Veroshpiron capsules 50mg, No. 30
Expiration Date: 05/2027
Russian Pharmacy name:
Верошпирон капсулы 50мг, №30
- 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, 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 aid for its prevention during treatment with diuretics and when it is impossible to use other methods of correcting potassium concentration);
- primary hyperaldosteronism (Conn's syndrome) - for a short preoperative course of treatment;
- to establish a diagnosis of primary haperaldosteronism.
Inside.
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 are made if necessary.
With idiopathic hyperaldosteronism: 100-400 mg / day.
With severe hyperaldosteronism and hypokalemia: 300 mg / day (maximum 400 mg) for 2-3 doses, with improvement of the condition, the dose is gradually reduced to 25 mg / day.
Hypokalemia / hypomagnesemia
In case of hypokalemia and / or hypomagnesemia caused by diuretic therapy, the drug is prescribed in 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.
Diagnosis and treatment of primary hyperaldosteronism
As a diagnostic tool for a short diagnostic test: 400 mg / day for 4 days, divided 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: 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.
A short course of preoperative therapy for primary hyperaldosteronism
After the diagnosis of hyperaldosteronism is established using more accurate diagnostic methods, Veroshpiron should be taken at 100-400 mg / day, divided into 1-4 doses per day 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.
Edema against the background of nephrotic syndrome
The daily dose for adults is usually 100-200 mg / day. 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 daily, for 5 days, 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 dose is 200 mg / day.
Edema on the background of liver cirrhosis
If the ratio of sodium and potassium ions (Na + / K +) in urine exceeds 1.0, then the daily dose for adults is usually 100 mg. If the ratio is less than 1.0, then the daily dose for adults is usually 200-400 mg. The maintenance dose is selected individually.
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, increased by 3 times compared to the initial one.
1 capsule contains:
Capsules 50 mg
Active ingredient: spironolactone - 50.00 mg
Excipients in the capsule: sodium lauryl sulfate - 2.50 mg; magnesium stearate - 2.50 mg; corn starch - 42.50 mg; lactose monohydrate - 127.50 mg.
Hard gelatin capsule:
Size No. 3.
Cap: quinoline yellow dye E 104 - 0.48%; titanium dioxide E 171 - 2.0%; gelatin - up to 100%.
Case: titanium dioxide E 171 - 2.00%; gelatin - up to 100%.
Hypersensitivity to any of the drug's components, lactose intolerance, lactase deficiency or glucose-galactose malabsorption, Addison's disease, hyperkalemia, hyponatremia, severe renal failure (creatinine clearance less than 10 ml / min), anuria, pregnancy, lactation, children age (up to 3 years) for this dosage form.
WITH CAUTION
Hypercalcemia, metabolic acidosis, atrioventricular block (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; old age, menstrual irregularities, liver failure, liver cirrhosis.
Trade name: Veroshpiron
International Non-Proprietary Name (INN): spironolactone
Dosage form:
Capsules
Composition:
1 capsule contains:
Capsules 50 mg
Active ingredient: spironolactone - 50.00 mg
Excipients in the capsule: sodium lauryl sulfate - 2.50 mg; magnesium stearate - 2.50 mg; corn starch - 42.50 mg; lactose monohydrate - 127.50 mg.
Hard gelatin capsule:
Size No. 3.
Cap: quinoline yellow dye E 104 - 0.48%; titanium dioxide E 171 - 2.0%; gelatin - up to 100%.
Case: titanium dioxide E 171 - 2.00%; gelatin - up to 100%.
Capsules 100 mg
Active ingredient: spironolactone - 100.00 mg.
Excipients in the capsule:sodium lauryl sulfate - 5.00 mg; magnesium stearate - 5.0 mg; corn starch - 85.00 mg; lactose monohydrate - 255.00 mg.
Hard gelatin capsule:
Size # 0.
Cap: sunset yellow dye E 110 - 0.04%; titanium dioxide E 171 - 2.0%; gelatin - up to 100%.
Housing: sunset yellow dye E 110 - 0.04%; titanium dioxide E 171 - 2.0%, quinoline yellow dye E 104 - 0.50%; gelatin - up to 100%.
Pharmacological group: potassium-sparing diuretic
ATX code: C03DA01
PHARMACOLOGICAL PROPERTIES
Pharmacodynamics
Spironolactone is a potassium-sparing diuretic, prolonged action, competitive antagonist of aldosterone (mineralocorticosteroid 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 section 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 the acidity of urine.
The hypotensive effect of the drug is due to the presence of a diuretic effect; the diuretic effect appears on days 2-5 of treatment.
Pharmacokinetics
When taken orally, it is rapidly and completely absorbed from the gastrointestinal tract; bioavailability is almost 100%, and priming food increases it to 100%; the connection with blood plasma proteins is about 98%. After taking a daily dose of 100 mg for 15 days, the maximum concentration (Cmax) is 80 ng / ml, the time to reach the maximum plasma concentration (TCmax) after the next morning dose is 2-6 hours.
Active sulfur-containing metabolites are formed in the liver during biotransformation 7 -alpha-thiomethylspironolactone and canrenone. Canrenone reaches Cmax in 2-4 hours, its connection with blood plasma proteins is 90%.
Spironolactone poorly penetrates organs and tissues, while itself and its metabolites penetrate the placental barrier, and canrenone - into breast milk.
The volume of distribution is 0.05 l / kg. The half-life (T1 / 2) is 13-24 hours.
It is excreted by the kidneys: 50% - in the form of metabolites, 10% - unchanged and partially - through the intestines. Excretion of canrenone (mainly by the kidneys) is biphasic, T1 / 2 in the first phase - 2-3 hours, in the second -12-96 hours.
With 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 insufficiency and hyperkalemia.
