Description of the dosage form
Tablets are white or white with a creamy tint, round, flat-cylindrical, with a score on one side and a bevel, almost odorless or with a weak specific odor.
pharmachologic effect
Spironolactone is a potassium-sparing diuretic, a specific antagonist of aldosterone (mineralocorticosteroid hormone of the adrenal cortex) with prolonged action. In the distal parts of the nephron, spironolactone prevents the retention of sodium and water by aldosterone and suppresses the potassium-removing effect of aldosterone, reduces the synthesis of permeases in the aldosterone-dependent area of the collecting ducts and distal tubules. By binding to aldosterone receptors, it increases the excretion of sodium, chlorine and water ions in the urine, reduces the excretion of potassium and urea ions, and reduces the acidity of urine.
The maximum effect is observed 7 hours after oral administration and lasts for at least 24 hours. The hypotensive effect of the drug is due to the presence of a diuretic effect, which is not constant: the diuretic effect appears on days 2-5 of treatment.
Pharmacokinetics
Suction and distribution
When taken orally, it is quickly and completely absorbed from the gastrointestinal tract. The maximum concentration of Cmax canrenone in the blood plasma is achieved 2-4 hours after administration. Binds to plasma proteins by approximately 98% (canrenone - 90%). Volume of distribution (Vd) - 0.05 l/kg.
After daily administration of spironolactone at a dose of 100 mg for 15 days, Cmax is 80 ng/ml, the time to reach Cmax after the next morning dose is 2-6 hours.
Spironolactone penetrates poorly into organs and tissues, while itself and its metabolites penetrate the placental barrier, and canrenone passes into breast milk.
Metabolism
Spironolactone is converted into active metabolites: a metabolite containing sulfur (80%) and partly canrenone (20%).
Removal
Excreted by the kidneys: 50% - in the form of metabolites, 10% - unchanged and partially through the intestines. The half-life (T1/2) of spironolactone is 13-24 hours, of active metabolites - up to 15 hours. The elimination of canrenone (mainly by the kidneys) is two-phase, T1/2 in the first phase is 2-3 hours, in the second - 12-96 hours.
Pharmacokinetics in selected patient groups
In liver cirrhosis and heart failure, the duration of T1/2 increases without signs of cumulation, the likelihood of which is higher in chronic renal failure and hyperkalemia.
Veroshpiron tablets: main characteristics
"Veroshpiron" refers to diuretic drugs; its effects are an antagonist of the adrenal hormone aldosterone. Available in the form of capsules and tablets of identical composition.
The active ingredient is spironolactone. Each tablet contains 25 mg, and capsules contain dosages of 50 mg and 100 mg. Spironolactone stimulates water excretion, reduces potassium loss and the formation of permease enzymes. The most pronounced effect occurs 7 hours after taking the drug, it continues for 24 hours.
Due to regular exposure to spironolactone, a decrease in blood pressure is observed, which is associated with a diuretic effect. A decrease in blood pressure is observed 2-5 weeks after the start of therapy.
The medicine is sold in pharmacies only with a prescription. It is necessary to agree with the doctor, who determines the duration of the course and dosage. The drug is stored at room temperature (maximum 30 degrees).
Indications for use of Veroshpiron
- Essential hypertension (as part of combination therapy);
- edema syndrome in chronic heart failure (can be used in monotherapy and in combination with standard therapy);
- conditions in which secondary hyperaldosteronism may be detected, including cirrhosis of the liver accompanied by ascites and/or edema, nephrotic syndrome, as well as other conditions accompanied by edema;
- hypokalemia/hypomagnesemia (as an adjuvant for its prevention during treatment with diuretics and when it is impossible to use other methods of correcting potassium levels);
- primary hyperaldosteronism (Conn's syndrome) - for a short preoperative course of treatment;
- to establish the diagnosis of primary hyperaldosteronism.
