Primary hyperaldosteronism. Congestive heart failure with inefficiency or intolerance of other diuretics or, if necessary, increase their effectiveness. Essential arterial hypertension, mainly with hypokalemia, usually in combination with other antihypertensive drugs. Cirrhosis of the liver, accompanied by edema and / or ascites. Edema due to nephrotic syndrome. Hypokalemia in case of impossibility of using other therapy. Prevention of hypokalemia for patients receiving cardiac glycosides, when other methods of therapy are considered inappropriate or inappropriate.
Composition and form of release
Active ingredient: spironolactone (25 mg).
Spironolactone is produced in tablet form.
It is a competitive antagonist of aldosterone. Acts on the distal renal tubules. Blocking aldosterone, inhibits water retention, sodium, promotes potassium retention.
Spironolactone is used:
- with primary hyperaldosteronism;
- with congestive heart failure in patients who do not respond to therapy with other diuretics;
- with cirrhosis of the liver with edema, ascites;
- with essential arterial hypertension;
- with hypokalemia (if it is impossible to prescribe another therapy);
- with edema caused by nephrotic syndrome;
- for the prevention of hypokalemia in the treatment of cardiac glycosides.
Spironolactone is not used:
- if you are allergic to spironolactone;
- with intolerance to auxiliary components;
- with anuria;
- with acute renal failure;
- with a pronounced violation of the nitrogen-excreting function of the kidneys;
- with oliguria, anuria;
- with hyperkalemia;
- with hyponatremia;
- with Addison’s disease;
- with hypovolemia or dehydration;
- in the treatment of potassium-sparing diuretics, potassium preparations.
Application during pregnancy and lactation
Spironolactone should not be used during pregnancy, lactation.
In experiments carried out on animals, feminization of the genitals was observed in male offspring, hormonal disorders in female and male offspring. Antiandrogenic effects have been described in humans.
The active metabolite of the drug is excreted in breast milk. If necessary, breastfeeding is stopped.
Method of administration and dosage
Spironolactone is used internally.
The standard dose for primary hyperaldosteronism is 100-400 mg / day (in preparation for surgery). If the operation is not planned, the minimum effective dose is used (determined individually).
The standard dose for edema (congestive heart failure, nephrotic syndrome), the starting dose for adults is 100 mg (25-200 mg) in one or two divided doses.
The standard dose for cirrhosis of the liver, accompanied by ascites, edema – the initial daily and maximum doses are 100 mg (if the Na / K ratio in urine is more than 1) or 200 mg, the maximum is 400 mg / day (if the Na / K ratio in urine is less than 1 ).
The standard starting dose for essential arterial hypertension is 50-100 mg / day. The therapy is continued for at least two weeks, then the dose is adjusted individually.
The standard dose for hypokalemia is 25-100 mg / day.
The recommended starting dose for children is 1-3 mg / kg in one to two doses daily for five days.
Overdose symptoms: drowsiness, lethargy, arrhythmia, confusion, electrolyte disturbances, cardiac conduction disturbances, ECG changes.
Treatment: correction of hyperkalemia, maintenance of water-electrolyte, acid-base balance, hemodialysis.
- Gastrointestinal disorders: nausea, diarrhea, vomiting, ulcers, stomach bleeding, gastritis, stomach pain, dry mouth, intestinal colic.
- Hematological disorders: thrombocytopenia, eosinophilia, agranulocytosis.
- Immune disorders: allergic reactions (rash, itching, urticaria, redness of the face and skin, angioedema, bronchospasm, shortness of breath).
- Endocrine Disorders: Hirsutism.
- Metabolic disorders: dehydration, hyperkalemia, hyponatremia, porphyria, hyperchloremic acidosis.
- Neurological disorders: confusion, drowsiness, vertigo, headache, paraplegia, paralysis, dizziness, ataxia.
- Cardiovascular disorders: arrhythmia, vasculitis, arterial hypotension.
- Hepatobiliary disorders: hepatotoxicity, hepatitis, liver dysfunction.
- Dermatological disorders: exanthema, erythema, alopecia, erythema annulus, eczema, lupus-like lesions, hypertrichosis, hirsutism in women, Stevens-Johnson syndrome.
- Musculoskeletal disorders: muscle cramps, osteomalacia.
- Genitourinary disorders: kidney dysfunction, decreased libido, gynecomastia in men, erectile dysfunction, increased blood urea, nipple tenderness, tenderness and / or enlargement of the mammary glands, dysmenorrhea, infertility, amenorrhea, benign mammary tumors.
- General: fatigue, change in tone of voice, asthenia.
Storage conditions and periods
Store Spironolactone for no more than three years at temperatures up to + 25 ° C.