Jardins (empagliflozin) coated tablets 10 mg. №30

Description

Jardins Composition
active substance: empagliflozin;

1 tablet contains empagliflozin 10 mg;

Jardins excipients: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose; croscarmellose sodium; colloidal silicon dioxide, magnesium stearate, shell Opadry® Yellow 02B38190 (hypromellose 2910, titanium dioxide (E171), talc, macrogol 400, iron oxide yellow (E172)).

Jardins Dosage form
Film-coated tablets.

Basic physical and chemical properties:

10 mg tablets: pale yellow, round, biconvex film-coated tablets with beveled edges, embossed with the Boehringer Ingelheim symbol on one side and embossed with “S10” on the other /

Pharmacotherapeutic group
Drugs used in diabetes mellitus. Other drugs to lower blood glucose levels, excluding insulin. ATX code A10B K03.

Pharmacodynamics
Mechanism of action

Empagliflozin is a reversible, potent (IC50 1.3 nmol) and selective competitive inhibitor of sodium glucose cotransporter 2 (SGLT2). Empagliflozin does not inhibit other glucose transporters, which play an important role in the delivery of glucose to peripheral tissues, and is 5000 times more selective for SGLT2 compared to SGLT1, the main transporter responsible for glucose uptake in the intestine.

SGLT2 is expressed at high levels in the kidney, while expression in other tissues is absent or very low. It responds as the main transporter for the reabsorption of glucose from the tubular lumen back into the bloodstream. In patients with type 2 diabetes and hyperglycemia, more glucose is filtered and absorbed.

Empagliflozin improves glycemic control in patients with type 2 diabetes mellitus by reducing renal glucose reabsorption. The amount of glucose excreted by the kidneys through this glucurretic mechanism depends on the concentration of glucose in the blood and the glomerular filtration rate (GFR).

Inhibition of SGLT2 in patients with type 2 diabetes mellitus and hyperglycemia results in increased urinary glucose excretion. In addition, Empagliflozin increases sodium excretion, leads to osmotic diuresis and decreases intravascular volume.

In patients with type 2 diabetes mellitus, glucose excretion increased immediately after the first dose of empagliflozin and persisted throughout the 24-hour dosing interval. The increase in urinary glucose excretion was maintained at the end of the 4-week treatment period and averaged about 78 g / day. An increase in urinary glucose excretion resulted in an immediate decrease in plasma glucose levels in patients with type 2 diabetes.

Indications
Treating type 2 diabetes in adults if diet and exercise do not provide adequate glycemic control:

as monotherapy for metformin intolerance.
in combination with other hypoglycemic drugs.
According to the results of the study of combination therapy, control of glycemia and cardiovascular complications, see the sections “Peculiarities of use”, “Interaction with other drugs and other types of interactions” and “Pharmacological properties”.

Contraindications
Hypersensitivity to the active substance or to any of the excipients.