Medicinal Products

ALDACTONE 25 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 nephrotic syndrome,

o cirrhotic ascites,

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

In the adult

Treatment of NYHA class III or IV heart failure (systolic ejection fraction ≤35%), in combination with treatment with loop diuretic, angiotensin converting enzyme inhibitor, and a digitalis in the majority of the cases.

Long-term treatment with Aldactone 25 mg in combination with the above DMARD significantly improved survival in the Rales study (see section 5.1 ).

Dosage ALDACTONE 25 mg scored tablet Box of 100

In the child

For children under 6, it is necessary to crush the tablet (or the fraction
of tablet) so as to make a suspension in a liquid (the liquid will be
preferably a syrup or a solution of methyl cellulose of 20% so as to
promote suspension).

The dose is 1 to 4 mg / kg / day in 1 to 2 doses / day.

· Treatment of hyperaldosteronism: the doses will be adapted to the patient's needs.

· Hypertension: The dose of 1 to 4 mg / kg / day will be administered once a day.

· Heart failure: Spironolactone can be given alone or in combination with another diuretic.

· Nephrotic syndromes: Spironolactone is not an anti-inflammatory, its use is only recommended if glucocorticoids are insufficiently active.

Myasthenia: the doses will be adapted to the patient's needs.

In the adult

In stage III or IV heart failure in accordance with NYHA standard therapy, treatment will initially be given at a dose of 25 mg spironolactone once daily after verifying that serum 5 mmol / l and serum creatinine less than 220 μmol / l. Serum potassium and creatinine will be measured one week after initiation of treatment, at 4 weeks, then every 4 weeks up to 3 months, then every 3 months during the 1st year, then every 6 months.

In cases of persistent water-soluble retention 8 weeks after the start of treatment and provided that the serum potassium remains below 5 mmol / l, the dose may be increased to 50 mg / day in one dose by controlling serum potassium and serum creatinine one week later. .

If serum potassium is greater than 5.5 mmol / l or serum creatinine greater than 220 μmol / l, the dose of spironolactone should be reduced to 25 mg every other day.

If serum potassium greater than or equal to 6 mmol / l or serum creatinine greater than 350 μmol / l, it is recommended that spironolactone be discontinued.

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 spironolactone is discontinued; however, in rare cases it may 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 case of hyperkalemia, treatment with spironolactone will be adjusted or discontinued (in the case of treatment of NYHA stage III or IV heart failure (see sections 4.2 Posology and method of administration and Warnings and Precautions). employment ).

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