Glibenclamide tablets are indicated for non-insulin-dependent diabetes in adults (type II diabetes mellitus), if other measures, such as strict adherence to a diet, weight loss, and sufficient physical activity, have not led to satisfactory correction of blood glucose levels.
Composition
Active ingredient: 1 tablet contains glibenclamide 5 mg;
Excipients: mannitol (E 421), povidone, calcium stearate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate.
Contraindication
Hypersensitivity to the components of the drug, other sulfonylurea drugs, sulfonamides, sulfonamide diuretics and probenecid. In cases of diabetes mellitus, and when insulin treatment is required: insulin-dependent diabetes mellitus (type I diabetes mellitus), complete secondary ineffectiveness of glibenclamide therapy in type II diabetes mellitus, metabolism with a bias towards acidosis, coma or diabetic coma, condition after pancreatic resection. Severe liver dysfunction. Severe kidney dysfunction. Use with bosentan.
Method of application
The drug should be taken only as prescribed by a doctor and necessarily with diet correction. The dosage depends on the results of metabolic status tests (blood and urine sugar levels). Blood and urine sugar levels should be monitored when switching from another hypoglycemic agent.
Application features
Pregnant women
Contraindicated.
Children
Glibenclamide is not used in pediatric practice.
Drivers
Hypoglycemia may reduce the patient's ability to concentrate and react.
Overdose
A single overdose or the use of slightly increased doses for a long time can lead to severe prolonged hypoglycemia, which is life-threatening. In case of overdose and intentional abuse of the drug, the development of prolonged hypoglycemia is expected, which tends to normalize after successful initial therapy of this condition. Symptoms of overdose (hypoglycemic shock): sudden sweating, rapid heartbeat, tremor, feeling of hunger, anxiety, paresthesias in the mouth, pale skin, headache, sleep disorders (drowsiness, sleep disturbances), timidity, unsteadiness of movements, reversible neurological deficits (speech and vision disorders, the appearance of paralysis or sensitivity disorders). With progressive hypoglycemia, the patient may lose control of his condition and lose consciousness (hypoglycemic shock). In such cases, the skin is moist and cold to the touch, tachycardia, hyperthermia, motor agitation, hyperreflexia, paresis and a positive Babinski reflex occur, and convulsions may occur.
Side effects
Metabolism and nutrition: hypoglycemia is the most common side effect associated with taking glibenclamide, weight gain. This undesirable effect of glibenclamide therapy can be prolonged and lead to the development of severe hypoglycemia, accompanied by hypoglycemic coma with a threat to life. From the organ of vision: visual impairment and accommodation, especially at the beginning of treatment. Gastrointestinal tract: nausea, feeling of fullness of the stomach, vomiting, abdominal pain, diarrhea, belching, metallic taste in the mouth. These complaints are temporary and do not require discontinuation of the drug. From the liver and gallbladder: temporary increase in AST and ALT, alkaline phosphatase, drug-induced hepatitis, intrahepatic cholestasis, which may be caused by an allergic reaction of the hyperergic type of liver cells. These disorders are reversible after discontinuation of the drug, but can lead to life-threatening liver failure. From the skin and subcutaneous tissue: itching, urticaria, erythema nodosum, crusted or maculopapular rash, purpura, photosensitivity. These hypersensitivity reactions are reversible, but very rarely can develop into life-threatening conditions, accompanied by shortness of breath and a decrease in blood pressure, very rarely, up to the development of shock; generalized hypersensitivity reactions, accompanied by skin rash, arthralgia, fever, proteinuria and jaundice; allergic vasculitis, is life-threatening. If skin reactions occur, you should consult a doctor. From the blood and lymphatic system: thrombocytopenia, leukopenia, erythrocytopenia, granulocytopenia, up to the development of agranulocytosis; pancytopenia, hemolytic anemia. Anemia, eosinophilia, aplastic anemia have been reported with sulfonamides. These changes in the blood picture are reversible after drug withdrawal, but very rarely can be life-threatening.
Interaction
When used simultaneously with other medications, its effect may be enhanced or weakened, so you should consult a doctor about the use of other medications.
In patients receiving glibenclamide concomitantly with bosentan, an increased incidence of elevated liver enzymes was observed. Both glibenclamide and bosentan inhibit the function of the pump that removes bile salts from the cell. This leads to intracellular accumulation of bile salts, which have a cytotoxic effect, so this combination should not be used.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life - 3 years.
