Gliucofaj coated tablets 850 mg. №30

Description

Gliucofaj №30 Storage:

active substance: metformin hydrochloride;

1 film-coated tablet of 500 mg contains 500 mg of metformin hydrochloride, which corresponds to 390 mg of metformin;

Gliucofaj №30 excipients: povidone K 30, magnesium stearate;

film coating for tablets of 500 mg, 850 mg: hypromellose;

film-coated tablets for tablets of 1000 mg: opadray Klia (hypromellose, macrogol 400, macrogol 8000).

Gliucofaj №30 Dosage form.

Film-coated tablets.

Basic physical and chemical properties:

film-coated tablets, 500 mg, 850 mg: round tablets with a biconvex surface, white, film-coated;

film-coated tablets, 1000 mg: oval tablets with a biconvex surface, white, film-coated, with a line on both sides and engraved “1000” on one side.

Pharmacotherapeutic group. Oral hypoglycemic agents, except insulins. Biguanides. ATX code A10B A02.

Pharmacological properties.

Pharmacodynamics.

Metformin is a biguanide with antihyperglycemic effect. Reduces plasma glucose levels both on an empty stomach and after meals. It does not stimulate insulin secretion and does not cause a hypoglycemic effect mediated by this mechanism.

Metformin works in three ways:

– leads to a decrease in glucose production in the liver by inhibiting gluconeogenesis and glycogenolysis;

– improves insulin sensitivity in muscles, which leads to improved peripheral glucose uptake and utilization;

– delays the absorption of glucose in the intestine.

Pharmacokinetics.

Absorption. After oral administration of metformin, the time to reach the maximum concentration (Tmax) is about 2.5 hours. The absolute bioavailability of 500 mg or 800 mg tablets is approximately 50-60% in healthy volunteers. After oral administration, the fraction that is not absorbed and excreted in the feces is 20-30%.

After oral administration, the absorption of metformin is saturated and incomplete.

The pharmacokinetics of metformin absorption are assumed to be non-linear. When using the recommended doses of metformin and dosing regimens, stable plasma concentrations are reached within 24-48 hours and are less than 1 μg / ml. In controlled clinical trials, maximum plasma levels of metformin (Cmax) did not exceed 5 μg / ml even at maximum doses.

At simultaneous food absorption of metformin decreases and is slightly slowed down.