Compound
Active ingredients:
metformin hydrochloride – 400 mg,
glibenclamide – 2.5 mg.
Excipients: core:
microcrystalline cellulose – 65.0 mg,
corn starch – 57.5 mg,
colloidal silicon dioxide – 20.0 mg,
gelatin – 40.0 mg,
glycerin (glycerol) -17.5 mg,
talc – 15.0 mg,
magnesium stearate – 7.5 mg.
Shell:
acetylphthalylcellulose – 2.0 mg,
diethyl phthalate – 0.5 mg,
talc – 2.5 mg.
pharmachologic effect
Glibomet® is an oral combined hypoglycemic agent, a second generation sulfonylurea derivative and bituanide. It has pancreatic and extra-pancreatic effects.
Glibenclamide belongs to the group of second generation sulfonylurea derivatives. Stimulates insulin secretion by lowering the threshold of glucose irritation of pancreatic beta cells, increases insulin sensitivity and the degree of its binding to target cells, increases insulin release, enhances the effect of insulin on glucose uptake by muscles and liver, and inhibits lipolysis in adipose tissue. Acts in the second stage of insulin secretion.
Metformin belongs to the group of biguanides. Stimulates the peripheral sensitivity of tissues to the action of insulin (increases the binding of insulin to receptors, enhances the effects of insulin at the post-receptor level), reduces the absorption of glucose in the intestine, inhibits gluconeogenesis and has a beneficial effect on lipid metabolism, helps to reduce excess body weight in patients with diabetes mellitus, and also has a fibrinolytic effect by suppressing a tissue-type plasminogen activator inhibitor.
The hypoglycemic effect of the drug develops after 2 hours and lasts 12 hours.
The synergistic combination of the two active components of the drug – the stimulating effect of a sulfonylurea derivative in relation to the production of endogenous insulin (pancreatic effect) and the direct effect of biguanide on muscle and adipose tissue (a significant increase in glucose uptake – extra-pancreatic effect) and hepatic tissue (decrease in gluconeogenesis), allows at a certain ratio doses to reduce the content of each component. This helps to avoid over-stimulation of the pancreatic beta cells and therefore reduces the risk of pancreatic dysfunction, as well as improves the safety of hypoglycemic drugs and reduces the incidence of side effects.Indications
Type 2 diabetes mellitus (with the ineffectiveness of diet therapy and previous therapy with sulfonylurea derivatives or biguanides, as well as other oral hypoglycemic agents).
Use during pregnancy and lactation
The use of the drug Glibomet during pregnancy and during breastfeeding is contraindicated.
Contraindications
hypersensitivity to metformin, glibenclamide or other sulfonylurea derivatives, as well as to other components of the drug;
type 1 diabetes;
gestational diabetes;
diabetic ketoacidosis, diabetic precoma, diabetic coma;
lactic acidosis (including history);
conditions accompanied by impaired absorption of food and the development of hypoglycemia;
liver dysfunction;
acute conditions that can lead to a change in kidney function: dehydration, severe infection, shock, intravascular administration of iodine-containing contrast agents;
renal failure or impaired renal function (creatinine level above 135 mmol / l for men and above 110 mmol / l for women);
infectious diseases, gangrene, major surgery, trauma, acute massive blood loss, extensive burns and other conditions requiring insulin therapy;
hypoxic conditions (cardiac or respiratory failure, recent myocardial infarction, shock, severe respiratory disease);
a period of 48 hours before and 48 hours after radioisotope or X-ray studies with the introduction of an iodine-containing contrast agent;
the period within 48 hours before the start and 48 hours after the surgical intervention;
dystrophic diseases (myotonic dystrophy, lipodystrophy);
leukopenia;
porphyria;
chronic alcoholism, acute alcohol intoxication;
adherence to a strict hypocaloric diet (less than 1000 kcal / day);
deficiency of glucose-6-phosphodehydrogenase;
pregnancy, breastfeeding period;
age up to 18 years.
It is not recommended to use the drug in people over 60 years of age who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis in them.
Carefully
febrile syndrome;
thyroid disease (with impaired function);
hypofunction of the anterior pituitary and / or adrenal cortex;
heavy physical work (risk of developing lactic acidosis).
Side effects
From the digestive system:
Rare: nausea, vomiting, loss of appetite, abdominal pain, diarrhea, metallic taste; in some cases: increased activity of liver enzymes.
From the hematopoietic system:
Rare: leukopenia, thrombocytopenia, erythrocytopenia; very rarely, agranulocytosis, hemolytic or megaloblastic anemia, pancytopenia.
From the side of the central nervous system:
Uncommon: headache.
From the side of the skin:
Rare: urticaria, erythema, pruritus, photosensitivity.
From the side of metabolism:
Rare: hypoglycemia.
Very rare: lactic acidosis.
If symptoms of lactic acidosis appear (vomiting, abdominal pain, general weakness, muscle cramps), you should immediately stop taking the drug and consult a doctor immediately.
Others: disulfiram-like reaction while taking alcohol (the most common signs: redness of the skin of the face and upper half of the body, headache, nausea and vomiting, palpitations, increased blood pressure).How to take, course of administration and dosage
inside.
The dose and regimen of the drug, as well as the duration of treatment, are set by the attending physician, primarily in accordance with the state of the patient’s carbohydrate metabolism, depending on the concentration of glucose in the blood plasma.
As a rule, the initial dose is 1-3 tablets per day with the main meal, with a gradual selection of the dose until a stable normalization of the concentration of glucose in the blood plasma is achieved. The maximum daily dose is 6 tablets of Glibomet®.
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