Diadeon modified release tablets 60mg №15×4

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Diadeon tablets with modified highs 60mg in a 15×4 box
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White oblong tablets with a division line and the sign “DIA 60” squeezed out on both sides The main active substance Gliclazide Release form Tablets Dosage 60 mg Pharmacological action Pharmacodynamics Gliclazide is an oral antidiabetic hypoglycemic drug that differs from similar compounds by the presence of an N-containing heterocyclic ring with an endocyclic bond. Gliclazide lowers blood glucose levels by stimulating insulin secretion from the beta cells of the islets of Langerhans. After 2 years of treatment, an increase in the level of postprandial insulin and the secretion of C-peptide persisted. In addition to metabolic properties, gliclazide has hemovascular activity. Effect on insulin secretion In type 2 diabetes, gliclazide restores the first peak of insulin secretion in response to glucose intake and enhances the second phase of insulin secretion. A significant increase in insulin secretion is observed in response to stimulation due to the introduction of glucose or food intake. Hemovascular properties: Gliclazide reduces the risk of small vessel thrombosis by influencing two mechanisms that may be involved in the development of complications in diabetes mellitus: partial inhibition of platelet aggregation and adhesion and a decrease in platelet activation markers (beta-thromboglobulin, thromboxane B2). restoration of fibrinolytic activity of the vascular endothelium and an increase in the activity of tissue plasminogen activator. Indications Non-insulin-dependent diabetes (type 2) in adults when diet, exercise and weight loss are not sufficient to adequately control blood glucose levels. Dosing and Administration Tablets are taken orally once a day during breakfast, without chewing, drinking plenty of water. The daily dose of Diadeon can vary from 30 to 120 mg, i.e. 1/2 to 2 tablets. If you miss a dose, do not increase the dose the next day. As with any other hypoglycemic drug, the dose of the drug is adjusted depending on the patient’s individual metabolic response (blood glucose, HbA1c). Starting dose The recommended starting dose is 30 mg per day (half a tablet). With effective control of blood glucose levels, this dose can be used as maintenance therapy. If blood glucose levels are not adequately controlled, then the daily dose may be gradually increased to 60, 90 or 120 mg. The interval between each increase in dose should be at least 1 month, except for patients in whom, after two weeks of administration, the level of glucose in the blood has not decreased. In such cases, the dose may be increased at the end of the second week of administration. The maximum recommended dose is 120 mg per day. One 60 mg modified release tablet is equivalent to two 30 mg modified release tablets. The modified-release tablet of Diadeon is easily divisible, which allows you to adapt the dosage of the drug. Switching from 80 mg gliclazide tablets to 60 mg Diadeon modified-release tablets: One 80 mg gliclazide tablet is comparable to a 30 mg modified-release formula (i.e., with half a 60 mg Diadeon tablet), so with strict monitoring of performance blood such a transition can be carried out. Switching from one antidiabetic drug to Diadeon: Diadeon may be used to replace other oral antidiabetic drugs. When switching to Diadeon, the dosage and half-life of the previous antidiabetic drug should be taken into account. As a rule, no transition period is required. Reception should be started with a dose of 30 mg, with subsequent adjustment depending on the response of blood glucose levels, as described above. When switching from hypoglycemic drugs of the sulfonylurea group with an extended elimination period, a drug-free period of several days may be necessary to avoid the additive effect of the two drugs, which can lead to hypoglycemia. The transition to Diadeon should be carried out according to the procedure described for the start of treatment, i.e. the initial dosage is 30 mg / day, followed by a gradual increase in dose, depending on the metabolic response. Use in combination with other antidiabetic drugs: Diadeon may be given in combination with biguanides, alpha-glucosidase inhibitors or insulin. Patients whose blood glucose levels are not adequately controlled by Diadeon may be given insulin therapy under strict medical supervision. Special groups of patients Elderly patients: correction of the drug dosing regimen for patients over 65 years of age is not required. Patients with impaired renal function: Patients with mild to moderate impaired renal function may be given the same dosage as patients with normal renal function, under close medical supervision. These recommendations have been confirmed by clinical studies. Patients at risk of developing hypoglycemia: with insufficient or malnutrition, with severe or poorly compensated