Description
Product form
coated tablets
Packing
30 pcs.
Pharmacological action
Glucovans is a combined hypoglycemic drug for oral use. Glucovans is a fixed combination of two oral hypoglycemic agents of various pharmacological groups. Metformin belongs to the group of biguanides and reduces serum glucose by increasing the sensitivity of peripheral tissues to insulin and enhancing glucose uptake. Metformin reduces the absorption of carbohydrates from the digestive tract and inhibits gluconeogenesis in the liver. It also has a beneficial effect on the lipid composition of the blood, reducing the level of total cholesterol, LDL and TG. Glibenclamide refers to sulfonylurea derivatives of the second generation. The glucose level when taking glibenclamide decreases as a result of stimulation of insulin secretion by β-cells of the pancreas.
Indications
Type 2 diabetes mellitus in adults:
– As a second-line drug for the ineffectiveness of diet therapy, exercise and previous therapy with metformin or glibenclamide.
– To replace previous therapy with two drugs (metformin and glibenclamide) in patients with a stable and well-controlled level of glycemia.
Contraindications
– Type 1 diabetes mellitus.
– Diabetic ketoacidosis.
– Diabetic precoma, diabetic coma.
– Renal failure or impaired renal function (serum creatinine levels above 135 mmol / L for men and above 110 mmol / L for women).
– Acute conditions that can lead to a change in kidney function: dehydration, severe infection, shock, intravascular administration of iodine-containing contrast agents.
– Acute or chronic diseases that are accompanied by tissue hypoxia: heart failure, respiratory failure, recent myocardial infarction, shock.
– Liver failure.
– Porfiry.
– Pregnancy.
– Lactation (breastfeeding).
– Concurrent use of miconazole.
– Conditions requiring insulin therapy, including: infectious diseases, major surgical interventions, injuries, extensive burns.
– Impaired liver function.
– Chronic alcoholism, acute alcohol intoxication.
– Lactic acidosis (including a history of).
– Use for at least 48 hours before and within 48 hours after conducting radioisotope or x-ray studies with the introduction of an iodine-containing contrast medium.
– Compliance with a low-calorie diet (less than 1000 cal / day).
– Hypersensitivity to metformin, glibenclamide or other sulfonylureas, as well as excipients.
It is not recommended to use the drug in people over 60 years old who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis in them.
Caution should be used in the following cases:
– Fever.
– Diseases of the thyroid gland (with impaired function).
– Hypofunction of the anterior pituitary or adrenal cortex.
– Alcoholism.
Use during pregnancy and lactation
During treatment with Glucovans, the patient should inform the doctor about the planned pregnancy and the onset of pregnancy. When planning pregnancy, as well as in the event of pregnancy during the period of taking Glucovans, the drug should be discontinued and treatment with insulin should be prescribed. Glucovans is contraindicated in breastfeeding, as there is no evidence of its ability to pass into breast milk.
Special instructions
During the treatment with Glucovans, it is necessary to regularly monitor the level of glucose in the blood on an empty stomach and after eating. The patient should be warned that if vomiting and abdominal pain accompanied by muscle cramps or general malaise appear during Glucovans treatment, then the drug should be discontinued and you should immediately consult a doctor, since these symptoms may be signs of lactic acidosis. The patient should inform the doctor about the appearance of a bronchopulmonary infection or urinary tract infection. 48 hours before surgery or iv administration of an iodine-containing radiopaque agent, glucovans should be discontinued. Glucovans treatment is recommended to be resumed after 48 hours. Alcohol is not recommended during treatment.
Use in cases of impaired renal function: the drug is contraindicated in cases of renal failure or impaired renal function (serum creatinine levels above 135 mol / L for men and above 110 mol / L for women).
Influence on the ability to drive vehicles and control mechanisms: during treatment with Glucovans, one should not engage in activities that require an increased concentration of attention and speed of psychomotor reactions.
Composition
1 coated tablet contains: metformin hydrochloride 500 mg, glibenclamide 5 mg.
Excipients: povidone K30, magnesium stearate, croscarmellose sodium, microcrystalline cellulose, Opadry (Opadri) 31F22700, purified water.
