Diabeton MB modified release tablets 60mg №15×4

NameDiabeton MB 60mg tab. 60mg No. 60 Main active ingredient gliclazide Release form Tablets Dosage 60mg Special indications Hypoglycemia . This drug should only be given to patients who are able to eat regularly (including breakfast). It is important to take carbohydrates regularly, since an increased risk of hypoglycemia occurs when food is taken late, in inadequate quantities, or if this food is low in carbohydrates. Hypoglycemia is more likely with a low-calorie diet, prolonged or strenuous exercise, alcohol consumption, or the use of a combination of antidiabetic drugs. When taking sulfonylurea drugs, hypoglycemia may occur (see section “Adverse reactions”). Sometimes hypoglycemia can be severe and prolonged. In this case, hospitalization and administration of glucose for several days may be required. To reduce the risk of episodes of hypoglycemia, it is necessary to take into account the individual characteristics of patients, give them clear explanations and carefully select the dose. Factors that increase the risk of hypoglycemia: the patient refuses or cannot follow the doctor’s recommendations (especially for elderly patients); poor, irregular meals, missed meals, periods of fasting or dietary changes; imbalance between exercise and carbohydrate intake; renal failure severe liver failure overdose of the drug certain endocrine system disorders: thyroid dysfunction, hypopituitarism and adrenal insufficiency simultaneous use of certain drugs (see section “Interaction with other drugs and other types of interactions”). Renal and liver failure. The pharmacokinetics and/or pharmacodynamics of gliclazide may change in patients with hepatic and severe renal insufficiency. Episodes of hypoglycemia in these patients may be prolonged and therefore require appropriate treatment. The patient and his family members should be informed about the risk factors and conditions that may contribute to the occurrence of hypoglycemia, about the symptoms of hypoglycemia (see section “Adverse reactions”) and how to eliminate them. The patient should be informed of the importance of following the doctor’s recommendations regarding diet, the importance of regular exercise and regular monitoring of blood glucose. Deterioration of glycemic control in patients receiving hypoglycemic drugs may be caused by: St. In some cases, insulin may be required. The hypoglycemic efficacy of any intake of hypoglycemic agents, including gliclazide, may change over time. This may be a consequence of the progression of the severity of the disease or a consequence of a decrease in response to treatment. This phenomenon is known as secondary insufficiency, which is different from primary insufficiency when drugs are ineffective from the very beginning of treatment. Before making a conclusion on the development of secondary insufficiency in a patient, it is necessary to check the correctness of the prescribed dose and the patient’s compliance with the diet. Laboratory indicators. Glycosylated hemoglobin (or fasting blood glucose) is recommended to assess blood glucose control. Self-monitoring of blood sugar levels by patients may also be helpful. In patients with glucose-6-phosphate dehydrogenase (G6PDH) deficiency, the use of sulfonylurea preparations can cause hemolytic anemia. Since gliclazide belongs to the class of chemically derived sulfonylurea drugs, caution should be exercised and consideration should be given to alternative therapy in another class of G6PD-deficient patients. The composition of the drug includes lactose, so patients with rare hereditary disorders of galactose tolerance, malabsorption syndrome of glucose and galactose, Lapp lactase deficiency should not prescribe this drug. Pharmacological properties Pharmacodynamics Mechanism of action. The active substance is gliclazide it is an oral hypoglycemic agent that is a sulfonylurea derivative and differs from other drugs in the presence of a heterocyclic ring containing nitrogen and has endocyclic bonds. Gliclazide lowers plasma glucose levels by stimulating insulin secretion by the ?-cells of the islets of Langerhans of the pancreas. The increase in postprandial insulin levels and C-peptide secretion persist even after 2 years of drug use. In addition to these metabolic properties, gliclazide also has hemovascular properties. Clinical efficacy and safety. Influence on insulin secretion. In patients with type II diabetes, gliclazide restores the early peak of insulin secretion in response to glucose intake and increases the second phase of insulin secretion. An increase in insulin secretion occurs in accordance with the food intake or glucose load. hemovascular properties. Gliclazide reduces microthrombosis due to two mechanisms that can be involved in the development of complications of diabetes mellitus: it partially inhibits platelet aggregation and adhesion, reduces the number of platelet activation markers (?