endocrine disorders (hypopituitarism, hypothyroidism, adrenocorticotropic hormone deficiency), after discontinuation of prolonged and / or high-dose corticosteroid therapy, with severe vascular diseases (severe coronary disease, severe impaired patency of the carotid arteries, diffuse vascular disorders). It is recommended to start treatment with a minimum daily dose of 30 mg. Use in children There are no data on the efficacy and safety of the drug in children and adolescents under the age of 18 years. Pregnancy and lactation Pregnancy: There is no experience with gliclazide during human pregnancy or there are limited data (less than 300 pregnancy outcomes), although there are some data on other drugs of the sulfonylurea group. In animal studies, gliclazide has not been shown to be teratogenic. As a precautionary measure, the use of gliclazide during pregnancy should be avoided. Diabetes should be controlled before conception to reduce the risk of congenital abnormalities associated with uncontrolled diabetes. Oral hypoglycemic agents are not suitable; insulin is the first-line treatment for diabetes during pregnancy. It is recommended to switch from oral hypoglycemic therapy to insulin before conception or immediately after the fact of pregnancy has been confirmed. Lactation: It is not known whether gliclazide and its metabolites are excreted in milk. Given the risk of hypoglycemia in the newborn, this drug is contraindicated in breastfeeding. Fertility: In preclinical studies, no effect on fertility and reproductive function was observed in male and female rats. Influence on the ability to drive a car and potentially dangerous mechanisms Diadeone affects or slightly affects the ability to drive a car and potentially dangerous mechanisms. However, patients should be aware of the symptoms of hypoglycemia and should exercise caution when driving and engaging in other potentially hazardous activities that require increased concentration and psychomotor speed, especially at the beginning of therapy. Precautions Hypoglycemia: This therapy should only be used in patients with guaranteed regular meals (including breakfast). The importance of regular carbohydrate intake is due to the increased risk of hypoglycemia when eating is delayed, insufficient, or low in carbohydrates. The risk of hypoglycemia increases with a low-calorie diet, after prolonged or excessive exercise, alcohol consumption, or in the case of combined use of several hypoglycemic drugs. Hypoglycemia may develop after taking drugs of the sulfonylurea group. Sometimes it is severe and protracted, requiring the patient to be hospitalized and administered glucose for several days. To reduce the risk of hypoglycemic attacks, careful selection of patients, the correct choice of dose and clear recommendations for taking it are necessary. Factors that increase the risk of developing hypoglycemia: refusal or (especially in older patients) inability to follow the instructions of a doctor, insufficient or improper nutrition, irregular intake or skipping meals, periods of fasting or changes in diet, imbalance in exercise and carbohydrate intake, kidney failure, severe liver failure, an overdose of Diadeon, some endocrine disorders: thyroid dysfunction, hypopituitarism and adrenal insufficiency, concomitant use of certain other drugs. Insufficiency of liver or kidney function: The pharmacokinetic and / or pharmacodynamic parameters of gliclazide may change in patients with hepatic or severe renal insufficiency. In such patients, episodes of hypoglycemia may be longer, which requires the adoption of adequate measures. Informing patients: Patients and their families should be informed about the dangers of hypoglycemia, its symptoms, treatment methods and factors predisposing to the development of this complication. The patient should be informed of the importance of diet, regular exercise and regular monitoring of blood glucose levels. Poor blood glucose control: The effectiveness of blood glucose control in a patient receiving antidiabetic therapy may be reduced by the following factors: St. John’s wort (Hypericum perforatum), fever, trauma, infection, or surgery. In some cases, insulin administration may be required. The hypoglycemic efficacy of any oral antidiabetic agent, including gliclazide, decreases over time in many patients: this may be due to the progression of diabetes or a weakening of the response to the drug. This phenomenon is known as secondary failure of therapy, in contrast to its primary failure already at the very beginning of the use of the primary line of treatment. The conclusion about the secondary lack of effect can be made only after an adequate dose adjustment and subject to the patient’s diet. Abnormal blood glucose levels Abnormal blood glucose levels, including hypoglycemia and hyperglycemia, have been reported in diabetic patients receiving fluoroquinolones, especially in elderly patients. All patients receiving both Diadeon and a drug of the