Amaryl 2mg tab 30 pc

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Amaryl 2mg tab 30 pc

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Description

Composition
Active substance:
Glimepiride 1 mg, 2 mg, 3 mg or 4 mg.
Excipients:
Lactose monohydrate, sodium carboxymethyl starch, povidone, microcrystalline cellulose, magnesium stearate, colorant: a colorant Iron oxide red (E 172), iron oxide yellow dye (E 172), or indigo carmine (E 132).
Description:
Amaryl 1 mg: pink tablets, oblong, flat with dividing line on both sides. Engraving NMK and stylized «h» on both sides.
Amaryl 2 mg Tablets green, oblong, flat with dividing line on both sides. Engraving NMM and stylized «h» on both sides.
Amaryl 3 mg Tablets pale yellow, oblong, flat with dividing line on both sides. Engraving NMN and stylized «h» on both sides.
Amaryl 4 mg Tablets blue, oblong, flat with dividing line on both sides. Engraving NMO and stylized «h» on both sides.
Product form:
Tablets 1 mg, 2 mg, 3 mg, 4 mg.
15 tablets in blister PVC / aluminum foil. At 2, 4, 6 or 8 blisters together with instructions for use in a cardboard box.
Contraindications
– Type 1 diabetes. – Diabetic ketoacidosis, diabetic coma and precoma. – Increased sensitivity to glimepiride or any preparation auxiliary substance, other sulfonylurea derivatives or other sulfanilamides (risk of hypersensitivity reactions). – Severe liver disorders (lack of clinical application experience). – Severe renal impairment, including patients on hemodialysis (no experience clinical application). – Pregnancy and lactation. – Children ages (no clinical application experience). – Rare hereditary diseases such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
Precautions – In the first week of treatment (increased risk of hypoglycaemia). – In the presence of risk factors for hypoglycaemia (see section “Special Instructions”, you may need correction of dose of glimepiride or the entire therapy.). – When intercurrent diseases during treatment or when you change the patient’s lifestyle (diet modification and meal times, increase or decrease in physical activity). – In case of insufficient glucose-6-phosphate dehydrogenase. – In violation of absorption of food and drugs in the gastrointestinal tract (ileus, intestinal paresis).
Dosage
2 mg
Indications
Type 2 diabetes mellitus (in monotherapy or in combination therapy with metformin, or insulin).
Interaction with other drugs
Glimepiride is metabolized by cytochrome R4502S9 (CYP2C9), which should be considered when an application with inducers (e.g. rifampicin) or inhibitors (e.g., fluconazole) CYP2C9. Potentiation of hypoglycemic action and in some cases associated with this possible development of hypoglycemia may occur in combination with one of the following medications: insulin and other hypoglycemic agents for oral administration, angiotensin converting enzyme (ACE) inhibitors, anabolic steroids and male sex hormones, chloramphenicol derivatives coumarin, cyclophosphamide, disopyramide, fenfluramine, feniramidol, fibrates, fluoxetine, guanethidine, ifosfamide, monoamine oxidase inhibitors (MAO), fluconazole, na ra-aminosalicylic acid, pentoxifylline (high dose parenteral), phenylbutazone, azapropazone, oxyphenbutazone, probenecid, quinolones, salicylates, sulfinpyrazone, clarithromycin, sulfonamides, tetracyclines, tritokvalin, trofosfamide. Attenuation hypoglycemic action, and the associated increase in blood glucose concentration, can be observed in combination with one of the following medications: acetazolamide, barbiturates, steroids, diazoxide, diuretics, epinephrine and other sympathomimetic agents, glucagon, laxatives (with prolonged use) , nicotinic acid (high dose), estrogens and progestogens, phenothiazines, phenytoin, rifampin, iodine-containing thyroid hormones. Blockers H2-histamine receptors, beta- blockers, clonidine and reserpine capable both enhance and reduce the hypoglycemic effect of glimepiride. Under the influence of sympatholytic agents such as beta-blockers, clonidine, guanethidine and reserpine, features adrenergic kontrregulyatsii in response to hypoglycemia may be reduced or absent. In patients receiving glimepiride may be a strengthening or weakening of the action of coumarin derivatives. Single or chronic alcohol consumption can both strengthen and weaken the hypoglycemic action of glimepiride. Bile acid sequestrants: colesevelam binds glimepiride glimepiride and reduces the absorption from the gastrointestinal tract. In the case of glimepiride, at least 4 hours prior to receiving colesevelam, no interaction was observed. Therefore glimepiride necessary to take at least 4 hours prior to receiving colesevelam.
