Veroshpiron for what it is needed. Veroshpiron capsules - official * instructions for use

Veroshpiron refers to potassium-sparing diuretics of synthetic origin.

Applied 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 information about Veroshpiron: complete 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. Want to leave your opinion? Please write in the comments.

Clinical and pharmacological group

Potassium-sparing diuretic.

Terms of dispensing from pharmacies

Released by prescription.

Prices

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

Release form and composition

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

Additional substances in 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. It acts in the kidneys - the nephron, eliminates fluid and sodium retention, and suppresses the potassium excretion effect. Spironolactone interferes with the production of renal tubular enzymes. By binding to receptors, it increases the excretion of sodium and chlorine ions from 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 ingestion, it is completely absorbed in the gastrointestinal tract, bioavailability is 100%, eating food increases it to a maximum. The highest concentration of spironolactone reaches 2-6 hours after the morning intake. The substance binds to plasma proteins by 98%, penetrates poorly into organs and tissues, but metabolites are able to overcome the placental barrier and get into 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. Edema syndrome against the background (as the main drug or in combination with other drugs);
3. Primary hyperaldosteronism (Crohn's syndrome) - a short time in the preoperative period;
4. Essential (in combination with other drugs);
5. Hypokalemia or hypomagnesemia (for the purpose of prevention in the treatment of diuretics).

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

Contraindications

Contraindications to the use of Veroshpiron are:

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

With caution, Veroshpiron is prescribed to patients with metabolic acidosis, hypercalcemia, diabetes mellitus, diabetic nephropathy, liver failure, cirrhosis of the liver, as well as the elderly, women with menstrual irregularities, with breast enlargement and with local or general anesthesia.

Use during pregnancy and lactation

Veroshpiron is contraindicated in 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 penetrate into milk and have 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. In 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 increasing the dose should be gradual, 1 time in 2 weeks. To achieve an adequate response to therapy, the drug must be taken for at least 2 weeks. Dose adjustment if necessary.
3. With 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 preparations or other methods of replenishing its deficiency are ineffective.
4. With severe hyperaldosteronism and hypokalemia, the daily dose is 300 mg (maximum 400 mg) for 2-3 doses, with improvement in the condition, the dose is gradually reduced to 25 mg / day.
5. In the diagnosis and treatment of primary hyperaldosteronism, as a diagnostic tool for a short diagnostic test, Veroshpiron is prescribed for 4 days at 400 mg / day, distributing the daily dose into several doses per day. With an increase in the concentration of potassium in the blood during the administration of the drug and a decrease after its withdrawal, the presence of primary hyperaldosteronism can be assumed. With a long-term diagnostic test, the drug is prescribed at the same dose for 3-4 weeks. When correction of hypokalemia 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 at a daily dose of 100-400 mg, dividing it into 1-4 doses during the entire period of preparation for surgical operation. If the operation is not indicated, then Veroshpiron is used for long-term maintenance therapy, while using the smallest effective dose, which is selected individually for each patient.
7. With edematous 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. With edema on the background of cirrhosis of the liver, 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. In the treatment of edema associated with nephrotic syndrome, the daily dose for adults is usually 100-200 mg. No effect of spironolactone on the main pathological process, and therefore the application this drug recommended only when other therapies have failed.

With edema in children, the initial dose is 1-3.3 mg / kg of body weight or 30-90 mg / m2 / day in 1-4 doses. After 5 days, the dose is adjusted and, if necessary, it is increased by 3 times compared to the original.

Side effects

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

1. Hematopoiesis: thrombocytopenia, agranulocytosis, megaloblastosis.
2. CNS: ataxia, headaches, drowsiness and lethargy, impaired concentration, in severe cases, lethargy.
3. Gastrointestinal: exacerbation of gastritis, constipation or diarrhea, internal intestinal bleeding, intestinal colic.
4. Metabolism: increased urea concentration, hyperchloremic acidosis, alkalosis, hyperuricemia.
5. urinary system: acute renal failure.
6. Muscular system: cramps and spasm of the calf muscles.
7. Endocrine system: coarsening of the voice in women, enlargement of the mammary glands in men, decrease or loss of potency, decreased erection function. Also, women may experience bleeding during the established menopause, or the absence of menstruation in 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 such symptoms:

