Table Glyukovans n / v + 2.5 mg 500mg film 60 pcs

$10.01

Table Glyukovans n / v + 2.5 mg 500mg film 60 pcs

Quantity:

SKU: 01822221850 Categories: , , Tags: ,

Description

Composition
Active substance:
Glibenclamide – 2.5 mg, metformin hydrochloride – 500 mg.
Excipients:
Kernel: croscarmellose sodium – 14.0 mg Povidone K 30 – 20.0 mg, I microcrystalline cellulose – 56.5 mg Magnesium stearate – 7.0 mg. Coating: Opadry OY-L-24808 pink – 12.0 mg: lactose monohydrate – 36.0%, hypromellose 15sR – 28.0%, titanium dioxide – 24.39%, macrogol – 10.00%, Iron oxide yellow – 1.30% iron oxide red – 0.3%, iron oxide black – 0.010%; Purified water – q.s.
Description:
Kapsulovidnye biconcave tablets, film-coated light orange, marked “2.5” on one side.
Product form:
15 tablets in blister PVC / aluminum foil. 2 or 4 blister together with instructions for use placed in a cardboard box.
On the blister and cardboard box has a symbol “M” to protect against fraud.
Contraindications
– Hypersensitivity to metformin, glibenclamide or other derivatives of sulfonylureas, and also to the auxiliary substances; – type 1 diabetes; – diabetic ketoacidosis, diabetic precoma, diabetic coma; – Renal failure or renal dysfunction (creatinine clearance less than 60 mL / min); – acute conditions that may lead to changes in renal function: dehydration, severe infection, shock, intravascular administration of iodinated contrast agents (see “special instructions”.); – chronic or acute diseases which are accompanied by tissue hypoxia: cardiac or respiratory failure, recent myocardial infarction, shock; – liver failure; – porphyria; – pregnancy, breast-feeding; – concomitant use of miconazole; – extensive surgical operation; – chronic alcoholism, acute alcohol intoxication; – lactic acidosis (including history); – compliance with hypocaloric diet (less than 1000 kcal / day);
Do not use the drug in patients older than 60 years, performing heavy physical work, which is associated with an increased risk of developing lactic acidosis.
Glyukovans® contains lactose, however its use is not recommended for patients with the rare genetic diseases associated with galactose intolerance, lactase deficiency syndrome or glucose-galactose malabsorption.
Precautions: febrile syndrome, adrenal insufficiency, hypofunction of the anterior pituitary, thyroid disease with uncompensated violation of its function.
Dosage
2.5 mg + 500 mg
Indications
Type 2 Diabetes in Adults: – the poor diet, physical exercise and the previous monotherapy with metformin or sulfonylureas; – to replace two previous therapy drugs (metformin and sulfonylurea derivatives) in patients with a stable and well controlled blood glucose level.
Interaction with other drugs
Fugacity contraindicated in combination with the use of Glibenclamide
Miconazole can induce hypoglycemia (up to coma development).
Associated with the use of metformin
Iodine-containing contrast media: Depending on renal function receiving the drug should be discontinued 48 hours before or after the intravenous administration of iodinated contrast agents. Not recommended combinations
Associated with the use of sulfonylureas Alcohol: Rarely observed disulfiramopodobnye reaction (intolerance to alcohol) while taking alcohol and glibenclamide.
Drinking alcohol can increase the hypoglycemic action (by inhibiting compensatory reactions or delay its metabolic inactivation), which may contribute to the development of hypoglycemic coma. The period of treatment should Glyukovans® avoid alcohol and drugs containing ethanol.
Phenylbutazone enhances hypoglycemic effect of sulfonylurea derivatives (derivatives replacing sulfonylurea binding sites of the protein and / or reducing their elimination). Preferably, the use of other anti-inflammatory drugs exhibiting less interaction or the need to prevent patient self-monitoring of blood glucose levels; If necessary, adjust the dose in the combined use of anti-inflammatory agent and after its termination.
Associated with the use of glibenclamide Bosentan in combination with glibenclamide increases the risk of hepatotoxicity. Recommended to avoid simultaneous reception of these drugs. It may also decrease the hypoglycemic effect of glibenclamide.
Associated with the use of metformin
Alcohol: The risk of lactic acidosis increases with acute alcohol intoxication, particularly in case of starvation or malnutrition or hepatic insufficiency. The period of treatment should Glyukovans® avoid alcohol and drugs containing ethanol.