Overdose
Acute overdose, as well as long-term treatment with high doses of glimepiride too can cause severe life-threatening hypoglycaemia. As soon as an overdose is detected, you must immediately inform your doctor. Hypoglycaemia can almost always be quickly cupped immediate intake of carbohydrates (glucose or sugars, sweet fruit juice or tea). In this regard, the patient should always be in possession of at least 20 grams of glucose (sugar 4 slices). Sweeteners are not effective in the treatment of hypoglycemia. Until such time as the physician determines that the patient is out of danger, the patient requires careful medical supervision. It should be remembered that hypoglycemia can be renewed after the initial recovery of blood glucose concentration. If a patient suffering from diabetes mellitus treated by different doctors (for example, during a stay in the hospital after the accident, with the disease at the weekend), it should be sure to inform them about the disease and previous treatment. Sometimes the patient may require hospitalization, even if only as a precaution. A considerable overdose and severe reaction with symptoms such as loss of consciousness, or other severe neurological disorders is a medical condition and requires immediate treatment and hospitalization. In the case of the unconscious state of the patient must be intravenous concentrated dextrose (glucose) (for adults, starting from 40 ml of 20% solution). Alternatively adults may intravenous, subcutaneous or intramuscular administration of glucagon, e.g., at a dose of 0,5-1 mg. When treating hypoglycaemia due to accidental ingestion Amaryl infants or young children the dose administered dextrose should be carefully adjusted in terms of the possibility of dangerous hyperglycemia and administration of dextrose should be under the permanent control of blood glucose concentration. If overdose Amaryl may require gastric lavage and activated charcoal method. After rapid recovery of blood glucose concentration must be carefully holding dextrose intravenous infusion at a lower concentration to prevent a recurrence of hypoglycemia. The concentration of glucose in the blood of such patients should be monitored continuously for 24 hours. In severe cases, a prolonged course of hypoglycemia risk of lowering glucose levels in the blood to hypoglycemic levels may persist for several days.
pharmachologic effect
Pharmacological group:
Hypoglycemic agent for ingestion group III generation sulfonylureas.
Pharmacodynamics:
Glimepiride lowers blood glucose concentration mainly by stimulating release of insulin from pancreatic beta cells. Its effect is mainly linked to the improvement of the ability of pancreatic beta cells respond to physiological glucose stimulation. Compared with low-dose glibenclamide glimepiride causes release of fewer insulin in achieving approximately the same reduction in blood glucose concentration. This fact testifies in favor of a extrapancreatic glimepiride hypoglycemic effects (increased sensitivity to insulin and insulinomimetichesky effect).
insulin secretion
Like all other sulfonylurea, glimepiride regulates insulin secretion by interaction with the ATP-sensitive potassium channels in the membranes of the beta cells. Unlike other sulfonylureas glimepiride selectively binds to a protein having a molecular weight of 65 kilodaltons (kDa), located in the membranes of the pancreatic beta cells. This interaction with glimepiride binding protein with it regulates the opening or closure of ATP-sensitive potassium channels. Glimepiride closes potassium channels. This causes a depolarization of the beta cells leads to the opening of voltage-sensitive calcium channels and calcium entry into the cell. As a result, an increase in intracellular calcium concentration activates secretion of insulin by exocytosis. Glimepiride is much faster and therefore more likely to enter into bond and is released from the connection with the binding protein with him than glibenclamide. It is expected that this high rate of glimepiride exchange property with the binding protein causes him it pronounced effect sensitization of beta cells to glucose, and their protection from desensitization and premature exhaustion.