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

If these symptoms are observed, it is necessary to arrange a gastric lavage (provoke vomiting) and visit a doctor. Assistance is reduced to symptomatic therapy.

special instructions

1. Do not drink alcohol during treatment with spironolactone.
2. Should be avoided rapid 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 (eg, diabetes mellitus).
6. Caution must also be exercised in patients with moderate renal insufficiency (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 composition of the dosage form includes lactose. The drug should not be administered to patients with rare congenital forms lactose intolerance: Lapp lactase deficiency, glucose-galactose malabsorption.
8. Treatment should be discontinued or suspended if blood potassium levels exceed 4 mg/dl.
9. Therapy with spironolactone may interfere with the determination of serum and digoxin, plasma cortisol and epinephrine.
10. Concomitant use of potassium-containing supplements, 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 can lead to severe hyperkalemia, especially in patients with renal insufficiency.
11. Hyperkalemia can be life threatening. Serum potassium levels should be closely monitored in patients with severe heart failure. If the level of potassium in the blood exceeds 3.5 mmol / l, potassium-sparing diuretics should be avoided. It is recommended to monitor the level of potassium and creatinine in the blood one week after the start of 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 can cause the development of reversible hyperchloremic metabolic acidosis. Thus, in patients with impaired renal and hepatic function, as well as in elderly patients, regular examination should be carried out. biochemical parameters kidney function, and electrolyte balance.

drug interaction

1. GCS and diuretics mutually reinforce and accelerate the diuretic and natriuretic effects.
2. The drug enhances the metabolism of phenazole, triptorelin, buserelin, gonadorelin, 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 preparations, 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 anhydrous silica, magnesium stearate, corn starch talc, 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:o 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. Lower part of the capsule: sunset yellow (E 110), titanium dioxide (E 171), quinoline yellow (E 104), gelatin.

Description

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

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

pharmachologic effect

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

Pharmacokinetics

Suction

Food increases the bioavailability of spironolactone, which causes an increase in absorption and possibly impairs the first pass metabolism of spironolactone.

Bioavailability > 90%

When taking 100 mg of spironolactone for 15 days, no empty stomach healthy volunteers observed Tmax 2.6 h, Stakh 80 ng/mL and tVA 1.4 h. .8 hours, and for canrenone - tmax 4.3 hours, Cmax 181 ng / ml and tUg 16.5 hours.

Distribution

Canrenone and spironolactone are more than 90% protein bound.

Metabolism

After oral intake Spironolactone is rapidly and completely metabolized.

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

breeding

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 hypertension, mainly in cases of hypokalemia, usually in combination with other antihypertensive drugs.

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

For the treatment of primary hyperaldosteronism.

With edema caused by nephrotic syndrome.

For the treatment of hypokalemia in cases where other therapy is not possible.

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, a pronounced violation of the nitrogen excretion function of the kidneys (speed 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 an emergency is recognized

use of the drug, the child must be weaned.

Dosage and administration

In general, the daily dose of Veroshpiron is administered in one or two divided 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 may be prescribed in preparation for surgery at a dose of 100-400 mg. In patients in whom surgery is not planned, the drug can be used as long-term maintenance therapy at the least effective dosage determined individually. In the situation described, it is permissible to reduce the initial dose every 14 days until the minimum is reached.
Edema (congestive heart failure, nephrotic syndrome):
Adults: The initial daily dose is 100 mg (25-200 mg) given in one or two divided doses.
If more than high doses, Veroshpiron can be taken in combination with other groups of diuretics that act in the 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 the 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, administered 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 by the end of this period the maximum antihypertensive effect is achieved. 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 methods of potassium- replacement therapy, the drug is taken in a daily dose of 25-100 mg.
Children:
The initial daily dose is 1-3 mg/kg of body weight in one or two divided 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 start treatment with lower doses, followed by a gradual increase until reaching maximum effect. Hepatic and renal disorders because they affect drug metabolism and excretion.

Side effect

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

Adverse reactions are presented by classes of organ systems, according to medical dictionary regulatory activity using MedDRA frequency definitions: very common (> 1/10), frequent (> 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 violation of the water and electrolyte balance (for example, hyperkalemia or hyponatremia) or dehydration.

