Glucovance pills 500mg/5mg №30

Dosage form

Coated Tablets

Packaging

30 pieces

Mechanism of action

Glucovance is a combined hypoglycemic drug for oral use. Glucovance is a fixed combination of two oral hypoglycemic agents of different pharmacological groups. Metformin belongs to the group of biguanides and reduces the level of glucose in blood serum by increasing the sensitivity of peripheral tissues to the action of insulin and increasing glucose uptake. Metformin reduces the absorption of carbohydrates from the gastrointestinal tract and inhibits gluconeogenesis in the liver. It also has a beneficial effect on blood lipid composition, reducing the level of total cholesterol, LDL and TG. Glibenclamide is a second-generation sulfonylurea derivative. Glucose level is reduced when glibenclamide is taken as a result of stimulation of insulin secretion by β-cells of the pancreas.

Indications and usage

Type 2 diabetes in adults:
- As a second-line drug for the ineffectiveness of diet therapy, exercise and previous treatment with metformin or glibenclamide.
- To replace the previous treatment with two drugs (metformin and glibenclamide) in patients with a stable and well-controlled level of glycemia.

Contraindications

- Type 1 diabetes.
- Diabetic ketoacidosis.
- Diabetic precoma, diabetic coma.
- Renal failure or impaired renal function (the level of serum creatinine above 135 mmol / l - for men and above 110 mmol / l - for women).
- Acute conditions that can lead to changes in kidney function: dehydration, severe infection, shock, intravascular injection of iodine-containing contrast media.
- Acute or chronic diseases that are accompanied by tissue hypoxia: heart failure, respiratory failure, recent myocardial infarction, shock.
- Liver failure.
- Porphyria.
- Pregnancy.
- Lactation period (breastfeeding).
- Simultaneous intake of miconazole.
- Conditions requiring insulin therapy, including: infectious diseases, major surgical procedures, injuries, extensive burns.
- Impaired liver function.
- Chronic alcoholism, acute alcohol intoxication.
- Lactic acidosis (including in history).
- Use for at least 48 hours before and within 48 hours after conducting radioisotope or x-ray studies with the introduction of iodine-containing contrast material.
- The observance of a low-calorie diet (less than 1000 calories / day).
- Hypersensitivity to metformin, glibenclamide or other sulfonylurea derivatives, as well as to excipients.
Not recommended use the drug in persons older than 60 years, performing heavy physical work, which is associated with an increased risk of lactic acidosis.
Caution should be used in the following cases: 
- Feverish syndrome.
- Diseases of the thyroid gland (with dysfunction).
- Hypofunction of the anterior lobe of the pituitary gland or the adrenal cortex.
- Alcoholism.

Pregnancy and Breastfeeding

During the period of Glucovance treatment, the patient must inform the doctor about the planned pregnancy and the onset of pregnancy. When planning a pregnancy, as well as in the event of pregnancy in the period of taking Glucovance, the drug should be canceled and treatment with insulin should be prescribed. Glucovance contraindicated in breastfeeding, because there are no data on its ability to penetrate into breast milk.

Dosage and administration

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 Glucovance is 1 pill 500 mg / 2.5 mg (Glucovans tablets. 2.5 mg / 500 mg unit. 30 Nycomed) per day. When replacing the previous combination therapy with metformin and glibenclamide, 1-2 pills of Glucovance 500 mg / 2.5 mg are prescribed, depending on the previous dose level. Every 1-2 weeks after the start of treatment, the dose of the drug is adjusted depending on the level of glycemia. pills should be taken with meals.The maximum daily dose is 4 pills Glucovance 500 mg / 2.5 mg or 2 pills Glucovance 500 mg / 5 mg.

Adverse reactions

Due to metformin
Gastrointestinal: at the beginning of treatment, nausea, vomiting, abdominal pain, loss of appetite may occur (in most cases they pass by themselves and do not require special treatment; it is recommended to take the drug in 2 or 3 doses in order to prevent the development of these symptoms; slowly increasing the dose also improves its tolerability); possibly a "metallic" taste in the mouth.
Other: erythema, megaloblastic anemia, lactacidosis.

Due to glibenclamide
Gastrointestinal: nausea, vomiting, epigastric pain, increased liver enzymes.
Hemic and lymphatic: leukopenia, thrombocytopenia; rarely - agranulocytosis, hemolytic anemia, pancytopenia.
Allergic reactions: urticaria, rash, pruritus.
Other: hypoglycemia, disulfiram-like reactions when taking alcohol.

Special notes

During the period of Glucovance treatment, it is necessary to regularly monitor the level of fasting blood glucose and after eating. The patient should be warned that if vomiting and abdominal pain occur with Glucovance during treatment, accompanied by muscle cramps or general malaise, then the drug should be stopped and consult a doctor immediately, as 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 h before surgical intervention or IV injection of an Iodine radiopaque agent, Glucovance should be stopped. Glucovance treatment is recommended to resume after 48 hours. During treatment it is not recommended to drink alcohol.
Application for violations of renal function: the drug is contraindicated in renal failure or impaired renal function (serum creatinine levels above 135 mmol / l are for men and above 110 mmol / l for women).
Influence on ability to drive motor transport and control mechanisms: during Glucovance treatment, one should not engage in activities requiring increased concentration of attention and quickness of psychomotor reactions.

Drug Interactions

Drugs that enhance the effect of Glucovance (increased risk of hypoglycemia)
With simultaneous use with Glucovance miconazole can provoke the development of hypoglycemia (up to the development of coma). Fluconazole increases T 1/2 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 period of treatment Glucovance should avoid taking alcohol and medicines containing ethanol (alcohol). The use of ACE inhibitors (captopril, enalapril) increases the likelihood of hypoglycemic reactions in patients with diabetes mellitus in the treatment of sulfonylureas by improving glucose tolerance and reducing the need for insulin. Beta-blockers increase the incidence and severity of hypoglycemia.Beta-blockers mask the symptoms of hypoglycemia, such as palpitations and tachycardia.
Drugs that weaken the effect of Glucovance
Danazol has a hyperglycemic effect. If necessary, treatment with danazol and discontinuation of the latter requires a dose correction Glucovance under the control of blood glucose levels. Chlorpromazine in high doses (100 mg / day) causes an increase in glycemia. GCS increases blood glucose levels and can lead to the development of ketoacidosis. Beta 2 -adrenostimulyatory due to the stimulation of β2-adrenergic receptors increase the level of glycemia. 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 such symptoms of hypoglycemia as palpitations and tachycardia.

Symptoms: overdose or the presence of risk factors may trigger the development of lactic acidosis, because The drug includes metformin. Lactic acidosis is a condition requiring emergency medical care; treatment of lactic acidosis should be carried out in the clinic. The most effective treatment is hemodialysis. Overdose can also lead to the development of hypoglycemia due to the presence of glibenclamide in the formulation. 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, fear, loss of coordination of movements, temporary neurological disorders. With the progression of hypoglycemia, loss of self-control and consciousness is possible.
Treatment: in hypoglycemia mild or moderate glucose or sugar solution is taken orally. In the case of severe hypoglycemia (loss of consciousness) injected into / in a 40% dextrose (glucose) solution or glucagon in / in, a / m, p / c. After the recovery of consciousness, the patient must be given food rich in carbohydrates in order to avoid the recurrence of hypoglycemia. In patients with diseases of the liver may increase the clearance of glibenclamide. Glibenclamide is not excreted during dialysis because it is actively bound to blood proteins.

The drug should be stored at a temperature not higher than 30 ° C