Veroshpiron (Verospiron)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceSpironolactoneSpironolactone
Similar drugsTo uncover
  • Vero-Spironolactone
    pills inwards 
    VEROPHARM SA     Russia
  • Verospilactone
    capsules inwards 
    OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC     Russia
  • Veroshpilakton®
    pills inwards 
    OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC     Russia
  • Veroshpiron
    capsules inwards 
    GEDEON RICHTER, OJSC     Hungary
  • Veroshpiron
    pills inwards 
    GEDEON RICHTER, OJSC     Hungary
  • Spironolactone
    pills inwards 
    SYNTHESIS, JSC Joint-stock Kurgan Society of Medical Preparations and Products     Russia
  • Spironolactone
    pills inwards 
    OZONE, LLC     Russia
  • Spironolactone
    pills inwards 
    MEDISORB, CJSC     Russia
    • Dosage form: & nbspcapsules
    Composition:
    1 capsule contains:
    Capsules 50 mg
    Active substance: 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: dye quinoline yellow E 104 - 0.48%; titanium dioxide E 171 -2.00 %; gelatin - up to 100%.
    Housing: titanium dioxide E 171 - 2.00%; gelatin - up to 100%.
    Capsules 100 mg
    Active substance: spironolactone - 100.00 mg.
    Excipients in the capsule: sodium lauryl sulfate - 5,00 mg; magnesium stearate -5.00 mg; corn starch - 85.00 mg; lactose monohydrate is 255.00 mg.
    Hard gelatin capsule:
    The size №0.
    Cap: dye sunset sunset yellow E110 - 0.04%; titanium dioxide E 171 - 2.00%; gelatin - up to 100%.
    Housing: dye sunset yellow E 110 - 0.04%; titanium dioxide E 171 -2.00 %, dye quinoline yellow E 104 - 0.50%; gelatin - up to 100%.
    Description:
    Capsules 50 mg: Content capsules: fine-grained granular powder mixture of white color.
    Capsule: hard gelatinous, size 3; Cap: opaque, yellow; Case: opaque, white.
    Capsules 100 mg: Content capsules: fine-grained granular powder mixture of white color.
    Capsule: hard gelatinous, size No.0; Cap: opaque, orange; Case: opaque, yellow.
    Pharmacotherapeutic group:Diuretic potassium-sparing agent
    ATX: & nbsp