Combinations requiring caution
Associated with the use of hypoglycemic agents
Chlorpromazine: in high doses (100mg / day) causes an increase in blood glucose levels (reducing the release of insulin).
Precautions: The patient should be warned of the need for self-monitoring of blood glucose; if necessary, the dose should be adjusted hypoglycemic agent during simultaneous use of neuroleptic and after stopping its application. Glucocorticosteroids (GCS) and tetrakozaktid: increase in blood glucose, sometimes accompanied by ketosis (GCS cause a decrease in glucose tolerance).
Precautions: The patient should be warned of the need for self-monitoring of blood glucose; if necessary, the dose should be adjusted hypoglycemic agent during simultaneous application of corticosteroids after termination of the application.
Danazol has a hyperglycemic effect. If necessary, the treatment with danazol and at the termination of the reception of the last dose required Glyukovans® preparation correction under the control of glycemia.
Beta-2 adrenoceptor agonists: due to stimulation of the 32-adrenoreceptor increase the concentration of glucose
Precautions must notify the patient and to control blood glucose, possible transfer to insulin therapy.
Diuretics: increase in blood glucose.
Precautions: The patient should be warned of the need for self-monitoring of blood glucose; It may require dose adjustment of hypoglycemic agents during simultaneous use of diuretics and after the termination of their use.
Angiotensin converting enzyme (ACE) inhibitors (captopril, enalapril): ACE inhibitors reduces blood glucose. If necessary to adjust the dose Glyukovans® during simultaneous use of ACE inhibitors and after termination of the application.
Associated with the use of metformin
Diuretics: Lactic acidosis occurring during metformin amid functional renal failure caused by diuretics, in particular loop.
Associated with the use of Glibenclamide
Beta-blockers, clonidine, reserpine, guanethidine and sympathomimetic mask some symptoms of hypoglycaemia: palpitations and tachycardia; most non-selective beta-blockers increase the incidence and severity of hypoglycemia.
It is necessary to warn the patient of the need to self-monitoring of blood glucose levels, especially at the beginning of treatment.
Fluconazole: Increase in half-life of glibenclamide with the possible occurrence of hypoglycemia manifestations. It is necessary to warn the patient of the need to self-monitoring of blood glucose; dose adjustment may require hypoglycemic drugs simultaneously during treatment with fluconazole after termination of its use.
Bile acid sequestrants: The simultaneous use of the drug decreases Glyukovans® glibenclamide concentration in plasma, which could lead to a decrease hypoglycemic effect. It is to be Glyukovans® at least 4 hours prior to receiving bile acid sequestrants.
Other interaction: combination to be taken into account:
Associated with the use of Glibenclamide
Desmopressin: Glyukovans® may reduce the antidiuretic effect of desmopressin.
Antibacterial drugs (PM) from the group of sulfonamides, fluoroquinolones, anticoagulants (coumarin derivatives), inhibitors of monoamine oxidase (MAO), chloramphenicol, pentoxifylline, fibrate hypolipidemic drugs of the group disopyramide – risk of hypoglycemia during treatment with glibenclamide. in blood.
Overdose
In case of overdose may develop hypoglycaemia due to the presence of the sulfonylurea in the composition of the drug (see. “Special Instructions”).
Mild to moderate hypoglycemia symptoms without loss of consciousness and neurological manifestations can be adjusted immediate consumption of sugar. It is necessary to correct the dose and / or to change the power mode. The emergence of severe hypoglycemic reactions in patients with diabetes accompanied by coma, paroxysm or other neurological disorders, requires emergency medical treatment.
It is necessary to intravenous administration of dextrose solution immediately after diagnosis of, or suspected to hypoglycemia before hospitalization. After recovery of consciousness is necessary to give the patient foods rich in carbohydrate (in order to avoid a recurrence of hypoglycemia). Long-term overdose or the existence of conjugate risk factors can trigger the development of lactic acidosis, since the drug enters metformin (see. “Special Instructions”). Lactic acidosis is a condition that requires urgent medical assistance; treatment of lactic acidosis must be carried out in the clinic. The most effective treatment, capable of displaying lactate and metformin is hemodialysis.
