Name:
Glibenclamide-Belmed tabl 0.005 No. 10×5
Description:
Tablets of white, almost white, or white with a beige tinge, flat-cylindrical, with a bevel. The main active ingredient Glibenclamide Release form Tablets Dosage 0.005 Pharmacological action Glibenclamide has a hypoglycemic effect. Specifically stimulates the beta cells of the islet apparatus, enhances the secretion of insulin by the pancreas. Activity is manifested mainly with preserved insulin-synthetic function of the pancreas. Restores the physiological sensitivity of beta cells to glycemia. Potentiates the effect of insulin (endogenous and exogenous), as it increases the number of insulin receptors, improves insulin-receptor interaction and restores post-receptor signal transduction. It increases the sensitivity of insulin receptors to insulin in peripheral tissues and causes extra-pancreatic effects: it increases the utilization of glucose in the liver and muscles, stimulates the formation of glycogen in them, and inhibits lipolysis in adipose tissue. Extrapancreatic effects are observed with prolonged use of glibenclamide. Indications for use Type 2 diabetes mellitus in adults with the impossibility of correcting hyperglycemia with diet, reducing excess body weight, and physical activity. Method of administration and doses The appointment of the drug Glibenclamide-Belmed and the change in dosage should be carried out by a doctor and accompanied by an appropriate dietary adjustment. The dose should correspond to the results of the analysis of the state of metabolism (blood and urine glucose levels) and is based on the achievement of the desired blood glucose level. Tablets should be taken before meals with plenty of liquid at the same time. It is important not to skip meals after taking the medicine. If you miss the next dose, you should not take a double dose to make up for the forgotten one, you should simply continue taking the drug according to the regimen recommended by your doctor. All questions regarding a possible violation of the recommended regimen (missing a dose, inability to take it at the set time, etc.) should be discussed by the doctor and the patient in advance. The duration of treatment depends on the dynamics of the development of the disease and is determined by the doctor. The patient’s metabolic status should be regularly reviewed. First of all, it is necessary to regularly monitor the level of glucose in the blood and urine, in addition, to additionally determine such parameters as the level of glycated hemoglobin (HbA1c) and / or fructosamine, as well as other indicators (for example, the level of blood lipids). Since the tablet of the drug Glibenclamide-Belmed is not divided into two equal parts, if it is necessary to use glibenclamide at a dose of less than 5 mg, it is recommended to use a drug from another manufacturer that provides the possibility of such a dosage. Initial dose and its adjustment Treatment begins with the smallest effective dose, with its gradual increase. This recommendation is especially relevant for patients weighing less than 50 kg. Usually start with a dose of 2.5 mg (see also “Special groups of patients”). Depending on the metabolic state, the dose is increased by 2.5 mg at intervals of one to two weeks until the required therapeutic dose is reached, which ensures the proper level of glucose in the blood. The maximum therapeutic dose of glibenclamide is 15 mg. Exceeding this dose is possible only in exceptional cases, but, as a rule, this does not lead to an improvement in the result of treatment. Daily doses up to 2 tablets (10 mg) may be taken as a single dose before breakfast. The total daily dose exceeding 10 mg should be divided into two doses (before breakfast and before dinner) in a ratio of 2:1. Secondary dose adjustment Consideration should be given to adjusting the dose in case of changes in body weight, habits and lifestyle, other factors that increase the risk of developing hypo- or hyperglycemia. Changing from another oral antidiabetic agent to glibenclamide Changing to another oral antidiabetic agent should be done with caution. If the patient has been taking sulfonylureas or biguanides, prior treatment should be discontinued 24 hours prior to taking glibenclamide to avoid a cumulative effect and hypoglycemia. Glibenclamide is prescribed according to the above scheme in the recommended initial dose above. Special groups of patients In elderly patients with impaired liver and / or kidney function, dose increases should be carefully monitored (see “Precautions”). In patients with liver disease or renal insufficiency, lower initial and maintenance doses may be required (see “Contraindications”). Glibenclamide is not used in children and adolescents under 18 years of age due to the lack of adequate data on efficacy and safety. Use during pregnancy and lactation text Precautions It is mandatory to eat food no later than 1 hour after taking the drug. During therapy, regular monitoring of glucose in the blood and urine is necessary. With physical and emotional overstrain, a change in diet, a dose adjustment of the drug is necessary. Major surgical interventions and injuries, extensive burns, infectious diseases with a febrile syndrome may require the abolition of oral hypoglycemic drugs and the appointment of insulin. When treating with glibenclamide, it is mandatory to avoid alcohol intake (possible disulfiram-like reaction and severe hypoglycemia), prolonged exposure to the sun. Clinical manifestations of hypoglycemia can be masked when taking ?