What is Veroshpiron for? Veroshpiron capsules - official* instructions for use

Veroshpiron is a potassium-sparing diuretic of synthetic origin.

Applicable in medical practice to establish water and electrolyte balance in the human body. The main active, potent component of the drug is spironolactone.

On this page you will find all the information about Veroshpiron: full instructions on application to this drug, average prices in pharmacies, complete and incomplete analogues of the drug, as well as reviews of people who have already used Veroshpiron. Would you like to leave your opinion? Please write in the comments.

Clinical and pharmacological group

Potassium-sparing diuretic.

Conditions for dispensing from pharmacies

Dispensed with a doctor's prescription.

Prices

How much does Veroshpiron cost? average price in pharmacies it is at the level of 220 rubles.

Release form and composition

The drug is available in the form of capsules and tablets. The active element of the drug Veroshpiron, which helps with high blood pressure, is spironolactone. The active ingredient is contained in an amount of 25 mg for tablets, 50 or 100 mg for capsules.

Additional substances in the tablets are talc, silicon dioxide, lactose monohydrate, magnesium stearate, corn starch. Capsules consist of sodium lauryl sulfate, lactose monohydrate, magnesium stearate, corn starch. The cap and body of the capsule also contain gelatin, dyes and titanium dioxide.

Pharmacological effect

The active substance spironolactone, according to the instructions, is a component that acts opposite to the adrenal hormone aldosterone. Acts in the kidney department - nephron, eliminates fluid and sodium retention, suppresses the potassium-removing effect. Spironolactone interferes with the production of kidney tubular enzymes. By binding to receptors, it increases the excretion of sodium and chlorine ions with water and urine, reduces the loss of potassium ions, and reduces the acidity of urine. According to doctors, it has a hypotensive effect due to the diuretic properties of the hormone aldosterone.

After administration, it is completely absorbed from the gastrointestinal tract, bioavailability is 100%, consumption of food increases it to the maximum. Spironolactone reaches its highest concentration 2-6 hours after morning administration. The substance binds to plasma proteins by 98%, penetrates poorly into organs and tissues, but metabolites are able to overcome the placental barrier and enter the breast milk.

Indications for use

According to the instructions, Veroshpiron is prescribed for:

1. Conditions accompanied by secondary hyperaldosteronism, including nephrotic syndrome, and other conditions accompanied by edema;
2. Edematous syndrome in the background (as the main drug or in combination with other drugs);
3. Primary hyperaldosteronism (Crohn's syndrome) – for a short time in the preoperative period;
4. Essential (in combination with other drugs);
5. Hypokalemia or hypomagnesemia (for the purpose of prevention during treatment with diuretics).

Veroshpiron is also prescribed to establish a diagnosis of primary hyperaldosteronism.

Contraindications

Contraindications to the use of Veroshpiron are:

• Anuria;
• Heavy renal failure;
• Lactose intolerance, lactase enzyme deficiency, glucose-galactose malabsorption;
• Pregnancy and breastfeeding period;
• Childhood up to three years;
• Hypersensitivity to any of the components of the drug;
• Hyponatremia;
• Hyperkalemia.

Veroshpiron is prescribed with caution to patients with metabolic acidosis, hypercalcemia, diabetes mellitus, diabetic nephropathy, liver failure, cirrhosis of the liver, as well as elderly people, women with irregular menstrual cycles, enlarged mammary glands and local or general anesthesia.

Use during pregnancy and lactation

Taking Veroshpiron is contraindicated for women during pregnancy and lactation.

If it is necessary to prescribe this drug to nursing mothers, it is recommended to stop breastfeeding, since spironolactone can pass into milk and have adverse effects. negative impact on the child's body.

Instructions for use

The instructions for use indicate that the dosage of Veroshpiron depends on the disease:

1. For idiopathic hyperaldosteronism, the drug is prescribed at a dose of 100-400 mg/day.
2. For essential hypertension daily dose for adults it is usually 50-100 mg once and can be increased to 200 mg, while 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.
3. For hypokalemia and/or hypomagnesemia caused by diuretic therapy, Veroshpiron 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 potassium deficiency are ineffective.
4. For severe hyperaldosteronism and hypokalemia, the daily dose is 300 mg (maximum 400 mg) in 2-3 doses; as the condition improves, the dose is gradually reduced to 25 mg/day.
5. When diagnosing and treating primary hyperaldosteronism, Veroshpiron is prescribed as a diagnostic tool for a short diagnostic test for 4 days at 400 mg/day, dividing the daily dose 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, the drug is prescribed in the same dose for 3-4 weeks. When correction of hypokalemia is achieved and arterial hypertension the presence of primary hyperaldosteronism can be assumed.
6. Once the diagnosis of hyperaldosteronism has been established using more accurate diagnostic methods, as a short course of preoperative therapy for primary hyperaldosteronism, Veroshpiron should be taken in a daily dose of 100-400 mg, divided into 1-4 doses throughout the entire period of preparation for surgery. If surgery is not indicated, then Veroshpiron is used for long-term maintenance therapy, using the lowest effective dose, which is selected individually for each patient.
7. In case of edema syndrome against the background of chronic heart failure, the drug is prescribed daily for 5 days, 100-200 mg/day in 2-3 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 daily dose is 200 mg.
8. For edema due to liver cirrhosis, the daily dose of Veroshpiron for adults is usually 100 mg if the ratio of sodium and potassium ions (Na+/K+) in the urine exceeds 1.0. If the ratio is less than 1.0, then the daily dose is usually 200-400 mg. The maintenance dose is selected individually.
9. When treating edema due to nephrotic syndrome, the daily dose for adults is usually 100-200 mg. There was no effect of spironolactone on the main pathological process, and therefore application this drug recommended only in cases where other types of therapy are ineffective.

For edema in children, the initial dose 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.

