Spironolactone: instructions for use

Indications for use

Indications for use are as follows:

• premenstrual syndrome;
• polycystic ovary syndrome;
• aldosterone-producing adrenal adenoma;
• primary hyperaldosteronism ;
• arterial hypertension;
• swelling in the second and third trimester of pregnancy;
• nephrotic syndrome;
• cirrhosis of the liver;
• edema due to chronic heart failure .

Spironolactone or Torsemide - which is better?

Manufacturer: Austria
Release form: tablets

Active ingredient: torasemide

Synonyms: Lotonel, Diuver, Trigrim

Torsemide belongs to another group of diuretics - loop ones. It enhances the excretion of potassium from the body, therefore this analogue of Spironolactone 25 mg is contraindicated in case of hypokalemia. Has less peak effect. Has a beneficial effect on the myocardium. Controls cardiac overload, therefore it will be the drug of choice for heart failure with reduced ejection fraction. Bioavailability is high and does not depend on food intake.

However, both drugs have many side effects, and therefore require monitoring of electrolyte balance and biochemical blood parameters.

Contraindications

The drug should not be taken if:

• hypersensitivity to the active substance;
• enlargement of the mammary glands;
• menstrual irregularities;
• metabolic acidosis;
• first trimester of pregnancy;
• diabetic nephropathy ;
• diabetes mellitus with suspected or confirmed chronic renal failure ;
• liver failure;
• anuria;
• chronic renal failure ;
• hyponatremia;
• hypercalcemia;
• hyperkalemia;
• Addison's disease.

Indications and contraindications

The instructions recommend the use of Spironolactone for the following pathologies:

• with premenstrual, nephrotic syndrome;
• Conn's syndrome, polycystic ovaries;
• increased blood pressure;
• swelling that occurs in the second half of pregnancy or with CHF;
• cirrhosis of the liver.

The medication is contraindicated:

• in case of individual intolerance to the component composition;
• menstrual irregularities;
• the first three months of gestation;
• unstable acid-base balance;
• diabetic glomerulosclerosis;
• diabetes mellitus, chronic renal failure;
• liver dysfunction, in the absence of urine entering the bladder;
• low sodium concentration in the blood;
• increased levels of calcium and potassium.

The drug is prohibited for patients with Addison's disease.

Side effects

When using the drug, the following symptoms may develop:

• decreased potency and muscle spasms ;
• itching , drug fever , erythematous and maculopapular rashes, urticaria ;
• breast carcinoma, pain in the mammary glands, deepening of the voice, hirsutism , metrorrhagia during menopause, amenorrhea , dysmenorrhea , erectile dysfunction in men and gynecomastia ;
• thrombocytopenia , agranulocytosis , megaloblastosis ;
• alkalosis , hyperuricemia , hypercreatininemia , increased urea concentration;
• ataxia , lethargy , headache , lethargy , drowsiness , dizziness ;
• constipation or diarrhea , intestinal colic , bleeding and ulceration in the gastrointestinal tract, gastritis , abdominal pain, nausea and vomiting .

Spironolactone tablets 100 mg No. 30

Name

Spironolactone.

Release forms

Pills.

INN

Spironolactone.

Description

Spironolactone 25 mg: Round, biconvex, film-coated, violet tablets. Spironolactone 100 mg: Round, biconvex, film-coated tablets, dark purple in color, scored on one side.

Compound

Spironolactone 25 mg contains: active ingredient - spironolactone - 25 mg; excipients: lactose monohydrate, corn starch, povidone K 25, magnesium stearate, talc, croscarmellose sodium, shell: opadry II 85 F 20086 violet (purified talc, FD&C Blue No. 2 (indigo carmine, E132), carmine (E120), polyethylene glycol, titanium dioxide, polyvinyl alcohol). Spironolactone 100 mg contains: active ingredient - spironolactone -100 mg; excipients: lactose monohydrate, corn starch, povidone K 25, magnesium stearate, talc, croscarmellose sodium; shell: opadry I 85 F 20084 violet (purified talc, FD&C Blue No. 2 (indigo carmine, E132), carmine (E120), polyethylene glycol, titanium dioxide, polyvinyl alcohol).