-adrenergic blockers, clonidine, reserpine, guanethidine. It is used with caution in febrile conditions, dysfunction of the adrenal glands, thyroid gland, and chronic alcoholism. The physician and patient must be aware of the risk of hypoglycemia. Factors that contribute to the development of hypoglycemia: unwillingness or (more often in elderly patients) inability to cooperate, malnutrition, irregular or skipping meals, imbalance between physical activity and carbohydrate intake, changes in diet, impaired renal function and severe liver failure , overdose of glibenclamide, concomitant use of certain drugs. If necessary, consideration should be given to changing the dose of Glibenclamide-Belmed or the entire therapy. Hypoglycemia can almost always be brought under control quickly with carbohydrate intake (see “Overdose”). Caution should also be exercised in the presence of cardiovascular risk factors (hypertension, smoking). Hypoglycemia. Hypoglycemia is difficult to recognize in patients with autonomic neuropathy in the elderly. In patients with reduced function of the thyroid gland, pituitary gland or adrenal cortex, special care is required. Patients with obvious signs of cerebral atherosclerosis and patients with whom contact is difficult, in general, are at greater risk of developing hypoglycemia. Prolonged abstinence from food intake, insufficient supply of carbohydrates, unusual physical activity, diarrhea or vomiting increase the risk of hypoglycemia. The intake of drugs that have an effect on the central nervous system, and ?-adrenergic blockers, as well as autonomic neuropathy, can mask symptoms that are precursors of hypoglycemia. Regular abuse of laxatives can lead to a deterioration in the state of metabolism. If the treatment plan is not followed, the hypoglycemic effect of glibenclamide is still insufficient, or in the presence of particularly stressful situations, the blood sugar level may increase. Symptoms of hyperglycemia can include: feeling very thirsty, dry mouth, frequent urination, itchy and/or dry skin, fungal or skin infections, and reduced performance. hemolytic anemia. In patients deficient in glucose-6-phosphate dehydrogenase, treatment with sulfonylurea drugs can cause hemolytic anemia. Since glibenclamide belongs to this class of sulfonylurea derivatives, it should be used with caution in patients with deficiency of glucose-6-phosphate dehydrogenase in the body and the possibility of alternative methods of treatment should be taken into account. Epidemiological studies show that the use of glibenclamide compared with treatment with metformin or gliclazide is associated with an increased risk of cardiovascular mortality (risk ratio from 1.14 to 2.91). This risk is highest in patients with diagnosed coronary heart disease. This medicinal product contains lactose and therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose/galactose malabsorption should not take this medicinal product. Features of use in the elderly. Elderly patients are at risk of developing prolonged hypoglycemia. Therefore, increasing the dose in this category of patients should be carried out with caution, under the control of blood glucose levels. In the initial stage of therapy, if possible, it is preferable for elderly patients to prescribe hypoglycemic agents with a shorter duration of action. Features of use in persons with liver and kidney diseases. In patients with impaired liver or kidney function, it is recommended to use the lowest dose of the drug that has a therapeutic effect, due to the risk of hypoglycemia. The drug is contraindicated in persons with severe renal and / or hepatic insufficiency. Children. Due to the lack of sufficient clinical experience, this drug is not used in children and adolescents. Use during pregnancy and lactation Use during pregnancy and lactation is contraindicated. Oral antidiabetic drugs are not able to regulate blood glucose with a high degree of reliability, so during pregnancy, insulin is used to treat diabetes. Influence on the ability to drive vehicles and other potentially dangerous mechanisms Hypoglycemia can reduce the patient’s reaction rate, therefore, during the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. Interaction with other drugs Glibenclamide is metabolized by cytochrome CYP2C9, which should be taken into account when it is used simultaneously with inducers or inhibitors of CYP2C9. The drug may enhance or weaken the action of coumarin derivatives. Urine acidifying agents (ammonium chloride, calcium chloride, ascorbic acid in large doses) enhance the effect of glibenclamide. Systemic antifungals (azole derivatives), fluoroquinolones, tetracyclines, clarithromycin, chloramphenicol, para-aminosalicylic acid, beta-blockers, angiotensin-converting enzyme inhibitors, non-steroidal anti-inflammatory drugs, antidepressants (eg, fluoxetine, MAO inhibitors), clofibrate, bezafibrate, probenecid, paracetamol, ethionamide, anabolic steroids and male sex hormones, pentoxifylline, disopyramide, fenfluramine, cyclophosphamide, sulfonamides, insulin potentiate hypoglycemia. Barbiturates, isoniazid, cyclosporine, phenothiazines, diazoxide, glucocorticoid and thyroid hormones, estrogens, gestagens, phenytoin, glucagon, adrenomimetic drugs, lithium salts, nicotinic acid derivatives, calcium channel blockers and saluretics weaken the hypoglycemic effect. Rifampicin accelerates inactivation and reduces the effectiveness of glibenclamide. With simultaneous use with pentamidine in isolated cases, a pronounced decrease or increase in the concentration of glucose in the blood is possible. Blockers of H2-histamine receptors, clonidine, reserpine, single or chronic alcohol consumption can both enhance and weaken the hypoglycemic effect of glibenclamide. In patients receiving glibenclamide simultaneously