Forxiga 5 mg 28 tablets

Trade name:

Forsiga

Forxiga

Composition:

Each tablet contains:

dapagliflozin 5 mg

Auxiliary components:

microcrystalline cellulose, anhydrous lactose, crospovidone, silicon dioxide, magnesium stearate.

Properties:

Dapagliflozin is a potent (inhibition constant (Ki) 0.55 nM), selective reversible inhibitor of the sodium glucose cotransporter type 2 (SGLT2).

Inhibition of SGLT2 by dapagliflozin causes a decrease in the reabsorption of glucose from the glomerular filtrate in the proximal renal tubules with a concomitant decrease in sodium reabsorption, leading to excretion of glucose by the kidneys and osmotic diuresis. Thus, dapagliflozin increases sodium delivery to the distal tubules, which is believed to enhance tubular-glomerular feedback and decrease intraglomerular pressure. Secondary effects of SGLT2 inhibition with dapagliflozin also include a moderate decrease in blood pressure, weight loss, and an increase in hematocrit.

Indications:

Type 2 diabetes mellitus in adult patients in addition to diet and exercise to improve glycemic control as:

– monotherapy, when the use of metformin is impossible due to intolerance;

– combined therapy with metformin, sulfonylurea derivatives (including in combination with metformin), thiazolidinediones.

– starting combination therapy with metformin, if this therapy is appropriate.

Type 2 diabetes mellitus in adult patients with an established diagnosis of cardiovascular disease or two or more cardiovascular risk factors to reduce the risk of hospitalization for heart failure.

Heart failure.

Method of administration and dosage:

The drug is taken orally, regardless of food intake, without chewing.

Type 2 diabetes mellitus:

Monotherapy: the recommended dose of Forsig is 10 mg 1 time / day.

Combination therapy: the recommended dose of Forsiga is 10 mg 1 time / day in combination with metformin, a sulfonylurea derivative.

Heart failure:

The recommended dose of Forsiga is 10 mg 1 time / day.

Contraindications:

-increased individual sensitivity to any component of the drug;

– type 1 diabetes mellitus;

diabetic ketoacidosis;

– impaired renal function;

– hereditary lactose intolerance;

-pregnancy;

-the period of breastfeeding;

– age up to 18 years (safety and efficacy have not been studied).

Precautionary measures:

Use in patients with impaired renal function:

The experience of using Forsiga in patients with severe renal impairment (eGFR <30 ml / min / 1.73 m2) or end-stage renal failure is limited. There is currently no available data on the use of Forsiga in patients on hemodialysis.

Side effects:

Infectious and parasitic diseases: often – vulvovaginitis, balanitis and related infections of the genital organs, urinary tract infections;

From the side of metabolism: very often – hypoglycemia (when used in combination with a sulfonylurea derivative or insulin);

From the nervous system: often – dizziness.

On the part of the skin and subcutaneous tissues: often – rash;

From the musculoskeletal system: often – back pain.

From the urinary system: often – dysuria, polyuria.

Storage method:

Store at a temperature not exceeding 30 degrees.

Package:

The cardboard box contains 2 blisters of 14 tablets, paper instructions.