Presentation

Spirocard 25 Tablet: Each film coated tablet contains 25 mg Spironolactone BP. Spirocard 50 Tablet: Each film coated tablet contains 50 mg Spironolactone BP. Spirocard 100 Tablet: Each film coated tablet contains 100 mg Spironolactone BP.

Description

Spironolactone is an antagonist of aldosterone & potassium-sparing diuretic. It acts primarily through competitive binding of receptors at the aldosterone dependent sodium-potassium exchange site in the distal convoluted renal tubule. Spironolactone causes increased amounts of sodium and water to be excreted, while potassium and magnesium is retained.

Indications

Spironolactone is indicated for the management of oedema and ascites in cirrhosis of the liver, malignant ascites, nephrotic syndrome, congestive heart failure and primary hyperaldosteronism.

Dosage and Administration

Primary hyperaldosteronism: Spironolactone may be employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.

Long test: Spironolactone is administered at a daily dosage of 400 mg for three to four weeks. Correction of hypokalemia and of hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism.

Short test: Spironolactone is administered at a daily dosage of 400 mg for four days. If serum potassium increases during Spironolactone administration but drops when Spironolactone is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered.

After the diagnosis of primary hyperaldosteronism has been established by more definitive testing procedures, it may be administered in doses of 75 mg to 400 mg daily in preparation for surgery. For those unsuitable for surgery, spironolactone may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual.

Edema in adults (congestive heart failure, hepatic cirrhosis, or nephrotic syndrome): An initial daily dosage of 50-100 mg of Spironolactone administered in either single or divided doses is recommended but may range from 25 to 200 mg daily. When given as the sole agent for diuresis, Spironolactone should be continued for at least five days at the initial dosage level, after which it may be adjusted to the optimal therapeutic or maintenance level administered in either single or divided daily doses. If, after five days, an adequate diuretic response to Spironolactone has not occurred, a second diuretic which acts more proximally in the renal tubule may be added to the regimen. Because of the additive effect of Spironolactone when administered concurrently with such diuretics, an enhanced diuresis usually begins on the first day of combined treatment; combined therapy is indicated when more rapid diuresis is desired. The dosage of Spironolactone should remain unchanged when other diuretic therapy is added.

Essential hypertension: For adults, an initial daily dosage of 50 to 100 mg of Spironolactone administered in either single or divided doses is recommended. Spironolactone may also be given with diuretics which act more proximally in the renal tubule or with other antihypertensive agents. Treatment with Spironolactone should be continued for at least two weeks, since the maximum response may not occur before this time. Subsequently, dosage should be adjusted according to the response of the patient.

Hypokalemia: Spironolactone in a dosage ranging from 25 mg to 100 mg daily is useful in treating a diuretic-induced hypokalemia, when oral potassium supplements or other potassium-sparing regimens are considered inappropriate.

Contraindications

Acute renal insufficiency, significant impairment of renal function, anuria, hyperkalemia or sensitivity to Spironolactone.

Side-Effects

Gynaecomastia may develop in association with the use of Spironolactone. The development of gynaecomastia appears to be related to both dosage level & duration of therapy and is normally reversible when Spironolactone is discontinued. In rare instances, some breast enlargement may persist. Other adverse reactions that have been reported in association with Spironolactone are: gastrointestinal symptoms including cramping and diarrhoea, drowsiness, lethargy, headache, maculopapular or erythematous cutaneous eruptions, urticaria, mental confusion, drug fever, ataxia, impotence, irregular menses or amenorrhoea, and post-menopausal bleeding. Adverse reactions are usually reversible upon discontinuation of the drug.

Precautions

All patients receiving diuretic therapy should be observed for evidence of fluid or electrolyte imbalance, eg, hypomagnesemia, hyponatremia, hypochloremic alkalosis, and hyperkalemia. Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids. Hyperkalemia may occur in patients with impaired renal function or excessive potassium intake and can cause cardiac irregularities, which may be fatal. Consequently, no potassium supplement should ordinarily be given with Spironolactone.

Use in Pregnancy and Lactation: The effects of Spironolactone during pregnancy have not been adequately studied. Spironolactone appears in breast milk and could affect a nursing infant.

Drug Interactions

The administration of potassium supplements, a diet rich in potassium, including salt substitutes, or of other potassium sparing agents is not recommended as it may induce hyperkalemia. Severe hyperkalemia has been reported in patients co-administered potassium-sparing diuretics, including Spironolactone and ACE inhibitors. Spironolactone reduces the vascular responsiveness to noradrenaline. Therefore, caution should be exercised in the management of patient subjected to regional or general anaesthesia while they are being treated with Spironolactone. Aspirin attenuates the diuretic effect of Spironolactone by blocking the secretion of canrenone in the renal tubule. Indomethacin and Mefenamic Acid have been shown to inhibit the excretion of canrenone. As carbenoxolone may cause sodium retention and thus may decrease the effectiveness of Spironolactone, concurrent use of the two agents should be avoided. Spironolactone enhances the metabolism of antipyrine.

Overdosage

Acute overdosage of Spironolactone may be manifested by drowsiness, mental confusion, maculopapular or erythematous rash, nausea, vomiting, dizziness, or diarrhoea. Rarely, instances of hyponatremia, hyperkalemia, or hepatic coma may occur in patients with severe liver disease, but these are unlikely due to acute overdosage. Hyperkalemia may occur, especially in patients with impaired renal function.

Pharmaceutical Precautions

Store at below 30oC in a dry place protected from light. Keep out of reach of children.