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.

Spironolactone FT tablets 50 mg No. 10x3

Name

Spironolactone Pharmtechnology.

Release forms

Tablets.

INN

Spironolactone.

FTG

Diuretic potassium-sparing agent.

Description

25 mg tablets are white or almost white flat-cylindrical round tablets with a chamfer, with a characteristic mercaptan odor. Tablets 50 mg and 100 mg are white or almost white flat-cylindrical round tablets with a score and bevel, with a characteristic mercaptan odor.

Compound

Active substance: spironolactone 25 mg, 50 mg or 100 mg. Excipients: corn starch, povidone, talc, colloidal anhydrous silicon dioxide, magnesium stearate, lactose monohydrate.

Pharmacotherapeutic group

Potassium-sparing diuretics. Aldosterone antagonist. ATC code: C03DA01.

Pharmacological properties

Spironolactone is an aldosterone antagonist that acts as a potassium-sparing diuretic by increasing the excretion of sodium and water from the body while delaying the excretion of potassium and magnesium. The maximum effect is observed 7 hours after ingestion and lasts 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.

Directions for use and doses

Orally once a day with meals. Adults Congestive heart failure with edema: To reduce edema, the initial daily dose of SPIRONOLACTONE is 100 mg once or in two divided doses, but can vary from 25 mg to 200 mg per day. The maintenance dose is determined individually. In patients with severe heart failure (NYHA class III-IV): Based on clinical trial data, treatment in combination with standard therapy is recommended to begin with spironolactone 25 mg once daily when potassium levels are ≤ 5.0 mEq/L and creatinine. serum ≤ 2.5 mg/dl. If treatment is well tolerated according to clinical indications, the dose is increased to 50 mg once a day. If the drug is poorly tolerated by the patient, 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, SPIRONOLACTONE is prescribed in a daily dose of 100 mg per day. If the ratio is less than 1.0, then daily doses of the drug vary from 200 to 400 mg. The dose for each patient is determined individually. Malignant ascites: the usual dose is 100-200 mg per day. In severe cases, the dose can be gradually increased to 400 mg per day. Based on the dynamics of the development of edema syndrome, the maintenance dose should be determined individually. Nephrotic syndrome: the usual dose is 100-200 mg per day. Spironolactone does not affect the underlying pathological process. Prescription of the drug is recommended only if treatment with glucocorticoids is ineffective. Diagnosis and treatment of primary aldosteronism: Spironolactone can be used as an initial diagnostic test to determine primary hyperaldosteronism in patients on a standard diet. Long test: spironolactone is prescribed at a daily dose of 400 mg for three to four weeks. Correction of hypokalemia and arterial hypertension suggests a diagnosis of primary hyperaldosteronism. Short test: the drug is prescribed at a daily dose of 400 mg for four days. If serum potassium levels increase while spironolactone is being taken but decrease when it is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered. Once hyperaldosteronism has been diagnosed by definitive testing procedures, spironolactone is recommended to be administered in doses of 100 mg to 400 mg daily in preparation for surgery. If there are no indications for surgery, then the drug is used for long-term maintenance therapy at the lowest effective dose, which is determined individually for each patient. Elderly patients Treatment is recommended to begin with low doses, followed by titration until maximum effect is achieved. Caution should be exercised in severe hepatic and renal impairment, which alter the metabolism and elimination of the drug. Children The initial daily dose should be 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 effects Gynecomastia may develop in connection with the use of SPIRONOLACTONE. Its occurrence is related to both the dose and duration of treatment. As a rule, gynecomastia is reversible and goes away after stopping the drug. In rare cases, some breast enlargement may persist. From the endocrine system: gynecomastia, erectile dysfunction in men; soreness and enlargement of the mammary glands, menstrual dysfunction, infertility, hirsutism, deepening of the voice in women; decreased libido. From the gastrointestinal tract: nausea, vomiting, stomach pain, gastritis, ulceration and gastrointestinal bleeding, diarrhea. From the hepatobiliary system: liver dysfunction. From the cardiovascular system: arrhythmias, vasculitis, hypotension. From the side of the central nervous system: drowsiness, headache, confusion, asthenia, cramps of the calf muscles, paralysis, paraplegia. From the blood and lymphatic system: thrombocytopenia, agranulocytosis, eosinophilia. Skin and subcutaneous tissue disorders: skin rash, itching, urticaria, alopecia, eczema, erythema annulare, hypertrichosis, lupus-like syndrome, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), rash accompanied by eosinophilia and systemic symptoms (DRESS syndrome). Metabolic: hyperkalemia, hyponatremia, dehydration, porphyria, osteomalacia, hyperchloremic acidosis. From the musculoskeletal system: cramps of the calf muscles. From the urinary system: acute renal failure. From the immune system: hypersensitivity. Neoplasms benign, malignant and unspecified (including cysts and polyps): benign breast tumors. General disorders: general weakness. If any side effect occurs or worsens, whether it is described in this section or not, you should contact your doctor immediately.