Possible violation of the formation and conduction of cardiac impulses (for example, atrioventricular heart block, atrial fibrillation, cardiac arrest) or ECG changes (high arcuate T-waves and an increase in the 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 U/g glucose). Potassium excreting 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 II receptor antagonists, aldosterone blockers, potassium preparations 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 - excessive hypotension may develop. Thus, the dose of antihypertensive drugs may be subject to reduction when adding Veroshpiron to the therapeutic regimen, with subsequent adjustment as necessary.

Alcohol, barbiturates, or narcotic drugs(can potentiate orthostatic hypotension caused 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 is able to 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 should not be given concomitantly with diuretics as they reduce renal clearance lithium and may increase the risk of toxicity.

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

Carbamazepine (for simultaneous reception with spironolactone can cause the development of clinically significant hyponatremia).

Derivatives of coumarin (their effect is weakened).

Triptorelin, buserelin, gonadorelin: their effects are enhanced.

Impact on results laboratory research: influence on the process of determining the concentration of digoxin by radioimmunoassay methods can be expected.

Application features

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 can cause the development of reversible hyperchloremic metabolic acidosis. Thus, in patients with impaired renal and hepatic function, as well as in elderly patients, biochemical parameters of renal function, as well as electrolyte balance, should be regularly examined.

Concomitant use of potassium-containing supplements, diet rich in potassium, 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 can lead to severe hyperkalemia especially in patients with renal insufficiency.

Caution should be exercised when prescribing to patients prone to acidosis or hyperkalemia due to an underlying disease (eg, diabetes mellitus).

Caution must also be exercised in patients with moderate renal insufficiency (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 closely monitored in patients with severe heart failure. If the level of potassium in the blood exceeds 3.5 mmol / l, potassium-sparing diuretics should be avoided. It is recommended to monitor the level of potassium and creatinine in the blood one week after the start of treatment, and then every six months. Treatment should be discontinued or suspended if blood potassium levels exceed 4 mg/dl.

Therapy with spironolactone may interfere with the determination of serum and digoxin, plasma cortisol and epinephrine.
- Do not drink alcohol during treatment with spironolactone.
- The composition of the dosage form includes lactose. The drug should not be administered to patients with rare congenital forms of lactose intolerance: Lapp lactase deficiency, glucose-galactose malabsorption.

Precautionary measures

Impact on ability to drive vehicles and work with mechanisms
At the beginning of treatment from 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 differently in each individual patient. Unwanted Effects usually stop after discontinuation of the drug.

Release form

Pills:
20 tablets in PVC/A1 blister.
1 blister in a cardboard box with attached instructions for use.
Capsules 50 mg and 100 mg:
10 capsules in 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 in 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 like) of aldosterone, veroshpiron and other potassium-sparing diuretics in Lately considered as a separate specific group cardiovascular drugs grouped under the name "aldosterone receptor blockers".

In the face of aldosterone, one can easily consider the most powerful mineralcorticoid hormone in terms of its effect 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 the constancy of homeostasis. This is achieved through two mechanisms: stimulation of reabsorption of sodium ions in the distal convoluted renal tubules and "pushing out" potassium ions from 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 reverse absorption 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 violations heart rate. Then the vicious circle closes and develops secondary hyperaldosteronism when, due to chronic heart failure, the formation of adrenocorticotropic hormone by the pituitary gland is activated, which, in turn, stimulates the release of aldosterone, which is already quite a lot due to the excessive activity of the renin-angiotensin-aldosterone system.

And here veroshpiron appears at the forefront, which, having rolled up its sleeves, immediately and for a long time (because the drug has a prolonged action) begins to confuse the aldosterone "Barbarossa plan": it inhibits the retention of sodium and water ions by aldosterone in the distal renal tubules, prevents excretion of potassium from the body. Interacting with aldosterone receptors, veroshpiron increases the excretion of sodium chloride and water ions in the urine, while reducing the acidity of the urine. Veroshpiron is not a diuretic in the full sense of the word: its diuretic effect is unstable and makes itself felt only on the 2nd-5th day of pharmacotherapy.

The drug is available in the form of tablets and capsules. The dosage regimen is set by the doctor. During treatment for any alcoholic products is strictly taboo. With existing diseases of the liver and kidneys, in elderly patients, as well as with the combined use of non-steroidal anti-inflammatory drugs, it is recommended to regularly "monitor" the blood electrolytes and kidney function.