Contraindications to the use of Veroshpiron
- Hypersensitivity to any of the components of the drug;
- Addison's disease;
- hyperkalemia;
- hyponatremia;
- severe renal failure (creatinine clearance less than 10 ml/min);
- anuria;
- pregnancy;
- lactation period (breastfeeding);
- children under 3 years of age (for solid dosage form);
- lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome (since the drug contains lactose monohydrate).
With caution: hypercalcemia, metabolic acidosis, AV block (hyperkalemia enhances it); diabetes mellitus (with confirmed or suspected chronic renal failure); diabetic nephropathy; surgical interventions during anesthesia; taking medications that cause gynecomastia; local and general anesthesia; elderly age; menstrual irregularities, enlarged mammary glands; liver failure, liver cirrhosis.
Side effects
From the gastrointestinal tract: nausea, vomiting, diarrhea, ulceration and bleeding from the gastrointestinal tract, gastritis, intestinal colic, abdominal pain, constipation.
From the liver: impaired liver function.
From the nervous system: ataxia, lethargy, dizziness, headache, drowsiness, lethargy, confusion, muscle spasm.
From the blood and lymphatic system: agranulocytosis, thrombocytopenia, megaloblastosis.
From laboratory parameters: hyperuricemia, hypercreatininemia, increased urea concentration, disturbance of water and electrolyte balance (hyperkalemia, hyponatremia) and acid-base status (metabolic hyperchloremic acidosis or alkalosis).
From the endocrine system: deepening of the voice, in men - gynecomastia (the likelihood of development depends on the dose, duration of treatment and is usually reversible, and disappears after discontinuation of the drug, and only in rare cases the mammary gland remains slightly enlarged), decreased potency and erection; in women - menstrual irregularities, dysmenorrhea, amenorrhea, metrorrhagia during menopause, hirsutism, pain in the mammary glands, breast carcinoma (no connection with the drug has been established).
Allergic reactions: urticaria, maculopapular and erythematous rash, drug fever, pruritus, eosinophilia, Stevens-Johnson syndrome, toxic epidermal necrolysis.
From the skin and subcutaneous tissues: alopecia, hypertrichosis.
From the kidneys and urinary tract: acute renal failure.
Musculoskeletal and connective tissue disorders: calf muscle cramps.
From the respiratory system: shortness of breath.
If any of the above adverse reactions worsen or other adverse events not listed in the instructions occur, the patient should inform the doctor.
Veroshpilakton (Veroshpiron) tablets 25 mg No. 20
A country
Russia
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.
Active substance
Spironolactone
Compound
Active substance: Spironolactone.
pharmachologic effect
It has a diuretic, potassium-sparing, hypotensive effect. Inhibits the reabsorption of sodium ions through the apical membrane of renal epithelial cells and increases the excretion of sodium, chlorine and water ions in the urine. It has a potassium-sparing effect: it inhibits the aldosterone-regulated exchange of sodium ions for potassium ions, reduces the secretion and excretion of potassium, magnesium, urea and increases their concentration in the blood. Increases excretion. Reduces urine acidity. The diuretic effect appears on the 2-5th day and persists for 2-3 days after stopping use. 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; appears in the 2-3rd week of treatment. Increases the activity of glucuronyl transferase, increases the amount of conjugated bilirubin in the urine, reduces the risk of arrhythmias. When taken orally, it is completely absorbed. It is quickly and intensively biotransformed in the liver with the formation of several active metabolites. Almost completely binds to blood plasma proteins. Excreted in urine, partially excreted in bile and feces.
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.
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 (in 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. Potentiates the effect of diuretic and antihypertensive drugs, enhances the toxic effects of lithium preparations, prevents the development of hypokalemia when prescribing furosemide and other diuretics that cause it, reduces the effect of cardiac glycosides, anticoagulants (coumarin derivatives, indandione, heparin), the vasoconstrictor effect of adrenaline and inhibits the antiulcer agent - carbenoxolone (accelerates biotransformation and excretion).
Side effect
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.