-thromboglobulin, thromboxane B 2 ) affects the fibrinolytic activity of the vascular endothelium (increases the activity of tRA). Prevention of complications of type II diabetes mellitus. ADVANCE is an international, multicenter, randomized, bifactorial design study to determine the benefits of an intensive glycemic control strategy (HbAlc level ≥ 6.5%) based on Diabeton ® MR compared to standard glycemic control and the benefits of lowering blood pressure with a fixed combination of perindopril / indapamide compared with placebo against the background of current standard therapy (double-blind comparison) for the effect on major macro- and microvascular complications in patients with type II diabetes. The primary endpoint consisted of major macrovascular (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) and microvascular (new or worsening nephropathy, retinopathy) events. The ADVANCE study included 11,140 patients. Patients continued to receive their usual hypoglycemic therapy during the 6 weeks of the study entry period. Further, the patients were randomly divided into the standard glycemic control group (n = 5569) and the group receiving Diabeton ® MR as the basis of the intensive glycemic control strategy (n = 5571). The intensive glycemic control strategy was based on prescribing Diabeton ® MR from the very beginning of treatment or on prescribing Diabeton ® MR in addition to standard therapy (therapy that the patient was receiving at the time of inclusion) with a possible increase in dose to the maximum (120 mg), and then in case of need? with the addition of other hypoglycemic drugs such as metformin, acarbose, thiazolidinediones or insulin. No other sulfonylurea drugs were used in the intensive glycemic control group. The patients were closely monitored and strictly adhered to the diet. The observation lasted 4.8 years. The result of treatment with Diabeton ® MR, which was the basis of the strategy of intensive glycemic control (average achieved level of HbAlc – 6.5%) compared with standard glycemic control (average achieved level of HbAlc – 7.3%), was a significant total reduction of 10% relative the risk of major macro- and microvascular complications ((HR) 0.90, 95% Cl 0.82; 0.98 p = 0.013; 18.1% of patients in the intensive control group compared with 20% of patients in the standard control group). The advantages of the strategy of intensive glycemic control with the appointment of Diabeton ® MR as the basis of therapy were due to: a significant reduction in the relative risk of major microvascular events by 14% (HR 0.86, 95% Cl 0.77; 0.97, p = 0.014; 9.4 % vs. 10.9%); a significant reduction in the relative risk of new cases or progression of nephropathy by 21% (HR 0.79, 95% Cl 0.66 – 0.93, p = 0.006; 4.1% vs. 5.2%); a significant decrease in the relative risk of microalbuminuria, which occurred for the first time, by 8% (HR 0.92, 95% Cl 0.85 – 0.99, p = 0.030; 34.9% vs. 37.9%); a significant reduction in the relative risk of renal events by 11% (HR 0.89, 95% Cl 0.83; 0.96, p = 0.001; 26.5% vs. 29.4%). At the end of the study, 65% and 81.1% of patients in the intensive control group (vs 28.8% and 50.2% in the standard control group) achieved the HbAlc ? 6.5% and ? 7% respectively. 90% of patients in the intensive control group took Diabeton ® MR (average daily dose was 103 mg), 70% of them took the maximum daily dose of 120 mg. In the intensive glycemic control group based on Diabeton ® MR, the body weight of the patients remained stable. The benefits of an intensive glycemic control strategy based on Diabeton® MR were independent of blood pressure reduction. Pharmacokinetics Absorption. The concentration of gliclazide in blood plasma increases progressively during the first 6:00 after administration, after which it reaches a constant level (plateau), contained in the pole at the twelfth hour after administration. Individual fluctuations are insignificant. Gliclazide is completely absorbed from the gastrointestinal tract. Eating does not affect the rate and degree of absorption. Distribution. The binding of gliclazide to plasma proteins is approximately 95%. The volume of distribution is about 30 liters. A single daily dose of Diabeton ® MR 60 mg provides an effective plasma concentration of gliclazide for 24 hours. Metabolism. Gliclazide is metabolized in the liver and excreted in the urine, less than 1% of the active substance is excreted in the urine unchanged. There are no active metabolites in plasma. Conclusion. The half-life of gliclazide is approximately 12-20 hours. Linearity / non-linearity. When using the drug at a dose of up to 120 mg, there is a linear relationship