Galvus pills 50mg №28

Active ingredient and dosage form

Galvus pills:
1 tab. contains vildagliptin 50 mg;
Excipients: MCC; anhydrous lactose; carboxymethyl starch sodium; Magnesium stearate;
pack of 14, 28, 56, 84, 112 and 168 pcs.

Mechanism of action

Galvus has a hypoglycemic effect.

Indications and usage

Type 2 diabetes:
- as monotherapy in combination with diet therapy 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.

Contraindications

Hypersensitivity to vildagliptin and any other Galvus components;
children under 18 years old (efficacy and safety not established).
Carefully:
severe violations of the liver, including patients with increased activity of liver enzymes (ALT or AST> 2.5 times higher than the upper limit of normal - 2.5 × VGN);
moderate or severe renal dysfunction (including end-stage CRF on hemodialysis) - experience is limited, the drug is not recommended to prescribe this category of patients;
rare hereditary disorders - galactose intolerance, lactase deficiency or impaired glucose-galactose absorption.

Pregnancy and Breastfeeding

In experimental studies when prescribed in doses 200 times higher than recommended, the drug did not cause impairment of fertility and early embryo development and did not have a teratogenic effect on the fetus. There are no sufficient data on the use of the drug Galvus in pregnant women, and therefore the drug should not be used during pregnancy. When violations of glucose metabolism in pregnant women, there is an increased risk of developing congenital abnormalities, as well as the frequency of neonatal morbidity and mortality.
Since it is not known whether vildagliptin is excreted in human breast milk, Galvus should not be used during lactation.

Adverse reactions

When using Galvus as monotherapy or in combination with other drugs, most adverse reactions were mild, temporary, and did not require discontinuation of therapy. No correlation was found between the incidence of adverse events (AE) and age, sex, ethnicity, duration of use, or dosing regimen. The incidence of angioedema during therapy with Galvus was ≥1 / 10,000,