Veroshpiron 50mg capsules 30
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1 capsule contains:
Active substance: spironolactone - 50 mg.
Excipients: sodium lauryl sulfate - 2.5 mg, magnesium stearate - 2.5 mg, corn starch - 42.5 mg, lactose monohydrate - 127.5 mg.
Composition of the hard gelatin capsule: lid - dye quinoline yellow (E104) - 0.48%, titanium dioxide (E171) - 2%, gelatin - up to 100%; housing - titanium dioxide (E171) - 2%, gelatin - up to 100%.
Veroshpiron- potassium-sparing, diuretic.
Spironolactone is a potassium-sparing diuretic, a specific antagonist of aldosterone (mineralocorticosteroid hormone of the adrenal cortex) prolonged actions. In the distal parts of the nephron, spironolactone prevents aldosterone retention of sodium and water and suppresses the potassium-excreting effect of aldosterone, reduces the synthesis of permeates in the aldosterone-dependent site of the collecting tubules and distal tubules. Binding to aldosterone receptors, increases the excretion of sodium, chlorine and water ions in the urine, reduces the excretion of potassium and urea ions, reduces the acidity of urine.
Increased diuresis is due to the presence of a diuretic effect, which is not constant; the diuretic effect is manifested on the 2-5th day of treatment.
Suction and distribution
When taken orally, it is quickly and completely absorbed from the digestive tract. It binds to blood plasma proteins by about 98% (canrenon - 90%). Tmax of canrenone in the blood plasma - 2-4 h. After daily intake of 100 mg of spironolactone for 15 days, Cmax reaches 80 ng / ml, Tmax after the next morning intake - 2-6 hours. Vd — 0,05 l/kg.
Spironolactone is converted into active metabolites: a metabolite containing sulfur (80%) and partially into canrenone (20%). Spironolactone does not penetrate well into organs and tissues, while it and its metabolites penetrate the placental barrier, and canrenone into breast milk.
It is excreted by the kidneys: 50% - in the form of metabolites, 10% - unchanged and partially through the intestine. T1 / 2 spironolactone - 13-24 h, active metabolites - up to 15 h. Excretion of canrenone (mainly by the kidneys) is biphasic, T1 / 2 in the first phase - 2-3 hours, in the second - 12-96 hours.
In cirrhosis of the liver and heart failure: the duration of T1 / 2 increases without signs of cumulation, the likelihood of which is higher in chronic renal failure and hyperkalemia.
Indications for use
- essential hypertension (as part 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, 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 adjuvant for its prevention during treatment with diuretics and if it is impossible to use other methods of correcting the level of potassium);
- primary hyperaldosteronism (Conn syndrome) - for a short preoperative course of treatment;
- establishing the diagnosis of primary hyperaldosteronism.
- hypersensitivity to any of the components of the drug;
- Addison's disease;
- severe renal failure (Cl creatinine <10 ml / min), anuria;
- breastfeeding period;
- children's age up to 3 years;
- lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
Dosage and Administration
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 gradually, 1 time in 2 weeks. To achieve an adequate response to therapy, the drug must be taken for at least 2 weeks. If necessary, dose adjustment is performed.
With 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 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 of 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 discontinuation, it can be assumed 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, 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 the lowest effective dose is used, 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. 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 for 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 equal to 200-400 mg. The maintenance dose is selected individually.
With edema in children, the initial dose is 1-3.3 mg / kg 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.
From the digestive system: nausea, vomiting, diarrhea, ulceration and bleeding from the gastrointestinal tract, gastritis, intestinal colic, abdominal pain, constipation, impaired liver function.
From the side of the central nervous system and the peripheral nervous system: ataxia, lethargy, dizziness, headache, drowsiness, lethargy, confusion.
On the part of the system of hematopoietic organs: agranulocytosis, thrombocytopenia, megaloblastosis.
From the side of metabolism: hyperuricemia, hypercreatininemia, increased concentration of urea, hyperkalemia, hyponatremia, metabolic hyperchloremic acidosis or alkalosis.
From the endocrine system: coarsening of the voice, u men - gynecomastia (the likelihood of development depends on the dose, duration of treatment and is usually reversible and after the abolition of Veroshpiron disappears, only in rare cases the mammary gland remains slightly enlarged), a decrease in potency and erection; in women - menstrual disorders, dysmenorrhea, amenorrhea, metrorrhagia in the climacteric period, 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 musculoskeletal system: muscle spasm, cramps of the calf muscles.
- Gedeon Richter Ltd
- Dosage form
- 50 mg
- Number of tablets
- INN Russian
- Russian title