Contraindications
Hypersensitivity, hyperkalemia, azotemia, anuria, renal failure (acute, chronic, with significant damage to excretory function, including chronic nephritis in the nephrotic stage).
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: maintaining vital functions, immediate removal of stomach contents; in case of hyperkalemia - rapid intravenous administration of a 20-50% glucose solution and insulin - 0.25-0.5 U/g glucose (repeat if necessary).
special instructions
Restrictions on use: Liver dysfunction, diabetes mellitus (especially diabetic nephropathy), predisposition to metabolic acidosis, hyponatremia, hypercalcemia, menstrual irregularities accompanied by enlarged mammary glands, the first 3 weeks of pregnancy, breastfeeding. Prescribed with caution in case of incomplete atrioventricular block, decompensated cirrhosis of the liver, surgical intervention, against the background of drugs that cause gynecomastia, local and general anesthetics, the elderly. When combined with cardiac glycosides, diuretics and antihypertensive drugs, doses should be reduced. During therapy, it is necessary to carefully monitor the content of electrolytes, the level of nitrogen, urea and creatinine in the blood, blood pressure, and avoid introducing excess amounts of potassium into the body.
Dispensing conditions in pharmacies
On prescription
Drug interactions
Reduces the effect of anticoagulants, indirect anticoagulants (heparin, coumarin derivatives, indanedione) and the toxicity of cardiac glycosides (since normalization of potassium content in the blood prevents the development of toxicity).
Enhances the metabolism of phenazone (antipyrine).
Reduces the sensitivity of blood vessels to norepinephrine (care is required when performing anesthesia), increases T1/2 of digoxin - digoxin intoxication is possible.
Increases the toxic effect of lithium due to decreased clearance.
Possibly enhances the effect of non-depolarizing muscle relaxants (for example, tubocurarine).
Accelerates the metabolism and excretion of carbenoxolone.
Carbenoxolone promotes sodium retention by spironolactone.
GCS and diuretics (thiazides and thiazide-like, furosemide, ethacrynic acid) enhance and accelerate the diuretic and natriuretic effects.
Enhances the effect of diuretic and antihypertensive drugs.
NSAIDs reduce the diuretic and natriuretic effects, increasing the risk of hyperkalemia.
Alcohol (ethanol), barbiturates, and narcotic substances increase orthostatic hypotension.
GCS enhance the diuretic and natriuretic effect in hypoalbuminemia and/or hyponatremia.
The risk of developing hyperkalemia increases when taken with potassium preparations, potassium supplements and potassium-sparing diuretics, ACE inhibitors (acidosis), angiotensin II receptor antagonists, aldosterone blockers, indomethacin, cyclosporine.
Salicylates and indomethacin reduce the diuretic effect of spironolactone.
Ammonium chloride and cholestyramine contribute to the development of hyperkalemic metabolic acidosis.
Fludrocortisone causes a paradoxical increase in tubular secretion of potassium.
Spironolactone reduces the effect of mitotane.
Enhances the effects of triptorelin, buserelin, gonadorelin.
Instructions for use VEROSPIRON® (VEROSPIRON®)
Spironolactone may increase the risk of hyperkalemia in patients with diabetic nephropathy.
Spironolactone therapy may cause a transient increase in blood urea nitrogen, especially in patients with pre-existing renal impairment and hyperkalemia. Spironolactone may cause the development of reversible hyperchloremic metabolic acidosis. Thus, in patients with impaired renal and hepatic function, as well as in elderly patients, biochemical indicators of renal function should be regularly examined, as well as electrolyte balance should be monitored.
Concomitant use of potassium supplements, a diet rich in potassium, taking other potassium-sparing diuretics, taking potassium-containing salt substitutes, taking ACE inhibitors, angiotensin II receptor antagonists, aldosterone receptor antagonists, heparin or low molecular weight heparins, trimethoprim or other drugs that cause hyperkalemia may lead to severe hyperkalemia, especially in patients with renal failure.
Caution should be exercised when prescribing the drug to patients prone to acidosis or hyperkalemia due to an underlying disease (for example, diabetes mellitus).
