Gliucovin XR tablets with prolonged release 1000 mg. №30

Description

Gliucovin XR Storage:

active substance: metformin hydrochloride;

1 prolonged-release tablet contains metformin hydrochloride 750 mg or 1000 mg;

Excipients:

hypromellose, carmellose sodium, magnesium stearate.

Dosage form.

Prolonged-release tablets.

Basic physical and chemical properties:

750 mg tablets: white or almost white in the form of caplets, engraved with “750” on one side and smooth on the other;

1000 mg tablets: white or almost white, oval, engraved with “1000” on one side and smooth on the other.

Gliucovin XR Pharmacotherapeutic group.

Oral hypoglycemic agents, except insulins.

ATX code A10B A02.

Gliucovin XR Pharmacological properties.

Pharmacodynamics.

Metformin is a biguanide with antihyperglycemic effect. Reduces both baseline glucose and postprandial glucose. Does not stimulate insulin secretion and does not cause a hypoglycemic effect.

Metformin works in three ways:

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

– improves insulin sensitivity in muscles by improving the uptake and utilization of peripheral glucose;

– delays the absorption of glucose in the intestine.

Pharmacokinetics.

Absorption. After oral administration, metformin is almost completely absorbed from the digestive tract, 20-30% is excreted in the feces. The time to reach the maximum concentration (Tmax) is 2.5 hours. The absolute bioavailability is about 50-60%.

At simultaneous meal absorption of metformin decreases and slows down.

Distribution. Plasma protein binding is negligible. Metformin penetrates erythrocytes. The maximum concentration in the blood is lower than the maximum concentration in the blood plasma, and is reached after about the same time. Erythrocytes most likely represent the second chamber of distribution. The average volume of distribution (Vd) varies in the range of 63-276 liters.

Clinical characteristics.

Indication.

Type 2 diabetes mellitus (non-insulin dependent) in adults with ineffective diet and exercise (especially in overweight patients) – as monotherapy or combination therapy in combination with other oral hypoglycemic agents or in combination with insulin.

Contraindication.

– Hypersensitivity to metformin or to any other component of the drug;

– diabetic ketoacidosis, diabetic precoma;

– renal impairment (creatinine clearance <60 ml / min);

– acute conditions with a risk of developing renal dysfunction, such as: dehydration, severe infectious diseases, shock;

– acute and chronic diseases that can lead to the development of hypoxia;

– heart or respiratory failure, acute myocardial infarction, shock;

– liver dysfunction, acute alcohol poisoning, alcoholism.