Veroshpiron

Active ingredient:

spironolactone 

Excipients:

sodium lauryl sulfate - 5 mg,

magnesium stearate - 5 mg,

corn starch - 85 mg,

lactose monohydrate - 255 mg.

Composition of a hard gelatin capsule:

lid - dye sunset yellow (E110) - 0.04%,

titanium dioxide (E171) - 2%,

gelatin - up to 100%;

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

titanium dioxide (E171) - 2%,

quinoline yellow dye (E104) - 0.5%,

gelatin - up to 100%.

Veroshpiron is a potassium-sparing diuretic, a 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 inhibits the potassium-excreting effect of aldosterone, reduces the synthesis of permeases in the aldosterone-dependent portion 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 urine acidity.

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

• Essential hypertension (as part of combination therapy).
• Edema syndrome in chronic heart failure (can be used as monotherapy and in combination with standard therapy).
• Conditions in which secondary hyperaldosteronism can be detected, incl. cirrhosis of the liver, accompanied by ascites and / or edema, nephrotic syndrome and other conditions accompanied by edema.
• Hypokalemia / hypomagnesemia (as an adjuvant for its prevention during treatment with diuretics and when it is impossible to use other methods of correcting potassium levels).
• Primary hyperaldosteronism (Connes syndrome) - for a short preoperative course of treatment.
• To diagnose primary hyperaldosteronism.

The use of Veroshpiron is contraindicated during pregnancy and lactation.

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

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

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

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

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

From the hematopoietic system: agranulocytosis, thrombocytopenia, megaloblastosis.

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

On the part of 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 and after the cancellation of Veroshpiron disappears, only in rare cases the mammary gland remains somewhat enlarged), decreased potency and erection; in women - menstrual irregularities, dysmenorrhea, amenorrhea, metrorrhagia in the climacteric period, hirsutism, pain in the mammary glands, breast carcinoma (no connection with the drug has been established).

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

Dermatological reactions: alopecia, hypertrichosis.

From the urinary system: acute renal failure.

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

Verospiron reduces the effect of anticoagulants, indirect anticoagulants (heparin, coumarin derivatives, indandione) and the toxicity of cardiac glycosides (since the normalization of potassium levels in the blood prevents the development of toxicity).

Strengthens the metabolism of phenazole.

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

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

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.

Strengthens the effect of diuretic and antihypertensive drugs.

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.

With essential hypertension, the daily dose for adults is usually 50-100 mg once and can be increased to 200 mg, while the dose should be increased gradually, once every 2 weeks. To achieve an adequate response to therapy, the drug must be taken for at least 2 weeks. Dose adjustments 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 an 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 supplements or other methods of replenishing potassium 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 while taking the drug and a decrease after its cancellation, one can assume the presence of primary hyperaldosteronism. With a long-term diagnostic test, the drug is prescribed in the same dose for 3-4 weeks. When the correction of hypokalemia and arterial hypertension is achieved, the presence of primary hyperaldosteronism can be assumed.

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

In the treatment of edema against the background of nephrotic syndrome, the daily dose for adults is usually 100-200 mg. The effect of spironolactone on the underlying pathological process has not been revealed, and therefore the use of this drug is recommended only in cases where other types of therapy are ineffective.

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

For edema in children, the initial dose is 1-3.3 mg / kg 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 initial one.

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 of dehydration and arterial hypotension. With hyperkalemia, it is necessary to normalize water-electrolyte metabolism using potassium-excreting diuretics, rapid parenteral administration of dextrose solution (5-20% solutions) with insulin at the rate of 0.25-0.5 U per 1 g of dextrose; if necessary, re-administration of dextrose is possible. In severe cases, hemodialysis is performed.

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

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

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

Despite the absence of a direct effect on carbohydrate metabolism, the presence of diabetes mellitus, especially with diabetic nephropathy, requires special care when prescribing Veroshpiron due to the possibility of hyperkalemia.

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

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

Drinking alcohol is contraindicated during treatment.

Influence on the ability to drive vehicles and use mechanisms

In the initial period of 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 on an individual basis.

Capsules