Spilakton 20s 50 mg film-coated tablets

The instruction for medical use of SPILAKTON medicine the Trade name Spilakton Mezhdunarodnoye the unlicensed name Spironolactonum Dosage Form of the Tablet, film coated Structure One tablet film coated supports Spilakton of 25 mg active agent - Spironolactonum of 25 mg, excipients: corn starch, silicon dioxide colloidal anhydrous, K30 povidone, calcium hydrophosphate dihydrate, magnesium stearate, structure of a cover: opadr yellow 02F22025 (gipromelloza, titan dioxide (E171), macrogoal 6000, ferrous oxide yellow (E172), talc). Spilakton of 50 mg active agent - Spironolactonum of 50 mg, excipients: corn starch, silicon dioxide colloidal anhydrous, K30 povidone, calcium hydrophosphate dihydrate, magnesium stearate, structure of a cover: opadr II orange 85F230047 (polyvinyl alcohol, titan dioxide (E171), makrogol/PEG, talc, ferrous oxide yellow (E172), ferrous oxide red (E172)). Spilakton of 100 mg active agent - Spironolactonum of 100 mg, excipients: corn starch, silicon dioxide colloidal anhydrous, K30 povidone, calcium hydrophosphate dihydrate, magnesium stearate, structure of a cover: opadr II orange 85F230020 (polyvinyl alcohol, titan dioxide (E171), makrogol/PEG, talc, ferrous oxide yellow (E172), ferrous oxide red (E172)). The description of the Tablet of round shape, biconvex, film coated from light yellow till yellow color, with dividing risky on one party (for a dosage of 25 mg). Tablets of round shape, biconvex, film coated from light orange till orange color, with dividing risky on one party (for a dosage of 50 mg). Tablets of round shape, biconvex, film coated yellowish-orange color, with dividing risky on one party (for a dosage of 100 mg). Pharmacotherapeutic group Diuretics. Kaliysberegayushchy diuretics. Aldosteronum antagonists. Spironolactonum. The ATX C03DA01 code the Pharmacological Pharmacokinetics Later properties of intake Spironolactonum is quickly soaked up from digestive tract. About 90% of drug contact proteins of blood plasma. The bioavailability is 92-99% and increases at a concomitant use with food, is distributed in a liver, kidneys, adrenal glands and gonads. Spironolactonum is quickly metabolized in a liver. The main pharmacological active metabolites are 7α-тиоспиронолактон, 7α-тиометилспиронолактон and kanrenon. Antialdosteronovy action defines kanrenon, making about 50% of all metabolites of Spironolactonum. The maximum concentration of a kanrenon in blood is reached in 2-4 hours after administration of drug, and elimination half-life averages 12.5 hours. Drug gets through a placenta and into breast milk. It is brought out of an organism with a stake and urine. A pharmacodynamics Spironolactonum - kaliysberegayushchy diuretic with moderate natriuretic effect. The diuretic effect of Spironolactonum is connected with its antagonism concerning adrenal hormone - Aldosteronum. Antagonistic effect of Spironolactonum is shown in distal renal tubules: drug reduces removal of potassium ions and strengthens removal of ions of sodium and water without disturbance of electrolytic balance, lowers titrable acidity of urine and reduces urea removal. Interferes with linking of Aldosteronum with proteinaceous receptors of cells. Effect of Spironolactonum in kidneys reaches a maximum in 7 hours after intake and remains within at least 24 hours. Strengthening of a diuresis causes hypotensive effect which is non-constant. The diuretic effect is shown for 2-5 day of treatment. Indications - primary aldosteronism: for a short, preoperative course of treatment, for prolonged use in case of not operability or at refusal of the patient of operation - the edematous syndrome caused by chronic heart failure (it is applied as monotherapy and also as a part of combination therapy), - a nephrotic syndrome in case of inefficiency of treatment of a basic disease, use of diuretics and restriction of consumption of salt in food - establishment of the diagnosis of primary hyper aldosteronism. The route of administration and doses Spilakton accept inside, it is desirable with food. The dose of drug is established individually taking into account extent of disturbances of water and electrolytic balance and the hormonal status of the patient. The daily dose of Spilakton can be accepted as in one step, and to divide it into several receptions. Primary aldosteronism: after diagnosis of 100-400 mg/days in quality of training to operational intervention. In case of not operability it is possible to carry out long-term treatment by the smallest effective dose which is picked up individually. In such cases, each 14 days the initial dose is subject to decrease until the smallest effective dose is reached. At long-term treatment it is reasonable to combine drug with other diuretics in order to avoid development of side reactions. Edematous syndrome (heart failure, cirrhosis, nephrotic syndrome): the usual initial dose for adults makes 100 mg/days (25-200 mg/days), distributed on 2 receptions. When assigning higher doses the appointment in a combination with the diuretics operating on proximal departments of renal tubules is reasonable, at the same time Spilakton's dose remains invariable. Children: To children appoint at the rate of 1-3 mg/kg of body weight a day, once or having distributed on 2 receptions. Treatment of children has to be performed only under control of the pediatrician. There are limited these uses of Spironolactonum in pediatrics. At