between the dose taken and the concentration in the blood plasma. Special groups of patients. Elderly patients. Elderly patients showed no clinically significant changes in the pharmacokinetics of the drug. Indications for use Type II diabetes mellitus in adults lowering and controlling blood glucose when it is impossible to normalize glucose levels only with diet, exercise and weight loss Prevention of complications of type II diabetes mellitus: reduced risk of macro- and microvascular complications, including new cases or worsening nephropathy in type II diabetic patients treated with an intensive glycemic control strategy. Method of administration and doses For oral administration. Appointed only by adults. The daily dose may vary from 0.5 to 2 tablets (from 30 to 120 mg per day). The tablet may be divided into equal parts. The daily dose should be taken once during breakfast. Half or whole tablet(s) should be swallowed whole (do not crush but do not chew). If the patient has forgotten to take the tablets, do not increase the dose the next day. Like all hypoglycemic drugs, Diabeton ® MR 60 mg requires individual dose selection depending on the patient’s response to treatment (blood glucose, glycated hemoglobin HbAlc). Initial dose and dose selection. The recommended starting dose is 30 mg (0.5 tablets) per day. With effective glucose control, treatment with this dose can be continued. If it is necessary to enhance blood glucose control, the daily dose can be successively increased to 60 mg (1 tablet), 90 mg (1.5 tablets) or 120 mg (2 tablets). It is recommended to increase the dose gradually, with an interval of 1 month, except in cases where a decrease in blood glucose levels was observed within 2 weeks of treatment. In this case, the dose can be increased at the end of the second week of treatment. The maximum recommended daily dose is 120 mg (2 tablets). 1 modified release tablet of Diabeton® MR 60 mg is equivalent to 2 modified release tablets of gliclazide 30 mg. Tablet with a modified release of the drug Diabeton ® MR 60 mg is subject to division, which makes it possible to use the drug at a dose of 30 mg (0.5 tablets) and at a dose of 90 mg (1.5 tablets). Transfer of a patient from preparations containing gliclazide 80 mg to Diabeton ® MR 60 mg, modified release tablets. 1 tablet containing gliclazide 80 mg corresponds to 0.5 tablets of Diabeton ® MR 60 mg. It is necessary to carefully monitor blood counts when transferring to Diabeton ® MR 60 mg. Transfer of a patient from other oral hypoglycemic drugs to Diabeton ® MR 60 mg. When transferring to Diabeton ® MR 60 mg, the dosage and half-life of the previous intake of the hypoglycemic drug should be taken into account. A transition period is usually not required. You should start with a dose of 30 mg, followed by dose adjustment (see “Initial dose and dose selection”). When switching from hypoglycemic sulfonylurea drugs with a long half-life, a break in treatment for several days may be required to prevent the cumulative effect of the two drugs and the development of hypoglycemia. Treatment with Diabeton ® MR 60 mg starts with a dose of 30 mg per day (0.5 tablets), followed by dose adjustment in compliance with the rules of treatment and dose selection (see above). Simultaneous use with other hypoglycemic drugs. Diabeton ® MR 60 mg can be used in combination with biguanides, alpha-glucosidase inhibitors or insulin. If adequate blood glucose control is not achieved in patients taking Diabeton ® MR 60 mg, simultaneous insulin therapy can be started under close medical supervision. Special groups of patients. Elderly patients. For patients over 65 years of age, the dosage regimen for Diabeton® MR 60 mg is the same as for patients under the age of 65 years. Patients with impaired renal function. For patients with mild to moderate renal insufficiency, the dosage regimen for Diabeton® MR 60 mg is the same as for patients with normal renal function, but the patient should be closely monitored. Risk factors for hypoglycemia: insufficient or poor nutrition; severe or insufficiently compensated disorders of the endocrine system (hypothyroidism, hypopituitarism and adrenocorticotropic insufficiency) cancellation of long-term corticosteroid therapy and / or therapy with high doses of corticosteroids; severe vascular disease (severe coronary heart disease, severe pathology of the carotid vessels, diffuse vascular disease). A minimum starting dose of 30 mg per day is recommended. To prevent complications of type II diabetes. According to the ADVANCE study, an intensive glycemic control strategy (HbAlc level ≥ 6.5%) should be followed. The intensive glycemic control strategy involves a gradual increase in the dose of Diabeton ® MR 60 mg to 120 mg per day. Dose escalation should be carried out under