Country of origin: Hungary
Pharm-Group: Potassium-sparing diuretics
Manufacturers: Gedeon Richter A.O. (Hungary)
International name: Spironolactone
Synonyms: Aldactone, Aldopur, Vero-Spironolactone, Veroshpilaktone, Prakton, Spiriks, Spiro, Spironaxan, Spironobene, Spironol, Spironolactone, Spironolactone (Unilan), Spironolactone-Ratiopharm, Uractone
Dosage forms: tablets 25 mg, capsules 50 mg, capsules 100 mg
Composition: Active substance: Spironolactone.
Indications for use: Primary hyperaldosteronism, aldosterone-producing adrenal adenoma, edema syndrome against the background of secondary hyperaldosteronism in chronic heart failure, liver cirrhosis (with ascites or edema), nephrotic syndrome; arterial hypertension due to secondary hyperaldosteronism, some forms of essential; hypokalemia, incl. during therapy with saluretics and digitalis preparations, edema and nephropathy in pregnant women, edematous syndrome in newborns, infectious-allergic bronchial asthma (especially complicated by right heart failure), myopathy, myasthenia gravis, parkinsonism, polycystic ovary syndrome (prevention and treatment), hirsutism (treatment), premenstrual syndrome, premature puberty in young men, bronchopulmonary dysplasia.
Contraindications: Hypersensitivity, hyperkalemia, azotemia, anuria, renal failure (acute, chronic, with significant damage to excretory function, including chronic nephritis in the nephrotic stage).
Side effects: Hyperkalemia, hyponatremia, increased blood concentrations of urea, creatinine, uric acid, disturbances of water-salt metabolism and acid-base balance (metabolic hyperchloremic acidosis or alkalosis); nausea, vomiting, dyspeptic symptoms, abdominal pain, intestinal motility disorders, diarrhea or constipation, intestinal colic, gastritis, ulceration and bleeding in the gastrointestinal tract; headache, dizziness, ataxia, drowsiness, mental disorders; muscle spasms; gynecomastia, erectile dysfunction, virilization in women (deepening of the voice, hirsutism and other androgenic effects), menstrual disorders, incl. dysmenorrhea, amenorrhea, metrorrhagia during menopause, etc., breast tenderness, breast carcinoma; megaloblastosis, agranulocytosis, thrombocytopenia, photosensitivity; allergic reactions - maculo-, papulo-, and erythematous rashes, urticaria, drug fever, itching, etc.
Interaction: Steroidal anti-inflammatory drugs and diuretics (benzothiadiazine derivatives, furosemide, ethacrynic acid, etc.) enhance and accelerate the diuretic and natriuretic effects, ACE inhibitors (because they inhibit the release of aldosterone), indomethacin, cyclosporine, other potassium-sparing diuretics, potassium preparations (including potassium chloride) and potassium supplements - increase the risk of developing hyperkalemia (especially against the background of renal failure). Sympathomimetic drugs reduce antihypertensive properties, NSAIDs (indomethacin and acetylsalicylic acid) - diuretic, natriuretic and antihypertensive activity and increase the risk of developing renal failure.
Overdose: Symptoms: nausea, vomiting, diarrhea; severe hyperkalemia (paresthesia, muscle weakness, arrhythmias), hyponatremia (dry mouth, thirst, drowsiness, etc.); hypercalcemia, increased urea levels in the blood. Treatment: maintenance of vital functions, symptomatic therapy.
Special instructions: Restrictions on use: liver dysfunction, diabetes mellitus, hyponatremia, hypercalcemia, menstrual irregularities, pregnancy, breastfeeding. Prescribe with caution for renal and hepatic