Verospiron capsules 100mg N30
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Active ingredients
Spironolactone
Release form
Capsules
Composition
Active ingredient: Spironolactone (Spironolactone). Concentration of active ingredient (mg): 100
Pharmacological effect
In the instructions to Verospiron the drug is described as a potassium-sparing diuretic. The main active ingredient competes with aldosterone (the hormone of the adrenal cortex) and inhibits its action. Na +, Cl- and water are not absorbed back into the renal tubules, and K + and urea, on the contrary, penetrate the endothelium of the glomerulus into the blood. Increased urination causes a decrease in blood pressure and the disappearance of edema. The diuretic effect is manifested only 3-5 days after the first day of taking the drug. Verospiron does not significantly affect the function of the renal tubules and does not lead to acid-base imbalance of the body.
Pharmacokinetics
When ingestion is quickly and completely absorbed from the gastrointestinal tract; bioavailability of almost 100%, and prim food increases it to 100%; communication with plasma proteins is about 98%. After a daily dose of 100 mg for 15 days, the maximum concentration (Cax) is 80 ng / ml, the time to reach the maximum plasma concentration (TCmax) after the next morning dose is 2-6 hours. During the biotransformation process, active sulfur-containing metabolites are formed in the liver 7 -alpha-thiomethylspironolactone and canrenone. Canrenone reaches Cmax after 2–4 h, its association with plasma proteins is 90%. Spironolactone penetrates poorly into organs and tissues, while itself and its metabolites penetrate the placental barrier, and canrenone - into breast milk. Distribution volume - 0.05 l / kg. The elimination half-life is (T1 / 2) -13-24 h. Excreted by the kidneys: 50% - in the form of metabolites, 10% - in unchanged form and partially through the intestines. Cranrenon excretion (mainly by the kidneys) is biphasic, T1 / 2 in the first phase - 2-3 hours, in the second - 12-96 hours. With liver cirrhosis and heart failure, the duration of T1 / 2 increases without signs of cumulation, the probability of which is higher in chronic renal deficiency and hyperkalemia.
Indications
Essential hypertension (as part of combination therapy), edematous syndrome in chronic heart failure (can be used as monotherapy and in combination with standard therapy), conditions in which secondary hyper aldosteronism can be detected, includingcirrhosis of the liver, accompanied by ascites or edema, nephrotic syndrome and other conditions accompanied by edema, hypokalemia and hypomagneemia (as an aid to its prevention during treatment with diuretics and with the inability to use other methods of correcting the level of potassium) preoperative treatment for the diagnosis of primary hyperaldosteronism.
Contraindications
Addison's disease, hyperkalemia, hyponatremia, severe renal failure (QC less than 10 mlmin), anuria, lactose intolerance, lactase deficiency, glucosegalactose absorption disorder syndrome, pregnancy, lactation (breastfeeding), children under 3 years old, increased sensitivity to components drug.
Precautionary measures
In case of intolerance of milk sugar (lactose), it should be taken into account that each tablet of Verospiron 25 mg contains 146 mg of milk sugar (lactose monohydrate), each capsule of Verospiron 50 mg contains 127.5 mg of milk sugar, each capsule of Verospiron 100 mg contains 255 mg of milk sugar.
Use during pregnancy and lactation
Before you start taking any drug, talk with your doctor or pharmacist. Verospiron is contraindicated during pregnancy and during breastfeeding.