Clearance glibenclamide plasma can be increased in patients with liver disease. Since glibenclamide avidly binds to blood proteins, the drug is not eliminated by dialysis.
pharmachologic effect
Pharmacological group:
Hypoglycemic agent for oral use (sulfonylurea + biguanide II generation).
Pharmacological properties:
Glyukovans® is a fixed combination of two oral hypoglycemic agents of various pharmacological groups: metformin and glibenclamide.
Metformin belongs to the biguanide and reduces the content of both basal and postprandial plasma glucose. Metformin does not stimulate insulin secretion and therefore does not cause hypoglycemia. 3 has a mechanism of action: – reduces hepatic glucose production through inhibition of gluconeogenesis and glycogenolysis; – increases the sensitivity of the peripheral receptor of insulin intake and utilization of glucose in muscle cells; – delays the absorption of glucose in the gastrointestinal tract. The drug also has a beneficial effect on the lipid composition of the blood, reducing total cholesterol, low density lipoprotein (LDL) and triglycerides.
Glibenclamide belongs to the group of the sulfonylureas II generation. Glucose when receiving glibenclamide decreases as a result of stimulation of insulin secretion Beta cells of the pancreas.
Metformin and glibenclamide have different mechanisms of action, but mutually complement each other hypoglycemic activity. A combination of two hypoglycemic agents has a synergistic effect in lowering glucose.
Pharmacokinetics:
Glibenclamide. The ingestion absorption from the gastrointestinal tract is greater than 95%. Glibenclamide, which is part of the preparation Glyukovans® is micronized.
peak plasma concentration is achieved in about 4 hours distribution volume – about 10 liters.
Communication with the plasma protein is 99%. Almost completely metabolized in the liver to form two inactive metabolites that are excreted by the kidney (40%) and in bile (60%). The half – from 4 to 11 hours.
Metformin after ingestion is absorbed from the gastrointestinal tract adequately, peak plasma concentration is reached within 2.5 hours. Approximately 20-30% of metformin is output through the gastrointestinal tract unchanged. The absolute bioavailability is 50 to 60%.
Metformin is rapidly distributed in the tissues, practically does not bind to plasma proteins.
It is metabolised to a very small extent and excreted by the kidneys. The half-life is an average of 6.5 hours. If the kidney function, reduced renal clearance, as well as the creatinine clearance, with half-life increases, leading to an increase in metformin plasma concentrations. The combination of metformin and glibenclamide in a single dosage form has the same bioavailability as that when taking tablets containing metformin and glibenclamide in isolation. The bioavailability of metformin in combination with glibenclamide did not affect food intake, as well as on the bioavailability of glibenclamide. However, the rate of absorption of glibenclamide is increased when eating.
Pregnancy and breast-feeding
Use of the drug is contraindicated during pregnancy. Patients should be warned that during the period of treatment Glyukovans® necessary to inform the doctor about a planned pregnancy and the occurrence of pregnancy. When planning a pregnancy, as well as in the case of pregnancy during the period of drug administration
Glyukovans®, the drug should be canceled and the prescribed treatment with insulin. Glyukovans® is contraindicated during breast-feeding, since there are no data on its ability to penetrate into breast milk.
Conditions of supply of pharmacies
On prescription.
side effects
In the course of drug treatment may be observed Glyukovans® following side effects.
The incidence of side effects of the drug is considered as follows:
Very common:> 1/10
Common:> 1/100, 1/1000, 1/10 000,
Metabolic disorders:
Hypoglycemia (See. “Overdose”, “Special Instructions”).
Rare: Seizures of hepatic porphyria and cutaneous porphyria.
Very rare: Lactic acidosis (See “Special Instructions”.).
Reduced absorption of vitamin B12, accompanied by a decrease in blood serum concentration for long-term use of metformin. Upon detection of megaloblastic anemia is necessary to consider the possibility of such a cause.
Disulfirampodobnaya reaction when consuming alcohol.
