Galvus 50 mg 28 tablets

Galvus 50 mg 28 tablets

Compound:

vildagliptin 50 mg

Auxiliary components:

microcrystalline cellulose, anhydrous lactose, sodium carboxymethyl starch, magnesium stearate.

Properties:

Hypoglycemic agent. Vildagliptin is a representative of the class of pancreatic islet stimulants that selectively inhibits the enzyme dipeptidyl peptidase-4 (DPP-4). Rapid and complete inhibition of DPP-4 activity (>90%) causes an increase in both basal and food-stimulated secretion of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) from the intestine into the systemic circulation throughout the day.

Indications:

Type 2 diabetes mellitus: as monotherapy in combination with diet and exercise; as part of a two-component combination therapy with metformin, sulfonylurea derivatives, thiazolidinedione or insulin in case of failure of diet therapy, exercise and monotherapy with these drugs.

Dosage and administration:

The optimal dosage regimen is determined by the doctor. Compliance of the dosage form of a particular drug with indications for use and dosing regimen should be strictly observed.

The dosage regimen is set individually depending on the effectiveness, tolerability and treatment regimen.

Single dose – 50 mg, daily dose – 100 mg (50 mg 2 times / day).

Contraindications:

Hypersensitivity to vildagliptin.

Precautionary measures:

Not recommended for use in patients with severe hepatic impairment, incl. with an increase in ALT or AST activity > 2.5 times higher than ULN.

It is not recommended for use in patients with moderate or severe renal impairment (including end-stage renal disease and the need for hemodialysis), because. data on the safety of use in this category of patients are limited.

Before starting treatment, as well as regularly (1 time in 3 months) during the first year of treatment, it is recommended to determine the biochemical parameters of liver function. In case of detection of increased activity of aminotransferases, this result should be confirmed by a second study, and then regularly determine the biochemical parameters of liver function until they are normal. If the excess of AST or ALT activity by 3 times or more ULN is confirmed by a repeated study, then it is recommended to cancel vildagliptin.

If jaundice or other signs of liver dysfunction develop, vildagliptin therapy should be discontinued immediately. After normalization of indicators of function of a liver treatment cannot be resumed.

If insulin therapy is required, vildagliptin is used only in combination with insulin.

Vildagliptin should not be used to treat type 1 diabetes mellitus or to treat diabetic ketoacidosis.

Side effects:

From the digestive system: sometimes – constipation; rarely – liver dysfunction (including hepatitis) of an asymptomatic course; when combined with insulin often – nausea, flatulence, GERD.

From the side of the central nervous system: often – tremor, dizziness, headache.

From the side of metabolism: often – hypoglycemia, weight gain.

Allergic reactions: rarely – angioedema (more often in combination with ACE inhibitors).

Other: often – asthenia, peripheral edema.

Storage method:

Store at a temperature not exceeding 30 degrees. In a dry place.

Package:

Cardboard pack contains 2 blisters of 14 tablets.