    C.03.D.A   Aldosterone antagonists

    C.03.D.A.01   Spironolactone

    Pharmacodynamics:
    Spironolactone is a potassium-sparing diuretic, a specific antagonist of prolonged-action aldosterone (mineralocorticosteroid hormone of the adrenal cortex). In the distal sections of the nephron spironolactone prevents the delay of aldosterone sodium and water and suppresses the potassium-releasing effect of aldosterone, reduces the synthesis of permeases in the aldosterone-dependent region of the collecting tubules and distal tubules.By 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.
    The increase in diuresis is due to the presence of a diuretic effect, which is unstable; diuretic effect is manifested on the 2-5 day of treatment.
    Pharmacokinetics:
    Suction and distribution
    When ingested quickly and completely absorbed from the gastrointestinal tract. It binds to blood plasma proteins by about 98% (canrenone - 90%). The maximum concentration (Сmах) of canrenone in blood plasma is reached in 2-4 hours after reception. After daily intake of 100 mg of spironolactone within 15 days, C max reaches 80 ng / ml, the time to reach C max after the next morning intake is 2-6 hours. The distribution volume is 0.05 l / kg.
    Metabolism
    Spironolactone is converted into active metabolites: a metabolite containing sulfur (80%), and partly canrenone (20%). Spironolactone poorly penetrates into organs and tissues, while himself and his metabolites penetrate the placental barrier, and canrenone - into breast milk.
    Excretion
    It is excreted by the kidneys; 50% - in the form of metabolites, 10% - in unchanged form and partially through the intestine. Half-life (T1/2) spironolactone 13-24 h, active metabolites - up to 15 h.The excretion of canrenone (mainly by the kidneys) is biphasic, T1/2 in the first phase - 2-3 hours, in the second -12-96 hours.
    Pharmacokinetics in selected patient groups
    With liver cirrhosis and heart failure, the half-life period increases without signs of cumulation, the probability of which is higher for chronic renal failure and hyperkalemia.
    Indications:
    - Essential arterial hypertension (as part of combination therapy).
    - Edemary syndrome with chronic heart failure (can be used as a monotherapy and in combination with standard therapy);
    - Conditions in which secondary hyperaldosteronism can be detected, including cirrhosis accompanied by ascites and / or edema, nephrotic syndrome, and other conditions accompanied by edema.
    - Hypokalemia / hypomagnesemia (as an aid for its prevention during treatment with diuretics and when other methods of correction of potassium content are not possible).
    - Primary hyperaldosteronism (Conn's syndrome) is for a short preoperative course of treatment.
    - To establish the diagnosis of primary hyperaldosteronism.
    Contraindications:
    - Hypersensitivity to any of the components of the drug;
    - Addison's disease;
    - Hyperkalemia;
    - Hyponatremia;
    - Severe renal failure (creatinine clearance less than 10 ml / min);
    - Anuria;
    - Pregnancy, the period of breastfeeding;
    - Children under 3 years of age (solid dosage form);
    - Deficiency of lactase, lactose intolerance, glucose-galactose malabsorption.
    Carefully:
    - Hypercalcemia, metabolic acidosis, atrioventricular blockade (hyperkalaemia contributes to its strengthening);
    - Diabetes mellitus (with confirmed or suspected chronic renal failure);
    - Diabetic nephropathy;
    - Surgical interventions, during anesthesia;
    - Taking medications that cause gynecomastia;
    - Local and general anesthesia;
    - Elderly age;
    - Violation of the menstrual cycle, increased mammary glands;
    - Liver failure, cirrhosis.
    Pregnancy and lactation:
    In pregnancy
    The drug is contraindicated in pregnancy.
    During lactation
    The drug is contraindicated during lactation. Breastfeeding should be discontinued if spironolactone is not possible.
    Dosing and Administration:
    Inside.
    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 gradual, 1 every 2 weeks. To achieve an adequate response to therapy, the drug should be taken at least 2 weeks. If necessary, adjust the dose.
    With idiopathic hyperaldosteronism 100-400 mg / day.
    With pronounced hyperaldosteronism and hypokalemia 300 mg / day (maximum 400 mg) for 2-3 doses, when the condition is improved, the dose is gradually reduced to 25 mg / day in another dosage form.
    Hypokalemia / hypomagnesemia
    With 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 of 400 mg, if oral potassium preparations or other methods of replenishing its deficiency are ineffective.
    Diagnosis and treatment of primary hyperaldosteronism
    As a diagnostic tool for a short diagnostic test: for 4 days at 400 mg / day, distributed to several doses per day. With an increase in the potassium content inblood at the time of taking the drug and lowering after cancellation it can be assumed the presence of primary hyperaldosteronism.
    With a long diagnostic test: in the same dose for 3-4 weeks. When the correction of hypokalemia and arterial hypertension is achieved, it is possible to assume the presence of primary hyperaldosteronism.
    Short course of preoperative therapy of primary hyperaldosteronism
    After the diagnosis of hyperaldosteronism is established using more accurate diagnostic methods, Veroshpiron should be taken at 100-400 mg / day, dividing by 1-4 doses per day during the entire period of preparation for a surgical operation. If the operation is not indicated, Veroshpiron is used for prolonged maintenance therapy, while the lowest effective dose that is selected individually for each patient is used.
    Edema on the background of nephrotic syndrome
    The daily dose for adults is usually 100-200 mg / day. No effect of spironolactone on the main pathological process was found, and therefore the use of this drug is recommended only in cases when other types of therapy are ineffective.
    With edematous syndrome in the background of chronic heart failure daily, for 5 days to 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 of 200 mg / day.
    Edemas on the background of liver cirrhosis
    If the ratio of sodium and potassium ions (Na + / K +) in urine exceeds 1.0, the daily dose for adults is usually 100 mg. If the ratio is less than 1.0, the daily dose for adults is usually 200-400 mg. The maintenance dose is selected individually.
