Spironolactone, tablets 25 mg 20 pcs

Potassium-, magnesium-saving diuretic. It is a competitive aldosterone antagonist in its effect on the distal nephron (competes for binding sites at cytoplasmic protein receptors, reduces permease synthesis in the aldosterone-dependent site of the collecting tubes and distal tubules), increases Na⁺, Cl^– and water and decreases K⁺ and urea excretion and decreases urine titratable acidity.

The increased diuresis causes a hypotensive effect that is intermittent.

The hypotensive effect is independent of plasma renin levels and is not seen with normal BP.

The diuretic effect is seen on days 2-5 of treatment.

Indications

Oedema in chronic heart failure, liver cirrhosis (especially in the simultaneous presence of hypokalemia and hyperaldosteronism), nephrotic syndrome.

Oedema in II and III trimesters of pregnancy.

Hypertension, including in aldosterone-producing adrenal adenoma (in combination therapy).

Primary hyperaldosteronism. Aldosterone-producing adrenal adenoma (long-term supportive therapy if surgical treatment is contraindicated or if it is rejected). Diagnosis of hyperaldosteronism.

Hypokalemia and its prevention in treatment with saluretics.

Polycystic ovarian syndrome, premenstrual syndrome.

Active ingredient

Spironolactone

Composition

25 mg

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Interaction

Concomitant use with antihypertensive drugs potentiates the hypotensive effect of spironolactone.

Concomitant use with ACE inhibitors may lead to hyperkalemia (especially in patients with renal impairment) because ACE inhibitors decrease aldosterone, which leads to potassium retention in the body with restricted potassium excretion.

Concomitant use with potassium preparations, other potassium-saving diuretics, table salt substitutes, and dietary supplements containing potassium may lead to hyperkalemia.

The diuretic effect of spironolactone decreases with concomitant use of salicylates due to blockage of renal excretion of canrenone.

Indomethacin and mefenamic acid inhibit renal excretion of canrenone.

The hypoprothrombinemic effect of oral anticoagulants decreases with concomitant use.

Concomitant use with digitoxin may both enhance and reduce the effects of digitoxin.

When used concomitantly, spironolactone inhibits the renal excretion of digoxin and probably reduces its volume of distribution. This may cause an increase in plasma concentrations of digoxin.

Concomitant use with candesartan, losartan, eprosartan causes the risk of hyperkalemia.

In concomitant use with colestiramine cases of hypochloremic alkalosis have been described.

Concomitant use with lithium carbonate may increase the concentration of lithium in plasma.

Concomitant use with noradrenaline may decrease vascular sensitivity to noradrenaline.

Concomitant use increases the effect of triptorelin, buserelin, gonadorelin.

Directions for use

The route of administration and dosing regimen of a particular drug depend on its formulation and other factors. The optimal dosing regimen is determined by the doctor. The compliance of the used dosage form of a particular drug with the indications for use and the dosing regimen should be strictly observed.

Set individually, depending on the severity of violations of water-electrolyte metabolism and hormonal status.

In case of edematous syndrome it is 100-200 mg/day (less often – 300 mg/day) in 2-3 doses (usually in combination with “loop” or/and thiazide diuretic) daily during 14-21 days. Dose adjustment should be made taking into account values of plasma potassium concentration. If necessary, courses should be repeated every 10-14 days. In cases of severe hyperaldosteronism and decreased content of potassium in plasma – 300 mg/day in 2-3 intakes.

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Special Instructions

With caution, use with AV-blockade (possibility of increasing due to the development of hyperkalemia), decompensated liver cirrhosis, surgical interventions, drugs causing gynecomastia, local and general anesthetics, elderly patients.

Potassium containing drugs containing potassium as well as other diuretics causing potassium retention in the body should not be prescribed against the background of spironolactone administration. Spironolactone should be avoided with carbenoxolone, which causes sodium retention.

Periodic determination of electrolytes and urea in the blood should be performed during treatment.

When using spironolactone in combination with other diuretics or antihypertensive agents, it is recommended to reduce the dose of the latter. When using spironolactone concomitantly with digoxin, it may be necessary to reduce both the saturation and maintenance doses of the latter.

Contraindications

Addison’s disease, hyperkalemia, hypercalcemia, hyponatremia, chronic renal failure, anuria, hepatic insufficiency, diabetes with confirmed or suspected chronic renal failure, diabetic nephropathy, first trimester of pregnancy, metabolic acidosis, menstrual cycle disorders or increased mammary glands, hypersensitivity to spironolactone.

Side effects

Gastrointestinal system disorders: nausea, vomiting, abdominal pain, gastritis, ulceration and bleeding in the stomach, intestinal colic, diarrhea or constipation.

CNS disorders: dizziness, somnolence, lethargy, headache, lethargy, ataxia.

Metabolism disorders: increased concentration of urea, hypercreatininemia, hyperuricemia, disorder of water-salt metabolism and acidosis (metabolic hypochloremic acidosis or alkalosis).

Hematopoietic system: megaloblastosis, agranulocytosis, thrombocytopenia.

Endocrine system disorders: with long-term use – gynecomastia, erectile dysmenorrhea in men; in women – dysmenorrhea, amenorrhea, menopausal metrorrhagia, hirsutism, coarsened voice, breast pain, breast carcinoma.

Allergic reactions: urticaria, maculopapular and erythematous rashes, drug fever, itching.

Others: muscle cramps, decreased potency.

Similarities

Veroshpiron, Veroshpilactone, Spironolactone