Gliutazon tablets 15 mg. №28

Description

Gliutazon 15 mg Composition
active substance: pioglitazone (pioglitazone);

1 tablet contains pioglitazone hydrochloride in terms of pioglitazone 15 mg;

excipients: lactose, hydroxypropyl cellulose, calcium carboxymethyl cellulose, magnesium stearate.

Gliutazon 15 mg Dosage form
Pills.

Basic physical and chemical properties: white, round, flat tablets with “K” embossing on one side and smooth on the other.

Gliutazon 15 mg Pharmacotherapeutic group
Antidiabetic drugs. Hypoglycemic agents, with the exception of insulins. Thiazolidinediones.

ATX code А10В G03.

Pharmacodynamics
Glutazone® is an oral hypoglycemic drug of the thiazolidinedione series. The action of pioglitazone depends on the presence of insulin. Highly selective agonist of peroxisome proliferator-activated receptors (γ-PPAR). γ-PPAR receptors are found in adipose, muscle and liver tissues. Activation of nuclear receptors PPAR-γ modulates the transcription of insulin-sensitive genes involved in glucose control and lipid metabolism. Glutazone® reduces insulin resistance in peripheral tissues and in the liver, as a result of which the consumption of insulin-dependent glucose increases and the release of glucose from the liver decreases. Unlike sulfonylurea derivatives, pioglitazone does not stimulate the secretion of insulin by the β-cells of the pancreas.

Pharmacokinetics
Suction. After oral administration, pioglitazone is rapidly absorbed. The maximum plasma concentrations of unchanged pioglitazone are usually reached within 2 hours after administration. A proportional increase in plasma concentration was observed for doses ranging from 2 to 60 mg. A stable state is achieved after taking the drug for 4-7 days. Repeated use does not lead to the accumulation of the drug or its metabolites. Food intake does not affect absorption. The bioavailability of pioglitazone exceeds 80%.

Distribution.

The estimated volume of distribution in humans is 0.25 L / kg. Pioglitazone and all of its active metabolites bind extensively to plasma proteins (> 99%).

Indications
Glutazone® is indicated as a second or third line of therapy for type 2 diabetes:

as monotherapy:

in adult patients (especially in overweight patients) with contraindications or intolerance to metformin in case of inadequate control of blood sugar levels by diet and exercise;
as dual therapy in combination with:

metformin in adult patients (especially in overweight patients) with insufficient glycerol

kemic control, despite the use of metformin monotherapy at the maximum tolerated dose;
sulfonylurea derivatives in adult patients (with intolerance and contraindication to metformin) with insufficient glycemic control, despite the use of monotherapy with sulfonylurea derivatives at the maximum tolerated dose;
as a triple therapy in combination with:

Contraindications
Hypersensitivity to the active substance or to any of the components of the drug.
Insulin-dependent type 1 diabetes mellitus.
Diabetic ketoacidosis.
Severe liver dysfunction.
Heart failure (stages I – IV NYHA).
Bladder cancer, present or in history.
Macroscopic hematuria of unknown etiology.