Laboratory findings:
Uncommon: Increase in serum creatinine and urea concentrations of medium to moderate.
Very rare: Hyponatremia.
Blood and lymphatic system:
These undesirable effects disappear after drug withdrawal.
Rare: Leukopenia and thrombocytopenia.
Very rare: Agranulocytosis, haemolytic anemia, bone marrow aplasia and pancytopenia.
Nervous system:
Often: Violation of taste (metallic taste in the mouth).
Vision:
At the beginning of the treatment of temporary blurred vision due to a decrease in blood glucose levels may occur.
Gastrointestinal disorders:
Very common: nausea, vomiting, diarrhea, abdominal pain and loss of appetite. These symptoms are more common at the beginning of treatment and in most cases are themselves. To prevent the development of these symptoms is recommended to take the drug in 2 or 3 divided doses; the slow increase in the dose of the drug also improves its portability.
Skin and subcutaneous tissue:
Rarely: skin reactions such as pruritus, urticaria, maculopapular rash.
Very rarely, cutaneous or visceral hypersensitivity vasculitis, erythema multiforme, exfoliative dermatitis, photosensitivity.
Immunological reactions:
Very rare: Anaphylactic shock.
Cross-reaction may occur hypersensitivity to sulfonamides and their derivatives.
Hepato-biliary disorders:
Very rare: Impairment indicators of liver function or hepatitis requiring treatment discontinuation.
special instructions
Against the background of treatment with Glyukovans® should regularly monitor blood glucose levels, fasting and after eating.
Lactic acidosis
Lactic acidosis is a very rare but serious (high mortality in the absence of acute treatment) complication that may arise due to accumulation of metformin.
Cases of lactic acidosis in patients receiving metformin appeared mostly in diabetic patients with significant renal failure. It is necessary to take into account other associated risk factors such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency and any condition associated with severe hypoxia.
It should take into account the risk of lactic acidosis when a non-specific signs such as muscle cramps, accompanied by dyspepsia, abdominal pain and severe malaise. In severe cases there may be a acidotic dyspnea, hypoxia, hypothermia, and coma. Diagnostic laboratory parameters are: low blood pH, lactate concentration in plasma is greater than 5 mmol / l, an increased ratio of anion gap and lactate / pyruvate.
hypoglycemia
Since Glyukovans® contains glibenclamide, then the drug is accompanied by the risk of hypoglycemia in the patient. Gradual dose titration after treatment may prevent the occurrence of hypoglycemia. This treatment may be administered to a patient only, adheres regular ingestion regime (including breakfast).
It is important that carbohydrate consumption has been regular since the risk of hypoglycaemia is increased by a late meal, insufficient or unbalanced carbohydrate consumption. Hypoglycaemia most likely with a hypocaloric diet, after intense or prolonged physical exercise, when alcohol is used or when receiving a combination of hypoglycemic agents.
Because of compensatory reactions induced hypoglycemia may occur sweating, fear, tachycardia, hypertension, palpitations, angina and arrhythmia. Последние симптомы могут отсутствовать, если гипогликемия развивается медленно, в случае вегетативной нейропатии или при одновременном приеме бета-адреноблокаторов, клонидина, резерпина, гуанетидина или симпатомиметиков.
Другими симптомами гипогликемии у больных сахарным диабетом могут являться головная боль, голод, тошнота, рвота, выраженная усталость, расстройства сна, возбужденное состояние, агрессия, нарушение концентрации внимания и психомоторных реакций, депрессия, спутанность сознания, нарушение речи, нарушение зрения, дрожь, паралич и парестезия, головокружение, делирий, судороги, сомноленция, бессознательное состояние, поверхностное дыхание и брадикардия.
Осторожное назначение препарата, подбор дозы и надлежащие инструкции для пациента являются важными для снижения риска развития гипогликемии. Если у пациента повторяются приступы гипогликемии, которые являются либо тяжелыми, либо связанными с незнанием симптомов, следует рассмотреть возможность лечения другими гипогликемическими средствами.