Dosage and administration
With essential hypertension, the daily dose for adults is usually 50-100 mg once and can be increased to 200 mg, while increasing the dose gradually, 1 time in 2 weeks. To achieve an adequate response to therapy, the drug must be taken at least 2 weeks. If necessary, carry out dose adjustment. With idiopathic hyperaldosteronism, the drug is prescribed in a dose of 100-400 mg / day. With pronounced hyperaldosteronism and hypokalemia, the daily dose is 300 mg (maximum 400 mg) in 2-3 doses, while improving the condition, the dose is gradually reduced to 25 mg days. In case of hypokalemia or hypomagnesemia caused by diuretic therapy, Verospiron is prescribed in a dose of 25-100 mg / day, once or in several doses. The maximum daily dose is 400 mg, if oral potassium preparations or other methods to compensate for its deficiency are ineffective.In the diagnosis and treatment of primary hyperaldosteronism as a diagnostic tool with a short diagnostic test, Verospiron is prescribed for 4 days at 400 mg days, spreading the daily dose into several doses per day. With an increase in the concentration of potassium in the blood while taking the drug and a decrease after it is canceled, it can be assumed that there is primary hyper aldosteronism. With a long diagnostic test, the drug is prescribed in the same dose for 3-4 weeks. When correction of hypokalemia and arterial hypertension is achieved, one can assume the presence of primary hyper aldosteronism. After the diagnosis of hyper aldosteronism is established using more accurate diagnostic methods, Verospiron should be taken in a daily dose of 100-400 mg as a short course of preoperative therapy of primary hyper aldosteronism, dividing it into 1-4 doses throughout the entire period of preparation for surgery. If the operation is not indicated, Verospiron is used for long-term maintenance therapy, using the smallest effective dose, which is selected individually for each patient. In the treatment of edema on the background of nephrotic syndrome, the daily dose for adults is usually 100-200 mg. No effect of spironolactone on the main pathological process has been identified, and therefore the use of this drug is recommended only in cases when other types of therapy are ineffective. In case of edema syndrome against the background of chronic heart failure, the drug is prescribed daily for 5 days, 100-200 mg daily in 2-3 doses, in combination with a loop or thiazide diuretic. Depending on the effect, the daily dose is reduced to 25 mg. Maintenance dose is adjusted individually. The maximum daily dose is 200 mg. For edema associated with cirrhosis, the daily dose of Verospiron for adults is usually 100 mg, if the ratio of sodium and potassium ions (Na + K +) in the urine exceeds 1. 0. If the ratio is less than 1. 0, then the daily dose is usually 200-400 mg . Maintenance dose is selected individually. When edema in children, the initial dose is 1-3. 3 mgkg body weight or 30-90 mgm2sut in 1-4 doses. After 5 days, dose adjustment is carried out and, if necessary, it is increased 3 times as compared with the initial dose.
Side effects
On the part of the digestive system: nausea, vomiting, diarrhea, ulceration and bleeding from the gastrointestinal tract, gastritis, intestinal colic, abdominal pain, constipation, abnormal liver function. On the part of the central nervous system and peripheral nervous system: ataxia, lethargy, dizziness, headache, drowsiness, lethargy, confusion. On the part of the blood system: agranulocytosis, thrombocytopenia, megaloblastosis. On the part of metabolism: hyperuricemia, hypercreatininemia, increased concentration of urea, hyperkalemia, hyponatremia, metabolic hyperchloremic acidosis or alkalosis. On the part of the endocrine system: coarsening of the voice, in men, gynecomastia (the likelihood of development depends on the dose, the duration of treatment and is usually reversible and disappears after the cancellation of Verospiron, only rarely does the mammary gland remain somewhat enlarged), the potency and erection decrease. in women, menstrual disorders, dysmenorrhea, amenorrhea, metrorrhagia in menopause, hirsutism, pain in the mammary gland, carcinoma of the mammary gland (connection with the administration of the drug is not established). Allergic reactions: urticaria. rarely - maculo-papular and erythematous rash, drug fever, pruritus. Dermatological reactions: alopecia, hypertrichosis. On the part of the urinary system: acute renal failure. On the part of the musculoskeletal system: muscle spasm, calf muscle cramps.
Overdose
According to reviews of Verospiron patients, drug overdose occurs extremely rarely. In case of its occurrence, all side effects of the drug are exacerbated. An urgent need to flush the stomach, consume a large amount of liquid and caffeine to increase blood pressure. For hyperkalemia, the doctor prescribes dextrose and insulin.
Interaction with other drugs
Please inform your doctor or pharmacist if you are taking or have recently taken any other drugs, including over-the-counter drugs. While taking the drug Verospiron with the following drugs, it is possible mutual change of drug action: for example, other diuretics (diuretics), cholestyramine, ammonium chloride, hypnotics,some vasoconstrictor drugs (vasoconstrictors), some steroidal anti-inflammatory drugs (glucocorticosteroids), blood pressure lowering drugs (antihypertensives), potassium, lithium preparations, carbamazepine, some NSAIDs (eg, acetylsalicylic acid), drugs of potassium, lithium, carbamazepine, some NSAIDs (eg, acetylsalicylic acid, preparations of potassium, lithium, carbamazepine); , carbenoxolone, drugs that prevent the formation of blood clots (anticoagulants), some anticancer drugs (triptorelin, buserelin, gon adorelin, cyclosporine, tacrolimus).
special instructions
Management of motor transport and other mechanisms. At the beginning of treatment, you should abandon driving and working with dangerous machinery for a period of time, the duration of which is determined individually. In the future, the doctor will decide on this restriction.