Veroshpilactone

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Veroshpilacton: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Use in childhood
11. In case of impaired renal function
12. For violations of liver function
13. Use in the elderly
14. Drug interactions
15. Analogs
16. Terms and conditions of storage
17. Terms of dispensing from pharmacies
18. Reviews
19. Price in pharmacies

Latin name: Verospilactone

ATX code: C03DA01

Active ingredient: spironolactone (Spironolactone)

Producer: Obolenskoe - pharmaceutical company CJSC (Russia)

Description and photo updated: 2019-27-08

Prices in pharmacies: from 52 rubles.

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Veroshpilactone is a potassium-sparing diuretic.

Release form and composition

tablets: round, flat-cylindrical, with a line on one side and a bevel, white or white with a creamy shade, with a weak specific odor or almost odorless (10, 15, 20 and 30 pcs. in blisters, in a cardboard box 1, 2 or 3 packs);
capsules: 25 mg - size No. 3, with a white body and lid; 50 mg - size No. 3, with a white body and a blue cap; 100 mg - size No. 1, with a blue body and cap; the contents of the capsules are white or white with a yellowish sheen powder (10, 14, 15 and 20 pcs. in blisters, in a cardboard box 1, 2 or 3 packages).

Each pack also contains instructions for the use of Veroshpilactone.

The active substance is spironolactone:

1 tablet - 25 mg;
1 capsule - 25, 50 or 100 mg.

Excipients of tablets: lactose (milk sugar), colloidal silicon dioxide (aerosil), potato starch, talc, magnesium stearate.

Additional components of capsules: lactose monohydrate, magnesium stearate, povidone, potato starch, sodium lauryl sulfate, talc, colloidal silicon dioxide (aerosil).

Capsule composition:

25 mg: body and lid - gelatin, titanium dioxide;
50 mg: body - gelatin, titanium dioxide; cap - gelatin, titanium dioxide, brilliant black dye, patented blue dye;
100 mg: body and cap - gelatin, titanium dioxide, patented blue dye.

Pharmacological properties

Pharmacodynamics

The active ingredient of Veroshpilactone is spironolactone, a potassium-sparing diuretic, a specific antagonist of aldosterone (a mineralocorticosteroid hormone of the adrenal cortex) of prolonged action.

The mechanism of action of the drug is due to its ability to retain sodium aldosterone and water in the distal nephron, suppress the potassium-excreting effect of the mineralocorticosteroid hormone, and reduce the synthesis of permeases in the aldosterone-dependent area of the collecting ducts and distal tubules.

Spironolactone binds to aldosterone receptors, as a result of which it increases urinary excretion of sodium, chlorine and water ions, reduces urine acidity, and reduces the excretion of urea and potassium ions.

The effect of the drug reaches a maximum 7 hours after taking Veroshpilactone and lasts for at least 24 hours.

The hypotensive effect of spironolactone is explained by the presence of a diuretic effect, which is variable: it develops on days 2-5 of treatment.

Pharmacokinetics

Once in the gastrointestinal tract, spironolactone is rapidly and completely absorbed.

It binds to plasma proteins by about 98% (metabolite canrenone - by 90%). The maximum plasma concentration (Cmax) of canrenone is achieved within 2-4 hours after taking Veroshpilactone.

The volume of distribution is 0.05 l / kg.

With regular intake of Veroshpilactone for 15 days at a dose of 100 mg, Cmax is 80 ng / ml. After the next morning intake, the time to reach Cmax is 2–6 hours.

The drug poorly penetrates into tissues and organs, however, spironolactone itself and its metabolites penetrate the placental barrier, canrenone - into breast milk.

The drug is metabolized with the formation of active metabolites: mainly (80%) - a metabolite containing sulfur, to a lesser extent (20%) - canrenone.