the control of HbAlc levels, following strict recommendations regarding diet and exercise, controlling the risk of hypoglycemia. It is also possible to add other hypoglycemic drugs such as metformin, acarbose, thiazolidinediones or insulin. Use during pregnancy and lactation Pregnancy. Oral hypoglycemic drugs (including Diabeton® MR 60 mg) should not be used during pregnancy. Experience with the use of gliclazide during pregnancy is limited (less than 300 cases of use by pregnant women), and data on the use of other sulfonylurea drugs is also limited. Animal studies have shown that gliclazide is not teratogenic. It is advisable to avoid taking gliclazide during pregnancy. Glucose control should be achieved before pregnancy is planned to reduce the risk of abnormalities associated with uncontrolled diabetes. When planning or immediately after the establishment of pregnancy, it is necessary to transfer a woman from oral hypoglycemic drugs to insulin. Breastfeeding. There are no data on the penetration of gliclazide or its metabolites into breast milk. Diabeton® MR 60 mg is contraindicated during lactation due to the possibility of neonatal hypoglycemia. A risk to neonates and infants cannot be excluded. Fertility. In preclinical studies, no effect on fertility or reproductive ability of female and male rats has been established. Interaction with other drugs When prescribing drugs, the simultaneous use of which can lead to hypo- or hyperglycemia (see below), it is necessary to warn the patient about the need for careful monitoring of blood glucose levels during treatment. It may be necessary to adjust the dose of the hypoglycemic drug during and after treatment with these drugs. Drugs, the simultaneous appointment of which may increase the risk of hypoglycemia. Contraindicated simultaneous use Miconazole (for systemic use, oral gel) enhances the hypoglycemic effect with the possible development of symptoms of hypoglycemia and even the development of coma. Quinolone enhances the hypoglycemic effect with the possible development of severe, deep, persistent hypoglycemia, the symptoms of which are difficult to control, or even the development of coma, in particular in elderly patients with renal insufficiency. The simultaneous use of Phenylbutazone (for systemic use) is not recommended, it enhances the hypoglycemic effect of sulfonylurea drugs (replaces their association with plasma proteins and / or reduces their excretion). Alcohol increases the risk of hypoglycemic reactions (due to inhibition of compensatory reactions), which can lead to hypoglycemic coma. Drinking alcohol and taking medications containing alcohol should be avoided. Combinations requiring caution When used simultaneously with one of the following drugs, in some cases, hypoglycemia may occur due to an increase in the hypoglycemic effect: other hypoglycemic drugs (insulins, acarbose, metformin, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists (GLP-1 )), ? blockers, fluconazole, ACE inhibitors (captopril, enalapril), H 2 receptor antagonists, MAO inhibitors, sulfonamides, clarithromycin and non-steroidal anti-inflammatory drugs. Drugs, the simultaneous appointment of which may increase the risk of hyperglycemia The simultaneous use of Danazol is not recommended, it has a diabetogenic effect. Combinations requiring caution Chlorpromazine (an antipsychotic), when used in high doses (more than 100 mg per day), increases blood glucose levels (due to a decrease in insulin release). Glucocorticoids (for systemic and local use: intra-articular, skin and rectal preparations) and tetracosactide increase blood glucose levels with the possible development of ketoacidosis (reduce carbohydrate tolerance). Intravenous: ritodrine, salbutamol, terbutaline increase blood glucose levels through? 2 – agonistic effect. St. John’s wort (Hypericum perforatum) preparations reduce the concentration of gliclazide. The importance of blood glucose control should be emphasized. Combinations to be considered Anticoagulants (eg warfarin, etc.). When used simultaneously with anticoagulants, sulfonylurea preparations can enhance the anticoagulant effect of the latter. If necessary, the dose of anticoagulants can be adjusted. Contraindications Hypersensitivity to gliclazide or other sulfonylurea drugs, sulfonamides or any component of the drug type I diabetes mellitus; diabetic coma and coma, diabetic ketoacidosis (in such cases, the use of insulin is recommended) severe liver or kidney failure treatment with miconazole; quinolone treatment; period of breastfeeding. Active ingredient: gliclazide; 1 tablet contains gliclazide 60 mg excipients: lactose, hypromellose, magnesium stearate, maltodextrin, colloidal silicon dioxide. Overdose Overdose of sulfonylurea drugs can cause hypoglycemia. Symptoms of moderate