Pharmacology

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

In the distal nephron, spironolactone prevents the retention of sodium and water by aldosterone and suppresses the potassium excretion 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 the urine.

The hypotensive effect is due to the diuretic effect. The diuretic effect is manifested on the 2nd-5th day of treatment.

Pharmacokinetics

Suction

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

Distribution

Plasma protein binding is 98%.

Spironolactone does not penetrate well into organs and tissues, while spironolactone itself and its metabolites penetrate the placental barrier, and canrenone passes into breast milk. V d - 0.05 l / kg.

Metabolism

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

breeding

T 1 / 2 - 13-24 hours. It is excreted mainly by the kidneys (50% - in the form of metabolites, 10% - unchanged) and partially - through the intestines. Excretion of canrenone (mainly by the kidneys) is two-phase, T 1/2 in the first phase - 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 T 1/2 increases without signs of cumulation, the likelihood of which is higher in chronic renal failure and hyperkalemia.

Release form

Capsules hard gelatin, size No. 3, with an opaque yellow cap and an opaque white body; the contents of the capsules are a fine-grained granular powdery 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) - packs of cardboard.

Dosage

With essential hypertension, the daily dose for adults is usually 50-100 mg once and can be increased to 200 mg, while increasing the dose should be gradual, 1 time in 2 weeks. To achieve an adequate response to therapy, the drug must be taken for at least 2 weeks. Dose adjustment if necessary.

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

With severe hyperaldosteronism and hypokalemia, the daily dose is 300 mg (maximum 400 mg) for 2-3 doses, with improvement in the condition, the dose is gradually reduced to 25 mg / day.

With 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 preparations or other methods of replenishing its deficiency are ineffective.

In the diagnosis and treatment of primary hyperaldosteronism, as a diagnostic tool for a short diagnostic test, Veroshpiron is prescribed for 4 days at 400 mg / day, distributing the daily dose into several doses per day. With an increase in the concentration of potassium in the blood during the administration of the drug and a decrease after its withdrawal, the presence of primary hyperaldosteronism can be assumed. With a long-term diagnostic test, the drug is prescribed 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.

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 at a daily dose of 100-400 mg, dividing it into 1-4 doses during the entire period of preparation for surgery. If the operation is not indicated, then Veroshpiron is used for long-term maintenance therapy, while using the smallest effective dose, which is selected individually for each patient.

In the treatment of edema associated with 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.

With edematous syndrome against the background of chronic heart failure, the drug is prescribed daily for 5 days at 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.

With edema on the background of cirrhosis of the liver, 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.

With edema in children, the initial dose is 1-3.3 mg / kg of body weight or 30-90 mg / m 2 / day in 1-4 doses. After 5 days, the dose is adjusted and, if necessary, it is 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 the water-electrolyte metabolism with the help of potassium-excreting 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; possible if necessary reintroduction dextrose. In severe cases, hemodialysis is performed.

Interaction

Veroshpiron reduces the effect of anticoagulants, indirect anticoagulants (heparin, coumarin derivatives, indandione) and the toxicity of cardiac glycosides (since normalization of 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 when conducting anesthesia).

Increases T 1/2 of digoxin, so digoxin intoxication is possible.

Enhances 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 action of diuretic and hypotensive 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, indomethacin reduce the diuretic effect.

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

Fludrocortisone causes a paradoxical increase in tubular potassium secretion.

Reduces the effect of mitotane.

Enhances the effect of triptorelin, buserelin, gonadorelin.

Side effects

From the side digestive system: nausea, vomiting, diarrhea, ulceration and bleeding from the gastrointestinal tract, gastritis, intestinal colic, abdominal pain, constipation, abnormal liver function.

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

From the side of the hematopoietic system: agranulocytosis, thrombocytopenia, megaloblastosis.

From the side of metabolism: hyperuricemia, hypercreatininemia, increased urea concentration, hyperkalemia, hyponatremia, metabolic hyperchloremic acidosis or alkalosis.