The effect of increasing insulin sensitivity
Glimepiride increases the effects of insulin on glucose uptake by peripheral tissues.
Insulinomimetichesky effect
Glimepiride has effects similar to the effects of insulin on glucose uptake by peripheral tissues and glucose output from the liver. Glucose uptake by peripheral tissues is carried out by its transport into the muscle cells and adipocytes. Glimepiride directly increases the amount of glucose transporter molecules in the plasma membranes of adipocytes and muscle cells. Increased glucose Incoming inside cells leads to activation of glycosylphosphatidylinositol-specific phospholipase C. The resulting intracellular calcium concentration is reduced, causing a decrease in the activity of protein kinase A, which in turn leads to stimulation of glucose metabolism. Glimepiride inhibits glucose output from the liver by increasing the concentration of fructose 2,6-bisphosphate, which inhibits gluconeogenesis.
Effect on platelet aggregation
Glimepiride reduces platelet aggregation in vitro and in vivo. This effect appears to be associated with the selective inhibition of cyclooxygenase responsible for the formation of thromboxane, an important endogenous platelet aggregation factor.
Anti-atherogenic effects of the drug
Glimepiride helps normalize lipid content, reduces the content of malonaldehyde in the blood, which leads to a significant reduction in lipid peroxidation. In animals, glimepiride leads to a significant reduction in the formation of atherosclerotic plaques.
Reducing the severity of oxidative stress, which is always present in patients with type 2 diabetes. Glimepiride increases the content of endogenous a-tocopherol, catalase, glutathione peroxidase and superoxide dismutase.
Cardiovascular Effects
Through ATP-sensitive potassium channels (see above), the sulfonylurea derivatives also have an effect on the cardiovascular system. Compared with conventional sulfonylureas, glimepiride has significantly less effect on the cardiovascular system that may be due to the specific nature of its interaction with the protein binding with him the ATP-sensitive potassium channels. In healthy volunteers, the minimum effective dose of glimepiride is 0.6 mg. The effect of glimepiride is dose-dependent and reproducible. The physiological response to physical stress (reduced insulin secretion) is stored when receiving glimepiride. There are no significant differences in effect depending on whether the drug was passed for 30 minutes before a meal or immediately before a meal. Patients with diabetes can achieve adequate metabolic control over 24 hours after a single dose. Moreover, in a clinical study in 12 of 16 patients with renal failure (creatinine clearance 4-79 ml / min) was also achieved adequate metabolic control.
Combination therapy with metformin
In patients with inadequate metabolic control in the application of the maximum dose of glimepiride can be started combination therapy with glimepiride and metformin. In two studies during combination therapy has been proven improvement of metabolic control as compared with that in the treatment of each of these drugs alone.
Combination therapy with insulin
In patients with inadequate metabolic control in the application of the maximum dose of glimepiride can be started simultaneously with insulin therapy. According to the results of two studies in the application of this combination produces the same improvement in metabolic control as when using only one insulin; However, the combination therapy requires a lower dose of insulin.
Use in children
There is insufficient data on the long-term effectiveness and safety of the drug in children.
Pharmacokinetics:
Repeated reception of glimepiride in a daily dose of 4 mg of the maximum serum concentration (Cmax) is achieved after about 2.5 hr. And is 309 ng / ml. There is a linear relationship between dose and peak plasma concentrations of glimepiride (Cmax) as well as between the dose and the area under the curve “concentration – time» (AUC). If ingestion of glimepiride its absolute bioavailability is complete. Food intake has no significant effect on the absorption, with the exception of a slight slowing its speed. For glimepiride characterized by a very low volume of distribution (about 8.8 liters) approximately equal to the albumin distribution volume, a high degree of binding to plasma proteins (99%) and low clearance (about 48 ml / min). The average half-life, as measured by serum concentrations in a multi-dose formulation is about 5-8 hours. Upon receiving the high dose, there is a slight increase in half-life periods. After a single dose of glimepiride inwardly 58% of the dose excreted by the kidneys and 35% of the dose – through the intestine. Glimepiride unchanged in the urine is detected. Urine and feces were detected two metabolites formed as a result of metabolism in the liver (mainly via CYP2C9), one of them is hydroxy compound, and the other – carboxy derivative. After oral administration of glimepiride terminal half-life of these metabolites was 3-5 hours and 5-6 hours, respectively. Glimepiride is excreted in breast milk and crosses the placenta. Comparison of single and multiple (once daily) receiving glimepiride revealed no significant differences in the pharmacokinetic parameters, and observed their very low variability between different patients. No significant accumulation of the drug. The pharmacokinetic parameters are similar in patients of different genders and different age groups. Patients with impaired renal function (low creatinine clearance) there is a tendency to increase clearance glimepiride and to reduce its average serum concentrations, probably due to more rapid clearance of the drug due to its lower binding protein. Thus, in these patients there is no additional risk of accumulation of the drug.