Side effects

Veroshpiron can provoke the appearance of such side effects from various systems body, like:

1. Hematopoiesis: thrombocytopenia, agranulocytosis, megaloblastosis.
2. Central nervous system: ataxia, headaches, drowsiness and lethargy, impaired concentration, in severe cases, lethargy.
3. Gastrointestinal tract: exacerbation of gastritis, constipation or diarrhea, internal intestinal bleeding, intestinal colic.
4. Metabolism: increased concentration of urea, hyperchloremic acidosis, alkalosis, hyperuricemia.
5. urinary system: acute renal failure.
6. Muscular system: cramps and spasms of the calf muscles.
7. Endocrine system: deepening of the voice in women, enlargement of the mammary glands in men, decrease or loss of potency, decreased erectile function. Women may also experience bleeding during established menopause, or absence of menstruation during reproductive age, breast pain of unknown etiology and hirsutism (male pattern hair growth).

Based on the above list, Veroshpiron has a number of side effects.

Overdose

Overdose is expressed in the following symptoms:

• confusion of thoughts;
• drowsy state;
• nausea and vomiting;
• diarrhea;
• skin rash;
• dehydration.

If these symptoms are observed, you should perform gastric lavage (induce vomiting) and visit a doctor. Providing assistance is limited to symptomatic therapy.

special instructions

1. During treatment with spironolactone, alcohol intake is prohibited.
2. Should be avoided quick loss body weight.
3. Hyperkalemia in patients with severe heart failure
4. Spironolactone may increase the risk of hyperkalemia in patients with diabetic nephropathy.
5. Caution should be exercised when prescribing to patients prone to acidosis or hyperkalemia due to an underlying disease (for example, diabetes mellitus).
6. 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.
7. The dosage form contains lactose. The drug should not be prescribed to patients with rare congenital forms lactose intolerance: Lapp lactase deficiency, glucose-galactose malabsorption.
8. Treatment should be stopped or suspended if blood potassium levels exceed 4 mg/dL.
9. Spironolactone therapy may interfere with the determination of serum and digoxin, plasma cortisol and epinephrine.
10. Concomitant use of potassium supplements, a diet rich in potassium, use of other potassium-sparing diuretics, use of potassium-containing salt substitutes, use of ACE inhibitors, angiotensin II 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 impairment.
11. Hyperkalemia can be life-threatening. Serum potassium levels should be carefully monitored in patients with severe heart failure. If blood potassium levels exceed 3.5 mmol/L, potassium-sparing diuretics should be avoided. It is recommended to monitor potassium and creatinine levels in the blood one week after starting treatment, and then every six months.
12. Spironolactone therapy may cause a transient increase in serum urea nitrogen, especially in patients with pre-existing renal impairment and hyperkalemia. Spironolactone may cause the development of reversible hyperchloremic metabolic acidosis. Therefore, in patients with impaired renal and hepatic function, as well as in elderly patients, the biochemical parameters renal function, and electrolyte balance.

Drug interactions

1. GCS and diuretics mutually enhance and accelerate the diuretic and natriuretic effects.
2. The drug enhances the metabolism of phenazole, triptorelin, buserelin, gonadorelin, and reduces the sensitivity of blood vessels to norepinephrine.
3. Veroshpiron reduces the effectiveness of anticoagulants, indirect anticoagulants and toxicity of cardiac glycosides.
4. When taking Veroshpiron with potassium supplements, potassium supplements and potassium-sparing diuretics, ACE inhibitors(acidosis), angiotensin II antagonists, aldosterone blockers, indomethacin, cyclosporine increases the risk of developing hyperkalemia.
5. Veroshpiron enhances toxic effect lithium, due to a decrease in its clearance, accelerates the metabolism and excretion of carbenoxolone, the latter in turn contributes to sodium retention.

Veroshpiron tablets 25 mg
Each tablet contains:
Active ingredient: spironolactone 25 mg
Excipients: colloidal silicon dioxide anhydrous, magnesium stearate, talc corn starch, lactose monohydrate
Veroshpiron capsules 50 mg
Each capsule contains:
Active ingredient: spironolactone 50 mg

Upper part of the capsule: quinoline yellow (E 104), titanium dioxide (E 171), gelatin. Bottom part capsules: titanium dioxide (E 171), gelatin.
Veroshpiron capsules 100 mg
Each capsule contains:
Active ingredient: spironolactone 100 mg
Excipients: sodium lauryl sulfate, magnesium stearate, corn starch, lactose monohydrate Capsule shell:
Upper part of the capsule: sunset yellow (E 110), titanium dioxide (E 171), gelatin. Bottom of capsule: sunset yellow (E 110), titanium dioxide (E 171), quinoline yellow (E 104), gelatin.

Description

Tablets 25 mg
White or almost white, flat, round tablets with a bevel, with a characteristic mercaptan odor and marked “VEROSPIRON” on one side. Diameter: about 9 mm.

Capsules 50 mg
Capsule: hard gelatin, size No. 3.
Top: opaque, yellow color.
Bottom: opaque, white.
Capsules 100 mg
Capsule: hard gelatin, size No. 0.
Upper part: opaque, orange.
Lower part: opaque, yellow.

pharmachologic effect

Spironolactone is a competitive antagonist of aldosterone. It acts in the distal tubule of the nephron to inhibit Na+ and water retention and K+ excretion - the effects of aldosterone. Not only does it increase Na+ and C1- excretion and decrease urinary K+ excretion - it also decreases H+ excretion. As a consequence of its diuretic effect, it has hypotensive effect.

Pharmacokinetics

Suction

Food increases the bioavailability of spironolactone, which causes increased absorption and possibly impairs the first-pass metabolism of spironolactone.

Bioavailability > 90%

When taking 100 mg spironolactone for 15 days, no empty stomach healthy volunteers observed Tmax 2.6 hours, Cmax 80 ng/ml and tVA 1.4 hours. For 7-alpha-(thiomethyl)-spironolactone these values ​​are: tmax 3.2 hours, Cmax 391 ng/ml and tVz 13 .8 hours, and for canrenone - tmax 4.3 hours, Cmax 181 ng/ml and tAr 16.5 hours.

Distribution

Canrenone and spironolactone are more than 90% protein bound.

Metabolism

After oral administration Spironolactone is rapidly and completely metabolized.

