INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
ALDACTONE® 25 Tablets
ALDACTONE® 100 Tablets

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

ALDACTONE^® 25 Tablets
ALDACTONE^® 100 Tablets

COMPOSITION :
ALDACTONE 25: Each tablet contains 25 mg spironolactone
ALDACTONE 100: Each tablet contains 100 mg spironolactone

PHARMACOLOGICAL CLASSIFICATION:
A18.1 Diuretics.

PHARMACOLOGICAL ACTION:
ALDACTONE promotes diuresis in patients with oedema or ascites. ALDACTONE acts in the distal portion of the renal tubule by competitive inhibition of aldosterone, a sodium-retaining, potassium-excreting hormone.

INDICATIONS:
Congestive cardiac failure, hepatic cirrhosis with ascites and oedema, the nephrotic syndrome, idiopathic oedema including premenstrual oedema, malignant ascites, essential hypertension, pre-operative management of primary aldosteronism, long-term treatment of primary aldosteronism where the patient is unable or unwilling to undergo surgery, as an aid to the diagnosis of mineralocorticoid excess, including primary aldosteronism.

CONTRA-INDICATIONS:
ALDACTONE should not be given in acute renal insufficiency, rapidly progressing impairment of renal function, anuria or hyperkalaemia.

WARNINGS:
Administration is not recommended in the presence of raised serum potassium and the concomitant use of triamterene or amiloride should be avoided as hyperkalaemia may be induced. The use of potassium supplements is also not recommended for the same reason, except in cases of initial potassium depletion.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
Congestive heart failure, hepatic cirrhosis with ascites and oedema, idiopathic oedema, including premenstrual oedema, the nephrotic syndrome, and malignant ascites:

The usual dosage is 100-200 mg/day (usually in association with a conventional diuretic).

Essential hypertension: The usual dosage is 100 mg/day. A higher dosage may be used if necessary.
Primary aldosteronism and other forms of hypertension associated with low plasma renin:

a)	Pre-operative management
	100-400 mg/day for 3-5 weeks before operation.
b)	Long-term management
	Where operative correction of primary aldosteronism is not desirable or possible, 200-400 mg/day frequently normalises blood pressure and electrolyte abnormalities. The smallest dose, which achieves the desired effect, should be used.
c)	Screening for mineralocorticoid excess including primary aldosteronism
	Mineralocorticoid excess may be detected by using 300-400 mg daily, in divided doses, in conjunction with in-vivo faecal dialysis, or rectal electrical potential measurements. Tests based on changes in serum potassium, and serum and urinary potassium have also been described.

Children: The recommended dosage is 3 mg/kg body weight daily.
ALDACTONE is insoluble in water but the tablets may be crushed and given in suspension if necessary.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal intolerance, drowsiness and mental confusion have been observed. Reversible unilateral or bilateral gynaecomastia may occur. A maculopapular or erythematous cutaneous eruption has been reported. There have been rare reports of mild androgenicity, hirsutism and menstrual irregularity.
Hyponatraemia may occur, especially with intense treatment in combination with conventional diuretics. Potentiation of the action of other anti-hypertensive drugs occurs.
Caution should be observed in the presence of liver disease as hepatic coma may be precipitated in susceptible subjects. As with all diuretic therapy, periodic estimation of serum electrolytes may be desirable.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
True toxic effects have not been reported in overdosage. Hyperkalaemia may be manifested clinically by paraesthesia, weakness, flaccid paralysis or muscle spasm, and may be difficult to distinguish clinically from hypokalaemia.
Electrocardiographic changes give the earliest indications of pathologically disturbed serum potassium levels. In the event of hyperkalaemia, discontinue the drug, reduce potassium intake and administer potassium-excreting diuretics and intravenous glucose with insulin or an oral ion-exchange resin as appropriate.

IDENTIFICATION:
ALDACTONE 25: 8,8 mm diameter, white, round, biconvex, film-coated tablets stamped SEARLE 39 on one side and plain on the other with a characteristic peppermint odour.
ALDACTONE 100: 11,1 mm diameter, white, round, biconvex, film-coated tablets stamped SEARLE 134 on one side and plain on the other with a characteristic peppermint odour.

PRESENTATION:
ALDACTONE 25: Blisters containing 60 or 100 tablets.
ALDACTONE 100: Blisters of 30 tablets.

STORAGE INSTRUCTIONS:
Store in a dry place below 25°C. Keep out of reach of children.

REGISTRATION/REFERENCE NUMBERS:
ALDACTONE 25 mg: H1941 (Act 101/1965)
ALDACTONE 100 mg: H/18.1/2

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacia South Africa (Pty) Ltd
Alphen West G
George Street
Midrand
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
7th May 1975

ZIMBABWE ALDACTONE 25: 84/12.5.1/1839 Dist. Cat. PP(10) ALDACTONE 100: 84/12.5.1/1840 Dist. Cat. PP(10)

Updated on this site: January 2005
Source: Pharmaceutical Industry
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