Contraindications

hypersensitivity to spironolactone or any of the excipients. acute renal failure. anuria. severe impairment of renal excretory function (with creatinine clearance

Pregnancy and lactation

In preclinical studies in rats, spironolactone caused feminization when administered to males. It is known that spironolactone and its metabolites cross the human placental barrier and are excreted in breast milk. Therefore, the drug should not be used during pregnancy and breastfeeding. Children Not recommended for use in children under 6 years of age.

Overdose

Symptoms of acute overdose: nausea, vomiting, drowsiness, confusion, dizziness, diarrhea, skin rash. Possible development of hyponatremia or hyperkalemia, dehydration. Hyperkalemia may manifest as paresthesia, weakness, flaccid paralysis, or muscle spasm. Clinically, these symptoms are difficult to distinguish from hypokalemia. Electrocardiographic changes are the earliest specific signs of disturbances in the level of potassium in the blood (a tall, pointed T wave with a shortening of the QT interval and a decrease in the amplitude of the P wave with a widening of the QRS complex). Severe heart rhythm disturbances are possible in the form of atrial fibrillation, atrioventricular block, up to cardiac arrest. Treatment: the drug should be discontinued immediately, induce vomiting and rinse the stomach. There is no specific antidote. Hyperkalemia is eliminated by rapid intravenous administration of 20-50% glucose with regular insulin (0.25-0.5 U/g glucose). Symptomatic treatment of water-electrolyte imbalances, dehydration and arterial hypotension is carried out. Saluretics and ion exchange resins are prescribed. Hemodialysis may be used. It is recommended to reduce potassium intake (including potassium-rich foods and dietary supplements).

Precautionary measures

Concomitant use of spironolactone with drugs that can cause an increase in potassium levels in the blood (potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, heparin and low molecular weight heparins), potassium supplements, potassium-containing salt substitutes, as well as a diet rich in potassium, can lead to serious hyperkalemia. While taking spironolactone, the risk of developing hyperkalemia in patients with diabetic nephropathy increases. Hyperkalemia in patients with severe heart failure can be life-threatening. It is very important to carefully monitor serum potassium levels. Potassium supplements and other potassium-sparing diuretics should not be used in patients with potassium levels above 3.5 mmol/L. It is recommended to monitor blood potassium and creatinine levels one week after starting treatment or increasing the dose of spironolactone, monthly for the first 3 months, then quarterly for a year, and every 6 months thereafter. Stop or interrupt treatment if serum potassium level is more than 5 mmol/L or creatinine level is more than 4 mg/dL. It has been reported that reversible hyperchloremic metabolic acidosis may occur with spironolactone therapy in some patients with decompensated liver cirrhosis due to hyperkalemia, even with normal renal function. Spironolactone may cause a reversible increase in serum urea nitrogen in patients with impaired renal function and hyperkalemia. Caution should be exercised when prescribing to patients prone to hyperkalemia and acidosis (diabetes mellitus). When performing a glucose tolerance test in patients with diabetic nephropathy, spironolactone should be discontinued at least 3 days before the test (due to the risk of severe hyperkalemia). When prescribing spironolactone to patients with impaired renal and hepatic function and elderly patients, electrolyte balance and renal function should be regularly monitored. In patients with moderate renal impairment (serum creatinine from 1.2 mg/100 ml to 1.8 mg/100 ml or creatinine clearance from 60 ml/min to 30 ml/min), hypotension or hypovolemia, caution should also be exercised. Treatment with spironolactone may interfere with the determination of serum digoxin, epinephrine and cortisol in the blood plasma. During treatment, alcohol consumption is prohibited. It should be taken into account that the excipients of the drug include lactose monohydrate. SPIRONOLACTONE should not be prescribed to patients with hereditary lactose intolerance, lactase deficiency and glucose-galactose malabsorption.

