Hlybenklamyd, Metformin | Gluconorm tablets 2.5 + 400 mg, 40 pcs.

release form

film-coated tablets



packaging 40 pcs

Pharmacological action

Gluconorm is a fixed combination of two oral hypoglycemic agents of different pharmacological groups: metformin and glibenclamide.

Metformin belongs to the group of biguanides and reduces serum glucose by increasing the sensitivity of peripheral tissues to insulin and enhancing glucose uptake. Reduces the absorption of carbohydrates in the gastrointestinal tract and inhibits gluconeogenesis in the liver. The drug also has a beneficial effect on the lipid profile of the blood, lowering the level of total cholesterol, LDL and triglycerides. Does not cause hypoglycemic reactions.

Glibenclamide belongs to the group of sulfonylurea derivatives of the second generation. It stimulates insulin secretion by lowering the threshold for pancreatic beta-cell glucose irritation, increases insulin sensitivity and its binding to target cells, increases insulin release, enhances the effect of insulin on muscle and liver glucose uptake, and inhibits lipolysis in adipose tissue. Acts in the second stage of insulin secretion.

Indications

Type 2 diabetes mellitus in adults: when diet therapy, exercise, and prior therapy with metformin or glibenclamide

are ineffective to replace previous therapy with two drugs (metformin and glibenclamide) in patients with stable and well-controlled blood glucose levels.

Contraindications

hypersensitivity to metformin, glibenclamide or other sulfonylurea derivatives, as well as adjuvants

diabetes mellitus type 1

diabetic ketoacidosis, diabetic precoma, diabetic coma srplic disease which can lead to a change in kidney function: dehydration, severe infection, shock

acute or chronic diseases accompanied by tissue hypoxia: heart or respiratory failure, recent myocardial infarction, shock

liver failure

porphyria

pregnancy, breastfeeding srdlkrd infectious diseases, major surgical interventions, injuries, extensive burns and other conditions requiring insulin therapy

chronic alcoholysis m, acute alcohol intoxication

lactic acidosis (including 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 medium

adhering to a low-calorie diet (less than 1000 cal / day).

It is not recommended to use the drug Gluconorm in people older than 60 who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis in them.

Use during pregnancy and lactation

During pregnancy, the use of gluconorm is contraindicated. When planning pregnancy, as well as in case of pregnancy during the period of taking Gluconorm, the drug should be discontinued and insulin therapy should be prescribed.

Gluconorm is contraindicated in breastfeeding, as metformin passes into breast milk. In this case, you must switch to insulin therapy or stop breastfeeding.

Composition

Each tablet contains: metformin hydrochloride - 400 mg glibenclamide - 2.5 mg

Dosage and administration

The drug is used orally, with meals. The dose of the drug is determined by the doctor individually for each patient, depending on the level of blood glucose.

Typically, the starting dose is 1 tablet of Gluconorm 400 mg / 2.5 mg per day. Every 1-2 weeks after the start of treatment, the dose of the drug is adjusted depending on the level of blood glucose. When replacing the previous combination therapy with metformin and glybeklamide, 1 to 2 Gluconorm tablets are prescribed, depending on the previous dose of each component. The maximum daily dose is 5 tablets of Gluconorm.

Side effects of

Carbohydrate metabolism: hypoglycemia is possible.

From the gastrointestinal tract and liver: rarely - nausea, vomiting, abdominal pain, loss of appetite, "metallic" taste in the mouth in some cases - cholestatic jaundice, increased activity of "liver" enzymes, hepatitis.

From the hemopoietic system: rarely - leukopenia, thrombocytopenia, erythrocytopenia very rarely - agranulocytosis, hemolytic or megaloblastic anemia, pancytopenia.

From the central nervous system: headache, dizziness, weakness, fatigue, rarely - paresis, sensitivity disorders.

Allergic and immunopathological reactions: rarely - urticaria, erythema, skin itching, fever, arthralgia, proteinuria.

Dermatological reactions: rarely - photosensitivity.

From the side of metabolism: lactic acidosis.

Other: an acute reaction of alcohol intolerance after drinking, expressed by complications of the circulatory and respiratory organs (disulfiram-like reaction: vomiting, sensation of heat in the face and upper body, tachycardia, dizziness, headache).

Overdose

Overdose or the presence of risk factors can trigger the development of lactic acidosis, as metformin is a part of the drug. If symptoms of lactic acidosis (vomiting, abdominal pain, general weakness, muscle cramps) occur, it is necessary to discontinue the drug. Lactic acidosis is a condition that requires immediate medical attention to treat lactic acidosis in a hospital. 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: hunger, sweating, weakness, palpitations, paleness of the skin, paresthesia of the oral mucosa, tremor, general anxiety, headache, pathological drowsiness, sleep disorders, fear, impaired movement coordination, temporary neurological disorders. With the progression of hypoglycemia, patients may lose self-control and consciousness.

In case of hypoglycemia, mild or moderate severity of dextrose (glucose) or sugar solution is taken orally. In the case of severe hypoglycemia (loss of consciousness), a 40% solution of dextrose (glucose) or glucagon is administered intravenously, intravenously, intramuscularly, subcutaneously. After regaining consciousness, the patient should be given carbohydrate-rich foods to avoid hypoglycemia.

Storage conditions

In a dry, dark place at temperatures below 25 РC.

Expiration

3 years.

Deystvuyuschee substances

Hlybenklamyd, Metformin



pharmacy terms and conditions for

dosage form

dosage form

tablets

MJ Biopharm, India