The two most important active metabolites are canrenone and 7-alpha-(thiomethyl)-spironolactone.

Removal

Metabolites are excreted mainly by the kidneys, some - with bile.

Indications for use

Congestive heart failure in cases where the patient does not respond to treatment with other diuretics or there is a need to potentiate their effects. Essential arterial hypertension, mainly in cases of hypokalemia, usually in combination with other antihypertensive drugs.

In cases of liver cirrhosis, accompanied by edema and/or ascites.

For the treatment of primary hyperaldosteronism.

For edema caused by nephrotic syndrome.

For the treatment of hypokalemia in cases where it is impossible to obtain other therapy.

For the prevention of hypokalemia in patients receiving cardiac glycosides in cases where other approaches are considered inappropriate or inappropriate.

Contraindications

- Hypersensitivity to active substance or to any of the excipients.
Anuria, acute renal failure, severe impairment of nitrogen excretion function of the kidneys (rate glomerular filtration Heart failure (in the case of a glomerular filtration rate of 220 µmol/l).
Hyperkalemia.
- Hyponatremia.
Addison's disease.
- Pregnancy and lactation.
- Children under 6 years old.

Pregnancy and lactation

Pregnancy: Veroshpiron is contraindicated.

Lactation: Veroshpiron is contraindicated. If urgent need is recognized

use of the drug, the child must be weaned.

Directions for use and doses

In general, the daily dose of Veroshpiron is prescribed in one or two doses after meals. It is recommended to take the daily dose or the first part of the daily dose in the morning.
Primary hyperaldosteronism:
In cases of diagnosed primary hyperaldosteronism, the drug can be prescribed in preparation for surgery at a dose of 100-400 mg. In patients for whom surgery is not planned, the drug can be used as long-term maintenance therapy in the least effective dosage, determined individually. In the described situation, it is permissible to reduce the initial dose every 14 days until the minimum
Edema (congestive heart failure, nephrotic syndrome):
Adults: the initial daily dose is 100 mg (25-200 mg) and is prescribed in one or two doses.
In case of appointment more high doses, Veroshpiron can be taken in combination with other groups of diuretics that act in more proximal parts of the renal tubules. In this case, the dosage of Veroshpiron should be adjusted.
Cirrhosis of the liver, accompanied by asyitis or edema:
If the Na+/K+ ratio in urine is greater than 1, the initial daily and maximum daily doses are 100 mg. If this ratio is less than 1, the initial daily dose is 200 mg, the maximum is 400 mg/day.
The maintenance dose should be determined individually.
Essential arterial hypertension:
The initial daily dose, prescribed in one or two doses, is 50-100 mg and is taken in combination with other antihypertensive drugs. Therapy should be continued for at least two weeks, since the maximum antihypertensive effect is achieved by the end of this period. Then the dose should be adjusted individually depending on the effect achieved.
Hypokalemia:
In patients who do not have enough food additives with K+ or other potassium methods replacement therapy, the drug is taken in a daily dose of 25-100 mg.
Children:
The initial daily dose is 1-3 mg/kg body weight in one or two doses. The dose should be reduced to 1-2 mg/kg in case of maintenance therapy in combination with other diuretics.
Elderly patients:
It is recommended to begin treatment with lower doses followed by gradual increases until maximum effect. It is necessary to take into account the existing hepatic and renal disorders, since they affect the metabolism of the drug and its excretion.

Side effect

Adverse reactions are a consequence of the competitive antagonism of aldosterone, which increases potassium excretion and the antiandrogenic effect of spironolactone.

Adverse reactions are presented by organ system class, according to Medical dictionary MedDRA regulatory activity, using MedDRA frequency definitions: very common (> 1/10), common (> 1/100, 1/1000, 1/10000,

Overdose

Symptoms: Acute overdose manifests itself in the form of nausea, vomiting, clouding of consciousness, confusion, maculopapular or erythematous rash, diarrhea.

Possible disturbance of water and electrolyte balance (for example, hyperkalemia or hyponatremia) or dehydration.

There may be disturbances in the formation and conduction of cardiac impulses (eg, atrioventricular heart block, atrial fibrillation, cardiac arrest) or changes in the ECG (tall, arched T waves and increased amplitude of the QRS complex).

Treatment: Symptomatic and supportive treatment is necessary. Induce vomiting or perform gastric lavage. There is no specific antidote. Dehydration, fluid and electrolyte imbalance, and hypotension should be treated traditional methods. Hyperkalemia can be treated with rapid administration of glucose (20-50%) and regular insulin (0.25-0.5 units/g glucose). Potassium-sparing diuretics and ion exchange resins can be used. Spironolactone should be discontinued and potassium intake should be limited (including potassium-containing foods).

Interaction with other drugs

Concomitant use of Spironolactone and other potassium-sparing diuretics, ACE inhibitors, angiotensin-P receptor antagonists, aldosterone blockers, potassium supplements can lead to severe hyperkalemia.

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 - may cause excessive hypotension. Thus, the dose of antihypertensive drugs may need to be reduced when Veroshpiron is added to the therapeutic regimen, followed by adjustments as necessary.

Alcohol, barbiturates or narcotic drugs(can potentiate orthostatic hypotension induced by spironolactone).

Pressor amines (norepinephrine): Veroshpiron reduces their effect. This should be taken into account when performing local or general anesthesia using these drugs.

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 of glycoside intoxication).

Lithium: Lithium preparations should not be prescribed concomitantly with diuretics as they reduce renal clearance lithium and may increase the risk of intoxication.

Carbenoxolone may cause sodium retention and thus reduce the effectiveness of spironolactone.

Carbamazepine (with simultaneous administration with spironolactone may cause the development of clinically significant hyponatremia).

Coumarin derivatives (their effect is weakened).

Triptorelin, buserelin, gonadorelin: their effects are enhanced.

Impact on results laboratory research: An effect on the determination of digoxin concentration by radioimmunoassay methods can be expected.

Features of application

Spironolactone may increase the risk of hyperkalemia in patients with diabetic nephropathy.

Spironolactone therapy may cause a transient increase in serum 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, as well as electrolyte balance, should be regularly examined.