Pregnancy and breast-feeding
Glimepiride is contraindicated in pregnant women. In the case of planned pregnancy or if pregnancy occurs the woman should be transferred to insulin. Glimepiride passes into breast milk, therefore it should not be taken during breastfeeding. In this case, you must go to insulin or to stop breastfeeding.
Conditions of supply of pharmacies
Prescription.
side effects
Violations by metabolism
As a result, a hypoglycemic drug action Amaryl may develop hypoglycemia, which, like the application of other sulphonylurea derivatives can be prolonged. Symptoms of hypoglycaemia include: headache, hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressiveness, impaired concentration, alertness and reaction rate, depression, confusion, speech disorders, aphasia, visual disorders, tremor, paresis, sensory disturbances, dizziness, loss of self-control, delirium, cerebral convulsions, somnolence and loss of consciousness up to coma, shallow breathing, bradycardia. Additionally, there may be symptoms of adrenergic kontrregulyatsii in response to hypoglycemia, such as cold-sticky appearance of sweat, anxiety, tachycardia, increased blood pressure, angina, heart and sense cardiac arrhythmias. The clinical picture of severe hypoglycemia may be similar to a stroke. The symptoms of hypoglycaemia nearly always disappear after its elimination.
Violations by the organ of vision
During treatment (especially at the beginning) may experience transient visual disturbances caused by changes in blood glucose concentration. Their cause is a temporary change in the swelling of the lens depending on the concentration of glucose in the blood, and thus the change in the refractive index of the lens.
Disorders of the gastrointestinal tract
In rare cases: nausea, vomiting, a feeling of heaviness or fullness in the epigastric pain, abdominal pain, diarrhea. In some cases: hepatitis, increased activity of “liver” enzymes and / or cholestasis and jaundice, which can progress to life-threatening liver failure, but may be subject to regress to remove the drug.
Blood disorders and lymphatic system
Rare: thrombocytopenia In some cases: leukopenia, hemolytic anemia, erythropenia, granulocytopenia, agranulocytosis and pancytopenia. When applying the drug post-marketing reports of severe cases of thrombocytopenia with platelet counts below 10,000 / ul and thrombocytopenic purpura (the frequency is unknown).
Violations by the immune system
In rare cases, and pseudo-allergic reactions such as itching, hives, skin rash. Such reactions are almost always an easy form, but can go into serious reactions with shortness of breath, a sharp decrease in blood pressure, sometimes progressing up to anaphylactic shock. If you have symptoms of urticaria should immediately consult a doctor. In some cases, there may occur a decrease in serum sodium concentration, allergic vasculitis, photosensitivity.
special instructions
In special clinical stressful conditions, such as trauma, surgery, infection, occurring with febrile temperature, it is possible worsening of metabolic control in patients with diabetes, and they may require temporary transfer to insulin therapy to maintain adequate metabolic control. In the first weeks of treatment may increase the risk of hypoglycemia, and therefore at this time require particularly careful monitoring of blood glucose levels.