Факторы, способствующие развитию гипогликемии: – Одновременное употребление алкоголя, особенно при голодании, – Отказ или (особенно касается пожилых пациентов) неспособность пациента взаимодействовать с врачом и следовать рекомендациям, изложенным в инструкции по применению, – Плохое питание, нерегулярный прием пищи, голодание или изменения в диете, – Дисбаланс между физической нагрузкой и приемом углеводов, – Почечная недостаточность, – Тяжелая печеночная недостаточность,
Данная версия инструкции по медицинскому применению действительна с 03 июля 2017 – Передозировка препарата Глюкованс®, – Отдельные эндокринные нарушения: недостаточность функции щитовидной железы, гипофиза и надпочечников, – Одновременный прием отдельных лекарственных препаратов.
Почечная и печеночная недостаточность
Фармакокинетика и/или фармакодинамика может меняться у пациентов с печеночной недостаточностью или тяжелой почечной недостаточностью. Возникающая у таких пациентов гипогликемия может быть продолжительной, в этом случае должно быть начато соответствующее лечение.
Нестабильность содержания глюкозы в крови
В случае хирургического вмешательства или другой причины декомпенсации диабета, рекомендуется предусмотреть временный переход на инсулинотерапию. Симптомами гипергликемии являются учащенное мочеиспускание, выраженная жажда, сухость кожи.
За 48 часов до планового хирургического вмешательства или внутривенного введения йодсодержащего рентгеноконтрастного средства прием препарата Глюкованс® следует прекратить. Лечение рекомендуется возобновить через 48 часов, и только после того, как функция почек была оценена и признана нормальной.
Функция почек
Поскольку метформин выводится почками, перед началом лечения, и регулярно в последующем, необходимо определять клиренс креатинина и/или содержание креатинина в сыворотке крови: не реже одного раза в год у пациентов с нормальной функцией почек, и 2-4 раза в год у пожилых пациентов, а также у пациентов с клиренсом креатинина на верхней границе нормы.
Рекомендуется соблюдать особую осторожность в случаях, когда функция почек может быть нарушена, например, у пожилых пациентов, или в случае начала антигипертензивной терапии, приема диуретиков или нестероидных противовоспалительных препаратов (НПВП).
Другие меры предосторожности
Пациент должен сообщить врачу о появлении бронхолегочной инфекции или инфекционного заболевания мочеполовых органов. Влияние на способность управлять автомобилем и работать с механизмами
Пациенты должны быть информированы о риске возникновения гипогликемии и должны соблюдать меры предосторожности при управлении автомобилем и работе с механизмами, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Storage conditions
At a temperature of not higher than 30 ° C.
Keep out of the reach of children.
Dosing and Administration
Дозу препарата определяет врач индивидуально для каждого пациента в зависимости от уровня гликемии.
Начальная доза составляет 1 таблетку препарата Глюкованс® 2.5 мг+500 мг или Глюкованс® 5 мг+500 мг 1 раз в день. Во избежание гипогликемии начальная доза не должна превышать дневную дозу глибенкламида (или эквивалентную дозу другого ранее принимаемого препарата сульфонилмочевины) или метформина, если они применялись в качестве терапии первой линии.
Рекомендуется увеличивать дозу не более чем на 5 мг глибенкламида + 500 мг метформина в день каждые 2 или более недель для достижения адекватного контроля содержания глюкозы в крови.
Замещение предшествующей комбинированной терапии метформином и глибенкламидом: начальная доза не должна превышать дневную дозу глибенкламида (или эквивалентную дозу другого препарата сульфонилмочевины) и метформина, принимаемых ранее. Каждые 2 или более недель после начала лечения дозу препарата корректируют в зависимости от уровня гликемии.
Максимальная суточная доза составляет 6 таблеток препарата.
Режим дозирования зависит от индивидуального назначения:
Один раз в день, утром во время завтрака, при назначении 1 таблетки в день.
Два раза в день, утром и вечером, при назначении 2 или 4 таблеток в день.
Три раза в день, утром, днем и вечером, при назначении 3, 5 или 6 таблеток в день.
Таблетки следует принимать во время еды. Каждый прием препарата должен сопровождаться приемом пищи с достаточно высоким содержанием углеводов для предотвращения возникновения гипогликемии.
elderly patients
Доза препарата подбирается исходя из состояния функции почек. Начальная доза не должна превышать 1 таблетку препарата Глюкованс® 2.5 мг+500 мг. Необходимо проводить регулярную оценку функции почек.
Children
Препарат Глюкованс® не рекомендован для применения у детей.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

MERCK

There are no reviews yet.

Add your review