Spironolactone FT tablets 50mg №10×3

Name:
Spironolactone Pharmtechnology. Forms of release Tablets. MNNspironolactone. FTHD is a diuretic potassium-sparing agent.
Description:
Tablets 25 mg – 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 notch and a chamfer, with a characteristic mercaptan odor. Composition Active substance: spironolactone 25 mg, 50 mg or 100 mg. Excipients: corn starch, povidone, talc, anhydrous colloidal silicon dioxide, magnesium stearate, lactose monohydrate. Pharmacotherapeutic group Potassium-sparing diuretics. Aldosterone antagonist. ATC code: C03DA01. Pharmacological properties Spironolactone is an aldosterone antagonist, acts as a potassium-sparing diuretic by increasing the excretion of sodium and water from the body while simultaneously delaying the release of potassium and magnesium. The maximum effect is observed 7 hours after ingestion and lasts at least 24 hours. Indications for use Congestive heart failure. Cirrhosis of the liver with ascites and edema Malignant ascites. nephrotic syndrome. Diagnosis and treatment of primary aldosteronism. Dosage and administration Inside 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 twice, 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, it is recommended to start treatment in combination with standard therapy with spironolactone 25 mg once daily with potassium ≤ 5.0 mEq/L and creatinine serum ≤ 2.5 mg/dl. With good tolerability of treatment 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. Cirrhosis of the liver with ascites and edema: if the Na + / K + ratio in the urine is greater than 1.0, SPIRONOLACTONE is prescribed at a daily dose of 100 mg per day. If the ratio is less than 1.0, then the 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 may be gradually increased to 400 mg per day. Based on the dynamics of the development of edematous 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. The appointment 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 given at a daily dose of 400 mg for three to four weeks. Correction of hypokalemia and arterial hypertension suggests the diagnosis of primary hyperaldosteronism. Short test: the drug is prescribed in a daily dose of 400 mg for four days. If serum potassium levels increase during the period of spironolactone, but decrease when it is discontinued, the presumptive diagnosis of primary hyperaldosteronism should be considered. Once hyperaldosteronism has been diagnosed by definitive testing procedures, spironolactone is recommended at 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 set individually for each patient. Elderly patients Treatment is recommended to start with low doses, followed by titration until the maximum effect is achieved. Caution should be exercised in severe hepatic and renal insufficiency, which alter the metabolism and excretion 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 associated with both dose and duration of treatment. As a rule, gynecomastia is reversible and disappears 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, coarsening 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: abnormal liver function. From the side of 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. From the skin and subcutaneous tissue: skin rash, pruritus, 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). From the side of metabolism: hyperkalemia, hyponatremia, dehydration, porphyria, osteomalacia, hyperchloremic acidosis. From the musculoskeletal system: spasms 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 tumors of the breast. 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. a pronounced violation of the excretory function of the kidneys (with creatinine clearance < 10 ml / min). Addison's disease. hyperkalemia. hyponatremia. pregnancy and breastfeeding. age up to 6 years. concomitant use of eplerenone or other potassium-sparing diuretics. Spironolactone should not be taken concomitantly with other diuretics that slow down the excretion of potassium, and potassium supplements, as hyperkalemia may develop. Pregnancy and lactation In preclinical studies in rats, spironolactone caused feminization when administered to males. Spironolactone and its metabolites are known to cross the human placental barrier and are excreted in breast milk. Therefore, during pregnancy and lactation, the drug should not be used. Children Not recommended for use in children under 6 years of age. Overdose Symptoms in acute overdose: nausea, vomiting, drowsiness, confusion, dizziness, diarrhea, skin rash. Perhaps the development of hyponatremia or hyperkalemia, dehydration. Hyperkalemia may present 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 (high pointed T wave with a shortening of the QT interval and a decrease in P wave amplitude with an expansion of the QRS complex). Severe cardiac arrhythmias are possible in the form of atrial fibrillation, atrioventricular blockade up to cardiac arrest. Treatment: the drug should be immediately discontinued, induce vomiting and gastric lavage. 