Factors contributing to the risk of hypoglycaemia include: – unwillingness or inability of the patient (more often seen in elderly patients) to cooperate with the doctor; – malnutrition, irregular food intake or omissions meal; – imbalance between physical exertion and carbohydrate intake; – changes in diet; – consumption of alcohol, especially in combination with skipping meals; – severe renal dysfunction; – severe liver function (in patients with severe hepatic impairment shows transfer to insulin therapy, at least, to achieve metabolic control). – an overdose of glimepiride; – some decompensated endocrine disorders, violating the carbohydrate metabolism or adrenergic kontrregulyatsii in response to hypoglycemia (eg certain disorders of thyroid function and anterior part of the pituitary gland, adrenal insufficiency); – simultaneous reception of certain drugs (see “Interaction with other drugs.”); – receiving glimepiride in the absence of evidence for its reception.
Treatment of sulfonylureas, which include glimepiride may lead to the development of hemolytic anemia, so in patients with deficiency of glucose-6-phosphate dehydrogenase should be very careful when assigning glimipirida and better use hypoglycemic agents, non-sulfonylurea. In the case of the above risk factors for the development of hypoglycemia may require correction dose glimepiride or the entire therapy. It also refers to the appearance of intercurrent disease during treatment or change in the patient’s lifestyle. Those symptoms of hypoglycaemia which reflect adrenergic kontrregulyatsii the body in response to hypoglycemia (see. Section “Side Effects”), may be mild or absent at the gradual development of hypoglycemia in elderly patients, in patients with neuropathy of the autonomic nervous system, or in patients receiving beta-blockers, clonidine, reserpine, guanethidine or other sympatholytic drugs. Гипогликемия может быть быстро устранена при немедленном приеме быстро усваивающихся углеводов (глюкозы или сахарозы). Как и при приеме других производных сульфонилмочевины, несмотря на первоначальное успешное купирование гипогликемии, гипогликемия может возобновиться. Поэтому пациенты должны оставаться под постоянным наблюдением. При тяжелой гипогликемии дополнительно требуется немедленное лечение и наблюдение врача, а в некоторых случаях – госпитализация пациента. During treatment glimepiride requires regular monitoring of liver function and peripheral blood picture (especially the number of leukocytes and platelets). Поскольку отдельные побочные действия, такие как: тяжелая гипогликемия, серьезные изменения картины крови, тяжелые аллергические реакции, печеночная недостаточность, могут при определенных обстоятельствах представлять собой угрозу для жизни, в случае развития нежелательных или тяжелых реакций больному необходимо сразу же информировать о них лечащего врача и ни в коем случае не продолжать прием препарата без его рекомендации.
Влияние на способность управления транспортными средствами и другими механизмами.
В случае развития гипогликемии или гипергликемии, особенно в начале лечения или после изменения лечения, или, когда препарат не принимается регулярно, возможно снижение внимания и скорости психомоторных реакций. Это может нарушить способность пациента управлять транспортными средствами или другими механизмами.
Storage conditions
At a temperature of not higher than 30 ° C.
Keep out of the reach of children.
Список Б.
Dosing and Administration
Как правило, доза препарата Амарил определяется целевой концентрацией глюкозы в крови. It should apply the lowest amount sufficient to achieve the necessary metabolic control. Во время лечения препаратом Амарил необходимо регулярно определять концентрацию глюкозы в крови. Кроме этого рекомендуется регулярный контроль за уровнем гликозилированного гемоглобина. Incorrect reception of preparation, for example, skipping a next dose should never be replenished by subsequently receiving the higher dose. Действия пациента при ошибках при приеме препарата Амарил (в частности, при пропуске приема очередной дозы или при пропуске приема пищи) или в ситуациях, когда нет возможности принять препарат, должны обговариваться пациентом и врачом заблаговременно.
Прием препарата Амарил
Таблетки препарата Амарил принимают, не разжевывая, запивая достаточным количеством жидкости (около 0,5 стакана). При необходимости таблетки препарата Амарил могут быть разделены вдоль риски на две равные части.
Начальная доза и подбор дозы
Начальная доза составляет 1 мг глимепирида 1 раз в день. При необходимости суточная доза может быть постепенно (с интервалами в 1-2 недели) увеличена. Рекомендуется увеличение дозы проводить под регулярным контролем концентрации глюкозы в крови и в соответствии со следующим шагом повышения дозы: 1 мг – 2 мг – 3 мг – 4 мг – 6 мг (- 8 мг).
