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Aldaron 25mg TB No. 20

Trade name Aldaron® International nonproprietary name Spironolactone Dosage form Tablets, 25 mg Composition One tablet contains the active substance - spironolactone 25.0 mg, excipients: lactose monohydrate, talc, anhydrous colloidal silicon dioxide, magnesium or calcium stearate, potato starch. Description Tablets are white, round, biconvex. Pharmacotherapeutic group Diuretics. Potassium-sparing diuretics. Aldosterone antagonists. Spironolactone ATC code C03DA01 Pharmacological properties Pharmacokinetics When taken orally, the active substance of the drug, spironolactone, is well absorbed from the gastrointestinal tract (bioavailability more than 90%), absorption increases when taken simultaneously with food (bioavailability almost 100%). It is quickly and extensively biotransformed in the liver with the formation of several sulfur-containing metabolites, incl. 7-alpha-thiomethylspirolactone, 6-beta-hydroxy−7-alpha-thiomethylspirolactone and the main active metabolite, canrenone. The binding of spironolactone and canrenone to plasma proteins is more than 90%. Spironolactone and its metabolites cross the placental barrier, and canrenone passes into breast milk. The maximum concentration (Cmax) of spironolactone is achieved after 2.6 hours and is 80 ng/ml, the maximum concentration (Cmax) of canrenone is after 4.3 hours and is 181 ng/ml, 7-alpha-thiomethylspirolactone after 3.2 hours and is 391 ng/ml, 6-beta-hydroxy−7-alpha-thiomethylspirolactone - after 5.1 hours and is 125 ng/ml. It is excreted mainly in the urine in the form of metabolites, 10% - unchanged, and also in the form of metabolites in bile/feces. The half-life (T1/2) of spironolactone is 10 minutes, the half-life (T1/2) of canrenone is 13–24 hours (on average 19 hours) when taken 1–2 times a day, 9–16 hours (on average 12.5 h) when taken 4 times a day. Pharmacodynamics Spironolactone is a potassium-sparing diuretic. Competes with aldosterone for binding sites on cytoplasmic mineralocorticoid receptors. Inhibits the aldosterone-regulated exchange of sodium ions for potassium ions in the collecting ducts and distal tubules. Inhibits the reabsorption of sodium ions through the apical membrane of renal epithelial cells, increases the urinary excretion of sodium, chlorine and water ions, reduces the secretion and excretion of potassium (potassium-sparing effect), magnesium, urea and increases their concentration in the blood. It has a moderate long-term diuretic effect and a weak antihypertensive effect. The diuretic effect appears on days 2–5 and persists for 2–3 days after discontinuation of use. The hypotensive effect appears in the 2-3rd week of treatment. Antihypertensive activity is due to an increase in the excretion of sodium ions and a decrease in the volume of circulating blood and extracellular fluid. As a diuretic, it is most effective for edema associated with increased aldosterone production, especially when a potassium-sparing diuretic effect is desired, incl. for congestive heart failure, liver cirrhosis and nephrotic syndrome. Indications for use - edema in chronic heart failure, when the patient does not respond to treatment with other diuretics or there is a need to potentiate their effects - cirrhosis of the liver with ascites and edema - nephrotic syndrome, especially with the simultaneous presence of hypokalemia and hyperaldosteronism (as part of combination therapy ) - malignant ascites - primary hyperaldosteronism Method of administration and dosage Orally once a day with meals. Adults Congestive heart failure with edema Initial daily dose of 100 mg (may range from 25 to 200 mg per day), recommended in one or more divided doses. The maintenance dose should be determined individually. Liver cirrhosis with ascites and edema If the Na+/K+ ratio in urine is more than 1.0, the initial daily and maximum daily doses are 100 mg. If this ratio is less than 1.0, the initial daily dose is 200 mg, the maximum is 400 mg/day. The dosage can be set individually. Malignant ascites The initial dose is usually 100-200 mg per day. In severe cases, the dose may be gradually increased to 400 mg per day. The maintenance dose should be determined individually. Nephrotic syndrome Usual doses are 100-200 