Caution should also be exercised in patients with moderate renal impairment (serum creatinine between 1.2 mg/100 ml and 1.8 mg/100 ml or creatinine clearance between 60 ml/min and 30 ml/min), hypotension or hypovolemia.
Rapid weight loss should be avoided.
Hyperkalemia in patients with severe heart failure.
Hyperkalemia can be life-threatening. In patients with severe heart failure, serum potassium levels should be carefully monitored. If the potassium level in the blood exceeds 3.5 mmol/l, potassium-sparing diuretics should be avoided. It is recommended to monitor potassium and creatinine levels in the blood 1 week after the start of treatment, and then every 6 months. Treatment should be stopped or suspended if the blood potassium level exceeds 5 mmol/l or the creatinine level exceeds 4 mg/dl.
Spironolactone therapy may interfere with the determination of serum digoxin, plasma cortisol and epinephrine.
During treatment with spironolactone, alcohol consumption is prohibited.
The dosage form contains lactose. The drug should not be prescribed to patients with rare congenital forms of lactose intolerance (lactase deficiency lapp, glucose-galactose malabsorption).
Impact on the ability to drive vehicles and operate machinery
At the beginning of treatment, you should stop driving vehicles and dangerous machinery for a period of time, the duration of which is determined individually. In the future, this limitation should be approached individually for each patient. Undesirable effects usually disappear after discontinuation of the drug.
Preclinical Safety Data
According to the literature, when Veroshpiron was administered to animals for a long time in doses many times higher than the maximum permissible doses for humans, the development of tumors and myeloid leukemia was observed. Given these data, it is recommended to avoid long-term use of spironolactone.
Dosage of Veroshpiron
Inside.
Essential hypertension
The daily dose for adults is usually 50-100 mg once and can be increased to 200 mg, and the dose should be increased gradually, once every 2 weeks. To achieve an adequate response to therapy, the drug must be taken for at least 2 weeks. If necessary, adjust the dose.
Idiopathic hyperaldosteronism
Prescribed at a dose of 100-400 mg/day.
Severe hyperaldosteronism and hypokalemia
Prescribe 300 mg/day (maximum 400 mg/day) in 2-3 doses; as the condition improves, the dose is gradually reduced to 25 mg/day.
Hypokalemia and/or hypomagnesemia
For hypokalemia and/or hypomagnesemia caused by diuretic therapy, the drug is prescribed at a dose of 25-100 mg/day, once or in several doses. The maximum daily dose is 400 mg if oral potassium supplements or other methods of replenishing the deficiency are ineffective.
Diagnosis and treatment of primary hyperaldosteronism
As a diagnostic agent for a short diagnostic test: for 4 days, 400 mg/day, divided into several doses per day. If the concentration of potassium in the blood increases while taking the drug and decreases after its discontinuation, the presence of primary hyperaldosteronism can be assumed.
For a long-term diagnostic test: at the same dose for 3-4 weeks. When correction of hypokalemia and arterial hypertension is achieved, the presence of primary hyperaldosteronism can be assumed.
Short course of preoperative therapy for primary hyperaldosteronism
After the diagnosis of hyperaldosteronism has been established using more accurate diagnostic methods, Verospilactone should be taken at a dose of 100-400 mg/day, divided into 1-4 doses during the entire period of preparation for surgery. If surgery is not indicated, then the drug Verospilactone is used for long-term maintenance therapy, using the lowest effective dose, which is selected individually for each patient.
Edema due to nephrotic syndrome
The daily dose for adults is usually 100-200 mg/day. No effect of spironolactone on the underlying pathological process has been identified, and therefore the use of this drug is recommended only in cases where other types of therapy are ineffective.
Edema syndrome due to chronic heart failure
Daily, for 5 days, 100-200 mg/day in 2-3 divided doses, in combination with a loop or thiazide diuretic. Depending on the effect, the daily dose is reduced to 25 mg. The maintenance dose is selected individually. Maximum dose 200 mg/day.