Диапазон доз у пациентов с хорошо контролируемым сахарным диабетом
Обычно ежедневная доза у пациентов с хорошо контролируемым сахарным диабетом составляет 1-4 мг глимепирида. A daily dose of more than 6 mg is more effective in only a small number of patients.
Режим дозирования
Время приема препарата Амарил и распределение доз в течение дня устанавливается врачом, в зависимости от образа жизни пациента в данное время (время приема пищи, количество физических нагрузок).
Обычно, достаточно однократного приема препарата Амарил в течение суток. Рекомендуется, чтобы в этом случае вся доза препарата Амарил принималась непосредственно перед полноценным завтраком или в случае, если она не была принята в это время, – непосредственно перед первым основным приемом пищи. Очень важно после приема таблеток препарата Амарил не пропускать прием пищи. Since the improvement in metabolic control is associated with increased insulin sensitivity, in the course of treatment may decrease the need for glimepiride. Для того чтобы избежать развития гипогликемии необходимо своевременно снижать дозы или прекращать прием препарата Амарил.
Состояния, при которых также может потребоваться коррекция дозы глимепирида: — снижение массы тела у пациента; — изменения образа жизни пациента (изменение диеты, времени приема пищи, количества физических нагрузок); — возникновение других факторов, которые приводят к предрасположенности к развитию гипогликемии или гипергликемии (см. раздел «Особые указания»).
duration of treatment
Лечение глимепиридом обычно проводится длительно.
Перевод пациента с приема другого гипогликемического средства для приема внутрь на прием препарата Амарил
Не существует точного соотношения между дозами препарата Амарил и других гипогликемических средств для приема внутрь. Когда другое гипогликемическое средство для приема внутрь заменяется на препарат Амарил, рекомендуется, чтобы процедура его назначения была такой же, как при первоначальном назначении препарата Амарил, то есть лечение должно начинаться с начальной дозы 1 мг (даже в том случае, если пациента переводят на препарат Амарил с максимальной дозы другого гипогликемического препарата для приема внутрь). Любое повышение дозы следует проводить поэтапно, с учетом реакции на глимепирид, в соответствии с приведенными выше рекомендациями. Необходимо учитывать силу и продолжительность эффекта предшествующего гипогликемического средства для приема внутрь. Может потребоваться прерывание лечения для того, чтобы избежать какой-либо суммации эффектов, которая может увеличить риск развития гипогликемии.
Use in combination with metformin
У пациентов с недостаточно контролируемым сахарным диабетом при приеме максимальных суточных доз или глимепирида или метформина может быть начато лечение комбинацией этих двух препаратов. При этом проводившееся ранее лечение или глимепиридом, или метформином продолжается на том же самом уровне доз, а дополнительный прием метформина или глимепирида начинают с низкой дозы, которая затем титруется в зависимости от целевого уровня метаболического контроля вплоть до максимальной суточной дозы. Комбинированная терапия должна начинаться под строгим медицинским наблюдением.
Use in combination with insulin
Пациентам с недостаточно контролируемым сахарным диабетом при приеме максимальных суточных доз глимепирида может быть одновременно назначено введение инсулина. В этом случае последняя назначенная пациенту доза глимепирида остается неизменной. При этом лечение инсулином начинается с низких доз, которые постепенно повышаются под контролем концентрации глюкозы в крови. Комбинированное лечение требует тщательного медицинского наблюдения.
Use in patients with renal insufficiency
Имеется ограниченное количество информации по использованию препарата Амарил у пациентов с почечной недостаточностью. Пациенты с нарушенной функцией почек могут быть более чувствительны к гипогликемическому эффекту глимепирида (см. разделы «Фармакокинетика», «Противопоказания»).
Use in patients with hepatic insufficiency
Имеется ограниченное количество информации по использованию препарата Амарил при печеночной недостаточности (см. раздел «Противопоказания»).
Use in children
Данных по применению препарата Амарил у детей недостаточно.
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

SANOFI RUSSIA

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