Vildagliptin

Aiglip® tablets are indicated for the treatment of adult patients with type II diabetes mellitus.

As monotherapy. Patients in whom the use of diet and exercise alone does not provide sufficient control, as well as for patients in whom the use of metformin is considered unacceptable due to contraindications or intolerance.

As part of a double oral therapy in combination with:

• Metformin in patients with inadequate glycemic control, despite the use of the maximum tolerated dose for metformin monotherapy.
• Sulfonylurea in patients with insufficient glycemic control, despite the use of the maximum tolerated dose of sulfonylurea, and for patients in whom the use of metformin is considered unacceptable due to the presence of contraindications or intolerance.
• Thiazolidinedione for patients with insufficient glycemic control, for whom the use of thiazolidinedione is considered acceptable.

As part of triple oral therapy in combination with sulfonylurea and metformin, when diet and exercise with dual therapy with these drugs do not provide adequate glycemic control.

In combination with insulin (with or without metformin), when diet and exercise, together with a stable dose of insulin, do not provide adequate glycemic control.

Structure

Active substance: vildagliptin;

1 tablet contains vildagliptin - 50 mg.

Excipients: microcrystalline cellulose, lactose, low-substituted hydroxypropyl cellulose, magnesium stearate.

Contraindications

Hypersensitivity to vildagliptin or to an excipient.

Mode of application

When used as monotherapy, in combination with metformin, in combination with thiazolidinedione in combination with metformin and sulfonylurea, or in combination with insulin (with or without metformin), the recommended daily dose of vildagliptin is 100 mg, divided into two doses: 50 mg in the morning and 50 mg in the evening.

When used as part of a double combination with sulfonylurea, the recommended dose of vildagliptin is 50 mg once a day, in the morning. In this patient population, vildagliptin at a dose of 100 mg per day was no more effective than vildagliptin at a dose of 50 mg once a day.

Application features

Children

The use of Aiglip® is not recommended for children and adolescents under the age of 18 due to the lack of safety and efficacy data.

Drivers

Studies on the effect of the drug on the ability to drive a car and work with mechanisms have not been conducted. Patients experiencing dizziness should not drive vehicles or other machinery.

Overdose

Information on possible overdose symptoms was obtained from a dose-tolerance study in healthy volunteers who received vildagliptin for 10 days. At a dosage of 400 mg, three cases of muscle pain were observed, as well as several cases of mild and short-term paresthesia, fever, the development of edema and a temporary increase in lipase levels. At a dosage of 600 mg, one of the volunteers developed swelling of the legs and arms, a significant increase in the level of creatinine phosphokinase (PKK), which was accompanied by an increase in the levels of AST, C-reactive protein and myoglobin. Three volunteers of this group had edema of both legs, in two cases accompanied by paresthesia. All symptoms and laboratory abnormalities disappeared after discontinuation of the study drug.

In case of an overdose, supportive therapy is recommended. Vildagliptin is not excreted during hemodialysis, but most hydrolysis metabolites (LAY 151) can be removed by hemodialysis.

Side effects

• dizziness;
• headache;
• hypoglycemia.

Interaction

Combination with ACE inhibitors.

With simultaneous use with ACE inhibitors, a higher risk of developing angioneurotic edema.

As with other oral antidiabetic drugs, certain active substances, including thiazides, corticosteroids, thyroid hormone preparations, and sympathomimetics, can reduce the hypoglycemic effect of vildagliptin.

Storage conditions

For the drug does not require special storage conditions.

Keep out of the reach of children.

Shelf life is 3 years.