Edema due to liver cirrhosis
If the ratio of sodium and potassium ions (Na+/K+) in the urine exceeds 1.0, then the daily dose for adults is usually 100 mg. If the ratio is less than 1.0, then the daily dose for adults is usually 200-400 mg. The maintenance dose is selected individually.
Edema in children
The initial dose in children over 3 years of age is 1-3.3 mg/kg body weight or 30-90 mg/m2/day in 1-4 doses. After 5 days, the dose is adjusted and, if necessary, increased by 3 times compared to the original.
Veroshpilakton (Veroshpiron) (caps. 100 mg No. 30)
A country
Russia
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.
Active substance
Spironolactone
Compound
1 capsule contains: spironolactone 100 mg. Excipients: povidone - 10 mg, lactose monohydrate - 112 mg, potato starch - 82.4 mg, colloidal silicon dioxide (aerosil) - 4 mg, sodium lauryl sulfate - 5.2 mg, talc - 3.2 mg, magnesium stearate - 3.2 mg. Capsules No. 1 with a blue body and cap; the contents of the capsules are white or white powder with a yellowish tint.
pharmachologic effect
Spironolactone is a potassium-sparing diuretic, a specific antagonist of aldosterone (mineralocorticosteroid hormone of the adrenal cortex) with prolonged action. In the distal parts of the nephron, spironolactone prevents the retention of sodium and water by aldosterone and suppresses the potassium-removing effect of aldosterone, reduces the synthesis of permeases in the aldosterone-dependent area of the collecting ducts and distal tubules. By binding to aldosterone receptors, it increases the excretion of sodium, chlorine and water ions in the urine, reduces the excretion of potassium and urea ions, and reduces the acidity of urine. The maximum effect is observed 7 hours after oral administration and lasts for at least 24 hours. The hypotensive effect of the drug is due to the presence of a diuretic effect , which is not permanent: the diuretic effect appears on days 2-5 of treatment.
Indications for use
— essential hypertension (as part of combination therapy); — edematous syndrome in chronic heart failure (can be used in monotherapy and in combination with standard therapy); — conditions in which secondary hyperaldosteronism may be detected, including cirrhosis of the liver, accompanied by ascites and/or edema , nephrotic syndrome, as well as other conditions accompanied by edema; - hypokalemia/hypomagnesemia (as an adjuvant for its prevention during treatment with diuretics and when it is impossible to use other methods of correcting potassium levels); - primary hyperaldosteronism (Conn's syndrome) - for a short preoperative course of treatment; - to establish a diagnosis of primary hyperaldosteronism.
Mode of application
Orally. Essential hypertension The daily dose for adults is usually 50-100 mg once and can be increased to 200 mg, and the dose should be increased gradually, once every 2 weeks. To achieve an adequate response to therapy, the drug must be taken for at least 2 weeks. If necessary, adjust the dose. Idiopathic hyperaldosteronism Prescribed at a dose of 100-400 mg/day. Severe hyperaldosteronism and hypokalemia Prescribed 300 mg/day (maximum 400 mg/day) in 2-3 doses; if the condition improves, the dose is gradually reduced to 25 mg/day. Hypokalemia and/or hypomagnesemia For hypokalemia and/or hypomagnesemia caused by diuretic therapy, the drug is prescribed at a dose of 25-100 mg/day, once or in several doses. The maximum daily dose is 400 mg, if potassium preparations for oral administration or other methods of replenishing its deficiency are ineffective. Diagnosis and treatment of primary hyperaldosteronism As a diagnostic tool for a short diagnostic test: for 4 days, 400 mg / day, divided into several doses per day. If the