands in India:

Aldactide Aldactone Dytor Plus-20 Spilactone Spilactone-T

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