Medicinal Products

ALDACTONE 75 mg

Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: Spironolactone
laboratory: Pfizer Holding France

Tablet breackable
Box of 100
All forms

Indication

Treatment of primary hyperaldosteronism.

Hyperaldosteronism reaction to effective diuretic treatment.

Essential hypertension.

Edematous states that may be accompanied by secondary hyperaldosteronism:

o edema and ascites of heart failure,

o cirrhotic ascites,

o nephrotic syndrome,

o Idiopathic cyclical edema.

Adjunctive Therapeutics for Myasthenia Gravis: Spironolactone is a medication used to maintain potash and reduce excess potassium requirements.

Dosage ALDACTONE 75 mg Tablet breakable Box of 100

Treatment of hyperaldosteronism : the usual treatment is 300 mg per day. The doses will be adapted according to the response of the patient.

Essential hypertension : the initial dose is 50 mg daily. After 6 to 8 weeks of treatment, this dosage will be increased if necessary to 75 mg per day or, after a new level of 6 to 8 weeks, to 100 mg per day. At each stage, in the event of insufficient blood pressure control, as an alternative to the dose increase, another antihypertensive agent may be associated.

Oedematous state and ascites of heart failure : Spironolactone can be administered alone or in combination with another diuretic. The usual daily dose is 50 to 100 mg continuously.
In severe cases, the dosage may be increased to 300 mg, the maintenance dose being between 50 to 150 mg per day.
Cirrhotic ascites :

o Attack treatment: 200 to 300 mg daily,

o maintenance treatment: 50 to 150 mg daily.

In both cases, the doses will be adapted to the diuretic response and the electrolyte balance of the patient.

Nephrotic syndromes : the average dose is 50 to 150 mg per day.

In children: 2 mg / kg on average per 24 hours.

Idiopathic cyclic edema : 150 to 300 mg daily at the time of relapses, then 50 to 100 mg daily in maintenance treatment.

Myasthenia gravis : 50 to 300 mg per day on average.

Against indications

This medicine should never be used in case of:

· Severe or acute renal failure including: anuria, fast-evolving renal dysfunction.

· Hyperkalemia.

· Terminal stage of liver failure.

Hypersensitivity to spironolactone or any of the excipients.

· Association with eplerenone.

· In combination with other potassium diuretics, potassium salts (except in case of hypokalemia) (see section 4.5 ).

This medicine is generally not recommended:

· In cirrhotic patients when the serum is less than 125 mmol / l.

· In subjects who may have acidosis.

Aldactone side effects

These side effects have been observed in adults:

Clinically

Gynecomastia may occur during the use of spironolactone, its development seems to be related to both the dosage used and the duration of therapy; it is usually reversible when stopping the administration of spironolactone; however in rare cases it can persist.

Other rare and generally reversible adverse effects at discontinuation of therapy have been encountered, these are:

· Gastrointestinal disorders: digestive intolerance.

· Hepatobiliary disorders: hepatitis.

· Musculoskeletal and systemic disorders: cramps of the lower limbs.

· Nervous system disorders: drowsiness.

· Disorders of the reproductive organs and breast: menstrual disorders in women, impotence in men.

· Skin and subcutaneous tissue disorders: rash.

· Renal and urinary disorders: acute renal failure.

Biologically

Electrolyte disturbances and hyponatraemia can be observed.

Under spironolactone, serum potassium may increase moderately. More marked hyperkalemias are reported in patients with renal insufficiency and in patients receiving potassium supplementation or ACE inhibitors: although the vast majority of these hyperkalaemias are asymptomatic, they must be rapidly corrected. In cases of hyperkalemia, treatment with spironolactone will be discontinued.

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