Verospiron, capsules 100 mg 30 pcs

Veroshpiron is a potassium-saving diuretic, competitive prolonged-acting aldosterone antagonist (mineralocorticoid hormone of the adrenal cortex).

In the distal nephron, spironolactone prevents sodium and water retention by aldosterone and suppresses potassium withdrawal effect of aldosterone, reduces the synthesis of permease in aldosterone-dependent section of the collecting tubes and distal tubules.

Binding to aldosterone receptors, increases excretion of sodium ions, chlorine and water with urine, reduces excretion of potassium ions and urea, reduces urine acidity.

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

Indications

Liver cirrhosis, Heart failure, Hypertension (high blood pressure), Edema

• Essential hypertension (in combination therapy).
• Oedematous syndrome in chronic heart failure (can be used as monotherapy and in combination with standard therapy).
• Conditions in which secondary hyperaldosteronism may be detected, including Hepatic cirrhosis with ascites and/or edema, nephrotic syndrome, and other conditions with edema.
• Primary hyperaldosteronism (Conn’s syndrome) – for short preoperative treatment.
• To establish the diagnosis of primary hyperaldosteronism.

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Active ingredient

Spironolactone

Composition

Active ingredients:

Spironolactone – 100 mg.

Auxiliary substances:

sodium lauryl sulfate – 5 mg,

magnesium stearate – 5 mg,

corn starch – 85 mg,

lactose monohydrate – 255 mg.

Composition of the hard gelatin capsule:

cap – sunset yellow dye (E110) – 0.04%,

titanium dioxide (E171) – 2%,

gelatin – up to 100%;

body – sunset yellow dye (E110) – 0.04%,

titanium dioxide (E171) – 2%,

quinoline yellow dye (E104) – 0.5%,

gelatin – up to 100%.

How to take, the dosage

In essential hypertension, the daily dose for adults is usually 50-100 mg once and may be increased to 200 mg, and the dose should be increased gradually, once every 2 weeks. To achieve an adequate response to therapy, the drug should be taken for at least 2 weeks. Dose adjustment is necessary.

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

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

In hypokalemia and/or hypomagnesemia caused by therapy with diuretics, Veroshpiron is prescribed in a dose of 25-100 mg/day, once or in several doses. Maximum daily dose is 400 mg if oral potassium preparations or other methods of potassium deficiency supplementation are ineffective.

In the diagnosis and treatment of primary hyperaldosteronism, Veroshpiron is prescribed for 4 days at 400 mg/day, distributing the daily dose into several doses per day. If blood potassium concentration increases during drug administration and decreases after drug withdrawal, the presence of primary hyperaldosteronism may be assumed. In a long-term diagnostic test, the drug is prescribed in the same dose for 3-4 weeks. If correction of hypokalemia and arterial hypertension is achieved, the presence of primary hyperaldosteronism may be assumed.

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

In the treatment of edema due to nephrotic syndrome, the daily dose for adults is usually 100-200 mg. Spironolactone has not been found to influence the basic pathological process, and therefore the use of this medicine is recommended only in cases when other forms of therapy are ineffective.

In case of edematous syndrome due to chronic heart failure, the drug is prescribed daily for 5 days at a dose of 100-200 mg/day in 2-3 times, in combination with “loop” or thiazide diuretic. Depending on the effect, the daily dose is reduced to 25 mg. The maintenance dose is adjusted individually. The maximum daily dose is 200 mg.

In case of edema due to cirrhosis, the daily dose of Verospiron for adults is usually 100 mg if the ratio of sodium to potassium ions (Na+/K+) in urine is greater than 1.0. If the ratio is less than 1.0, the daily dose is usually 200-400 mg. The maintenance dose is adjusted individually.

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

Interaction

Veroshpiron reduces the effect of anticoagulants, indirect anticoagulants (heparin, coumarin derivatives, indandion) and toxicity of cardiac glycosides (because normalization of blood potassium levels prevents development of toxicity).

It enhances the metabolism of phenazole.

Decreases vascular sensitivity to norepinephrine (requires caution during anesthesia).

Lengthens the T1/2 of digoxin, so digoxin intoxication is possible.