mg per day. Aldaron® is recommended only if monotherapy with glucocorticosteroids is ineffective. Primary hyperaldosteronism After diagnosis, 100-400 mg per day as preparation for surgery. If surgical treatment is not possible, long-term therapy can be carried out with the smallest effective dose, selected on an individual basis. In such cases, the initial dose should be reduced every 14 days until the lowest effective dose is reached. During long-term treatment, it is advisable to combine the drug with other diuretics to avoid the development of adverse reactions. The duration of treatment is determined individually by the attending physician. Children Children aged 12 years and older are prescribed at the rate of 3 mg/kg/day, once or in 2 doses, the dose is selected individually. Elderly patients It is recommended to begin treatment with lower doses, followed by gradual increases until maximum effect is achieved. Hepatic and renal impairment should be taken into account as they affect drug metabolism and excretion. Side effects Very common (1/10) - hyperkalemia (in patients with renal failure and those receiving potassium supplements) - arrhythmia (in patients with renal failure and those receiving potassium supplements) - decreased libido, erectile dysfunction, gynecomastia ( in men), breast tenderness, breast enlargement, menstrual irregularities (in women) Often (1/100, <1/10) - hyperkalemia (in elderly patients, diabetics and those receiving ACE inhibitors) - nausea, vomiting - infertility (in when using high doses (450 mg per day)) Uncommon (1/1000, <1/100) - headache, confusion, drowsiness, asthenia, fatigue, dizziness, muscle spasms, ataxia, calf muscle cramps Rare (1/10000 , <1/1000) - hypersensitivity - hyponatremia, dehydration, porphyria - gastritis, ulcer, gastric bleeding, stomach pain, diarrhea, constipation - rash, urticaria, hyperemia Very rare (<1/10000) - thrombocytopenia, agranulocytosis, eosinophilia, megaloblastosis - hirsutism - paralysis, paraplegia - vasculitis - change in voice timbre - hepatitis - alopecia, eczema, ring-shaped erythema, lupus-like skin lesions - osteomalacia - acute renal failure - increased serum urea, hypercreatininemia Unknown frequency - hyperchloremic acidosis or alkalosis - unwanted hypotension Undesirable effects usually stop after discontinuation of the drug. Contraindications - hypersensitivity, increased sensitivity to the active substance or to any of the excipients - Addison's disease - acute or rapidly progressing renal failure, chronic renal failure with a significant decrease in excretory function (creatinine clearance less than 10 ml/min) - anuria - hyperkalemia - hyponatremia - hypercalcemia - simultaneous use of other potassium-sparing diuretics and potassium supplements - pregnancy and lactation - children under 12 years of age Drug interactions When used together with: - other diuretics (increased diuresis) - cholestyramine, ammonium chloride (increased risk of hyperkalemia and hyperchloremic metabolic acidosis) - immunosuppressants (tacrolimus and cyclosporine) - increased risk of hyperkalemia - antihypertensive drugs (especially ganglion blockers) - excessive hypotension may develop, so the dose of antihypertensive drugs may need to be reduced when added to the Aldaron® therapeutic regimen, followed by adjustment as necessary - alcohol, barbiturates or narcotic drugs - can potentiate orthostatic hypotension caused by spironolactone - pressor amines (norepinephrine): Aldarone® reduces their effect, this should be taken into account when performing local or general anesthesia with the use of these drugs - non-steroidal anti-inflammatory drugs (NSAIDs), in particular acetylsalicylic acid, indomethacin and mefenamic acid - increased risk of hyperkalemia with a concomitant decrease in the diuretic, natriuretic and antihypertensive effects of Aldaron® - glucocorticosteroids, ACTH - paradoxical increase in potassium excretion - digoxin - spironolactone can increase the half-life of digoxin, which can lead to an increase in its content in the blood serum and the development glycoside intoxication - lithium - lithium preparations should not be prescribed concomitantly with diuretics, as they reduce the renal clearance of lithium and may increase the risk of intoxication - carbenoxolone - may cause sodium retention and thus reduce the effectiveness of spironolactone - carbamazepine - when taken concomitantly with spironolactone may cause the development clinically significant hyponatremia - coumarin derivatives - their effect is weakened - triptorelin, buserelin, gonadorelin - their effects are enhanced Impact on the results of laboratory tests - an influence on the process of determining the concentration of digoxin by radioimmunological methods can be expected. Special instructions Aldaron® should be used with extreme caution in patients with diseases that may cause the development of acidosis and/or hyperkalemia. The drug may increase the risk of developing hyperkalemia in patients with diabetic nephropathy. Prescribed with caution during surgery against the background of local and general anesthetics, in elderly patients (the risk of developing hyperkalemia is increased). Spironolactone should not be co-administered with drugs that cause gynecomastia. At doses above 100 mg/day, endocrine/antiandrogenic effects are more likely to develop, effects on the central nervous system and irritation of the gastrointestinal mucosa are manifested. During therapy, it is necessary to carefully monitor the content of electrolytes, the level of urea nitrogen, urea and creatinine in the blood (especially in elderly patients and in patients with impaired renal and/or liver function), and regularly monitor blood pressure. Hyperkalemia: Patients with impaired renal function or excessive potassium intake may develop a state of hyperkalemia, leading to cardiac problems. If hyperkalemia develops, use of Aldarone should be discontinued and, if necessary, active measures should be taken to reduce serum potassium levels. Some patients with decompensated cirrhosis, even with normal renal function, may develop reversible hyperchloremic metabolic acidosis, usually in combination with hyperkalemia. Concomitant use of Aldarone with other potassium-sparing diuretics, ACE inhibitors, angiotensin II antagonists, aldosterone blockers, heparin, low molecular weight heparins or other drugs that cause hyperkalemia, or with a diet rich in potassium or salt substitutes containing potassium, can lead to serious hyperkalemia. In patients with severe heart failure, hyperkalemia can be fatal. It is very important to monitor serum potassium levels in patients with severe heart failure receiving Aldarone®. The use of two potassium-sparing diuretics and potassium supplements should be avoided in patients with serum potassium levels above 3.5 mEq/L. It is recommended to monitor potassium and creatinine levels one week after starting or increasing the dose of Aldaron®, then monthly for the first 3 months, quarterly for a year, then every 6 months. Treatment should be discontinued if serum potassium levels exceed 5 mEq/L or creatinine levels exceed 4 mg/dL. When performing a glucose tolerance test in patients with diabetic nephropathy, spironolactone should be discontinued at least 3 days before the test (due to the risk of severe hyperkalemia). During treatment with Aldaron®, alcohol intake is prohibited. Pregnancy and lactation Spironolactone and its metabolites cross the placental barrier. In experiments on rats, it was found that spironolactone causes feminization of male fetuses. Breastfeeding should be discontinued while using Aldaron®. The drug contains lactose and is therefore contraindicated in cases of congenital lactose intolerance, Lapp lactase deficiency, and glucose-galactose malabsorption. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms. Caution is required for vehicle drivers and people whose profession is associated with increased concentration. Overdose Symptoms: drowsiness, dizziness, confusion, calf muscle cramps, nausea, vomiting, diarrhea, dehydration, water-electrolyte imbalance, skin rash. Treatment: discontinuation of the drug, induction of vomiting, gastric lavage, symptomatic treatment of dehydration and water-electrolyte imbalance, arterial hypotension, maintenance of vital functions; in case of hyperkalemia - rapid intravenous administration of a 20-50% glucose solution and insulin - 0.25-0.5 U/g glucose; potassium-sparing diuretics and ion exchange resins are used; hemodialysis is possible; there is no specific antidote.