Concomitant use of potassium supplements, a diet rich in potassium, use of other potassium-sparing diuretics, use of potassium-containing salt substitutes, use of ACE inhibitors, angiotensin II 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 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. Serum potassium levels should be carefully monitored in patients with severe heart failure. If blood potassium levels exceed 3.5 mmol/L, potassium-sparing diuretics should be avoided. It is recommended to monitor potassium and creatinine levels in the blood one week after starting treatment, and then every six months. Treatment should be stopped or suspended if blood potassium levels exceed 4 mg/dL.

Spironolactone therapy may interfere with the determination of serum and digoxin, plasma cortisol and epinephrine.
- During treatment with spironolactone, alcohol intake is prohibited.
- The dosage form contains lactose. The drug should not be prescribed to patients with rare congenital forms of lactose intolerance: Lapp lactase deficiency, glucose-galactose malabsorption.

Precautionary measures

Effect on ability to drive vehicles and work with machinery
At the beginning of treatment for driving and dangerous mechanisms should be abandoned for a period of time, the duration of which is determined individually. In the future, this limitation should be approached differentially for each individual patient. Undesirable effects usually stop after discontinuation of the drug.

Release form

Pills:
20 tablets in a PVC/A1 blister.
1 blister in a cardboard box with attached instructions for use.
Capsules 50 mg and 100 mg:
10 capsules in a PVC/A1 blister.
3 blisters in a cardboard box with attached instructions for use.

Storage conditions

Pills:
Store at a temperature not exceeding 25 °C.
Capsules 50 mg and 100 mg:
Store at a temperature not exceeding 30 °C.
Keep out of the reach of children.

Veroshpiron (INN - spironolactone) is a potassium-sparing diuretic used for primary arterial hypertension, chronic heart failure and closely related primary and secondary hyperaldosteronism (excessive production of aldosterone by the adrenal cortex). Acting as a competitive antagonist (“antipode”, if you will) of aldosterone, veroshpirone and other potassium-sparing diuretics in Lately are considered as a separate specific group cardiovascular drugs, grouped under the name “aldosterone receptor blockers”.

In the person of aldosterone, one can easily consider the most powerful mineralcorticoid hormone in terms of the degree of its influence on the body, which is formed in the adrenal cortex. Its main function is to control the levels of sodium and potassium ions in order to maintain constant homeostasis. This is achieved through two mechanisms: stimulation of the reabsorption of sodium ions in the distal convoluted renal tubules and “pushing” potassium ions out of the blood into the filtrate. Normally, this process is in balance, but if chronic heart failure develops against the background of excess aldosterone, then the reabsorption of sodium, and, consequently, water, increases. This circumstance causes the appearance of edema and an increase in the volume of circulating blood. A deficiency of potassium and magnesium ions provokes disorders heart rate. Then the vicious circle closes and develops secondary hyperaldosteronism, when, as a result of chronic heart failure, the process of formation of adrenocorticotropic hormone by the pituitary gland is activated, which, in turn, stimulates the release of aldosterone, of which there is already a lot due to the excessive activity of the renin-angiotensin-aldosterone system.

And here veroshpiron appears in the foreground, which, rolling up its sleeves, immediately and for a long time (since the drug has a prolonged effect) begins to create confusion in the aldosterone “Barbarossa plan”: it inhibits the retention of sodium and water ions by aldosterone in the distal parts of the renal tubules, prevents removal of potassium from the body. By interacting with aldosterone receptors, veroshpiron increases the excretion of sodium chloride ions and water in the urine, while simultaneously reducing the acidity of urine. Veroshpiron is not a diuretic in the full sense of the word: its diuretic effect is inconsistent and makes itself felt only on days 2-5 of pharmacotherapy.

The drug is available in the form of tablets and capsules. The dosage regimen is determined by the doctor. During treatment for any alcoholic products a strict taboo is imposed. In case of existing liver and kidney diseases, in elderly patients, as well as in concomitant use of non-steroidal anti-inflammatory drugs, it is recommended to regularly “monitor” the content of electrolytes in the blood and the functioning of the kidneys.

Pharmacology

Potassium-sparing diuretic, long-acting competitive aldosterone antagonist (mineralocorticoid hormone of the adrenal cortex).

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 hypotensive effect is due to the diuretic effect. The diuretic effect appears on days 2-5 of treatment.

Pharmacokinetics

Suction

After oral administration, it is quickly and completely absorbed from the gastrointestinal tract. Bioavailability is about 100%, and food intake increases it to 100%. After a daily dose of 100 mg of spironolactone for 15 days, Cmax is 80 ng/ml, the time to reach Cmax after the next morning dose is 2-6 hours.

Distribution

Plasma protein binding is 98%.

Spironolactone penetrates poorly into organs and tissues, while spironolactone itself and its metabolites penetrate the placental barrier, and canrenone penetrates into breast milk. Vd - 0.05 l/kg.

Metabolism

During the biotransformation process in the liver, active sulfur-containing metabolites 7-alpha-thiomethylspironolactone and canrenone are formed. Canrenone reaches its Cmax after 2-4 hours, its binding to plasma proteins is 90%.

Removal

T1/2 - 13-24 hours. Excreted mainly by the kidneys (50% in the form of metabolites, 10% unchanged) and partially through the intestines. Canrenone excretion (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 special clinical situations

With cirrhosis of the liver 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.

Release form

Hard gelatin capsules, size No. 3, with an opaque yellow cap and an opaque white body; the contents of the capsules are a fine-grained granular powder mixture of white color.

Excipients: sodium lauryl sulfate - 2.5 mg, magnesium stearate - 2.5 mg, corn starch - 42.5 mg, lactose monohydrate - 127.5 mg.

Solid composition gelatin capsule: cap - quinoline yellow dye (E104) - 0.48%, titanium dioxide (E171) - 2%, gelatin - up to 100%; body - titanium dioxide (E171) - 2%, gelatin - up to 100%.

10 pieces. - blisters (3) - cardboard packs.

Dosage

For 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.