Pharmacotherapeutic group

Potassium-sparing diuretics. Aldosterone antagonists. Code ATX-C03DA01.

Pharmacological properties

Pharmacodynamics

Spironolactone is a potassium-sparing diuretic, a specific antagonist of long-acting aldosterone (mineralocorticosteroid hormone of the adrenal cortex). In the distal nephron, Spironolactone prevents the retention of sodium and water by aldosterone and suppresses the potassium-removing effect of aldosterone. 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 maximum effect is observed 7 hours after oral administration and lasts for at least 24 hours. The hypotensive effect of the drug is due to the presence of a diuretic effect, which is not constant: the diuretic effect appears on days 2-5 of treatment.

Pharmacokinetics

Spironolactone is well absorbed after oral administration and is mainly metabolized into active metabolites: sulfur-containing metabolites (80%) and partly canrenone (20%). The plasma half-life of Spironolactone is short (1.3 hours), the half-life of active metabolites is longer (from 2.8 to 11.2 hours). Excretion of metabolites occurs mainly through urine, a small part is excreted in feces. Spironolactone and its metabolites cross the placenta and are excreted in breast milk. After administering 100 mg of spironolactone per day for 15 days to healthy volunteers, Tmax was reached in 2.6 hours, Cmax was approximately 80 ng/ml and Ti/2 was approximately 1.4 hours. For 7-alpha-(thiomethyl)spironolactone and canrenone, Tmax was 3.2 hours and 4.3 hours, Cmax was 391 ng/ml and 181 ng/ml and T1/213.8 hours and 16.5 hours, respectively. The renal effects of a single dose of Spironolactone reach their peak after 7 hours and activity persists for at least 24 hours.

Indications for use

Congestive heart failure. Liver cirrhosis with ascites and edema. Malignant ascites. Nephrotic syndrome. Diagnosis and treatment of primary aldosteronism. Method of administration and dosage It is recommended to take Spironolactone once a day with meals. Adults Congestive heart failure with edema The initial daily dose is 100 mg of spironolactone, administered as a single or divided dose, which can be adjusted in the range of 25 to 200 mg/day depending on the patient's response. The maintenance dose must be determined individually. In patients with severe heart failure (NYHA class III-IV) Based on the Randomized Evaluation Study (RALES), treatment in combination with standard therapy should be initiated at a dose of Spironolactone 25 mg once daily if potassium levels are ≤ 5 mEq/day. ml and serum creatinine ≤ 2.5 mg/dl. In patients who tolerate 25 mg once daily, the dose may be increased to 50 mg once daily as clinically indicated. For patients who cannot tolerate 25 mg once daily, the dose is reduced to 25 mg every other day. Liver cirrhosis with ascites and edema If the Na+ / K+ ratio in the urine is more than 1.0, the dose is 100 mg/day. If the ratio is less than 1.0, then 200-400 mg/day. In each individual case, the dose must be determined personally. Malignant ascites Initial dose is usually 100-200 mg/day. In severe cases, the dose may be gradually increased to 400 mg/day. Based on the dynamics of the development of edema syndrome, the maintenance dose should be determined individually. Nephrotic syndrome Usual dose 100-200 mg/day. Spironolactone has not been shown to affect the underlying pathological process. Its use is recommended only if glucocorticoids alone are not effective enough. Diagnosis and Treatment of Primary Aldosteronism Spironolactone can be used as an initial diagnostic test to determine primary hyperaldosteronism while patients are on a normal diet. Long test: Spironolactone is administered at a daily dose of 400 mg for 3-4 weeks. Correction of hypokalemia and hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism. Brief test: Spironolactone is administered at a daily dose of 400 mg for four days. If serum potassium levels rise when spironolactone is administered and fall when spironolactone is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered. Once the diagnosis of hyperaldosteronism has been established following definitive testing procedures, spironolactone can be administered in doses of 100 mg to 400 mg per day in preparation for surgery. For patients who cannot undergo surgery, spironolactone can be used for long-term therapy at a low effective dose determined for the individual patient. Elderly Patients Recommended treatment should be started at a low dose and titrated to achieve the desired effect. Caution should be exercised in patients with severe hepatic or renal impairment, which may alter drug metabolism and elimination. Children The initial daily dose should provide 3 mg of Spironolactone per kilogram of body weight. Dosage should be adjusted based on response and tolerability. If necessary, a suspension can be obtained by crushing Spironolactone tablets.