From the side endocrine system: coarsening of the voice, in men - gynecomastia (the likelihood of development depends on the dose, duration of treatment and is usually reversible and disappears after the abolition of Veroshpiron, only in rare cases breast remains slightly increased), decreased potency and erection; in women - violations menstrual cycle, dysmenorrhea, amenorrhea, metrorrhagia in menopause, hirsutism, pain in the mammary glands, breast carcinoma (the presence of a connection with taking the drug has not been established).

allergic reactions: urticaria; rarely - maculo-papular and erythematous rash, drug fever, itching.

Dermatological reactions: alopecia, hypertrichosis.

From the urinary system: acute renal failure.

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

Indications

• essential hypertension (composed of combination therapy);
• edematous 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. cirrhosis of the liver, 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 when it is impossible to use other methods of correcting the level of potassium);
• primary hyperaldosteronism (Conn's syndrome) - for a short preoperative course of treatment;
• for the diagnosis of primary hyperaldosteronism.

Contraindications

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

With caution, the drug should be prescribed for hypercalcemia, metabolic acidosis, AV blockade (hyperkalemia contributes to its increase), diabetes mellitus (with confirmed or suspected chronic renal failure), diabetic nephropathy, surgical interventions, taking drugs that cause gynecomastia, conducting local and general anesthesia, menstrual disorders, breast enlargement, liver failure, liver cirrhosis, as well as elderly patients.

Application features

Use during pregnancy and lactation

The use of Veroshpiron is contraindicated during pregnancy and lactation.

If necessary, the use of the drug during lactation, breastfeeding should be discontinued.

Application for violations of liver function

With caution, the drug should be prescribed for liver failure, cirrhosis of the liver.

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

Application for violations of kidney function

The drug is contraindicated in severe renal failure (CC less than 10 ml / min). With caution, the drug should be prescribed for diabetic nephropathy.

When prescribing Veroshpiron to patients with impaired renal function, regular monitoring of blood serum electrolytes and kidney 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 kidney function and hyperkalemia. It is also possible to develop reversible hyperchloremic metabolic acidosis.

When prescribing Veroshpiron to patients with impaired renal and hepatic function, elderly patients need regular monitoring of blood serum electrolytes and kidney function.

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

Despite no direct impact on carbohydrate metabolism, Availability diabetes, especially with diabetic nephropathy, requires special care when prescribing Veroshpiron because of 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, rich in potassium.

During treatment, alcohol is contraindicated.

Influence on the ability to drive vehicles and control mechanisms

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

01.06.2017

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

Veroshpiron is a remedy 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 ovarian cysts and other gynecological problems and diseases associated with high testosterone in the female body.

The manufacturer of the medicinal product is a Hungarian company Gedeon Richter.

Active ingredient Spironolactone

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

Aldosterone is the hormone that stimulates the release of potassium and magnesium from the body with 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 content of potassium in the blood increases. Veroshpiron exhibits a diuretic effect.

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

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

Indications for treatment with Veroshpiron

The 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 hyperaldosteronism.

The use of the drug in hypertension

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

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

Malignanthypertonicdisease, is considered a state of the body 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% of patients have malignant hypertension. Veroshpiron is beneficial in many cases of treating this disease.

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

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

For this reason, it is classified as a potassium-sparing diuretic. Sodium and chlorine salts are removed from the body, like other diuretic drugs.

For a good and positive therapeutic effect, it is worth taking Veroshpiron for at least two weeks. During this time, it may be necessary to adjust the daily dose. medicinal product.

With high blood pressure (hypertension), daily required dose means is 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 from pressuretake with meals or after meals with a glass of water big amount still water. If you take the drug before meals, then the effectiveness is reduced by half. Taking the pills with meals reduces the risk of nausea and diarrhea, and if you take them before 6 pm, then you will not have to go to the bathroom often at night.

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

Do not drink alcohol while taking the medicine.

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

Interaction with other drugs

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

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

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

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 an overdose of Veroshpiron

While taking the drug Veroshpiron, you may experience side effects. Many adverse reactions cannot be a reason for discontinuation of the drug:

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

In extreme rare cases, there are more severe adverse reactions that need to be brought to the attention of the attending physician:

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

In the event of such symptoms, it is necessary to stop 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 is extremely rare, but in the event of an overdose, all adverse reactions to the drug increase.

