Spironolacton Sandoz (spironolactone) tablets 100 mg. №30

Description

Spironolacton Sandoz (spironolactone) tablets 100 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 Sandoz 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 Sandoz 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.

Method of administration and dosage

Spironolacton Sandoz is used internally.

The dose is determined individually depending on the severity of the course and the degree of hyperaldosteronism.

• Primary hyperaldosteronism
  With diagnosed primary hyperaldosteronism, the drug can be prescribed in preparation for surgery in a daily dose of 100–400 mg. Patients who are not planned for surgery can be used as long-term maintenance therapy at the lowest effective dose, which is determined individually. In the described situation, the initial dose can be reduced every 14 days until the minimum effective dose is reached. With prolonged use, it is recommended to use in combination with diuretics of other groups to reduce side effects.
• Edema (congestive heart failure, nephrotic syndrome)
  Adults: The initial daily dose is 100 mg (25–200 mg) given in 1 or 2 divided doses. If higher doses are prescribed, Spironolactone Sandoz® can be taken in combination with other groups of diuretics that act in the more proximal renal tubules. In this case, the dosage of Spironolactone Sandoz® should be adjusted.
• Cirrhosis of the liver with ascites or edema
  If the ratio of Na + / K + in the urine is greater than 1, the initial daily and maximum daily dose is 100 mg. If this ratio is less than 1, the initial daily dose is 200 mg, the maximum is 400 mg per day.
  The maintenance dose should be determined individually.
• Essential arterial hypertension
  The initial daily dose, administered in 1 or 2 doses, is 50-100 mg, it should be taken in combination with other antihypertensive drugs. Therapy is continued for at least two weeks, since by the end of this period the maximum antihypertensive effect is achieved. Then the dose should be adjusted individually depending on the effect achieved.
• hypokalemia
  Patients who are not sufficiently supplemented with K + or other methods of potassium replacement therapy should take the drug in a daily dose of 25-100 mg.
• Children
  The recommended starting dose for children is 1-3 mg of spironolactone per 1 kg of body weight in 1 or 2 doses daily for 5 days. If it is necessary to use the drug for children under 3 years old, the tablet must be crushed, dissolved and given to the child to drink in the form of a suspension.
  With continued treatment, the dose should be reduced, keeping the achieved effect of the drug.

Children

Spironolacton Sandoz 25 mg tablets can be used in pediatric practice.

Due to the high content of the active substance Spironolacton-Darnitsa (100 mg) is not suitable for the treatment of children.

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.