Verospilactone is excreted from the body mainly by the kidneys (50% - in the form of metabolites, 10% - unchanged) and partially through the intestines. T _1/2 (half-life) of spironolactone - 13-24 hours, active metabolites - up to 15 hours. Canrenone is excreted mainly by the kidneys in two phases: T _{1/2 of the} first phase - 2-3 hours, T _{1/2 of the} second phase - 12 –96 hrs.

In patients with heart failure and liver cirrhosis, the duration of T _{1/2 is} increased. However, there are no signs of cumulation of Veroshpilactone. The likelihood of drug accumulation in the body increases in the presence of concomitant hyperkalemia and chronic renal failure.

Indications for use

edematous syndrome in chronic heart failure (as a monopreparation or in combination with standard therapy);
essential hypertension (as part of combination therapy);
hypokalemia and / or hypomagnesemia (as part of complex therapy for their prevention during the use of diuretics and if it is impossible to prescribe other methods for correcting potassium content);
conditions in which secondary hyperaldosteronism is possible, including nephrotic syndrome, liver cirrhosis with edema and / or ascites, and other conditions accompanied by edema;
primary hyperaldosteronism (Conn's syndrome) - for a short preoperative course of therapy.

Also, Veroshpilactone is used as a diagnostic tool for establishing primary hyperaldosteronism.

Contraindications

hyponatremia;
hyperkalemia;
anuria;
severe renal failure (creatinine clearance less than 10 ml / minute);
diabetes mellitus with confirmed renal failure;
Addison's disease;
lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome;
children under 3 years old;
During pregnancy and breastfeeding;
simultaneous use of potassium preparations, eplerenone or other potassium-sparing diuretics;
hypersensitivity to any component of Veroshpilactone.

Carefully:

diabetic nephropathy;
metabolic acidosis;
hypercalcemia;
liver failure;
cirrhosis of the liver;
atrioventricular (AV) block;
anesthesia (general or local);
diabetes mellitus with suspected or confirmed chronic renal failure;
surgical interventions;
enlargement of the mammary glands;
violation of the menstrual cycle;
taking medications that cause gynecomastia;
elderly age.

Veroshpilactone, instructions for use: method and dosage

Veroshpilactone capsules and tablets should be taken orally.

Recommended dosing regimens for adults:

edematous syndrome in chronic heart failure (in combination with thiazide or loop diuretics): daily dose - 100-200 mg in 2-3 doses for 5 days. Depending on the effect, it is possible to reduce the daily dose to 25 mg. The doctor selects the maintenance dose individually. The highest permissible dose is 200 mg per day;
Essential hypertension (as part of combination therapy): 50-100 mg once a day, if necessary, the dose is gradually increased (1 time in 2 weeks) to 200 mg. It takes at least 2 weeks to achieve an adequate response to therapy. The dose is adjusted depending on the effect and tolerability of Veroshpilactone;
hypokalemia and / or hypomagnesemia: daily dose - 25-100 mg in one or more doses. If oral potassium supplements and other methods of its replacement are ineffective, it is possible to increase the daily dose to 400 mg;
edema in liver cirrhosis: if the ratio of sodium and potassium ions in the urine exceeds 1, the daily dose is usually 100 mg, if the ratio is less than 1, the daily dose is 200-400 mg. The doctor selects the optimal maintenance dose individually;
edema in nephrotic syndrome: in a daily dose of 100-200 mg (if other types of therapy are ineffective);
severe hyperaldosteronism and hypokalemia: daily dose - 300-400 mg in 2-3 doses, after improvement of the condition, the dose is gradually reduced to 25 mg per day;
idiopathic hyperaldosteronism: 100-400 mg per day.

Diagnosis and treatment of primary hyperaldosteronism:

short diagnostic test: daily dose - 400 mg in several doses for 4 days. If the concentration of potassium in the blood increases while taking Veroshpilactone, and after its withdrawal decreases, there is reason to assume that the patient has primary hyperaldosteronism;
long-term diagnostic test: daily dose - 400 mg in several doses for 3-4 weeks. If with the help of Veroshpilactone it is possible to correct arterial hypertension and hypokalemia, it can be assumed that the patient has primary hyperaldosteronism.