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

Situations in which the drug is not prescribed:

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

During pregnancy, in an extremely rare case, it is used to relieve swelling in the 2nd or 3rd trimester, when the benefits 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 strictest supervision of a doctor and only in a hospital.

Be very careful when taking medicine complex diseases in the heart muscle, performed surgical operations, with the intake of various hormonal drugs prescribed by the doctor medicinal substances. Special attention pay when taking the drug to the age of the patient, it is not advisable for the elderly to take this remedy.

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

• do not take the drug without a doctor's prescription;
• do not stop taking the drug without the doctor's recommendation;
• do not change yourself daily dosage- it 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 in 25 milligrams of the main substance - spironolactone. These white-looking, standard-form tablets contain auxiliary components. Tablets with a specific characteristic odor.

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

Keep the medicine in a place where children cannot get it. and when the air temperature is not higher than 30 degrees.

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P N011953/01

Tradename drug: Veroshpiron

International non-proprietary 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.
Lid: dye quinoline yellow 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.
Auxiliary substances 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 #0.
Lid: dye sunset yellow E 110 - 0.04%; titanium dioxide E 171 - 2.0%; gelatin - up to 100%.
Frame: dye sunset yellow E 110 - 0.04%; titanium dioxide E 171 - 2.0%, quinoline yellow dye E 104 - 0.50%; gelatin - up to 100%.

Description
Capsules 50 mg:
Capsule: hard gelatin, size No. 3; Lid: opaque, yellow;
Case: opaque, white.
Capsules 100 mg: Capsule contents: white fine-grained granular powder mixture.
Capsule: hard gelatin, size No.0; Lid: opaque, orange; Case: opaque, yellow.

Pharmacotherapeutic group:

diuretic potassium-sparing agent.

ATX Code C03DA01

Pharmacological properties
Pharmacodynamics
Spironolactone is a potassium-sparing diuretic, a specific long-acting aldosterone antagonist (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 excretion 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 the urine.
Increased diuresis due to the presence of a diuretic effect, which is unstable; the diuretic effect is manifested on the 2nd-5th day of treatment.
Pharmacokinetics
Suction and distribution
When taken orally, it is rapidly and completely absorbed from gastrointestinal tract.
It binds to plasma proteins by about 98% (canrenone - 90%). The maximum concentration (Cmax) of canrenone in the blood plasma is reached 2-4 hours after ingestion.
After daily intake 100 mg of spironolactone for 15 days C max reaches 80 ng / ml, the time to reach C max after the next morning intake is 2-6 hours. The 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 does not penetrate well into organs and tissues, while itself and its metabolites penetrate the placental barrier, and canrenone - into breast milk.
breeding
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, active metabolites - up to 15 hours. Removal of canrenone (mainly by the kidneys) is two-phase, T 1 / 2 in the first phase - 2-3 hours, in the second - 12-96 hours .
Pharmacokinetics in selected groups of patients
With cirrhosis of the liver and heart failure, the half-life period increases without signs of cumulation, 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 can 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 aid for its prevention during treatment with diuretics and when other methods of potassium correction cannot be used).
- Primary hyperaldosteronism (Conn's syndrome) - for a short preoperative course of treatment.
- To establish the diagnosis of primary hyperaldosteronism.

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 period;
- Children's age up to 3 years (solid dosage form);
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Carefully
- Hypercalcemia, metabolic acidosis, atrioventricular blockade (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;
- Elderly age;
- Violation of the menstrual cycle, enlargement of the mammary glands;
- Liver failure, cirrhosis of the liver.