fluoroquinolone group are advised to carefully monitor blood glucose levels. Laboratory Tests: Measurement of glycated hemoglobin (or fasting venous plasma glucose) is recommended when assessing blood glucose control. Self-monitoring of blood glucose levels may also be helpful. The administration of sulfonylurea drugs to patients with G6PD (glucose-6-phosphate dehydrogenase) deficiency can lead to hemolytic anemia. Because gliclazide belongs to the sulfonylurea chemical class, caution should be exercised when prescribing it to patients with G6PD deficiency and consideration should be given to alternative treatment with another drug class. Special Information on Excipients: Diadeon contains lactose and is therefore not recommended for use in patients with hereditary lactose intolerance, Lapp galactosemia or glucose-galactose malabsorption. Children The safety and efficacy of Diadeon in children under 18 years of age have not been established. Interaction with other drugs The risk of developing hypoglycemia increases under the influence of the following drugs Contraindicated combinations: with miconazole (systemic administration or application to the oral mucosa in the form of a gel): the hypoglycemic effect is enhanced, symptoms of hypoglycemia may appear and even the onset of hypoglycemic coma. Not recommended combinations: with phenylbutazone (systemic administration): enhances the hypoglycemic effect of sulfonylurea drugs (since it replaces their bonds with blood plasma proteins and / or reduces their excretion from the body). It is preferable to prescribe another anti-inflammatory agent, as well as to warn the patient and explain to him the importance of self-monitoring of blood glucose levels. If necessary, the dose should be adjusted during and after anti-inflammatory drug therapy. with alcohol: alcohol enhances the hypoglycemic effect (by suppressing compensatory reactions), which can lead to hypoglycemic coma. Drinking alcohol and taking medications containing alcohol should be avoided. Combinations requiring caution: An increase in the hypoglycemic effect and, therefore, in some cases, hypoglycemia, is possible when taking one of the following drugs: other antidiabetic drugs (insulins, acarbose, metformin, thiazolidinidiones, dipeptidyl peptidase-4 inhibitors, GLP-1 agonists), beta-blockers, fluconazole, angiotensin-converting enzyme inhibitors (cappropril, enalapril), H2 receptor antagonists, MAO inhibitors, sulfonamides, clarithromycin and non-steroidal anti-inflammatory drugs. The following foods may cause an increase in blood glucose. Not recommended combinations: with danazol: danazol has a diabetogenic effect. If this drug cannot be avoided, warn the patient and explain the importance of monitoring blood and urine glucose levels. Sometimes it is necessary to adjust the dose of the antidiabetic agent during and after danazol therapy. Combinations requiring caution: with chlorpromazine (neuroleptic): in high doses (>100 mg chlorpromazine per day), it increases blood glucose levels (decrease in insulin secretion). Warn the patient about this and explain to him the importance of self-monitoring of glucose levels. It may be necessary to adjust the dose of the antidiabetic drug during and after antipsychotic therapy. with glucocorticoids (systemic and local use: intra-articular, sub- or cutaneous, rectal); and with tetracosactide: these drugs increase blood glucose levels and can cause ketosis (decrease in carbohydrate tolerance under the influence of glucocorticoids). Warn the patient about this and explain to him the importance of self-monitoring of glucose levels, especially at the beginning of therapy. It may be necessary to adjust the dose of the antidiabetic drug during and after glucocorticoid therapy. with ritodrine, salbutamol, terbutaline: (intravenous) increase in blood glucose under the action of beta-2 agonists. Emphasize the importance of self-monitoring blood glucose levels. If necessary, switch the patient to insulin. with preparations of St. John’s wort (Hypericum perforatum): St. John’s wort (Hypericum perforatum) reduces the concentration of gliclazide. Emphasize the importance of self-monitoring blood glucose levels. Combinations requiring caution: fluoroquinolones: when diadeon is used concomitantly with fluoroquinolones, the patient should be warned about the possibility of abnormal blood glucose levels and emphasize the importance of self-monitoring of glucose levels. Combinations to consider Anticoagulants (eg, warfarin, etc.): Concomitant therapy with drugs of the sulfonylurea group may increase the anticoagulant effect. Adjustment of anticoagulant therapy may be required. Contraindications – Hypersensitivity to gliclazide, any other of the excipients, or other drugs of the sulfonylurea group, sulfonamides; – type 1 diabetes; – diabetic ketoacidosis, precoma and diabetic coma; – severe renal or hepatic insufficiency: in such cases it is recommended to use insulin; – miconazole therapy; – lactation. Composition