diagnostics of primary hyper aldosteronism, drug is appointed on 400 mg/days for 4 days, distributing on several receptions. If potassium concentration in blood increases in 4 days of reception, and after cancellation decreases, is admissible to assume primary hyper aldosteronism. Side effects - an indisposition - new growths (including cysts and polyps) - benign tumors of a mammary gland - disturbance from digestive tract, nausea - a leukopenia (including an agranulocytosis), thrombocytopenia - an abnormal liver function - disturbance of electrolytic balance, a hyperpotassemia - spasms in legs - the increased drowsiness - change of a libido, confusion of consciousness - disturbance of a menstrual cycle, morbidity of mammary glands - the Stephens-Johnson's syndrome (SJS), the toxic epidermal necrolysis (TEN) - an alopecia, a hypertrichosis, an itching, urticaria - an acute renal failure - pemphigoid - DRESS syndrome (the medicinal induced hypersensitivity with an eosinophilia and system manifestations) Against the background of administration of drug Spilakton can develop a gynecomastia. Usually after drug withdrawal this reaction disappears. In rare instances some increase in a breast can remain. Contraindications - hypersensitivity to drug components - a hyperpotassemia - an anury - severe forms of chronic kidney disease - pregnancy - the lactation period - an acute renal failure - Addison's disease - to children with a moderate and heavy renal failure the Simultaneous use with indometacin, APF inhibitors, drugs of potassium leads Medicinal interactions ment of a hyperpotassemia. In order to avoid a hyperpotassemia do not accept Spironolactonum along with amiloride or Triamterenum. At a concomitant use with karbenoksolony the therapeutic effect of Spironolactonum as karbenoksolon causes a sodium delay in an organism decreases. Spironolactonum reduces sensitivity of vessels to noradrenaline that needs to be considered when carrying out the general and local anesthesia at the patients receiving Spironolactonum. Acetylsalicylic acid weakens diuretic effect of Spironolactonum. Spironolactonum exponentiates action diuretic and antihypertensives (at simultaneous use with antihypertensives the dose of the last should be reduced by 50%), reduces effect of anticoagulants of indirect action (coumarin derivatives). Raises elimination half-life, plasma levels and toxicity of digoxin (at their joint reception it is necessary to reduce a dose or to increase an interval between intake of digoxin). Spironolactonum combination with triptoreliny, busereliny, gonadoreliny strengthens their action. The special instructions Respect for Extra Care it is necessary in cases of presence of the disease contributing ment of acidosis and/or a hyperpotassemia. At reduced renal function and a hyperpotassemia perhaps tranzitorny increase in level of urea nitrogen in blood. The reversible giperkhloremichesky metabolic acidosis is possible. In diseases of kidneys, a liver, at advanced age it is necessary to control electrolytes of blood and a condition of renal function. Affects concentration of digoxin, cortisol and epinephrine in blood. During treatment Spironolactonum forbids alcohol intake. Children: kaliysberegayushchy diuretics should be used with care at supertension at children with easy degree of a renal failure because of risk of a hyperpotassemia. Pregnancy and a lactation Spilakton is contraindicated at pregnancy. When prescribing drug in the period of a lactation it is necessary to stop breastfeeding as Spironolactonum discharge with breast milk is possible. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms In an initial stage which duration is individual needs to abstain from occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions. Overdose Symptoms: drowsiness, confusion of consciousness, disturbance of water and electrolytic balance. Treatment: symptomatic. Specific antidote does not exist. It is necessary to provide water and electrolytic and acid-base equilibrium: use of kaliyvyvodyashchy diuretics, parenteral administration of glucose with insulin, in hard cases - carrying out a hemodialysis. A form of release and packing On 10 tablets in blister strip packaging from a film of polyvinylchloride and aluminum foil. On 2 planimetric packs together with the instruction for medical use in the state and Russian languages put in a pack cardboard. To Store storage conditions at a temperature not above 25 °C. To store out of children's reach! 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription the Producer/packer "UORLD of ILACh DIGNITY MEDICINE. VE TIDZh. A.Sh.", TURKEY (Bagdzhylar Ilchesi, Gyuneshli, Evren Makhallesi, Dzhami to the Dzhad Yole. No. 50 K. 1B Zemin 4-5-6, Istanbul) "WORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş.", TURKEY (Bağcılar İlçesi, Güneşli, Evren Mahallesi, Cami Yolu Cad. No: 50 K. 1B of Zemin 4-5-6, İstanbul). Owner of the registration certificate "UORLD of ILACh DIGNITY MEDICINE. VE TIDZh. A.Sh.", TURKEY the Address of the organization in the territory of the Republic of Kazakhstan the accepting claim (offer) from consumers on quality of RK medicine, Almaty, RIN Pharm LLP, Turksibsky district, Suyunbaya Ave., 222b Ph. / fax: 8 (7272) 529090 Address of the organization responsible for post-registration observation of safety of medicine of TROKA-S PHARMA LLP, Almaty, Suyunbaya Avenue 222-b Cellular ph. +7 701 786 33 98, (24-hour access).