Verospilactone caps 50mg #30

Verospilactone instruction

You can buy Verospilactone here

Verospilactone is a potassium-sparing diuretic.

Release form and composition

    tablets: round, flat-cylindrical, with a line on one side and a chamfer, 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 lid; 100 mg - size No. 1, with a blue body and lid; the contents of the capsules are white or white with a yellowish tinge 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 Verospilactone.
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 cap - gelatin, titanium dioxide;
    50 mg: body - gelatin, titanium dioxide; cap - gelatin, titanium dioxide, diamond black dye, patented blue dye;
    100 mg: body and cap - gelatin, titanium dioxide, patented blue dye.

Pharmacodynamics

The active ingredient of Verospilactone 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 mineralocorticosteroid hormone, and reduce the synthesis of permeases in the aldosterone-dependent section of the collecting ducts and distal tubules.
Spironolactone binds to aldosterone receptors, as a result of which it increases the excretion of sodium, chlorine and water ions with urine, reduces the acidity of urine, and reduces the excretion of urea and potassium ions.
The effect of the drug reaches a maximum 7 hours after taking Verospilactone and lasts for at least 24 hours.
The hypotensive effect of spironolactone is explained by the presence of a diuretic effect, which is not constant: 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 reached within 2-4 hours after taking Verospilactone.
The volume of distribution is 0.05 l / kg.
With a regular intake of Verospilactone 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. T1 / 2 (half-life) of spironolactone - 13-24 hours, active metabolites - up to 15 hours. Canrenone is excreted mainly by the kidneys in two phases: T1 / 2 of the first phase - 2-3 hours, T1 / 2 of the second phase - 12-96 hours ...
In patients with heart failure and liver cirrhosis, the duration of T1 / 2 increases. However, there are no signs of cumulation of Verospilactone. 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, cirrhosis of the liver with edema and / or ascites, and other conditions accompanied by edema;
    primary hyperaldosteronism (Conn's syndrome) - for a short preoperative course of therapy.
Also, Verospilactone is used as a diagnostic tool to establish 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;
    concomitant use of potassium preparations, eplerenone or other potassium-sparing diuretics;
    hypersensitivity to any component of Verospilactone.

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.

Verospilactone, instructions for use: method and dosage

Verospilactone 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 (once every 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 Verospilactone;
    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 cirrhosis of the liver: if the ratio of sodium and potassium ions in 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 Verospilactone, and after its withdrawal decreases, there is reason to assume that the patient has primary hyperaldosteronism;
    long-term diagnostic test: a daily dose of 400 mg in several doses for 3-4 weeks. If with the help of Verospilactone it is possible to correct arterial hypertension and hypokalemia, it can be assumed that the patient has primary hyperaldosteronism.
After carrying out any of the above tests, primary hyperaldosteronism is established using more accurate diagnostic methods. As a short preoperative course, Verospilactone is prescribed in a daily dose of 100-400 mg in 1-4 doses during the entire preparatory period. If surgery is not indicated, Verospilactone 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 of age with edema in the first 5 days, Verospilactone is prescribed in a daily dose of 1–3.3 mg / kg or 30–90 mg / m2 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;
    from the 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;
    from 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 - decreased potency and erection, gynecomastia (the risk of development depends on the dose, duration of treatment, is usually reversible and disappears after the discontinuation of Verospilactone, 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 parameters: violation of water and electrolyte balance (hyponatremia, hyperkalemia), increased concentration of urea, hypercreatininemia, hyperuricemia, violation of the acid-base state (alkalosis, metabolic hyperchloremic acidosis).

Overdose

In case of an overdose of Verospilactone, 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 that is significantly higher than the recommended one, it is advisable to perform gastric lavage. Treatment of arterial hypotension and dehydration is symptomatic. With hyperkalemia, restoration of water and electrolyte balance is shown through the use of potassium-excreting diuretics and the rapid introduction of a solution of glucose / dextrose 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 at the same time.
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 penetrate the placental barrier, therefore Verospilactone 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.

Childhood use

Verospilactone 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 Verospilactone.

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, Verospilactone 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: ​​its metabolism and excretion are accelerated;
    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.
Verospilactone reduces vascular sensitivity to norepinephrine, therefore, caution should be exercised during anesthesia.

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.

Reviews about Verospilactone

Reviews of Verospilactone are mostly positive. Patients note the high efficiency of the drug when 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.

Terms of sell

You don't need a prescription to buy Verospilactone.