Spire Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Special Precautions Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Spironolactone

Indications/Uses

Management of heart failure, both to treat refractory oedema & in lower doses as adjunct to standard therapy. Refractory oedema associated w/ liver cirrhosis or nephrotic syndrome & ascites associated w/ malignancy. Diuretic-induced hypokalemia. Essential HTN. Diagnosis & treatment of primary hyperaldosteronism.

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Dosage/Direction for Use

Edema Initially 100 mg daily, subsequently adjusted as necessary, some may require up to 400 mg daily. Hepatic cirrhosis w/ ascites & edema Initially 100 mg daily in patients w/ urinary Na/K ratio >1, & 200-400 mg daily in ratio <1. Presumptive diagnosis of primary hyperaldosteronism 400 mg daily. Pre-op management of hyperaldosteronism 100-400 mg daily. Long-term maintenance therapy of primary hyperaldosteronism in the absence of surgery Use lowest effective dose. Childn 1-3 mg/kg in divided doses.

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Overdosage

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Special Precautions

Patients at increased risk of developing hyperkalemia eg, elderly w/ DM, patients w/ renal or hepatic impairment. Patients likely to develop acidosis. Should not be used in patients w/ hyperkalemia or severe renal impairment. Periodically measure serum electrolytes & BUN.

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Adverse Reactions

Headache, drowsiness, GI disturbances including cramp & diarrhoea. Ataxia, mental confusion, skin rashes. Gynaecomastia. Hirsutism, deepening of the voice, menstrual irregularities, impotence. Transient increases in BUN conc, mild acidosis. Hyponatremia, hyperkalemia.

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Drug Interactions

Increased risk of hyperkalemia w/ K supplements or other K-sparing diuretics; ACE inhibitors, AIIA, NSAIDs, ciclosporin, or trilostane. Increased risk of nephrotoxicity w/ NSAIDs or ciclosporin. May reduce excretion of lithium leading to increased risk to lithium toxicity. Risk of hyponatremia w/ thiazide; increased risk w/ chlorpropamide. May reduce ulcer-healing properties of carbenoxolone. May enhance effects of other anti-hypertensive drugs & may reduce vascular responses to noradrenaline.

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Storage

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Description

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Action

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MIMS Class

Diuretics

ATC Classification

C03DA01 - spironolactone ; Belongs to the class of aldosterone antagonists. Used as potassium-sparing diuretics.

Regulatory Classification

Presentation/Packing

Form

Spire FC tab 25 mg

Packing/Price

30's

Form

Spire FC tab 50 mg

Packing/Price

30's

Spire

spironolactone

Manufacturer:

Mepro Pharmaceutical

Distributor:

Corbridge