Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
SPIRONOLACTONE
Pharmacia Ireland
100 Milligram
Tablets
2000-03-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aldactone 100mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100mg of spironolactone. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet (Tablets) Round, buff coloured, biconvex tablet with a peppermint odour embossed ‘SEARLE over 134’ on one side and the other side plain. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Administration of Aldactone once daily with a meal is recommended. ADULTS CONGESTIVE HEART FAILURE: Usual dose - 100 mg/day. In difficult or severe cases the dosage may be gradually increased up to 200 mg/day. When oedema is controlled, the usual maintenance level is 75-200 mg/day. FOR SEVERE HEART FAILURE IN CONJUNCTION WITH STANDARD THERAPY (NYHA CLASS IIIIV): Based on the Randomized Aldactone Evaluation Study (RALES), treatment in conjunction with standard therapy should be initiated at a dose of spironolactone 25 mg once daily in patients with a serum potassium 5.0 mEq/L and serum creatinine 2.5 mg/dL. Patients who tolerate 25 mg once daily may have their dose increased to 50 mg once daily as clinically indicated. Patients who do not tolerate 25 mg once daily may have their dose reduced to 25 mg every other day. See section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE: HYPERKALEMIA IN PATIENTS WITH SEVERE HEART FAILURE for advice on monitoring serum potassium and serum creatinine. HEPATIC CIRRHOSIS WITH ASCITES AND OEDEMA: If urinar Read the complete document