hypoglycemia (without loss of consciousness and without neurological symptoms) must be corrected by the intake of carbohydrates (sugar), dose adjustment of the hypoglycemic drug and / or diet. Careful monitoring of the patient should be continued until the clinician is confident that the patient is safe. Severe hypoglycemia with the development of coma, seizures or other neurological disorders requires emergency medical care with immediate hospitalization. When a hypoglycemic coma is diagnosed or coma is suspected, the patient should be given a rapid intravenous injection of 50 ml of a concentrated glucose solution (20% to 30%), followed by continuous administration of a less concentrated glucose solution (10%) at a frequency that will maintain the glucose level in blood more than 1 g / l. It is necessary to ensure constant monitoring of the patient. Depending on the patient’s condition, the doctor decides on further monitoring. Gliclazide has a high level of plasma protein binding, so the use of dialysis is ineffective. Side effects The most common adverse reaction when using gliclazide is hypoglycemia. As with other sulfonylurea drugs, gliclazide may cause hypoglycemia with irregular meals and especially if meals are skipped. Hypoglycemia may be accompanied by characteristic symptoms, such as: headache, severe hunger, nausea, vomiting, fatigue, sleep disturbance, agitation, aggressiveness, decreased concentration and attention, slow reactions, depression, confusion, impaired vision and speech, aphasia, tremor , paresis, impaired sensitivity, dizziness, feeling of impotence, loss of self-control, delirium, convulsions, shallow breathing, bradycardia, drowsiness and loss of consciousness, which can lead to coma and death. In addition, disturbances from the adrenergic system are possible: sweating, clammy skin, anxiety, tachycardia, arterial hypertension, palpitation, chest pain, arrhythmia. Usually, the symptoms of hypoglycemia disappear after the intake of carbohydrates (sugar). However, taking sweeteners in this case will not be effective. Experience with other sulfonylurea preparations suggests that even if the measures taken are effective, hypoglycemia may occur again. If the episode of hypoglycemia is severe or prolonged and the patient’s condition is temporarily controlled by sugar intake, emergency medical attention or even hospitalization is necessary. Gastrointestinal disorders including abdominal pain, nausea, vomiting, dyspepsia, diarrhea and constipation. Following the recommendations for taking the drug during breakfast will help to avoid or minimize the occurrence of these manifestations. The following side effects are less common. From the skin and subcutaneous tissue: rash, itching, urticaria, angioedema, erythema, maculopapular rash, bullous reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) and very rarely? drug-induced rashes with eosinophilia and systemic symptoms (DRESS). From the blood and lymphatic system: hematological disorders are rare and may include anemia, thrombocytopenia, leukopenia, granulocytopenia. Usually these phenomena disappear after discontinuation of treatment. From the digestive system: increased levels of liver enzymes (ALT, AST, alkaline phosphatase), hepatitis (isolated cases). In the event of cholestatic jaundice, treatment should be discontinued. These side effects usually disappear after discontinuation of the drug. On the part of the organs of vision: through changes in blood glucose levels, temporary visual disturbances may occur, especially at the beginning of treatment. Reactions characteristic of the sulfonylurea class: cases of erythrocytopenia, agranulocytosis, hemolytic anemia, pancytopenia, allergic vasculitis, hyponatremia, elevated liver enzymes and even liver dysfunction (for example, with cholestasis and jaundice), hepatitis with regression after discontinuation of sulfonylurea drugs or in some cases with subsequent life-threatening liver failure. Clinical researches. Serious adverse reactions were monitored during the ADVANCE study. In the group of patients with type II diabetes mellitus who were treated with an intensive glycemic control strategy, no previously undescribed adverse reactions were found. Several patients suffered severe hypoglycemia. Most episodes of hypoglycemia have been observed in patients on concomitant insulin therapy. Report suspected adverse reactions. Reporting suspected adverse reactions after drug registration is important. This will allow continued monitoring of the benefit/risk ratio. Healthcare professionals are requested to report suspected adverse reactions through the national reporting system. Storage conditionsDoes not require special storage conditions. Keep out of the reach of children. Buy Diabeton MB modified release tablets 60mg No. 15×4