For idiopathic hyperaldosteronism, the drug is prescribed at a dose of 100-400 mg/day.

For severe hyperaldosteronism and hypokalemia, the daily dose is 300 mg (maximum 400 mg) in 2-3 doses; as the condition improves, the dose is gradually reduced to 25 mg/day.

For hypokalemia and/or hypomagnesemia caused by diuretic therapy, Veroshpiron 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 potassium deficiency are ineffective.

When diagnosing and treating primary hyperaldosteronism, Veroshpiron is prescribed as a diagnostic tool for a short diagnostic test for 4 days at 400 mg/day, dividing the daily dose 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, the drug is prescribed in the same dose for 3-4 weeks. When correction of hypokalemia and arterial hypertension is achieved, the presence of primary hyperaldosteronism can be assumed.

After the diagnosis of hyperaldosteronism is established using more accurate diagnostic methods, as a short course of preoperative therapy for primary hyperaldosteronism, Veroshpiron should be taken in a daily dose of 100-400 mg, divided into 1-4 doses during the entire period of preparation for surgery. If surgery is not indicated, then Veroshpiron is used for long-term maintenance therapy, using the lowest effective dose, which is selected individually for each patient.

When treating edema due to nephrotic syndrome, the daily dose for adults is usually 100-200 mg. 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.

In case of edema syndrome against the background of chronic heart failure, the drug is prescribed daily for 5 days, 100-200 mg/day in 2-3 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 daily dose is 200 mg.

For edema due to liver cirrhosis, the daily dose of Veroshpiron for adults is usually 100 mg if the ratio of sodium and potassium ions (Na + /K +) in the urine exceeds 1.0. If the ratio is less than 1.0, then the daily dose is usually 200-400 mg. The maintenance dose is selected individually.

For edema in children, the initial dose 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.

Overdose

Symptoms: nausea, vomiting, dizziness, decreased blood pressure, diarrhea, skin rash, hyperkalemia (paresthesia, muscle weakness, arrhythmias), hyponatremia (dry mouth, thirst, drowsiness), hypercalcemia, dehydration, increased urea concentration.

Treatment: gastric lavage, symptomatic treatment dehydration and arterial hypotension. In case of hyperkalemia, it is necessary to normalize water-electrolyte metabolism with the help of potassium-removing diuretics, rapid parenteral administration dextrose solution (5-20% solutions) with insulin at the rate of 0.25-0.5 IU per 1 g of dextrose; if necessary it is possible reintroduction dextrose. In severe cases, hemodialysis is performed.

Interaction

Veroshpiron reduces the effect of anticoagulants, indirect anticoagulants (heparin, coumarin derivatives, indanedione) and the toxicity of cardiac glycosides (since normalizing the level of potassium in the blood prevents the development of toxicity).

Enhances the metabolism of phenazole.

Reduces the sensitivity of blood vessels to norepinephrine (requires caution during anesthesia).

Increases T1/2 of digoxin, so digoxin intoxication is possible.

Strengthens the toxic effect of lithium due to a decrease in its clearance.

Accelerates the metabolism and excretion of carbenoxolone.

Carbenoxolone promotes sodium retention by spironolactone.

GCS and diuretics (benzothiazine derivatives, furosemide, ethacrynic acid) enhance and accelerate the diuretic and natriuretic effects.

Enhances the effect of diuretic and antihypertensive drugs medicines.

GCS enhance the diuretic and natriuric effect in hypoalbuminemia and/or hyponatremia.

The risk of developing hyperkalemia increases when taking Veroshpiron with potassium preparations, potassium supplements and potassium-sparing diuretics, ACE inhibitors (acidosis), angiotensin II antagonists, aldosterone blockers, indomethacin, cyclosporine.

Salicylates and indomethacin reduce the diuretic effect.

Ammonium chloride and cholestyramine contribute to the development of hyperkalemic metabolic acidosis.

Fludrocortisone causes a paradoxical increase in tubular secretion of potassium.

Reduces the effect of mitotane.

Enhances the effect of triptorelin, buserelin, gonadorelin.

Side effects

From the outside digestive system: nausea, vomiting, diarrhea, ulcerations and bleeding from the gastrointestinal tract, gastritis, intestinal colic, abdominal pain, constipation, liver dysfunction.

From the central nervous system and peripheral nervous system: ataxia, lethargy, dizziness, headache, drowsiness, lethargy, confusion.

From the hematopoietic system: agranulocytosis, thrombocytopenia, megaloblastosis.

Metabolic: hyperuricemia, hypercreatininemia, increased urea concentration, hyperkalemia, hyponatremia, metabolic hyperchloremic acidosis or alkalosis.

From the outside 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 Veroshpiron, only in in rare cases breast remains slightly increased), decreased potency and erection; in women - disorders menstrual cycle, dysmenorrhea, amenorrhea, metrorrhagia in menopause, hirsutism, pain in the mammary glands, breast carcinoma (no connection with the drug has been established).

Allergic reactions: urticaria; rarely - maculopapular and erythematous rash, drug fever, itching.

Dermatological reactions: alopecia, hypertrichosis.

From the urinary system: acute renal failure.

From the outside musculoskeletal system: muscle spasm, cramps of the calf muscles.

Indications

• essential hypertension (as part of combination therapy);
• edema syndrome in chronic heart failure (can be used as monotherapy and in combination with standard therapy);
• conditions in which secondary hyperaldosteronism can be detected, incl. liver cirrhosis, accompanied by ascites and/or edema, nephrotic syndrome and other conditions accompanied by edema;
• hypokalemia/hypomagnesemia (as aid for its prevention during treatment with diuretics and if 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

• Addison's disease;
• hyperkalemia;
• hyponatremia;
• severe renal failure (creatinine clearance less than 10 ml/min);
• anuria;
• lactose intolerance, lactase deficiency, glucose/galactose malabsorption syndrome;
• pregnancy;
• lactation period (breastfeeding);
• children under 3 years of age;
• hypersensitivity to the components of the drug.