Side effect

In connection with taking Spironolactone, gynecomastia may develop. The development of gynecomastia depends on the dose and duration of use of Spironolactone and is usually reversible after discontinuation of the drug. In rare cases, gynecomastia may persist. The following adverse reactions are also possible: General disorders: general weakness. Neoplasms benign, malignant and unspecified (including cysts and polyps): benign breast tumors. Gastrointestinal disorders: gastrointestinal disorders, nausea. Blood and lymphatic system disorders: leukopenia (including agranulocytosis), thrombocytopenia. Hepatobiliary system disorders: liver dysfunction. Metabolic and nutritional disorders: electrolyte imbalance, hyperkalemia. From the musculoskeletal system: cramps of the calf muscles. Nervous system disorders: dizziness. Mental disorders: changes in libido, confusion. Reproductive system and breast disorders: menstrual irregularities, chest pain. Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis, rash accompanied by eosinophilia and systemic symptoms (DRESS syndrome), alopecia, hypertrichosis, itching, rash, urticaria. Disorders of the kidneys and urinary systems: acute renal failure. If any adverse reactions occur, including those not listed in these instructions, you should consult a doctor.

Contraindications

Hyperkalemia. Acute renal failure. Severe renal failure (creatinine clearance

QC

less than 10 ml/min). Anuria. Addison's disease. Hyponatremia. Pregnancy. Breast-feeding. Hypersensitivity to any of the components of the drug. Concomitant use of eplerenone or other potassium-sparing diuretics. Spironolactone should not be taken concomitantly with other potassium-inhibiting diuretics or potassium supplements, as hyperkalemia may develop. The drug should be prescribed with caution in case of hypercalcemia, metabolic acidosis, AV 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, menstrual irregularities, breast enlargement, liver failure, liver cirrhosis, as well as elderly patients.

Overdose

Symptoms: nausea, vomiting, dizziness, 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. In case of hyperkalemia, it is necessary to normalize water-electrolyte metabolism with the help of potassium-removing diuretics, rapid parenteral administration of a dextrose solution (5-20% solutions) with insulin at the rate of 0.25-0.5 units per 1 g of dextrose; if necessary, dextrose can be reintroduced.

Precautionary measures

When using Spironolactone, a temporary increase in serum urea nitrogen levels is possible, especially with reduced renal function and hyperkalemia. It is also possible to develop hyperchloremic metabolic acidosis. When prescribing Spironolactone to patients with impaired renal and liver function, and elderly patients, regular monitoring of serum electrolytes and renal function is necessary. Hyperkalemia may develop in patients with impaired renal function or in patients with excessive potassium intake and lead to the development of fatal arrhythmias. If hyperkalemia occurs, spironolactone should be discontinued and active measures should be taken to reduce serum potassium to normal levels. Concomitant use of Spironolactone with other potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, non-steroidal anti-inflammatory drugs, angiotensin II antagonists, aldosterone blockers, heparin, low molecular weight heparins or other drugs that contribute to the development of hyperkalemia, as well as in conditions where hyperkalemia may occur (supplements). potassium, a diet rich in potassium, or salt substitutes containing potassium) may lead to the development of severe hyperkalemia. Hyperkalemia in patients with severe heart failure Hyperkalemia can be fatal. Careful monitoring and regulation of blood potassium levels is necessary when Spironolactone is prescribed to patients with severe heart failure. The use of other potassium-sparing diuretics should be avoided. Potassium supplementation should be avoided in patients with serum potassium levels > 3.5 mEq/L. It is recommended to monitor potassium and creatinine levels for one week after starting or increasing the dose of spironolactone, then monthly for the first 3 months, then quarterly for a year, then every 6 months. If the serum potassium level is more than 5 mEq/L or the serum creatinine level is more than 4 mg/dL, treatment should be discontinued. Due to the lactose content, the drug is not recommended for patients with congenital galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. Despite the absence of a direct effect on carbohydrate metabolism, the presence of diabetes mellitus, especially with diabetic nephropathy, requires special caution when prescribing Spironolactone due to the possibility of developing hyperkalemia. During treatment with Spironolactone, alcohol consumption is contraindicated, and food rich in potassium should be avoided.

