Metglyb, 2.5mg+400 mg 40 pcs

A fixed combination of two oral hypoglycemic agents of different pharmacological groups: metformin and glibenclamide.

Metformin belongs to the group of biguanides and reduces both basal and postprandial plasma glucose. Metformin does not stimulate insulin secretion and therefore does not cause hypoglycemia.

It has 4 mechanisms of action:

– reduces glucose production by the liver by inhibiting gluconeogenesis and glycogenolysis;

– increases peripheral receptor sensitivity to insulin, glucose consumption and utilization by cells in the muscles;

– delays glucose absorption in the gastrointestinal tract;

– stabilizes or reduces body weight in patients with diabetes.

The drug also has beneficial effects on blood lipid composition, reducing total cholesterol, low-density lipoproteins (LDL) and triglycerides.

Glibenclamide belongs to the group of sulfonylurea derivatives of II generation. Glucose content when taking glibenclamide decreases as a result of stimulation of insulin secretion by pancreatic β-cells. Metformin and glibenclamide have different mechanisms of action, but mutually complement the hypoglycemic activity of each other. The combination of the two hypoglycemic agents has a synergistic effect in reducing glucose.

Indications

Type 2 diabetes mellitus in adults:

– when diet therapy, exercise, and prior monotherapy with metformin or sulfonylurea derivatives are ineffective;

– to replace prior therapy with two drugs (metformin and sulfonylurea derivative) in patients with stable and well-controlled glycemia levels.

Composition

1 tablet contains:

the active ingredients:

metformin hydrochloride 400 mg,

glibenclamide 2.5 mg;

excipients:

calcium hydrophosphate dihydrate 50 mg,

corn starch 45 mg,

croscarmellose sodium 12 mg,

sodium stearyl fumarate 3 mg,

povidone 52 mg,

microcrystalline cellulose 35.5 mg;

film jacket:

Opadray orange 20 mg, including: [hypromellose (hydroxypropyl methylcellulose) 6.75 mg,

hyprolose (hydroxypropyl cellulose) 6.75 mg,

talc 4 mg,

/p>

Titanium dioxide 2.236 mg,

Red iron oxide dye 0.044 mg,

Yellow iron oxide dye 0.22 mg].

How to take, the dosage

Ingestion.

The dose and regimen of the drug, as well as the duration of treatment are established by the attending physician, primarily in accordance with the state of carbohydrate metabolism of the patient, depending on the concentration of glucose in the blood plasma.

As a rule, the initial dose is 1-2 tablets a day with the main meal, with gradual selection of the dose until steady normalization of plasma glucose concentration is achieved.

The maximum daily dose of Metglyb® is 6 tablets divided into 3 doses.

Interaction

Contraindicated combinations:

Related to the use of glibenclamide

Miconazole may provoke hypoglycemia (up to and including coma).

Injurious to metformin use

Iodine-containing contrast agents: Depending on renal function, the drug should be discontinued 48 hours before or after intravenous administration of iodine-containing contrast agents.

Unrecommended combinations: Related to the use of sulfonylurea derivatives

Ethanol: a disulfiram-like reaction (ethanol intolerance) is very rarely observed with concomitant administration of ethanol and glibenclamide. Ethanol may increase the hypoglycemic effect (by inhibiting the compensatory reactions or delaying its metabolic inactivation), which may contribute to the development of hypoglycemic coma. During treatment with Metglib® , alcohol and medicinal products containing ethanol should be avoided. Phenylbutazone increases the hypoglycemic effect of sulfonylurea derivatives (by replacing the sulfonylurea derivatives at the sites of binding to protein and/or reducing their excretion). It is preferable to use other anti-inflammatory agents that find fewer interactions, or to warn the patient about the need for self-control of glycemic levels; if necessary, the dose should be adjusted when co-administering the anti-inflammatory agent and after discontinuation.

Related Use of Glibenclamide

Bozentan in combination with glibenclamide increases the risk of hepatotoxic effects.

The concomitant administration of these drugs is recommended to be avoided. The hypoglycemic effect of glibenclamide may also be reduced.

Risk of lactoacidosis is increased in acute alcohol intoxication, especially in case of starvation, or poor nutrition, or liver failure. Alcoholic beverages and medications containing ethanol should be avoided during treatment with Metglib®.

Special Instructions

The treatment with Metglib® is carried out only under a doctor’s supervision!

When taking the drug, it is necessary to strictly follow the doctor’s recommendations on diet and self-monitoring of blood glucose concentration.