concentration of potassium in the blood increases while taking the drug and decreases after its discontinuation, the presence of primary hyperaldosteronism can be assumed. For a long-term diagnostic test: at the same dose for 3-4 weeks. When correction of hypokalemia and arterial hypertension is achieved, the presence of primary hyperaldosteronism can be assumed. A short course of preoperative therapy for primary hyperaldosteronism After the diagnosis of hyperaldosteronism is established using more accurate diagnostic methods, Verospilactone should be taken 100-400 mg / day, divided into 1-4 doses during the entire period of preparation for surgery. If surgery is not indicated, then the drug Verospilactone is used for long-term maintenance therapy, using the lowest effective dose, which is selected individually for each patient. Edema due to nephrotic syndrome The daily dose for adults is usually 100-200 mg/day. No effect of spironolactone on the underlying pathological process has been identified, and therefore the use of this drug is recommended only in cases where other types of therapy are ineffective. Edema syndrome due to chronic heart failure Daily, for 5 days, 100-200 mg / day in 2 days 3 doses, in combination with a loop or thiazide diuretic. Depending on the effect, the daily dose is reduced to 25 mg. The maintenance dose is selected individually. The maximum dose is 200 mg/day. Edema due to cirrhosis of the liver. If the ratio of sodium and potassium ions (Na+/K+) in the urine exceeds 1.0, then the daily dose for adults is usually 100 mg. If the ratio is less than 1.0, then the daily dose for adults is usually 200-400 mg. The maintenance dose is selected individually. Edema in children The initial dose in children over 3 years of age is 1-3.3 mg/kg body weight or 30-90 mg/m2/day in 1-4 doses. After 5 days, the dose is adjusted and, if necessary, increased by 3 times compared to the original.
Interaction
Reduces the effect of anticoagulants, indirect anticoagulants (heparin, coumarin derivatives, indandione) and the toxicity of cardiac glycosides (since normalization of potassium levels in the blood prevents the development of toxicity). Enhances the metabolism of phenazone (antipyrine). Reduces the sensitivity of blood vessels to norepinephrine (care is required when carrying out anesthesia), increases T1/2 of digoxin - digoxin intoxication is possible. Increases the toxic effect of lithium due to decreased clearance. Possibly enhances the effect of non-depolarizing muscle relaxants (for example, tubocurarine). Accelerates the metabolism and excretion of carbenoxolone. Carbenoxolone promotes sodium retention by spironolactone. GCS and diuretics ( thiazides and thiazide-like, furosemide, ethacrynic acid) enhance and accelerate the diuretic and natriuretic effects. Enhances the effect of diuretic and antihypertensive drugs. NSAIDs reduce the diuretic and natriuretic effects, increasing the risk of hyperkalemia. Alcohol (ethanol), barbiturates, narcotic substances increase orthostatic hypotension. GCS enhance the diuretic and natriuretic effect in hypoalbuminemia and/or hyponatremia. The risk of developing hyperkalemia increases when taken with potassium preparations, potassium supplements and potassium-sparing diuretics, ACE inhibitors (acidosis), angiotensin II receptor antagonists, aldosterone blockers, indomethacin, cyclosporine. Salicylates, indomet qing reduce the diuretic effect of spironolactone. Ammonium chloride, cholestyramine contribute to the development of hyperkalemic metabolic acidosis. Fludrocortisone causes a paradoxical increase in tubular secretion of potassium. Spironolactone reduces the effect of mitotane. Enhances the effects of triptorelin, buserelin, gonadorelin.