with bosentan, an increase in the activity of liver enzymes is observed, since both drugs inhibit the transfer of bile acids from liver cells, which leads to their intracellular accumulation and an increase in their cytotoxic effect. Medicines that inhibit bone marrow hematopoiesis increase the risk of myelosuppression. Contraindications Glibenclamide-Belmed should not be taken: in case of hypersensitivity to the active substance or excipients; with hypersensitivity to other sulfonylurea derivatives, sulfonamides, sulfonamide diuretics and probenecid, since in such cases cross-hypersensitivity may occur; in cases of diabetes mellitus requiring insulin therapy: insulin-dependent diabetes mellitus (type 1), complete secondary absence of the effect of glibenclamide therapy in type 2 diabetes mellitus, metabolic acidosis, precoma or diabetic coma, surgical resection (removal) of the pancreas; with severe violations of liver function; with severe violations of kidney function; during pregnancy and lactation; while taking bosentan. Composition Each tablet contains: active substance – glibenclamide – 5 mg; excipients: lactose monohydrate, povidone K-25 (E-1201), magnesium stearate (E-470), potato starch. Overdose In absolute or relative overdose, symptoms occur due to hypoglycemia (possible signs, see the “Side effect” section). Treatment Rapid ingestion of carbohydrates such as grapes, 2-4 sugars (perhaps held between cheek and teeth), sweet orange juice, or other high carbohydrate foods. Hypoglycemia cannot be controlled with artificial sweeteners. In case of loss of consciousness – intravenous administration of 40-100 ml of 20% glucose solution, followed by infusion of 5-10% glucose solution or administration of glucagon 0.5-1 mg intravenously or intramuscularly. With prolonged hypoglycemia, it is necessary to monitor the patient’s condition for several days, to carry out symptomatic therapy. Dialysis is not used due to the high degree of binding of glibenclamide to plasma proteins. Side effect Classification of undesirable adverse reactions according to the frequency of development: very often (? 1/10), often (? 1/100 – < 1/10), infrequently (? 1/1000 - < 1/100), rarely (? 1/10000 - < 1/1000), very rare (< 1/10000), unknown (frequency cannot be estimated due to lack of data). On the part of the organ of vision: very rarely - visual impairment and accommodation. Gastrointestinal disorders: often - nausea, diarrhea; infrequently - vomiting, bloating and abdominal pain. On the part of the liver and biliary tract: in some cases, the activity of liver enzymes may increase, symptoms of impaired liver function (eg, cholestasis, jaundice), hepatitis may occur. Although these phenomena usually regress after discontinuation of glibenclamide, in some cases they can lead to the development of life-threatening liver failure. Blood and lymphatic system disorders: rarely - thrombocytopenia, thrombocytopenic purpura, leukocytopenia; very rarely - hypoplastic or hemolytic anemia, leukopenia, erythropenia, eosinophilia, agranulocytosis, pancytopenia, bone marrow aplasia, bleeding disorders. Immune system disorders: rarely - skin rashes, itching, urticaria, skin flushing, erythema nodosum; very rarely - angioedema, petechiae, shortness of breath, lowering blood pressure, anaphylactic shock, life-threatening allergic vasculitis. Possible cross-allergy to sulfonamides, sulfonamide derivatives and probenecid. If skin reactions occur, seek medical attention immediately. Metabolic and nutritional disorders: often - hypoglycemia, weight gain; very rarely - hyponatremia, disulfiram-like reactions (vomiting, feeling of heat in the skin of the face and upper body, tachycardia). Other: very rarely - tardive cutaneous porphyria, fever, arthralgia, photosensitivity. Hypoglycemia is the most common adverse effect of glibenclamide therapy. When treated with glibenclamide, its course can become protracted and lead to severe hypoglycemia with life-threatening coma. With very masked hypoglycemia (with autonomic neuropathy or concomitant therapy with sympatholytics), typical symptoms-precursors of hypoglycemia may be weakened or absent. Hypoglycemia is defined as a drop in blood sugar below 50 mg/dl. Harbinger symptoms that may draw the attention of the patient or his environment to an excessive drop in blood sugar are the following: sudden sweating, palpitations, trembling, hunger, anxiety, goosebumps in the mouth, pallor, headache, drowsiness, sleep disturbance, fearfulness, lack of confidence in movements, transient neurological symptoms of loss (eg speech and visual disturbances, paralysis or sensory disturbances). With progressive hypoglycemia, the patient may lose control of his condition and lose consciousness. In this case, the skin is most often damp and cold, and there is also a tendency to cramps. Mild hypoglycemia in a diabetic patient can be corrected by eating sugar or foods or drinks that are high in sugar. Therefore, patients with diabetes should always carry 20 grams of glucose with them. If hypoglycemia cannot be eliminated immediately, then you need to urgently call a doctor. In the event of the above adverse reactions or adverse reactions not listed in these instructions for medical use of the drug, you should consult a doctor. Storage conditionsKeep in a place protected from light at a temperature not exceeding 25°C. Keep out of the reach of children. Buy Glibenclamide-Belmed tablets 5mg No. 10x5
INN | GLIBENCLAMID |
---|---|
The code | 60 469 |
Barcode | 4 810 133 002 132 |
Dosage | 5mg |
Active substance | Glibenclamide |
Manufacturer | Belmedpreparaty RUE, Belarus |
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