INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo SPIRACTIN 100 TABLETS

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

SPIRACTIN 100 TABLETS

COMPOSITION:
Tablets containing 100 mg
Spironolactone.

PHARMACOLOGICAL CLASSIFICATION:
A 18.1 Medicines acting on genito-urinary system: Diuretics

PHARMACOLOGICAL ACTION:
Spironolactone blocks the sodium retaining action of aldosterone on the distal convoluted renal tubule and thereby increases urinary excretion of sodium and chloride; however, it reduces excretion of potassium and ammonium and decreases and titrable acidity or urine.

INDICATIONS:
Spironolactone may be used initially in the treatment of patients with oedema and ascites associated with hepatic cirrhosis to avoid depletion of potassium or precipitation of hepatic coma that may follow use of a thiazide diuretic. If more profound diuresis is necessary, or in patients with congestive heart failure and the nephrotic syndrome, a thiazide or other diuretics may be given concomitantly with spironolactone.

CONTRA-INDICATIONS:
Spironolactone is contra-indicated in patients with acute renal insufficiency, anuria and hyperkalaemia.

Spiractin should not be given with other potassium-sparing diuretics or potassium-supplements. Safety in pregnancy has not been established.

DOSAGE AND DIRECTIONS FOR USE'
The initial dosage is 100 mg daily. After 5 days the effect is evaluated; if the response is satisfactory the drug is continued, if possible, at a lower dose. If the response is not satisfactory, a conventional diuretic may be given concomitantly at usual doses. In certain circumstances the dose of spironolactone may have to be increased to 400 mg daily. On discontinuing the drug the dose should be gradually decreased.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Hyperkalaemia and hyponatraemia have been observed in patients treated with spironolactone. Drowsiness, headache, ataxia, coma, maculopapular or erythematous cutaneous eruptions, impotence, gynecomastia, mild androgenic effect including hirsutism, irregular menses and deepening voice may occur occasionally. Because of the risk of producing hyperkalaemia, spironolactone should be given with caution to patients with impaired renal function. It should be given under careful supervision in patients with severe hepatic disease as stupor and transient hepatic coma may develop in these patients.
Plasma electrolyte and blood-urea-nitrogen determinations must be carried out during treatment to prevent electrolyte imbalance, especially hyponatraemia and hypokalaemia.
Spironolactone may enhance the effects of other antihypertensive agents, the dose of which may need to be reduced. Serum electrolytes should be estimated periodically.
Spiractin should be given with care to patients with diabetes mellitus and patients likely to develop acidosis.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The symptoms of overdosage are hyperkalaemia clinically characterised by paralysis, or muscle spasm.
Treatment is symptomatic with emphasis on potassium excretion.

IDENTIFICATION:
While biconvex tablet.

PRESENTATION:
“Blister packs”or “Securitainers”of 60 and 200 tablets.

STORAGE INSTRUCTIONS:
Store below 25° C. Protect from light.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
U/18.1/52

NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited
7 Fairclough Road
PORT ELIZABETH 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
18/07/1988 K962
  Tradepak P.E.

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