Effect on the ability to drive and use machines

SPIRONOLACTONE, especially at the beginning of treatment, may cause drowsiness and dizziness in some patients. Therefore, during this period you should refrain from driving vehicles and potentially dangerous activities that require a quick psychomotor reaction and concentration. In the future, the restriction is determined by the doctor individually for each patient.

Interaction with other drugs

Concomitant use of SPIRONOLACTONE with other potassium-sparing diuretics, aldosterone receptor blockers, ACE inhibitors, angiotensin II receptor antagonists, heparin and low molecular weight heparins, with potassium-containing drugs can lead to severe hyperkalemia. In combination with other diuretics, the diuretic effect is enhanced. Spironolactone increases the half-life of digoxin, which leads to an increase in its concentration and the development of glycoside intoxication. In this regard, when taking them together, it is recommended to reduce the dose or increase the interval between doses of digoxin. With antihypertensive drugs, the effect is potentiated and their dosage may need to be reduced. Because ACE inhibitors reduce aldosterone production, they should not be routinely administered with spironolactone, especially in patients with severe renal impairment. Alcohol, barbituric acid derivatives, and narcotic analgesics potentiate the hypotension caused by spironolactone. Concomitant use of carbenoxolone may result in sodium retention and thus reduce the effectiveness of spironolactone. Nonsteroidal anti-inflammatory drugs can reduce the natriuretic, diuretic, and hypotensive effects of diuretics by inhibiting intrarenal prostaglandin synthesis. Spironolactone reduces the vascular response to norepinephrine. Caution should be exercised when administering anesthesia to patients taking SPIRONOLACTONE. Spironolactone increases the metabolism of antipyrine. When used simultaneously with glucocorticosteroids and adrenocorticotropic hormone, an increase in potassium excretion occurs. When taken concomitantly with carbamazepine, clinically significant hyponatremia may develop. Spironolactone weakens the effect of coumarin derivatives. With long-term administration of spironolactone with lithium preparations, an increase in serum lithium concentration is possible. Spironolactone enhances the effects of buserelin, triptorelin, gonadorelin. Cyclosporine and tacrolimus increase the risk of hyperkalemia. Cholestyramine and ammonium chloride increase the risk of hyperkalemia and hyperchloremic metabolic acidosis.

Package

Tablets 25 mg in blister packs No. 10×2, No. 10×3, No. 10×5 and in jars No. 20, No. 30, No. 100. Tablets 50 mg in blister packs No. 10×2, No. 10×3, No. 10×5 and in jars No. 20, No. 30, No. 50. Tablets 100 mg in jars No. 20, No. 30. Together with the leaflet, two, three or five blister packs or one jar are placed in a cardboard pack.

Storage conditions

Store at a temperature not exceeding 25 °C. Keep out of the reach of children.

Best before date

2 years. The expiration date is indicated on the packaging. Do not use after the date indicated on the package.

Conditions for dispensing from pharmacies

By doctor's prescription.

Buy Spironolactone FT tablet 50 mg in container pack No. 10x3 in the pharmacy

Price for Spironolactone FT tablet 50 mg in container pack No. 10x3

Instructions for use for Spironolactone FT tablet 50 mg in container pack No. 10x3

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, 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 milligrams per day in two or three doses; in case of edema syndrome, 100 to 200 milligrams per day in two or three doses is prescribed every day for two to three weeks. If necessary, the course can be repeated after two 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.

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.

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.

Spironolactone price, where to buy

The price of Spironolactone in Russia is on average 35 rubles, in Ukraine – 50 hryvnia.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine

ZdravCity

• Spironolactone Medisorb tablets 25 mg 20 pcs JSC Medisorb
  65 rub. order
• Spironolactone tablets 25 mg 20 pcs. Ozon LLC

  65 rub. order

• Spironolactone capsules 50 mg 30 pcs. Pranapharm LLC

  140 rub. order

• Spironolactone caps. 100 mg No. 30Pranafarm LLC

  RUB 208 order

• Spironolactone tablets 25 mg 20 pcs. Sintez OJSC

  49 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.