Dosage and administration of
The dose of the drug is determined by the doctor individually for each patient, depending on the level of glycemia. Typically, the initial dose of Glucovans is 1 tablet of 500 mg / 2.5 mg (Glucovans tablets, 2.5 mg / 500 mg, unit dose 30 Nikomed) per day. When replacing the previous combination therapy with metformin and glibenclamide, 1-2 Glucovans tablets of 500 mg / 2.5 mg are prescribed, depending on the previous dose level. Every 1-2 weeks after the start of treatment, the dose is adjusted depending on the level of glycemia. Tablets should be taken with meals. The maximum daily dose is 4 tablets of Glucovans 500 mg / 2.5 mg or 2 tablets of Glucovans 500 mg / 5 mg.
Side effects of
Metformin-induced
Digestive system: at the beginning of treatment, nausea, vomiting, abdominal pain, loss of appetite may occur (in most cases, pass independently and do not require special treatment to prevent the development of these symptoms, it is recommended to take the drug in 2 or 3 doses, a slow increase in the dose of the drug also improves its tolerance) possibly – a metallic taste in the mouth.
Other: erythema, megaloblastic anemia, lactic acidosis.
Conditioned by glibenclamide
From the digestive system: nausea, vomiting, epigastric pain, increased activity of liver enzymes.
From the hemopoietic system: leukopenia, thrombocytopenia rarely – agranulocytosis, hemolytic anemia, pancytopenia.
Allergic reactions: urticaria, rash, pruritus.
Other: hypoglycemia, disulfiram-like reactions when taking alcohol.
Drug interaction
Drugs that enhance the effect of glucovans (increased risk of hypoglycemia)
When used with glucovans, miconazole can provoke the development of hypoglycemia (up to the development of coma). Fluconazole increases T 1/2 of sulfonylurea derivatives and increases the risk of hypoglycemic reactions. Alcohol intake increases the risk of hypoglycemic reactions (up to the development of coma). During the treatment with Glucovans, alcohol and drugs containing ethanol (alcohol) should be avoided. The use of ACE inhibitors (captopril, enalapril) increases the likelihood of developing hypoglycemic reactions in patients with diabetes mellitus in the treatment of sulfonylurea derivatives by improving glucose tolerance and reducing the need for insulin. Beta-blockers increase the incidence and severity of hypoglycemia. Beta-blockers mask symptoms of hypoglycemia such as palpitations and tachycardia.
Drugs that weaken the effect of glucovans
Danazole has a hyperglycemic effect. If treatment with danazol is necessary and when you stop taking the latter, you need to adjust the dose of Glucovans under the control of the level of glycemia. Chlorpromazine in high doses (100 mg / day) causes an increase in glycemia. GCS increase glycemia and can lead to the development of ketoacidosis. Beta 2 -adrenostimulants increase the level of glycemia due to the stimulation of 2 -adrenoreceptors. Diuretics (especially loop) provoke the development of ketoacidosis due to the development of functional renal failure. In / in the introduction of iodine-containing contrast agents can cause the development of renal failure, which in turn will lead to cumulation of the drug in the body and the development of lactic acidosis. Beta-blockers mask symptoms of hypoglycemia such as palpitations and tachycardia.
Overdose
Symptoms: Overdose or the presence of risk factors can trigger the development of lactic acidosis, because the drug includes metformin. Lactic acidosis is a condition that requires immediate medical attention to treat lactic acidosis in the clinic. The most effective treatment is hemodialysis. Overdose can also lead to the development of hypoglycemia due to the presence in the preparation of glibenclamide. Symptoms of hypoglycemia: feeling of hunger, excessive sweating, weakness, palpitations, pallor of the skin, paresthesias in the mouth, trembling, general anxiety, headache, pathological drowsiness, sleep disorders, feelings of fear, impaired movement coordination, temporary neurological disorders. With the progression of hypoglycemia, loss of self-control and consciousness is possible.
Treatment: For hypoglycaemia of mild or moderate severity, glucose or sugar solution is taken orally. In the case of severe hypoglycemia (loss of consciousness), a solution of dextrose (glucose) or glucagon is administered into / in, in / m, n / a. After regaining consciousness, the patient should be given carbohydrate-rich foods to avoid hypoglycemia. Increased clearance of glibenclamide may be possible in patients with liver disease. Glibenclamide is not excreted in dialysis because it actively binds to blood proteins.
Storage Conditions
The product should be stored at a temperature not exceeding 30 ° C.
active substance
glibenclamide, Metformin
Prescription conditions
Prescription
lekarstvennaja form
tablets
Merck Sante, France