One tablet contains: active substance: gliclazide 60 mg; excipients: lactose monohydrate, maltodextrin, hypromellose, magnesium stearate, anhydrous colloidal silicon dioxide. OverdoseSymptoms: an overdose of drugs of the sulfonylurea group can cause hypoglycemia, loss of consciousness, hypoglycemic coma. Treatment: Symptoms of moderate hypoglycemia, without loss of consciousness or signs of neurological disorders, should be controlled by carbohydrate intake, dose adjustment and / or dietary changes. Careful monitoring of the patient’s condition is necessary until the doctor is satisfied that nothing threatens the patient’s health. Severe hypoglycemic episodes accompanied by coma, seizures, or other neurological disturbances should be treated as an emergency, with immediate hospitalization of the patient. If a hypoglycemic coma occurs or is suspected, the patient should be given a rapid infusion of 50 ml of concentrated glucose solution (20-30% intravenously) and then continue infusion with a more dilute glucose solution (10%) at a rate that will maintain the blood glucose concentration at level of more than 1 g/l. Careful monitoring of the patient’s condition is necessary, and, depending on his condition at the end of the attack, the doctor decides whether to continue monitoring or cancel it. Dialysis is not effective due to the strong binding of gliclazide to blood proteins. Side effects The following undesirable effects have been reported with gliclazide. The most common adverse reaction with gliclazide is hypoglycemia. Hypoglycemia As with other drugs of the sulfonylurea group, Diadeon can cause hypoglycemia in case of irregular meals and especially if meals are skipped. Possible symptoms of hypoglycemia include: headache, severe hunger, nausea, vomiting, fatigue, sleep disturbances, agitation, aggressiveness, decreased concentration, decreased ability to assess the situation, slow reactions, depression, clouding of consciousness, visual and speech disturbances, aphasia , tremor, paresis, impaired perception, dizziness, feeling of helplessness, loss of self-control, delirium, convulsions, shallow breathing, bradycardia, drowsiness and loss of consciousness, which can result in coma and death. In addition, signs of adrenergic dysregulation such as increased sweating, clammy skin, anxiety, tachycardia, high blood pressure, palpitations, angina pectoris, and cardiac arrhythmia may develop. Usually these clinical manifestations disappear after the intake of carbohydrates (sugar). At the same time, artificial sweeteners are ineffective. Experience with other sulfonylurea derivatives indicates the possibility of recurrence of hypoglycemia, even in cases where the measures taken to eliminate it initially seemed effective. Severe and prolonged episodes of hypoglycemia, and even if it can be temporarily eliminated by taking sugar, urgent medical attention or even hospitalization is necessary. Other adverse events: Gastrointestinal disorders: abdominal pain, nausea, vomiting, dyspepsia, diarrhea and constipation. Taking gliclazide with breakfast avoids or minimizes these effects. The following adverse events have been reported less frequently: Skin and subcutaneous tissue disorders: rash, pruritus, urticaria, angioedema (angioedema), erythema, maculopapular rashes, bullous reactions (such as Stevens-Johnson syndrome and toxic epidermal necrolysis), in exceptional cases cases of drug rash with eosinophilia and systemic manifestations (DRESS). Blood and lymphatic system disorders: Hematological changes are rare. Among them: anemia, leukopenia, thrombocytopenia, granulocytopenia. They are usually reversible upon discontinuation of the drug. Liver and biliary tract disorders: increased activity of liver enzymes (AST, ALT, alkaline phosphatase), hepatitis (isolated cases). Stop treatment if cholestatic jaundice occurs. The following adverse events usually disappear after treatment is stopped. On the part of the organ of vision: transient visual disturbances caused by a change in the concentration of glucose in the blood are possible, especially at the beginning of treatment. Effects inherent in this pharmacological group: against the background of taking other sulfonylurea derivatives, cases of erythrocytopenia, agranulocytosis, hemolytic anemia, pancytopenia, allergic vasculitis, hyponatremia have been described. There have been cases of increased levels of liver enzymes and even liver dysfunction (eg, cholestasis and jaundice) and hepatitis, which disappeared after discontinuation of the sulfonylurea, but in some cases led to life-threatening liver failure. Reporting Suspected Adverse Reactions Reporting suspected adverse reactions after drug registration is important. This allows continued monitoring of the benefit/risk ratio of the drug. Storage conditionsStore at temperatures below 30?C. Keep out of the reach of children. Buy Diadeon modified release tablets 60mg #15×4 Price for Diadeon modified release tablets 60mg #15×4