Forxiga coated tablets 10 mg. №30

Description

Forxiga Storage
active substance: dapagliflozin;

1 film-coated tablet contains 6.15 mg or 12.30 mg of dapagliflozin propanediol monohydrate in terms of dapagliflozin 5 mg or 10 mg;

Excipients: microcrystalline cellulose, anhydrous lactose, crospovidone, silicon dioxide, magnesium stearate, Opadry II yellow.

Forxiga Dosage form
Film-coated tablets.

Basic physical and chemical properties:

5 mg tablets: yellow, round, biconvex, film-coated tablets, engraved with 5 on one side and 1427 on the other side;

10 mg tablets: Yellow biconvex, diamond-shaped, film-coated tablets, engraved with 10 on one side and 1428 on the other side.

Pharmacotherapeutic group
Drugs used in diabetes mellitus, inhibitors of sodium-dependent glucose cotransporter type 2 (iNZKTG2). ATX code A10VK01.

Forxiga Pharmacological properties

Pharmacodynamics.

Mechanism of action

Dapagliflozin is a high-potency (Ki: 0.55 nM), selective and reversible inhibitor of the sodium-dependent cotransporter of glucose type 2 (INZKTG2).

Inhibition of inZKTG2 by dapagliflozin reduces the reabsorption of glucose from the glomerular filtrate in the proximal renal tubules with a simultaneous decrease in sodium reabsorption, which leads to urinary glucose excretion and osmotic diuresis. Thus, dapagliflozin increases the delivery of sodium to the distal tubules, which is thought to increase tubuloglomerular feedback and reduce intraglomerular pressure. This, in combination with osmotic diuresis, helps to reduce volume overload, lower blood pressure and preload and postload, which can have a positive effect on heart remodeling. Other effects include increased hematocrit and weight loss. The benefits of dapagliflozin for the heart do not depend solely on the effect of lowering blood glucose levels and are not limited to patients with diabetes, as demonstrated in the DAPA-HF study.

Indication
Type 2 diabetes

Forxig is indicated for adults in the treatment of insufficiently controlled type 2 diabetes mellitus as a supplement to diet and exercise;

as monotherapy, when the use of metformin is considered impossible due to intolerance to the drug;
in combination with other drugs for the treatment of type 2 diabetes.
The results of studies on the combination of drugs, effects on glycemic control and cardiovascular events, as well as population studies, see sections “Peculiarities”, “Interaction with other medicinal products and other forms of interaction” and “Pharmacodynamics”.

Heart failure

Forxig is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.

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