Glycemia levels should be monitored regularly on an empty stomach and after meals. Lactoacidosis

Contraindications

– hypersensitivity to metformin, glibenclamide or other sulfonylurea derivatives or other components of Metglib;

– type 1 diabetes mellitus;

– diabetic ketoacidosis, diabetic precoma, diabetic coma;

– renal insufficiency or impaired renal function (creatinine clearance less than 60 ml/min);

– acute conditions that may lead to altered renal function dehydration, severe infection, shock, intravascular administration of iodine-containing contrast agents;

– acute or chronic conditions that are accompanied by tissue hypoxia: heart or respiratory failure, recent myocardial infarction;

– hepatic failure;

-porphyria;

Pregnancy, breastfeeding;

– concomitant use of miconazole;

– infectious diseases, major surgical interventions, trauma, extensive burns and other conditions requiring insulin therapy;

– chronic alcoholism, acute alcohol intoxication;

– lactoacidosis (including history

– keeping a hypocaloric diet (less than 1000 kcal/d);

– children under 18 years of age.

The drug is not recommended for people over 60 years of age who perform heavy physical work, because of the increased risk of lactoacidosis in them.

With caution:

– febrile syndrome;

– adrenal insufficiency;

– hypofunction of the anterior pituitary lobe;

– Thyroid disease (with uncompensated thyroid dysfunction);

In the elderly over 70 years of age because of the danger of hypoglycemia.

Side effects

The following side effects may occur during treatment with Metglib® . WHO classification of the incidence of side effects:

very common – ≥1/10 appointments (>10%)

often – ≥1/100 to <1/10 appointments (>1% and

infrequent – ≥1/1000 to0.1% and

infrequent – ≥1/10000 to 0.01% and

very rare –

Classification of adverse adverse reactions according to organ and organ system involvement (Med-DRA Medical Dictionary for Regulatory Affairs).

– Blood and lymphatic system disorders:

These adverse events disappear after discontinuation of the drug.

Rarely: leukopenia and thrombocytopenia.

very rarely: agranulocytosis, hemolytic anemia, bone marrow aplasia and pancytopenia.

– Immune system disorders:

Very rare: anaphylactic shock.

Cross-sensitivity reactions to sulfonamides and their derivatives may occur.

– Metabolic and nutritional disorders: Hypoglycemia.

Rarely: episodes of hepatic porphyria and cutaneous porphyria.

Very rarely: lactoacidosis.

Decreased absorption of vitamin B12, accompanied by a decrease in its serum concentrations with long-term use of metformin. If megaloblastic anemia is detected, the possibility of this etiology must be considered. Disulfiram-like reaction with ethanol use.

– Disorders of the nervous system:

Often: impaired taste (“metallic” taste in the mouth).

Visual disorders: At the beginning of treatment there may be temporary visual impairment due to decreased blood glucose levels.

– Gastrointestinal disorders:

Very common: nausea, vomiting, diarrhea, abdominal pain and lack of appetite. These symptoms are more common at the beginning of treatment and in most cases go away on their own. To prevent these symptoms, it is recommended that the drug be taken in 2 or 3 doses; increasing the dose slowly also improves tolerability.

– Liver and biliary tract disorders:

Very rare: impaired liver function or hepatitis requiring discontinuation of treatment.

Skin and subcutaneous tissue disorders:

Rarely: skin reactions such as: itching, urticaria, maculopapular rash.

very rarely: cutaneous or visceral allergic vasculitis, erythema multiforme, exfoliative dermatitis, photosensitization.

– Laboratory and instrumental findings:

Infrequent: moderate to moderate increases in serum urea and creatinine concentrations.

Very rare: hyponatremia.

Overdose

In case of overdose, hypoglycemia may develop due to the presence of a sulfonylurea derivative in the drug.

Mild to moderate symptoms of hypoglycemia without loss of consciousness and neurological manifestations may be corrected by immediate consumption of sugar.

Dose adjustment and/or dietary changes should be made. The occurrence of severe hypoglycemic reactions in patients with diabetes accompanied by coma, paroxysm or other neurological disorders requires immediate medical attention.

Intravenous administration of dextrose solution is necessary immediately after diagnosis or suspicion of hypoglycemia, before hospitalization of the patient. After recovery of consciousness, the patient should be given food rich in easily digestible carbohydrates (to avoid the recurrence of hypoglycemia).

The plasma clearance of glibenclamide may increase in patients with liver disease. Since glibenclamide is actively bound to blood proteins, the drug is not excreted by dialysis.

Long-term overdose or the presence of associated risk factors can provoke lactoacidosis because the drug contains metformin.

Lactoacidosis is a medical emergency; treatment of lactoacidosis should be done in a hospital setting. Hemodialysis is the most effective treatment to remove lactate and metformin.