    Edema in children
    The initial dose in children older than 3 years is 1-3.3 mg / kg body weight or 30-90 mg / m2/ day in 1-4 hours. After 5 days, the dose is adjusted and, if necessary, increased 3 times as compared with the original dose.
    Side effects:
    From the gastrointestinal tract: nausea, vomiting, diarrhea, ulceration and bleeding from the gastrointestinal tract, gastritis, intestinal colic, abdominal pain, constipation.
    From the side of the liver: abnormal liver function.
    From the central nervous system: ataxia, inhibition, dizziness, headache, drowsiness, lethargy, confusion, muscle spasm.
    From the hematopoietic system: agranulocytosis, thrombocytopenia, megaloblastosis.
    From the laboratory indicators: hyperuricemia, hypercreatininaemia, increased urea concentration, disturbance of water-electrolyte balance (hyperkalemia, hyponatremia) and acid-base balance (metabolic hyperchloremia acidosis or alkalosis).
    From the endocrine system: coarsening of the voice, in men - gynecomastia (the probability of development depends on the dose, duration of treatment and, usually, is reversible); decreased potency and erection; in women - menstrual irregularities; dysmenorrhea; amenorrhea; metrorrhagia in menopause; hirsutism; pain in the area of ​​mammary glands; carcinoma of the mammary gland (the presence of a link with the drug is not established).
    When using the drug Veroshpiron can develop gynecomastia. The likelihood of gynecomastia depends both on the dose of the drug and on the duration of therapy. In this case, gynecomastia is usually reversible, and after discontinuation of the drug, Veroshpiron disappears, and only in rare cases does the breast gland remain slightly enlarged.
    Allergic reactions: urticaria, rarely maculopapular and erythematous rash, drug fever, pruritus, eosinophilia, Stephen-Johnson syndrome, toxic epidermal necrolysis.
    From the skin: alopecia, hypertrichosis.
    From the urinary system: acute renal failure.
    From the musculoskeletal system: cramps calf muscles.
    Overdose:
    Symptoms: nausea, vomiting, dizziness, diarrhea, skin rash, hyperkalemia (paresthesia, muscle weakness, arrhythmias), hyponatremia (dryness of the oral mucosa, thirst, drowsiness) hypercalcemia, dehydration, increased urea concentration.
    Treatment: gastric lavage, symptomatic treatment of dehydration and arterial hypotension. With hyperkalemia, it is necessary to normalize the water-electrolyte balance with the help of potassium-withdrawing diuretics, rapid parenteral administration of a solution of dextrose (5-20% solutions) with insulin from 0.25-0.5 units per 1 g of dextrose; If necessary, you can re-enter it. In severe cases, hemodialysis is performed.
    Interaction:
    Reduces the effect of anticoagulants, indirect anticoagulants (heparin, coumarin derivatives, and idanedione) and toxicity of cardiac glycosides (t.p.normalization of the potassium content in the blood prevents the development of toxicity).
    Enhances the metabolism of phenazol (antipyrine).
    Reduces the sensitivity of the vessels to norepinephrine (requires caution when conducting anesthesia), increases the half-life of digoxin - possible intoxication with digoxin.
    Increases the toxic effect of lithium due to a decrease in its clearance.
    It probably enhances the effect of nondepolarizing muscle relaxants (eg, tubocurarine).
    Accelerates the metabolism and excretion of carbenoksolona.
    Carbenoxolone promotes sodium retention by spironolactone.
    Glucocorticosteroids and diuretics (benzothiazine derivatives, furosemide, ethacrynic acid) intensify and accelerate diuretic and natriuretic effects.
    Strengthens the action of diuretic and antihypertensive drugs. Nonsteroidal anti-inflammatory drugs reduce diuretic and natriuretic effects, increases the risk of hyperkalemia.
    Alcohol (ethanol), barbiturates, narcotic substances strengthen orthostatic hypotension.
    Glucocorticosteroid preparations increase diuretic and natriuretic effect in hypoalbuminemia and / or hyponatremia.
    The risk of hyperkalemia increases with admission with potassium, potassium supplements and potassium-sparing diuretics, inhibitors of angiotensin-converting enzyme (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 secretion of potassium.
    Reduces the effect of mitotane.
    Strengthens the action of tryptorelin, buserelin, gonadorelin.
    Special instructions:
    There may be a temporary increase in urea nitrogen in the blood serum, especially with reduced kidney function and hyperkalemia. Possible reversible hyperchloremic metabolic acidosis.
    In diseases of the kidneys and liver, as well as in old age, regular monitoring of blood serum electrolytes and kidney function is necessary.
    The drug makes it difficult to determine digoxin, cortisol and adrenaline in the blood. Despite the absence of direct effects on carbohydrate metabolism, the presence of diabetes mellitus, especially with diabetic nephropathy, requires extreme caution because of the possibility of developing hyperkalemia.
    When treating non-steroidal anti-inflammatory drugs, kidney function and concentration of blood electrolytes should be monitored. Avoid eating foods rich in potassium.
    During treatment, alcohol consumption is contraindicated.
    Effect on the ability to drive transp. cf. and fur:
    In the initial period of treatment, it is prohibited to drive vehicles and engage in activities requiring an increased concentration of attention and speed of psychomotor reactions. The duration of restrictions is set individually.

    Form release / dosage:
    Capsules 50 mg, 100 mg.
    Packaging:

    10 capsules in a PVC blister - aluminum foilolga. For 3 blisters together with the instruction for application put in a pack of cardboard.

    Storage conditions:
    At a temperature of no higher than 30 ° C.
    Keep out of the reach of children!
    Shelf life:
    5 years
    Do not use after the date shown on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N011953 / 01
    Date of registration:02.06.2010 / 01.12.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary
    Manufacturer: & nbsp
    Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary
    Information update date: & nbsp06.02.2017
    Illustrated instructions
      Instructions
      Up