Use in children

The medicine is not recommended for children under 6 years of age.

Impact on the ability to drive vehicles and operate machinery

During the initial period of treatment, it is prohibited to drive a car or engage in activities that require increased concentration and speed of psychomotor reactions. The duration of restrictions is set individually.

Use for liver dysfunction

The drug should be prescribed with caution in case of liver failure or liver cirrhosis. When prescribing Spironolactone to patients with liver disorders, regular monitoring of serum electrolytes and renal function is necessary.

Use for renal impairment

The drug is contraindicated in severe renal failure (creatinine clearance less than 10 ml/min). The drug should be prescribed with caution for diabetic nephropathy. When prescribing Spironolactone to patients with impaired renal function, regular monitoring of serum electrolytes and renal function is necessary.

Use during pregnancy and lactation

The use of Spironolactone is contraindicated during pregnancy and breastfeeding.

Interaction with other drugs

Concomitant use of drugs that promote hyperkalemia with spironolactone may lead to the development of severe hyperkalemia. Spironolactone may increase serum digoxin concentrations and interfere with the assessment of serum digoxin concentrations. Patients receiving digoxin and spironolactone should be closely monitored to assess for increased or decreased digoxin effects. When Spironolactone is added, the effect of antihypertensive drugs is enhanced, which may require a reduction in their dosages; further dose adjustment is necessary. Because ACE inhibitors reduce aldosterone production, they should not be routinely administered with spironolactone, especially in patients with severe renal impairment. Taking carbenoxolone may lead to sodium retention and thus reduce the effectiveness of spironolactone; concomitant use should be avoided. Nonsteroidal anti-inflammatory drugs such as aspirin, indomethacin and mefenamic acid can weaken the natriuretic effect of diuretics by inhibiting intrarenal prostaglandin synthesis and reduce the diuretic effect of spironolactone. Spironolactone reduces the vascular response to norepinephrine. Caution should be exercised in case of local or general anesthesia in patients taking spironolactone. When performing fluorometric assays, Spironolactone may interfere with the evaluation of compounds with similar fluorescence characteristics. Spironolactone may increase the half-life of digoxin. Spironolactone increases the metabolism of antipyrine. Spironolactone may interfere with the results of determining plasma digoxin concentrations.

Storage conditions

The drug should be stored out of the reach of children, protected from moisture and light at a temperature of 15°C to 25°C.

Best before date

2 years. Do not use after expiration date.

Vacation conditions

Dispensed with a doctor's prescription.

Package

Cardboard packaging containing 100 tablets (10 blisters of 10 tablets).

Buy Spironolactone tablets 100 mg No. 30 in a pharmacy

Price for Spironolactone tablets 100 mg No. 30

Instructions for use for Spironolactone tablets 100 mg No. 30

Spironolactone, instructions for use (Method and dosage)

According to the instructions for use of Spironolactone, the dose is set individually depending on the hormonal status and the severity of the disturbance in water-electrolyte metabolism.

In case of reduced potassium in plasma and severe hyperaldosteronism , it is recommended to take 300 mg per day in two or three doses; in case of edema syndrome, 100 to 200 mg per day in two or three doses is prescribed every day for 2 to 3 weeks. If necessary, the course can be repeated after 2 weeks.

Features of the composition and action of Spironolactone

The medicine is prepared in tablets and contains 25 or 100 mg of the active ingredient spironolactone. Additional components of the composition are presented:

• calcium stearate;
• povidone;
• lactose;
• potato starch;
• monohydrate.

