Spironolacton-Darnitsa (spironolactone) tablets 25 mg. №30

Description

Spironolacton-Darnitsa (spironolactone) tablets 25 mg. №30

Composition

active ingredient: spironolactone;

1 tablet contains: spironolactone 100 mg;

excipients: potato starch, lactose monohydrate, povidone, calcium stearate.

Dosage form

Tablets.

Basic physical and chemical properties: flat-cylindrical tablets with a chamfer and a risk, white or white with cream color.

Pharmacological group

Potassium-sparing diuretics. Aldosterone antagonists. Spironolactone.
ATX code C03D A01.

Pharmacological properties

It is a competitive antagonist of aldosterone. Acts on the distal renal tubules. Blocking aldosterone, inhibits water retention, sodium, promotes potassium retention.

Indications

Spironolacton-Darnitsa is used:

• with primary hyperaldosteronism;
• with congestive heart failure in patients who do not respond to therapy with other diuretics;
• with cirrhosis of the liver with edema, ascites;
• with essential arterial hypertension;
• with hypokalemia (if it is impossible to prescribe another therapy);
• with edema caused by nephrotic syndrome;
• for the prevention of hypokalemia in the treatment of cardiac glycosides.

Contraindications

Spironolacton-Darnitsa is not used:

• if you are allergic to spironolactone;
• with intolerance to auxiliary components;
• with anuria;
• with acute renal failure;
• with a pronounced violation of the nitrogen-excreting function of the kidneys;
• with oliguria, anuria;
• with hyperkalemia;
• with hyponatremia;
• with Addison’s disease;
• with hypovolemia or dehydration;
• in the treatment of potassium-sparing diuretics, potassium preparations.

Application during pregnancy and lactation

Spironolacton should not be used during pregnancy, lactation.
In experiments carried out on animals, feminization of the genitals was observed in male offspring, hormonal disorders in female and male offspring. Antiandrogenic effects have been described in humans.
The active metabolite of the drug is excreted in breast milk. If necessary, breastfeeding is stopped.

Dosage and administration

The drug is administered orally to adults and children. The daily dose of the drug should be taken in 1 or 2 divided doses after meals. The use of a daily dose in 1 dose or the first dose of the drug with a double application is recommended in the morning.

The duration of the course of treatment is individual, in some cases it can reach several years, but it is always necessary to use the drug in the lowest effective daily dose, subject to constant monitoring of the electrolyte composition of the blood serum and indicators of kidney function.

• Primary hyperaldosteronism
  In preparation for surgery, the drug should be used at a dose of 100-400 mg per day.
  If surgical treatment is not possible, spironolactone can be used for a long time as maintenance therapy at the lowest effective dose, which is determined individually. In this case, every 14 days the initial dose can be reduced until the minimum effective dose is reached. With long-term treatment, it is recommended to use the drug in combination with other diuretics to reduce side effects.
• Congestive heart failure, edema due to nephrotic syndrome
  The drug is used at an initial dose of 100 mg per day for 1 or 2 doses. The daily dose can also range from 25 to 200 mg.
  When prescribing higher doses, the drug can be used in combination with other diuretics acting in the more proximal parts of the renal tubules. In this case, the dose of spironolactone should be adjusted.
• Essential arterial hypertension
  The drug is used at an initial dose of 50-100 mg per day for 1 or 2 doses in combination with other antihypertensive drugs. Treatment should be continued for at least 2 weeks, since by the end of this period the maximum antihypertensive effect is achieved. Further dose adjustment is individual, depending on the effect achieved.
• Cirrhosis of the liver with edema or ascites
  If the Na + / K + ratio in the urine is more than 1, the drug should be used at an initial dose of 100 mg per day. The maximum daily dose is 100 mg/day. If this ratio is less than 1, the drug is used at a dose of 200 mg per day, while the maximum daily dose is 400 mg / day.
• Hypokalemia
  The drug should be used at a dose of 25-100 mg per day in patients who are not adequately supplemented with potassium or other methods of potassium replacement therapy.
• Сhildren
  The drug is used at a dose of 1-3 mg/kg of body weight per day for 1 or 2 doses. For maintenance therapy in combination with other diuretics, the daily dose is 1–2 mg/kg of body weight.
  If it is necessary to use the drug for children under 3 years old, the tablet should be crushed, dissolved and given to the child to drink in the form of a suspension.

Children

The drug Spironolacton is used in pediatric practice as prescribed by a doctor.

Overdose

Overdose symptoms: drowsiness, lethargy, arrhythmia, confusion, electrolyte disturbances, cardiac conduction disturbances, ECG changes.
Treatment: correction of hyperkalemia, maintenance of water-electrolyte, acid-base balance, hemodialysis.

Side effects:

• Gastrointestinal disorders: nausea, diarrhea, vomiting, ulcers, stomach bleeding, gastritis, stomach pain, dry mouth, intestinal colic.
• Hematological disorders: thrombocytopenia, eosinophilia, agranulocytosis.
• Immune disorders: allergic reactions (rash, itching, urticaria, redness of the face and skin, angioedema, bronchospasm, shortness of breath).
• Endocrine Disorders: Hirsutism.
• Metabolic disorders: dehydration, hyperkalemia, hyponatremia, porphyria, hyperchloremic acidosis.
• Neurological disorders: confusion, drowsiness, vertigo, headache, paraplegia, paralysis, dizziness, ataxia.
• Cardiovascular disorders: arrhythmia, vasculitis, arterial hypotension.
• Hepatobiliary disorders: hepatotoxicity, hepatitis, liver dysfunction.
• Dermatological disorders: exanthema, erythema, alopecia, erythema annulus, eczema, lupus-like lesions, hypertrichosis, hirsutism in women, Stevens-Johnson syndrome.
• Musculoskeletal disorders: muscle cramps, osteomalacia.
• Genitourinary disorders: kidney dysfunction, decreased libido, gynecomastia in men, erectile dysfunction, increased blood urea, nipple tenderness, tenderness and / or enlargement of the mammary glands, dysmenorrhea, infertility, amenorrhea, benign mammary tumors.
• General: fatigue, change in tone of voice, asthenia.