Medicinal Products

ALDACTAZINE 25 mg / 15 mg

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

Tablet breackable
Box of 30
All forms


- Hypertension.
- Edema of renal, cardiac and hepatic origin.

Dosage ALDACTAZINE 25 mg / 15 mg scored tablet Box of 30

- Hypertension:
1/2 to 1 tablet a day. The treatment is initiated at a dose of half a tablet a day; in case of ineffectiveness, after 6 to 8 weeks of treatment, the dosage is increased to 1 tablet / day.
- Edema of cardiac and renal origin:
. Attack treatment : 3 to 4 tablets a day. These doses will then be lowered depending on the patient's response.
. maintenance treatment : 1 to 2 tablets daily.
- Edema of hepatic origin:
. Attack treatment : 4 to 6 tablets a day.
. maintenance treatment : 1 to 2 tablets daily.
In the case of oedemas, these doses will be adapted to the response obtained (diuresis, weight) and the electrolyte balance of the patient.

Against indications

- This medicine MUST NEVER BE USED in case of:
. hypersensitivity to sulfonamides;
. hypersensitivity to spironolactone;
. severe or acute renal failure including: anuria, fast-evolving renal dysfunction;
. hyperkalemia;
. terminal 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.
- 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: The administration of this product is not recommended during pregnancy. Diuretics may cause fetal-placental ischemia with a risk of fetal hypotrophy. Studies in animals have not shown any teratogenic effect; however, in high doses, a feminization of male fetuses has been described during the administration of spironolactone throughout fetal life, 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. In general, the administration of thiazide and related diuretics should be avoided in pregnant women and should never be prescribed during physiological edema (and therefore not requiring treatment) of pregnancy. Diuretics can, in fact, lead to fetal-placental ischemia, with a risk of fetal hypotrophy. In rare cases, severe neonatal thrombocytopenia has been reported. Diuretics remain nevertheless an essential element of the treatment of oedemas of cardiac, hepatic and renal origin occurring in the pregnant woman.
- 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). Thiazides are excreted in small amounts in breast milk. However, they should not be used during breastfeeding because of a decrease or even a suppression of the milk secretion, their adverse effects, including biological (potassium), their membership in sulfonamides with allergy risks and nuclear jaundice.
- Associations discouraged : ciclosporin, tacrolimus; 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; drugs giving torsades de pointes (astemizole, bepridil, diphemanil, erythromycin IV, halofantrine, pentamidine, sparfloxacin, sultopride, vincamine); lithium; angiotensin II receptor antagonists (unless there is hypokalemia).

Aldactazine side effects

- These adverse effects have been observed in adults:
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 may 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.
- Biologically:
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.
These disorders are usually reversible upon discontinuation of treatment.
The biological or clinical adverse effects are most dose-dependent and can be reduced by finding the lowest effective dose, especially in high blood pressure.
Thiazide and related diuretics may result in:
- Biologically:
. Potassium depletion with hypokalemia, particularly in the case of intensive diuresis, and particularly severe in some at-risk populations (see precautions for use).
. Hyponatremia with hypovolemia leading to dehydration and orthostatic hypotension. The concomitant loss of chlorine ions may secondarily cause a compensatory metabolic alkalosis: the incidence and the amplitude of this effect are small.
. Elevation of serum uric acid and blood glucose during treatment: The use of these diuretics will be carefully discussed in gouty and diabetic subjects.
. haematological disorders, much rarer, thrombocytopenia, leukopenia, agranulocytosis, bone marrow suppression, haemolytic anemia.
. an exceptional hypercalcemia.
- Clinically:
. in case of hepatic insufficiency, possibility of occurrence of hepatic encephalopathy (see contraindications and warnings),
. hypersensitivity reactions, mainly dermatological, in subjects predisposed to allergic and asthmatic manifestations,
. cases of photosensitivity reaction (uncommon) have been reported (see section on warnings and precautions for use),
. maculopapular eruptions, purpura, possibility of aggravation of pre-existing systemic acute lupus erythematosus,
. nausea, constipation, dizziness, asthenia, paresthesia, headache, rarely seen and usually giving way to a reduction in dosage,
. exceptionally: pancreatitis.

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