After conducting any of the above tests, primary hyperaldosteronism is established using more accurate diagnostic methods. As a short preoperative course, Veroshpilactone is prescribed in a daily dose of 100–400 mg in 1–4 doses during the entire preparatory period. If surgery is not indicated, Veroshpilactone is used for long-term maintenance therapy, prescribing in the minimum effective dose, which the doctor selects individually depending on the clinical situation.

For children from 3 years old with edema in the first 5 days, Veroshpilactone is prescribed in a daily dose of 1–3.3 mg / kg or 30–90 mg / m ² in 1–4 doses, after which the dose is adjusted. If necessary, it is possible to increase the daily dose by 3 times compared to the initial one.

Side effects

from the central nervous system: drowsiness, confusion, dizziness, lethargy, lethargy, headache, ataxia, muscle spasm;
on the part of musculoskeletal and connective tissue: osteomalacia, cramps of the calf muscles;
from the kidneys and urinary tract: acute renal failure;
from the respiratory system: shortness of breath;
from the liver: impaired liver function;
from the gastrointestinal tract: intestinal colic, constipation, gastritis, diarrhea, nausea, abdominal pain, vomiting, ulceration and bleeding from the gastrointestinal tract;
on the part of the endocrine system: coarsening of the voice, in women - amenorrhea, dysmenorrhea, metrorrhagia in menopause, pain in the mammary glands, hirsutism, menstrual irregularities, breast carcinoma; in men - a decrease in potency and erection, gynecomastia (the risk of development depends on the dose, duration of treatment, is usually reversible and disappears after the withdrawal of Veroshpilactone, in some cases the mammary gland remains slightly enlarged);
on the part of the blood and lymphatic system: thrombocytopenia, agranulocytosis, megaloblastosis;
on the part of the skin and subcutaneous tissues: hypertrichosis, alopecia;
allergic reactions: drug fever, maculopapular and erythematous rash, eosinophilia, pruritus, urticaria, toxic epidermal necrolysis, Stephen-Johnson syndrome;
on the part of laboratory indicators: violation of water and electrolyte balance (hyponatremia, hyperkalemia), increased urea concentration, hypercreatininemia, hyperuricemia, violation of the acid-base state (alkalosis, metabolic hyperchloremic acidosis).

Overdose

In case of an overdose of Veroshpilactone, the following symptoms are possible: diarrhea, nausea, vomiting, increased urea concentration, dehydration, hypercalcemia, hyponatremia (drowsiness, dry mouth, thirst), hyperkalemia (muscle weakness, paresthesia, arrhythmias), skin rash, dizziness.

After taking a dose significantly higher than the recommended dose, it is advisable to perform gastric lavage. Treatment of arterial hypotension and dehydration is symptomatic. With hyperkalemia, the restoration of water and electrolyte balance is shown through the use of potassium-excreting diuretics and the rapid introduction of a glucose / dextrose solution of 5-20% with insulin (0.25-0.5 U of insulin per 1 g of glucose / dextrose), if necessary, the administration is repeated. In severe conditions, hemodialysis is performed.

special instructions

Elderly people, patients with impaired liver and kidney function require monitoring of renal function and serum electrolytes. The same applies to cases where non-steroidal anti-inflammatory drugs are used simultaneously.

Verospilactone makes it difficult to determine adrenaline, cortisol and digoxin in the blood.

During treatment, it is forbidden to consume alcoholic beverages, it is recommended to exclude foods rich in potassium from the diet.

Influence on the ability to drive vehicles and complex mechanisms

Care should be taken in activities that require quick reactions and high concentration of attention, including driving vehicles and working with complex mechanisms.

