Gliurenorm tablets 30 mg. №60

Description

Gliurenorm №60 Storage
active substance: glicvidone;

1 tablet contains 30 mg of glyquidone;

excipients: lactose monohydrate; corn starch; magnesium stearate.

Gliurenorm №60 Dosage form
Tablets.

Main physical and chemical properties: white, round, flat tablets on both sides, with beveled edges; on the one hand – a notch and marking “57C” on both sides of the notch; on the other hand – a symbol of the company.

Gliurenorm №60 Pharmacotherapeutic group
Hypoglycemic drugs, except insulin. Sulfonylurea preparations. Glyquidone.

ATX code A10B B08.

Pharmacological properties

Pharmacodynamics.

Mechanism of action.

Glicvidone stimulates the secretion of endogenous insulin by pancreatic beta cells.

Pharmacodynamic effects.

The effect of lowering blood sugar begins 60-90 minutes after oral administration and reaches a maximum 2-3 hours after ingestion, the duration of the effect is about 8-10 hours. Glicvidone can be considered a short-acting drug, so it is recommended for the treatment of patients with type II diabetes with an increased risk of hypoglycemia, such as the elderly and patients with renal insufficiency. Because renal elimination of gliquidone is negligible, GLURENORM can preferably be prescribed to patients with renal insufficiency or diabetic nephropathy. The efficacy and safety of glycidone treatment in a limited number of patients with diabetes mellitus who respond to sulfonylurea therapy and have concomitant liver disease have been demonstrated. Only the elimination of metabolically inactive metabolites was delayed. However, severe hepatic insufficiency is contraindicated (see Contraindications).

Pharmacokinetics.

Absorption. Following a single oral dose of 30 mg, gliquidone is rapidly and almost completely (80–95%) absorbed in the gastrointestinal tract with a maximum plasma concentration of 0.65 μg / ml (ranging from 0.12 to 2.14 μg / ml). The maximum concentration of the drug in plasma is reached after 2.25 hours (in the range from 1.25 to 4.75 hours). Based on the two-chamber model, the mean maximum plasma concentration of gliquidon under the concentration-time curve from zero to infinity (AUC0-∞) is 5.1 μg / hour / ml (ranging from 1.5 to 10.1 μg / hour). ml). No differences were observed between plasma levels between diabetic patients and healthy volunteers.
Distribution. Glicvidon is actively bound to plasma proteins (> 99%). There are no clinical data on the penetration of gliquidone or its metabolites across the blood-brain barrier or placenta. Preclinical data suggest that glicvidone and its metabolites do not cross these barriers. There are no data on the ability of glicvidone to pass into breast milk.

Indication
Treatment of type II diabetes mellitus in middle-aged and elderly patients, when carbohydrate metabolism cannot be successfully controlled by diet therapy alone.

Contraindication
Hypersensitivity to the active substance or to derivatives of sulfonylureas, sulfonamides and other components of the drug; insulin-dependent diabetes mellitus type I; diabetic coma and precoma; metabolic disorders complicated by acidosis and ketosis; resection of the pancreas; period of severe infections; the period before surgery; severe liver dysfunction; intermittent acute (hepatic) porphyria.