Spironolactone capsules 100mg, No. 30

• Edema in chronic heart failure, cirrhosis of the liver (especially with the simultaneous presence of hypokalemia and hyperaldosteronism), with nephrotic syndrome.

• Edema in the II and III trimesters of pregnancy.

• Arterial hypertension, incl. with aldosterone-producing adrenal adenoma (as part of combination therapy).

• Primary hyperaldosteronism.

• Aldosterone-producing adrenal adenoma (long-term maintenance therapy in case of contraindication to surgical treatment or in case of refusal from it).

• Diagnosis of hyperaldosteronism.

• Hypokalemia and its prevention in the treatment of saluretics.

• Polycystic ovary syndrome, premenstrual syndrome.

Set individually, depending on the severity of violations of water-electrolyte metabolism and hormonal status. In edematous syndrome - 100-200 mg / day (less often - 300 mg / day) in 2-3 doses (usually in combination with 'loop' and / and thiazide diuretic) daily for 14-21 days. Dose adjustments should be made taking into account the values ??of the concentration of potassium in the plasma. If necessary, courses are repeated every 10-14 days. With pronounced hyperaldosteronism and a reduced content of potassium in plasma - 300 mg / day in 2-3 doses.

Hard gelatin capsules, No. 0, white; the contents of the capsules are a white or almost white with a cream shade of color, a mixture of powder and granules, almost odorless or with a weak specific odor.

1 caps.

spironolactone 100 mg

Excipients: lactose monohydrate - 260 mg, corn starch - 85 mg, magnesium stearate - 5 mg.

• Addison's disease

• hyperkalemia,

• hypercalcemia,

• hyponatremia,

• chronic renal failure,

• anuria,

• liver failure,

• diabetes mellitus with confirmed or suspected chronic renal failure,

• diabetic nephropathy,

• I trimester of pregnancy,

• metabolic acidosis

• violation of the menstrual cycle or enlargement of the mammary glands,

• hypersensitivity to spironolactone.

pharmachologic effect

Potassium-, magnesium-sparing diuretic. It is a competitive antagonist of aldosterone in terms of its effect on the distal nephron (competes for binding sites on cytoplasmic protein receptors, reduces the synthesis of permeases in the aldosterone-dependent section of the collecting ducts and distal tubules), increases the excretion of Na +, Cl- and water and reduces the excretion of K + and urea, reduces the titratable acidity of urine. Increased diuresis causes a hypotensive effect, which is variable. The antihypertensive effect does not depend on the level of renin in the blood plasma and does not manifest itself at normal blood pressure. The diuretic effect appears on days 2-5 of treatment.

Pharmacokinetics

After oral administration, it is absorbed from the gastrointestinal tract, absorption is 90%. It is metabolized in the liver, the main active metabolite is canrenone. T1 / 2 is 13-24 hours. It is excreted mainly by the kidneys, a certain amount is excreted in the bile.

Side effect

From the digestive system: nausea, vomiting, abdominal pain, gastritis, ulceration and bleeding in the gastrointestinal tract, intestinal colic, diarrhea or constipation. From the side of the central nervous system: dizziness, drowsiness, lethargy, headache, lethargy, ataxia. From the side of metabolism: increased concentration of urea, hypercreatininemia, hyperuricemia, impaired water-salt metabolism and acid base balance (metabolic hypochloremic acidosis or alkalosis). From the hematopoietic system: megaloblastosis, agranulocytosis, thrombocytopenia. From the endocrine system: with prolonged use - gynecomastia, erectile dysfunction in men; in women - dysmenorrhea, amenorrhea, metrorrhagia in menopause, hirsutism, coarsening of the voice, breast tenderness, breast carcinoma. Allergic reactions: urticaria, maculopapular and erythematous rashes,drug fever, itching.

Others: muscle cramps, decreased potency.

Application during pregnancy and lactation

There are no data on the negative effect of spironolactone on pregnancy and fetal development. However, in the I trimester of pregnancy, the use is contraindicated, in the II and III trimesters, it is possible to use it according to indications. If it is necessary to use it during lactation, it should be borne in mind that the metabolite of spironolactone canrenone is excreted in breast milk in small quantities.

Application for violations of liver function

Contraindicated in liver failure. Use with caution in decompensated liver cirrhosis.

Application for impaired renal function

Contraindicated in chronic renal failure, anuria, diabetic nephropathy.

Use in elderly patients

Use with caution in elderly patients.

special instructions

Use with caution in AV blockade (the possibility of strengthening due to the development of hyperkalemia), decompensated cirrhosis of the liver, surgical interventions, taking drugs that cause gynecomastia, when taking local and general anesthetics, in elderly patients. Against the background of the use of spironolactone, you should not prescribe drugs containing potassium, as well as other diuretics that cause potassium retention in the body. The use of spironolactone with carbenoxolone, which causes sodium retention, should be avoided. During the period of treatment, periodic determination of the content of electrolytes and urea in the blood should be carried out. When using spironolactone in combination with other diuretic or antihypertensive drugs, it is recommended to reduce the dose of the latter.When spironolactone is used concomitantly with digoxin, it may be necessary to reduce both the saturating and maintenance dose of the latter.

Ћекарственное взаимодействие

With simultaneous use with antihypertensive drugs, the hypotensive effect of spironolactone is potentiated. With simultaneous use with ACE inhibitors, hyperkalemia may develop (especially in patients with impaired renal function), because ACE inhibitors reduce the content of aldosterone, which leads to a retention of potassium in the body against the background of limited excretion of potassium. With simultaneous use with potassium preparations, other potassium-sparing diuretics, table salt substitutes and dietary supplements containing potassium, hyperkalemia may develop. With simultaneous use with salicylates, the diuretic effect of spironolactone decreases due to the blockade of excretion of canrenone by the kidneys. Indomethacin and mefenamic acid inhibit renal excretion of canrenone.With simultaneous use, the hypoprothrombinemic effect of oral anticoagulants decreases. When used simultaneously with digitoxin, it is possible to both increase and decrease the effects of digitoxin. With simultaneous use, spironolactone inhibits the excretion of digoxin by the kidneys and probably reduces its volume of distribution. This can cause an increase in the concentration of digoxin in the blood plasma. With simultaneous use with candesartan, losartan, eprosartan, there is a risk of developing hyperkalemia. With simultaneous use with cholestyramine, cases of hypochloremic alkalosis have been described. With simultaneous use with lithium carbonate, an increase in the concentration of lithium in the blood plasma is possible. With simultaneous use with norepinephrine, it is possible to reduce the sensitivity of blood vessels to norepinephrine.With simultaneous use, the effect of triptorelin, buserelin, gonadorelin is enhanced.