The drug should be prescribed with caution in case of hypercalcemia, metabolic acidosis, AV block (hyperkalemia contributes to its intensification), diabetes mellitus (with confirmed or suspected chronic renal failure), diabetic nephropathy, surgical interventions, taking medications that cause gynecomastia, local and general anesthesia, menstrual irregularities, breast enlargement, liver failure, liver cirrhosis, as well as elderly patients.

Features of application

Use during pregnancy and breastfeeding

The use of Veroshpiron is contraindicated during pregnancy and lactation.

If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Use for liver dysfunction

The drug should be prescribed with caution in case of liver failure or liver cirrhosis.

When prescribing Veroshpiron to patients with liver disorders, regular monitoring of serum electrolytes and renal function is necessary.

Use for renal impairment

The drug is contraindicated in severe renal failure (creatinine clearance less than 10 ml/min). The drug should be prescribed with caution for diabetic nephropathy.

When prescribing Veroshpiron to patients with impaired renal function, regular monitoring of serum electrolytes and renal function is necessary.

special instructions

When using Veroshpiron, a temporary increase in the level of urea nitrogen in the blood serum is possible, especially with reduced renal function and hyperkalemia. It is also possible to develop reversible hyperchloremic metabolic acidosis.

When prescribing Veroshpiron to patients with impaired renal and liver function, and elderly patients, regular monitoring of serum electrolytes and renal function is necessary.

Taking Veroshpiron makes it difficult to determine the concentration of digoxin, cortisol and adrenaline in the blood.

Despite the lack of direct impact on carbohydrate metabolism, Availability diabetes mellitus, especially with diabetic nephropathy, requires special caution when prescribing Veroshpiron due to the possibility of developing hyperkalemia.

When treating NSAIDs while taking Veroshpiron, kidney function and blood electrolyte levels should be monitored.

During treatment with Veroshpiron, you should avoid eating food, rich in potassium.

During treatment, alcohol consumption is contraindicated.

Impact on the ability to drive vehicles and operate machinery

IN initial period During treatment, it is prohibited to drive a car or engage in activities that require increased concentration and speed of psychomotor reactions. The duration of restrictions is set individually.

01.06.2017

Before taking the product you need to clarify:Veroshpiron instructions for use, at what pressure.

Veroshpiron is a drug that is prescribed for a complex form of hypertension if it cannot be treated with drugs for high blood pressure. blood pressure. From swelling with various diseases heart and edema that are caused by these diseases.

This remedy is also prescribed for swelling in liver diseases (cirrhosis). Women are prescribed for cysts on the ovaries and other gynecological problems and diseases associated with excessive testosterone in the female body.

The manufacturer of the drug is a Hungarian company Gedeon Richter.

Active ingredient: Spironolactone

Spironolactone is a substance that reduces the effects of the hormone aldosterone produced by the adrenal glands.

Aldosterone is the hormone that stimulates the release of potassium and magnesium from the body in the urine, but only retains water and sodium salts. Spironolactone has an effect that is opposite to that of the hormone aldosterone. During treatment with the drug, fluid and salt are removed from the body, and swelling is significantly reduced. At the same time, the potassium content in the blood increases. Veroshpiron exhibits a diuretic effect.

Spironolactone is excreted from the human body through the kidneys. If the patient has kidney failure, then the accumulation of spironolactone may increase in the blood.

Due to their diuretic effect, the tablets are taken from hypertension.

Indications for treatment with Veroshpiron

Main symptoms and diseases for drug treatment:

• heart failure;
• hypertension;
• diseases and problems in the endocrine system (ovarian cyst, Conn's disease);
• cerebral edema and edema in other acute and chronic diseases;
• myasthenia gravis;
• lack of potassium and magnesium in the body;
• ascites;
• primary stage of hyperoldosteronism.

Use of a drug for hypertension

Veroshpiron is not the drug of choice for hypertension, but it is prescribed to patients if the tablets drops to lower blood pressure do not have a positive effect if it is impossible to lower the pressure below 140/90.

In many patients, the cause of severe hypertension is increased level aldosterone in the blood. In these cases, you need to add Veroshpiron to medications used for high blood pressure.

Malignanthypertensivedisease, a condition of the body is considered when blood pressure does not drop below 140/90, despite the fact that the patient is taking specialized blood pressure medications. He also takes diuretics. 10 percent of patients suffer from malignant hypertension. Veroshpiron is beneficial in many cases of treating this disease.

The drug Veroshpiron has diuretic properties due to its connection with aldosterone and blocks the action of the hormone by interacting with its receptors.

The peculiarity of this medicine is that, having diuretic properties, the drug does not reduce potassium levels, but rather helps its accumulation in the human body.

For this reason, it is classified as a diuretic with a potassium-sparing effect. It removes sodium and chlorine salts from the body, like other diuretics.

For a good and positive therapeutic effect, you should take Veroshpiron for at least two weeks. During this time, you may need to adjust your daily dose. medicinal product.

For high blood pressure (hypertension), daily required dose The dosage ranges from 50 to 100 mg, which is divided into several times. The initial dosage is prescribed for 5 days, after which the daily dose may be reduced. In the future, the drug is used based on the achieved therapeutic effect of Veroshpiron from pressure.

Veroshpiron for blood pressuretake during meals or after meals with a drink big amount still water. If you take the drug before meals, the effectiveness is reduced by half. Taking the tablets with meals reduces the risk of nausea and diarrhea, and if you take them before 18 hours, then you won’t have to get up to go to the toilet often at night.

In many patients, the medicine does not cause a diuretic effect, do not worry, this is normal. Blood pressure does not decrease immediately, but 2 weeks after taking the drug.

When taking medication, do not drink alcohol under any circumstances.

Unauthorized cancellation or adjustment of the daily dose of Veroshpiron is unacceptable, as the condition may worsen and death may occur.

Interaction with other drugs

If you take Veroshpiron simultaneously with anticoagulants, glycosides (cardiac), in this case there is a decrease toxic influence on the body of these substances.

When used simultaneously with furosemide-based diuretic tablets, an enhanced diuretic effect occurs and, as a result, increases sodium loss in the body. Much stronger positive effect drugs when taking antihypotensive substances together with Veroshpiron.