Application during pregnancy and lactation

Spironolactone and its metabolites cross the placental barrier, therefore Veroshpilactone is contraindicated in pregnant women.

The metabolites of the active substance are found in mother's milk. In this regard, it is necessary to stop breastfeeding if treatment is required during lactation.

Pediatric use

Veroshpilactone is not prescribed for children under 3 years of age (due to the solid dosage form of the drug).

With impaired renal function

Severe renal failure (creatinine clearance <10 ml / min) is a contraindication to the use of Veroshpilactone.

For violations of liver function

Verospilactone should be used with caution to treat patients with concomitant liver cirrhosis or liver failure.

Use in the elderly

In old age, Veroshpilactone is used with caution.

Drug interactions

diuretics (ethacrynic acid, furosemide, thiazides and thiazide-like), glucocorticosteroids: the diuretic and natriuretic effects of spironolactone are enhanced and accelerated;
carbenoxolone: promotes sodium retention by spironolactone;
indomethacin, salicylates: the diuretic effect of spironolactone decreases;
lithium: its clearance decreases, the toxic effect increases;
carbenoxolone: accelerates its metabolism and excretion;
cardiac glycosides: their toxicity decreases;
diuretic and antihypertensive drugs: their effect is enhanced;
non-steroidal anti-inflammatory drugs: the diuretic and natriuretic effects of spironolactone decrease, the likelihood of hyperkalemia increases;
narcotic substances, barbiturates, ethanol: orthostatic hypotension increases;
non-depolarizing muscle relaxants (for example, tubocurarine): their effect may be enhanced;
digoxin: its half-life increases, the likelihood of digoxin intoxication increases;
mitotane: its effect decreases;
cholestyramine, ammonium chloride: the risk of developing hyperkalemic metabolic acidosis increases;
indomethacin, cyclosporine, aldosterone blockers, angiotensin II receptor antagonists, angiotensin-converting enzyme inhibitors, potassium preparations, potassium-sparing diuretics, potassium supplements: the likelihood of hyperkalemia increases;
phenazone (antipyrine): its metabolism increases;
indirect anticoagulants (heparin, indandione, coumarin derivatives): their effectiveness decreases;
buserelin, triptorelin, gonadorelin: their effectiveness increases;
fludrocortisone: there is a paradoxical increase in tubular potassium secretion.

Veroshpilactone reduces vascular sensitivity to norepinephrine, therefore, caution should be exercised when conducting anesthesia.

Analogs

The analogues of Veroshpilactone are: Spironolactone, Veroshpiron, Spironol, Spironobene, Aldopur, Vero-Spironolactone, Prakton, Spironolacton-Ratiopharm, Spironaksan, Spiriks, Urakton.

Terms and conditions of storage

Store at temperatures up to 25 ° C in a place protected from light and moisture, out of reach of children.

Shelf life of tablets - 4 years, capsules - 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Veroshpilakton

Reviews of Veroshpilaktone are mostly positive. Patients note the high efficiency of the drug when it is used according to indications and in accordance with the doctor's recommendations.

Of the side effects, disorders of the gastrointestinal tract are the most frequently mentioned.

Price for Veroshpilactone in pharmacies

Approximate prices for Veroshpilactone: 25 mg tablets (20 pcs. In a package) - 58–86 rubles, 50 mg capsules (30 pcs in a package) - 163–205 rubles, 100 mg capsules (30 pcs in a package) - 243 –296 rubles.

Veroshpilactone: prices in online pharmacies

Drug name

Price

Pharmacy

Veroshpilactone 25 mg tablets 20 pcs.

52 RUB

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Veroshpilactone tablets 25mg 20 pcs.

RUB 81

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Veroshpilactone 100 mg capsules 30 pcs.

126 RUB

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Veroshpilactone 50 mg capsule 30 pcs.

168 RUB

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Veroshpilactone capsules 50mg 30 pcs.

190 RUB

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Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!