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 and electrolyte imbalance, dehydration and arterial hypotension is carried out. Saluretics, ion-exchange resins are prescribed. Perhaps the use of hemodialysis. It is recommended to reduce your potassium intake (including potassium-rich foods and dietary supplements). Precautions: Concomitant use of spironolactone with drugs that can increase the level of potassium in the blood (potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, heparin and low molecular weight heparins), with potassium-containing supplements, potassium-containing salt substitutes, as well as a diet rich in potassium, can lead to severe 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 the level of potassium in the blood serum. Potassium supplements, other potassium-sparing diuretics should not be used in patients with potassium levels above 3.5 mmol/L. It is recommended to monitor the level of potassium and creatinine in the blood one week after starting treatment or increasing the dose of spironolactone, monthly for the first 3 months, then quarterly for a year, thereafter every 6 months. Treatment should be discontinued or interrupted if the serum potassium level is more than 5 mmol / l or the creatinine level is more than 4 mg / dl. It has been reported that in some patients with decompensated liver cirrhosis due to hyperkalemia, even with normal renal function, reversible hyperchloremic metabolic acidosis may occur during spironolactone therapy. Spironolactone can cause a reversible increase in serum urea nitrogen in patients with impaired renal function and hyperkalemia. Care should be taken 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, elderly patients should regularly monitor electrolyte balance and renal function. Caution should also be exercised in patients with moderate renal impairment (serum creatinine 1.2 mg/100 ml to 1.8 mg/100 ml or creatinine clearance 60 ml/min to 30 ml/min), hypotension or hypovolemia. Treatment with spironolactone may interfere with the determination of serum digoxin, epinephrine, and plasma cortisol. During treatment, the use of alcohol is prohibited. It should be borne in mind that the excipients of the drug include lactose monohydrate. Spironolactone should not be administered to patients with hereditary lactose intolerance, lactase deficiency and glucose-galactose malabsorption. Influence 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, one should refrain from driving vehicles and potentially hazardous 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 Simultaneous 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, there is an increase in the diuretic effect. 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 they are taken 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. Since ACE inhibitors reduce aldosterone production, they should not be given routinely with spironolactone, especially in patients with severe renal insufficiency. Alcohol, barbituric acid derivatives, narcotic analgesics potentiate hypotension caused by spironolactone. Concomitant use of carbenoxolone may lead to sodium retention and thus reduce the effectiveness of spironolactone. Non-steroidal anti-inflammatory drugs can reduce the natriuretic, diuretic, hypotensive effects of diuretics by inhibiting intrarenal prostaglandin synthesis. Spironolactone reduces the vascular response to norepinephrine. Caution should be exercised when conducting anesthesia in patients taking SPIRONOLACTONE. Spironolactone increases the metabolism of antipyrine. With simultaneous use with glucocorticosteroids and adrenocorticotropic hormone, an increase in potassium excretion occurs. When taken simultaneously 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 the serum concentration of lithium is possible. Spironolactone enhances the effects of buserelin, triptorelin, gonadorelin. Cyclosporine, tacrolimus increase the risk of hyperkalemia. Cholestyramine, ammonium chloride increase the risk of hyperkalemia and hyperchloremic metabolic acidosis. Packaging Tablets 25 mg in blisters No. 10x2, No. 10x3, No. 10x5 and in jars No. 20, No. 30, No. 100. Tablets 50 mg in blisters 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 box. Storage conditionsStore at a temperature not exceeding 25 °C. Keep out of the reach of children. Shelf life 2 years. The expiration date is indicated on the packaging. Do not use after the date indicated on the packaging. Terms of dispensing from pharmaciesBy prescription. Buy Spironolactone FT tablets 50mg №10x3 Price for Spironolactone FT tablets 50mg №10x3