Veroshpiron reduces positive impact substances norepinephrine and mitotane on the body. If it is absolutely necessary to use them together, it is recommended to constantly adjust the dosage.

Indomethacin reduces healing effect Veroshpiron.It is advisable not to take aspirin and other antipyretic and anti-inflammatory drugs.

Side effects of the drug and overdose of Veroshpiron

While taking the medication Veroshpiron, you may experience side effects. Many adverse reactions cannot be a reason to discontinue the drug:

• dyspeptic disorders;
• dizziness, sharp and severe headache;
• state of lethargy, drowsiness (it is prohibited to perform work where a clear reaction is necessary);
• changes in blood tests;
• disruptions in the endocrine system (decreased libido in women and potency in men);
• cycle disruption or cessation of menstruation, uterine bleeding;
• spasms and cramps in the muscles.

In extremely rare cases, there are more severe adverse reactions that need to be brought to the attention of your doctor:

• allergic reactions on the skin (redness, itching, rash);
• the occurrence of renal failure;
• gastric and intestinal bleeding;
• nausea, turning into vomiting, diarrhea;
• hallucination, lethargy.

If such symptoms occur, it is necessary to discontinue the drug or reconsider the dosage.

For those patients who have an indication for the use of this drug, the benefits of taking it are much higher than its negative effects on the body.

An overdose of Veroshpiron occurs extremely rarely, but in the event of an overdose, all adverse reactions to the drug intensify.

Required in urgently rinse the stomach, drink as much liquid with caffeine as possible to raise blood pressure. In case of hyperkalemia, insulin and dextrose are prescribed.

Situations in which the drug is not prescribed:

• children under three years of age;
• for intolerance active component– spironolactone, as well as sensitivity to the components of the drug.
• renal failure;
• disease of the adrenal cortex (Addison's disease);
• high potassium levels in the blood;
• low percentage of sodium salt in the body;
• liver failure;
• diabetes mellitus;
• gynecological diseases;
• pregnancy and lactation.

During pregnancy, in extremely rare cases, it is used to relieve edema in the 2nd or 3rd trimester, when the benefit for the mother will be much higher than possible risk for the fetus. Recommended use only under strict medical supervision.

Spironolactone passes into breast milk, in which case it is necessary to refrain from breastfeeding. Such treatment is carried out for a short time and under the strict supervision of a doctor and only in a hospital hospital.

You should take the medicine very carefully when complex diseases in the heart muscle, during surgical operations, when taking various hormonal hormones as prescribed by the doctor medicinal substances. Special attention When taking a medicine, pay attention to the age of the patient; it is not advisable for older people to take this medicine.

Principles that you need to pay attention to when taking Veroshpiron:

• do not take the product without a doctor’s prescription;
• do not stop taking the medicine without a doctor’s recommendation;
• don't change it yourself daily dosage– this is fraught with negative consequences;
• do not use the product for severe and complex side effects on the body.

Composition of the drug Veroshpiron

Tablets are made with 25 milligrams of the main substance - spironolactone. These white-looking tablets, standard form, contain auxiliary components. Tablets with a specific characteristic odor.

Capsules are available in 50 and 100 mg doses of the main component - spironolactone. These are solid in structure and consist of a body and a lid. The contents in the capsules are granulated powder components: titanium dioxide, spironolactone, gelatin. The substance is white or cream-colored.

You need to save the medicine in a place where children cannot get it. and at an air temperature of no higher than 30 degrees.

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P N011953/01

Tradename drug: Veroshpiron

International nonproprietary name:

spironolactone

Dosage form:

capsules

COMPOUND
1 capsule contains:
Capsules 50 mg
Active substance: spironolactone - 50.00 mg
sodium lauryl sulfate - 2.50 mg; magnesium stearate - 2.50 mg; corn starch - 42.50 mg; lactose monohydrate - 127.50 mg.
Hard gelatin capsule:
Size No. 3.
Cap: quinoline yellow dye E 104 - 0.48%; titanium dioxide E 171 - 2.0%; gelatin - up to 100%.
Frame: titanium dioxide E 171 - 2.00%; gelatin - up to 100%.
Capsules 100 mg
Active substance: spironolactone - 100.00 mg.
Excipients in the capsule: sodium lauryl sulfate - 5.00 mg; magnesium stearate - 5.0 mg; corn starch - 85.00 mg; lactose monohydrate - 255.00 mg.
Hard gelatin capsule:
Size No. 0.
Cap: sunset yellow dye E 110 - 0.04%; titanium dioxide E 171 - 2.0%; gelatin - up to 100%.
Frame: sunset yellow dye E 110 - 0.04%; titanium dioxide E 171 - 2.0%, quinoline yellow dye E 104 - 0.50%; gelatin - up to 100%.

Description
50 mg capsules:
Capsule: hard gelatin, size No. 3; Cap: opaque, yellow;
Body: opaque, white.
100 mg capsules: Capsule contents: fine-grained granular powder mixture of white color.
Capsule: hard gelatin, size No.0; Cap: opaque, orange; Body: opaque, yellow.

Pharmacotherapeutic group:

diuretic potassium-sparing agent.

ATX Code C03DA01

Pharmacological properties
Pharmacodynamics
Spironolactone is a potassium-sparing diuretic, a specific antagonist of long-acting aldosterone (mineralocorticosteroid hormone of the adrenal cortex). 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.
Increased diuresis 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 gastrointestinal tract.
Binds to plasma proteins by approximately 98% (canrenone - 90%). The maximum concentration (Cmax) of canrenone in the blood plasma is achieved 2-4 hours after administration.
After daily intake 100 mg of spironolactone for 15 days Cmax reaches 80 ng/ml, the time to reach Cmax after the next morning dose is 2-6 hours. Volume of distribution is 0.05 l/kg.
Metabolism
Spironolactone is converted into active metabolites: a metabolite containing sulfur (80%) and partly canrenone (20%). Spironolactone penetrates poorly into organs and tissues, while itself and its metabolites penetrate the placental barrier, and canrenone passes into breast milk.
Removal
Excreted by the kidneys; 50% - in the form of metabolites, 10% - unchanged and partially through the intestines. The half-life (T 1/2) of spironolactone is 13-24 hours, of active metabolites - up to 15 hours. The elimination of canrenone (mainly by the kidneys) is two-phase, T 1/2 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 half-life increases without signs of accumulation, the likelihood of which is higher in chronic renal failure and hyperkalemia.