INDICATIONS FOR USE
- 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, 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 aid for its prevention during treatment with diuretics and when it is impossible to use other methods of correcting potassium concentration);
- primary hyperaldosteronism (Conn's syndrome) - for a short preoperative course of treatment;
- to establish a diagnosis of primary haperaldosteronism.
CONTRAINDICATIONS
Hypersensitivity to any of the drug's components, lactose intolerance, lactase deficiency or glucose-galactose malabsorption, Addison's disease, hyperkalemia, hyponatremia, severe renal failure (creatinine clearance less than 10 ml / min), anuria, pregnancy, lactation period children's age (up to 3 years) for this dosage form.
WITH CAUTION
Hypercalcemia, metabolic acidosis, atrioventricular block (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; old age, menstrual irregularities, liver failure, liver cirrhosis.
Application during pregnancy and lactation
Veroshpiron is contraindicated for use during pregnancy and lactation.
DOSAGE AND METHOD OF APPLICATION
Inside.
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 are made if necessary.
With idiopathic hyperaldosteronism: 100-400 mg / day.
With severe hyperaldosteronism and hypokalemia: 300 mg / day (maximum 400 mg) for 2-3 doses, with improvement of the condition, the dose is gradually reduced to 25 mg / day.
Hypokalemia / hypomagnesemia
In case of hypokalemia and / or hypomagnesemia caused by diuretic therapy, the drug is prescribed in 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.
Diagnosis and treatment of primary hyperaldosteronism
As a diagnostic tool for a short diagnostic test: 400 mg / day for 4 days, divided 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: 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.
A short course of preoperative therapy for primary hyperaldosteronism
After the diagnosis of hyperaldosteronism is established using more accurate diagnostic methods, Veroshpiron should be taken at 100-400 mg / day, divided into 1-4 doses per day 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.
Edema against the background of nephrotic syndrome
The daily dose for adults is usually 100-200 mg / day. 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 daily, for 5 days, 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 dose is 200 mg / day.
Edema on the background of liver cirrhosis
If the ratio of sodium and potassium ions (Na + / K +) in urine exceeds 1.0, then the daily dose for adults is usually 100 mg. If the ratio is less than 1.0, then the daily dose for adults is usually 200-400 mg. The maintenance dose is selected individually.
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, increased by 3 times compared to the initial one.
SIDE EFFECTS
From the gastrointestinal tract: nausea, vomiting, diarrhea, ulceration and bleeding from the gastrointestinal tract, gastritis, intestinal colic, abdominal pain, constipation.
From the liver: abnormal liver function.
From the side of the central nervous system: ataxia, lethargy, dizziness, headache, drowsiness, lethargy, confusion, muscle spasm.
From the hematopoietic system: agranulocytosis, thrombocytopenia, megaloblastosis.
On the part of laboratory parameters:hyperuricemia, hypercreatininemia, increased urea concentration, impaired water-salt metabolism (hyperkalemia, hyponatremia) and acid-base balance (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, usually, is reversible and after the withdrawal 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 menopause, hirsutism, pain in the area of ??the mammary glands, breast cancer (no connection with the drug has been established).
Allergic reactions:urticaria, rarely maculopapular and erythematous rash, drug fever, pruritus.
On the part of the skin: alopecia, hypertrichosis.
From the urinary system: acute renal failure.
From the side of the musculoskeletal system: cramps of the calf muscles.
OVERDOSE
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 and electrolyte metabolism using potassium-excreting diuretics, rapid parenteral administration of a dextrose solution (5-20% solutions) with insulin at the rate of 0.25-0.5 U per 1 g of dextrose; if necessary, you can enter it again. In severe cases, hemodialysis is performed.
INTERACTION WITH OTHER DRUGS
Reduces the effect of anticoagulants, indirect anticoagulants (heparin, coumarin derivatives, indandione) and the toxicity of cardiac glycosides (since the normalization of the level of potassium in the blood prevents the development of toxicity).
Strengthens the metabolism of phenazole (antipyrine).
Reduces the sensitivity of blood vessels to norepinephrine (requires caution during anesthesia), increases T1 / 2 of digoxin - intoxication with digoxin 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.
Glucocorticosteroid drugs and diuretics (benzothiazine derivatives, furosemide, ethacrynic acid) enhance and accelerate the diuretic and natriuretic effects.
Strengthens the effect of diuretic and antihypertensive drugs.
Glucocorticosteroid drugs enhance the diuretic and natriuric effect in hypoalbuminemia and / or hyponatremia.
The risk of hyperkalemia increases when taken with potassium supplements, potassium supplements and potassium-sparing diuretics, angiotensin converting enzyme inhibitors (acidosis), angiotensin II antagonists, aldosterone, indomethacin, cyclosporin blockers.
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.
SPECIAL INSTRUCTIONS A
temporary increase in the level of urea nitrogen in the blood serum is possible, especially with reduced renal function and hyperkalemia. Reversible hyperchloremic metabolic acidosis is possible.
In diseases of the kidneys and liver, as well as in old age, regular monitoring of serum electrolyte levels and kidney function is necessary.
The drug makes it difficult to determine 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 due to the possibility of developing hyperkalemia.
When treating with non-steroidal anti-inflammatory drugs, kidney function and blood electrolyte levels should be monitored. Avoid eating foods rich in potassium. Drinking alcohol is contraindicated during treatment.
The effect of the drug on the ability to drive a car and mechanisms, work on which is associated with an increased risk of injury
In the initial period of treatment, it is prohibited 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.
STORAGE CONDITIONS
At a temperature not exceeding 30 ? —.
Keep out of the reach of children!
SHELF LIFE
5 years.
Do not use the drug after the expiration date indicated on the package.
TERMS OF RELEASE FROM PHARMACIES
By prescription.