Worsens the toxic effects of lithium due to decreased lithium clearance.

Accelerates the metabolism and excretion of carbenoxolone.

Carbenoxolone promotes sodium retention by spironolactone.

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

It enhances the effect of diuretic and hypotensive drugs.

The GCS enhances diuretic and natriuretic effects with hypoalbuminemia and/or hyponatremia.

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

Salicylates, indomethacin reduce diuretic effect.

Ammonium chloride, colestyramine contribute to hyperkalemic metabolic acidosis.

Fludrocortisone causes paradoxical increase in tubular potassium secretion.

Decreases the effect of mitotane.

It enhances the effect of triptorelin, buserelin, gonadorelin.

Special Instructions

When using Veroshpiron, serum urea nitrogen levels may increase temporarily, especially with reduced renal function and hyperkalemia. Reversible hyperchloremic metabolic acidosis may also develop.

When prescribing Veroshpiron in patients with impaired renal and hepatic function and in elderly patients, regular monitoring of serum electrolytes and renal function is required.

The administration of Verospiron makes it difficult to determine the blood concentrations of digoxin, cortisol and adrenaline.

Although there is no direct effect on carbohydrate metabolism, the presence of diabetes mellitus, especially with diabetic nephropathy, requires special caution when prescribing Verospiron because of the possibility of hyperkalemia.

When treating with NSAIDs while taking Verospiron, renal function and blood electrolyte levels should be monitored.

Eating foods rich in potassium should be avoided during treatment with Verospiron.

Alcohol consumption is contraindicated during treatment.

Impact on the ability to drive and operate machinery

In the initial period of treatment it is prohibited to drive and engage in activities requiring increased concentration and rapid psychomotor reactions. The duration of restrictions is determined on an individual basis.

Contraindications

• Hypersensitivity.
• Addison’s disease.
• Hyperkalemia.
• Hyponatremia.
• Severe renal insufficiency (CK less than 10 ml/min).
• Anuria.
• Lactose intolerance, lactase deficiency, glucose/galactose malabsorption syndrome.

With caution: the drug should be administered in hypercalcemia, metabolic acidosis, AV blockade (hyperkalemia contributes to its enhancement), diabetes mellitus (with confirmed or suspected chronic renal failure), diabetic nephropathy, Surgical interventions, administration of drugs that cause gynecomastia, local and general anesthesia, menstrual disorders, breast enlargement, liver failure, liver cirrhosis, and elderly patients.

Side effects

Digestive system disorders: nausea, vomiting, diarrhea, ulceration and bleeding from the gastrointestinal tract, gastritis, intestinal colic, abdominal pain, constipation, liver function disorders.

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

Hematopoietic system disorders: agranulocytosis, thrombocytopenia, megaloblastosis.

Metabolism disorders: hyperuricemia, hypercreatininemia, increased concentration of urea, hyperkalemia, hyponatremia, metabolic hyperchloremic acidosis or alkalosis.

Endocrine system disorders: coarsening of the voice, in men – gynecomastia (the probability of development depends on the dose, duration of treatment and is usually reversible and disappears after withdrawal of Veroshpiron, only in rare cases the breast remains slightly enlarged), reduced potency and erections; in women – menstrual disorders, dysmenorrhea, amenorrhea, metrorrhagia in the menopausal period, hirsutism, pain in the breast, mammary carcinoma (no association with taking the drug was found).

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

Dermatological reactions: alopecia, hypertrichosis.

Urinary system disorders: acute renal failure.

Muscular system disorders: muscle spasm, calf cramps.

Overdose

Symptoms: nausea, vomiting, dizziness, decreased BP, diarrhea, skin rash, hyperkalemia (paresthesias, muscle weakness, arrhythmias), hyponatremia (dry mouth, thirst, sleepiness), hypercalcemia, dehydration, increased concentration of urea.

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

Pregnancy use

The use of Veroshpiron is contraindicated in pregnancy and lactation.

Breastfeeding should be stopped if it is necessary to use the drug during lactation.

Similarities

Veroshpiron, Veroshpilactone, Spironolactone