Indications for use
- Essential arterial hypertension (as part of combination therapy).
- Edema syndrome in chronic heart failure (can be used as 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
- Increased sensitivity 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, breastfeeding period;
- Children under 3 years of age (solid dosage form);
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Carefully
- Hypercalcemia, metabolic acidosis, atrioventricular block (hyperkalemia contributes to its intensification);
- 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, cirrhosis of the liver.

Use during pregnancy and lactation
During pregnancy:
The drug is contraindicated during pregnancy.
During lactation
The drug is contraindicated during lactation. Breast-feeding should be discontinued if spironolactone cannot be discontinued.

Directions for use and doses
Inside.
For 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.
For idiopathic hyperaldosteronism 100-400 mg/day.
With severe hyperaldosteronism and hypokalemia 300 mg/day (maximum 400 mg) in 2-3 doses, if the condition improves, the dose is gradually reduced to 25 mg/day in another dosage form.
Hypokalemia/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 tool for short diagnostic test: for 4 days, 400 mg/day, divided into several doses per day. If the potassium content 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, Veroshpiron should be taken at a dose of 100-400 mg/day, divided into 1-4 doses per day during the entire period of preparation for surgery. If surgery is not indicated, then Veroshpiron 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.
At edema syndrome against the background of chronic heart failure daily, for 5 days, 100-200 mg/day in 2-3 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. 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.

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: liver dysfunction.
From the central nervous system: ataxia, lethargy, dizziness, headache, drowsiness, lethargy, confusion, muscle spasm.
From the outside hematopoietic system: agranulocytosis, thrombocytopenia, megaloblastosis.
From the laboratory parameters: hyperuricemia, hypercreatininemia, increased urea concentrations, disturbances in water and electrolyte balance (hyperkalemia, hyponatremia) and acid-base balance (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); 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).
When using the drug Veroshpiron, gynecomastia may develop. The likelihood of gynecomastia depends on both the dose of the drug and the duration of therapy. In this case, gynecomastia is usually reversible, and after discontinuation of the drug Veroshpiron disappears, and only in rare cases the mammary gland remains somewhat enlarged.
Allergic reactions: urticaria, rarely maculopapular and erythematous rash, drug fever, pruritus, eosinophilia, Steven-Johnson syndrome, toxic epidermal necrolysis.
From the outside skin: alopecia, hypertrichosis.
From the urinary system: acute renal failure.
From the musculoskeletal system: cramps of the calf muscles.

Overdose
Symptoms: nausea, vomiting, dizziness, diarrhea, skin rash, hyperkalemia (paresthesia, muscle weakness, arrhythmias), hyponatremia (dry oral mucosa, 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 dextrose solution (5-20% solutions) with insulin at the rate of 0.25-0.5 units per 1 g of dextrose; can be re-entered if necessary. In severe cases, hemodialysis is performed.

Interaction with other drugs
Reduces the effect of anticoagulants, indirect anticoagulants (heparin, coumarin derivatives, idandione) and the toxicity of cardiac glycosides (since normalization of potassium content in the blood prevents the development of toxicity).
Enhances the metabolism of phenazole (antipyrine).
Reduces the sensitivity of blood vessels to norepinephrine (requires caution during anesthesia), increases the half-life of digoxin - digoxin intoxication is possible.
Strengthens the toxic effect of lithium due to a decrease in its 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.
Glucocorticosteroid drugs and diuretics (benzothiazine derivatives, furosemide, ethacrynic acid) enhance and accelerate the diuretic and natriuretic effects.
Enhances the effect of diuretic and antihypertensive drugs. Nonsteroidal anti-inflammatory drugs reduce the diuretic and natriuretic effects, increasing the risk of developing hyperkalemia.
Alcohol (ethanol), barbiturates, narcotic substances increase orthostatic hypotension.
Glucocorticosteroid drugs enhance the diuretic and natriuretic effect in cases of hypoalbuminemia and/or hyponatremia.
The risk of developing hyperkalemia increases when taken with potassium preparations, potassium supplements and potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (acidosis), angiotensin II antagonists, aldosterone blockers, indomethacin, cyclosporine.
Salicylates and indomethacin reduce the diuretic effect.
Ammonium chloride and cholestyramine contribute to the development of hyperkalemic metabolic acidosis.
Fludrocortisone causes a paradoxical increase in tubular secretion of potassium.
Reduces the effect of mitotane.
Enhances the effect of triptorelin, buserelin, gonadorelin.

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 kidney and liver diseases, as well as in old age, regular monitoring of serum electrolytes and kidney function is necessary.
The drug makes it difficult to detect 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 with non-steroidal anti-inflammatory drugs, renal function and blood electrolyte concentrations should be monitored. You should avoid eating foods rich in potassium.
During treatment, alcohol consumption is contraindicated.

The effect of the drug on the ability to drive a vehicle and operate machinery that involves increased risk injuries
In the initial period of treatment, driving vehicles and engaging in activities that require increased concentration and speed of psychomotor reactions are prohibited. The duration of restrictions is set individually.

Release form
Capsules of 50 and 100 mg.
10 capsules in an AL/PVC blister. 3 blisters in a cardboard box with attached instructions for use.

Storage conditions
At a temperature not exceeding 30 °C.
Keep out of the reach of children!

Best before date
5 years
Do not use later date indicated on the packaging.

Vacation conditions
Dispensed by prescription.

Manufacturer
JSC "Gedeon Richter"
1103 Budapest, st. Demrei 19-21, Hungary

Consumer complaints should be sent to:
Moscow Representative Office of JSC Gedeon Richter
119049 Moscow, 4th Dobryninsky lane, building 8.