Each package of medication contains 20, 30 tablets. Spironolactone is a diuretic that accelerates the elimination of sodium and chlorine from the body, reduces uric acidity, and preserves potassium and magnesium. The therapeutic effect occurs within 2-5 days from the start of administration.

Overdose

In case of overdose the following are observed:

• dehydration;
• increase in urea concentration;
• hypercalcemia;
• hyponatremia;
• hyperkalemia;
• diarrhea;
• dizziness;
• skin rash;
• nausea and vomiting.

Therapeutic measures include gastric lavage and treatment of dehydration and arterial hypotension . In severe cases, hemodialysis is indicated.

Epletor

Manufacturer: Netherlands, Spain
Release form: tablets

Active ingredient: eplerenone

Synonyms: Eplerenone

Epletor is a potassium-sparing diuretic, the active substance is eplerenone. Recommended as an addition to the main treatment. This analogue of Spironolactone 50 mg is effective for heart failure after myocardial infarction. Not prescribed in the children's age group.

Prescribe during pregnancy with caution, assessing the balance of benefits and risks.

Interaction

Simultaneous administration enhances the effect of Gonadorelin , Buserelin and Triptorelin . Simultaneous use with lithium carbonate increases the concentration of lithium in the blood plasma, with cholestyramine - causes hypochloremic alkalosis , with eprosartan , Losartan and Candesartan - increases the risk of hyperkalemia .

Concomitant use with drugs containing potassium, as well as potassium-sparing diuretics, dietary supplements and table salt substitutes that contain potassium, leads to the development of hyperkalemia.

pharmachologic effect

Manufacturer: Russia, Ukraine
Release form: tablets

Active ingredient: spironolactone

Synonyms: Veroshpilakton, Veroshpiron, Aldactone, Urakton, Inspra, Spironol, Spirix, Espiro, Eplenor, etc.

Spironolactone is an aldosterone antagonist and is a potassium-sparing diuretic. Reduces the body's loss of potassium, and, on the contrary, increases the excretion of water, sodium and chlorine ions. Due to this, a decrease in pressure occurs, which appears after 3–5 days.

Spironolactone price, where to buy

Price of Spironolactone 25 mg 20 pcs. in Russia is an average of 60 rubles.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine

ZdravCity

• Spironolactone tablets 25 mg 20 pcs Ozon LLC
  68 RUR order
• Spironolactone Medisorb tablets 25 mg 20pcs JSC Medisorb

  70 rub. order

• Spironolactone tab. 25mg 20pcs YuzhPharm LLC

  67 RUR order

• Spironolactone tab. 25mg No. 20Ozon LLC

  69 RUR order

Pharmacy Dialogue

• Spironolactone (25 mg tablet No. 20) Sintez (Kurgan) OJSC

  52 RUR order

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Pharmacy24

• Spironolactone Sandoz 50 mg No. 30 tablets Salutas Pharma GmbH, Nimechchina
  59 UAH.order
• Spironolactone-Darnitsa 100 mg No. 30 tablets PrAT" Pharmaceutical company "Darnitsa", Ukraine

  85 UAH order

• Spironolactone Sandoz 100 mg No. 30 tablets Salutas Pharma GmbH, Nimechchina

  96 UAH order

• Spironolactone-Darnitsa 25 mg No. 30 tablets PrAT" Pharmaceutical company "Darnitsa", Ukraine

  22 UAH order

Spironolactone analogues

The main purpose of prescribing this drug is to reduce blood pressure due to its diuretic effect. Additional effects - reduction of edema, normalization of potassium levels in the body, antiandrogenic effect. If, when selecting antihypertensive drugs, the question arises as to what can replace Spironolactone, then it is better to consider drugs with similar effects:

• Analogues in composition - Veroshpiron, Nolaxen, Eplerenone, Epletor.
• Group analogues - Inspra, Dekriz, Renial.
• Diuretics with a different mechanism of action - Diacarb, Trifas, Indapamide, Furosemide, Hydrochlorothiazide.
• Steroid antiandrogens – Cyproterone.

It is not recommended to switch to taking Spironolactone analogues and substitutes on your own.

Review of prices for Spironolactone analogues 25 mg and 50 mg on the Russian market.