Medicinal Products

ALDACTONE 50 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:
. edema and ascites of heart failure,
. cirrhotic ascites,
. nephrotic syndrome,
. idiopathic cyclic edema.
- Adjunctive therapy for myasthenia gravis: in this indication, spironolactone is a medication to maintain potash capital and to reduce the excessive need for potassium.

Dosage ALDACTONE 50 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 per day. 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.
- edematous 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:
. Attack treatment : 200 to 300 mg daily,
. 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 per day in maintenance treatment.
- Myasthenia gravis: 50 to 300 mg per day on average.

Against indications

CONTRAINDICATED:
- This medicine MUST NEVER be used in case of:
. hypersensitivity to spironolactone,
. severe or acute renal failure including: anuria, fast-evolving renal dysfunction, .
. hyperkalemia,
. end stage of liver failure,
. combination with other potassium diuretics, potassium salts (except in cases of hypokalemia) (see section on interactions).
- Due to the presence of lactose, this drug is contraindicated in case of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.
NOT RECOMMENDED :
- This drug is generally not recommended in cirrhotic patients when the serum is less than 125 mmol / L and in subjects who may have acidosis.
- Pregnancy: animal studies have not shown any teratogenic effect, however at high doses a feminization of male fetuses has been described during the administration of spironolactone throughout fetal life is ie after organogenesis. In the clinic, the risk is not known; however, to date, no case of feminization of male fetuses has been reported. In the absence of clinical data, spironolactone is not recommended during pregnancy and should be reserved for indications where there is no alternative treatment. In particular, the treatment of oedemas, fluid retention or gestational hypertension is not an indication for treatment with diuretics during pregnancy as these may result in fetal-placental ischemia with a risk of fetal hypotrophy.
- Breast-feeding: Spironolactone is excreted in a small amount in breast milk. However, it should not be used during breastfeeding because of a decrease or even a suppression of the milk secretion, its adverse effects, including biological (potassium).
- Associations discouraged : ciclosporin, tacrolimus; lithium; converting enzyme inhibitors (unless there is hypokalemia) except for spironolactone at doses of 12.5 mg to 50 mg / day in the treatment of heart failure; angiotensin II receptor antagonists (unless there is hypokalemia).

Aldactone side effects

CLINICAL PLAN:
- 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:
. impotence in humans,
. menstrual disorders,
. digestive intolerance,
. skin rash,
. drowsiness,
. cramps of the lower limbs.
AT THE BIOLOGICAL PLAN:
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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