Side effect
From the gastrointestinal tract: nausea, vomiting, diarrhea, ulcerations and bleeding from the gastrointestinal tract, gastritis, intestinal colic, abdominal pain, constipation. From the liver: impaired liver function. From the nervous system: ataxia, lethargy, dizziness, headache pain, drowsiness, lethargy, confusion, muscle spasm. From the blood and lymphatic system: agranulocytosis, thrombocytopenia, megaloblastosis. From laboratory indicators: hyperuricemia, hypercreatininemia, increased urea concentration, water-electrolyte imbalance (hyperkalemia, hyponatremia) and acid - the underlying condition (metabolic hyperchloremic acidosis or alkalosis). From the endocrine system: deepening of the voice, in men - gynecomastia (the likelihood of development depends on the dose, duration of treatment and is usually reversible, and disappears after discontinuation of the drug, and only in rare cases chest gland remains slightly enlarged), decreased potency and erection; in women - menstrual irregularities, dysmenorrhea, amenorrhea, metrorrhagia during menopause, hirsutism, pain in the mammary glands, breast carcinoma (no connection with the drug has been established). Allergic reactions: urticaria, maculopapular and erythematous rash, drug fever, pruritus, eosinophilia, Stevens-Johnson syndrome, toxic epidermal necrolysis. From the skin and subcutaneous tissues: alopecia, hypertrichosis. From the kidneys and urinary tract: acute renal failure. From the musculoskeletal and connective tissue: cramps of the calf muscles From the respiratory system: shortness of breath. If any of the above adverse reactions worsen or other adverse events not listed in the instructions occur, the patient should inform the doctor.
Contraindications
- hypersensitivity to any of the components of the drug; - Addison's disease; - hyperkalemia; - hyponatremia; - severe renal failure (creatinine clearance less than 10 ml/min); - anuria; - pregnancy; - lactation (breastfeeding); - children age up to 3 years (for solid dosage form); - lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome (since the drug contains lactose monohydrate). With caution: - hypercalcemia, metabolic acidosis, AV block (hyperkalemia contributes to its strengthening);—diabetes mellitus (with confirmed or suspected chronic renal failure);—diabetic nephropathy;—surgical interventions during anesthesia; taking medications that cause gynecomastia; local and general anesthesia; old age; menstrual irregularities, enlarged mammary glands; liver failure, liver cirrhosis.
Overdose
Symptoms: nausea, vomiting, dizziness, diarrhea, skin rash, hyperkalemia (paresthesia, muscle weakness, arrhythmias), hyponatremia (dry mouth, thirst, drowsiness), hypercalcemia, dehydration, increased urea concentration. Treatment: gastric lavage, symptomatic treatment of dehydration and arterial hypotension. In case of hyperkalemia, it is necessary to normalize the water-electrolyte balance with the help of potassium-removing diuretics, rapid parenteral administration of a 5-20% dextrose (glucose) solution with insulin at the rate of 0.25-0.5 units per 1 g of dextrose (glucose). You can re-enter if necessary. In severe cases, hemodialysis is performed.
special instructions
A temporary increase in serum urea nitrogen is possible, especially with reduced renal function and hyperkalemia. Reversible hyperchloremic metabolic acidosis is possible. In case of impaired renal and hepatic function, as well as in old age, regular monitoring of serum electrolytes and renal function is necessary. The drug makes it difficult to determine digoxin , cortisol and adrenaline in the blood. Despite the lack of a direct effect on carbohydrate metabolism, the presence of diabetes mellitus, especially with diabetic nephropathy, requires special caution due to the possibility of developing hyperkalemia. When treating NSAIDs simultaneously, renal function and electrolyte levels in the blood should be monitored. Avoid eating foods rich in potassium. During treatment, alcohol consumption is contraindicated. Impact on the ability to drive vehicles and operate machinery. During the initial period of treatment, it is prohibited to drive a vehicle and engage in activities that require increased concentration and speed of psychomotor reactions. The duration of restrictions is set individually.
Dispensing conditions in pharmacies
On prescription
Overdose
Symptoms: nausea, vomiting, dizziness, diarrhea, skin rash, hyperkalemia (paresthesia, muscle weakness, arrhythmias), hyponatremia (dry mouth, thirst, drowsiness), hypercalcemia, dehydration, increased urea concentration.
Treatment: gastric lavage, symptomatic treatment of dehydration and arterial hypotension. In case of hyperkalemia, it is necessary to normalize the water-electrolyte balance with the help of potassium-removing diuretics, rapid parenteral administration of a 5-20% dextrose (glucose) solution with insulin at the rate of 0.25-0.5 units per 1 g of dextrose (glucose); can be re-entered if necessary. In severe cases, hemodialysis is performed.