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

Dosage and administration
inside.
For essential hypertension
The daily dose for adults is usually 50-100 mg once and can be increased to 200 mg, while increasing the dose should be gradual, 1 time in 2 weeks.
To achieve an adequate response to therapy, the drug must be taken for at least 2 weeks. If necessary, adjust the dose.
With idiopathic hyperaldosteronism 100-400 mg / day.
With severe hyperaldosteronism and hypokalemia 300 mg / day (maximum 400 mg) in 2-3 doses, with improvement in the condition, the dose is gradually reduced to 25 mg / day in another dosage form.
Hypokalemia/hypomagnesemia
With 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 preparations or other methods of replenishing its 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. With an increase in the content of potassium in the blood during the administration of the drug and a decrease after its withdrawal, 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 is established using more accurate diagnostic methods, Veroshpiron should be taken at 100-400 mg / day, divided into 1-4 doses per day during the entire period of preparation for surgery. If the operation is not indicated, then Veroshpiron is used for long-term maintenance therapy, while using the smallest 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 edematous 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 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 older than 3 years is 1-3.3 mg / kg of body weight or 30-90 mg / m 2 / 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, ulceration and bleeding from the gastrointestinal tract, gastritis, intestinal colic, abdominal pain, constipation.
From the side of the liver: liver dysfunction.
From the side of the central nervous system: ataxia, lethargy, dizziness, headache, drowsiness, lethargy, confusion, muscle spasm.
From the side hematopoietic system: agranulocytosis, thrombocytopenia, megaloblastosis.
From the side of laboratory indicators: hyperuricemia, hypercreatininemia, increased urea concentration, impaired water and electrolyte balance (hyperkalemia, hyponatremia) and acid-base balance (metabolic hyperchloremic acidosis or alkalosis).
From the endocrine system: coarsening 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 in menopause; hirsutism; pain in the mammary glands; breast carcinoma (the relationship with the drug has not 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. At the same time, gynecomastia is usually reversible, and after discontinuation of the drug Veroshpiron disappears, and only in rare cases the mammary gland remains slightly enlarged.
Allergic reactions: urticaria, rarely maculopapular and erythematous rash, drug fever, pruritus, eosinophilia, Steven-Johnson syndrome, toxic epidermal necrolysis.
From the side skin: alopecia, hypertrichosis.
From the urinary system: acute renal failure.
From the musculoskeletal system: spasms of the calf muscles.

Overdose
Symptoms: nausea, vomiting, dizziness, diarrhea, skin rash, hyperkalemia (paresthesia, muscle weakness, arrhythmias), hyponatremia (dryness of the 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-releasing 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 (because the normalization of the potassium content in the blood prevents the development of toxicity).
Enhances the metabolism of phenazole (antipyrine).
Reduces the sensitivity of vessels to norepinephrine (requires caution when conducting anesthesia), increases the half-life of digoxin - digoxin intoxication is possible.
Enhances the toxic effect of lithium due to a decrease in its clearance.
Possibly enhances the effect of non-depolarizing muscle relaxants (eg, 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. Non-steroidal anti-inflammatory drugs reduce the diuretic and natriuretic effects, increasing the risk of developing hyperkalemia.
Alcohol (ethanol), barbiturates, narcotic substances exacerbate orthostatic hypotension.
Glucocorticosteroid drugs enhance the diuretic and natriuretic effect in hypoalbuminemia and / or hyponatremia.
The risk of developing hyperkalemia increases when taken with potassium supplements, potassium supplements and potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (acidosis), angiotensin II antagonists, aldosterone blockers, indomethacin, cyclosporine.
Salicylates, indomethacin reduce the diuretic effect.
Ammonium chloride, cholestyramine contribute to the development of hyperkalemic metabolic acidosis.
Fludrocortisone causes a paradoxical increase in tubular potassium secretion.
Reduces the effect of mitotane.
Enhances the action of triptorelin, buserelin, gonadorelin.

special instructions
A temporary increase in the content of urea nitrogen in the blood serum is possible, especially with reduced kidney function and hyperkalemia. Reversible hyperchloremic metabolic acidosis is possible.
In diseases of the kidneys and liver, as well as in old age, regular monitoring of blood serum electrolytes and kidney function is necessary.
The drug makes it difficult to determine digoxin, cortisol and adrenaline in the blood. Despite the absence of a direct effect on carbohydrate metabolism, the presence of diabetes mellitus, especially with diabetic nephropathy, requires special care due to the possibility of hyperkalemia.
When treating with non-steroidal anti-inflammatory drugs, kidney function and the concentration of blood electrolytes should be monitored. Potassium-rich foods should be avoided.
During treatment, alcohol is contraindicated.

The effect of the drug on the ability to drive a vehicle and mechanisms, work on which is associated with increased risk injuries
In the initial period of treatment, it is forbidden to drive vehicles and engage in activities that require increased concentration of attention and speed of psychomotor reactions. The duration of the restrictions is set individually.

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

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

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

Holiday conditions
Released by prescription.

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

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