Uses of Vildela Tablet: - Type 2 diabetes mellitus Type 2 DM Hypersensitivity to vildagliptin

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Vildagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones. Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal. These hormones are rapidly inactivated by the enzyme, DPP-4. The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis. When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signaling pathways involving cyclic AMP. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, leading to reduced hepatic glucose production. By increasing and prolonging active incretin levels, Vildagliptin increases insulin release and decreases glucagon levels in the circulation in a glucose-dependent manner.

How to use Vildagliptin: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Vildagliptin may be taken with or without food, but it is better to take it at a fixed time. Administration: May be taken with or without food. Adult Dose: Oral Type 2 diabetes mellitus Adult: 50 mg bid. Not recommended to use >100 mg/day. W/ metformin or a thiazolidinedione: 50 mg twice daily; w/ a sulfonylurea: 50 mg/day in the morning. Renal Dose: Renal impairment: Moderate, severe and ESRD: 50 mg once daily.

Decreased hypoglycaemic effect w/ thiazides, corticosteroids, thyroid products and sympathomimetics.

Hypersensitivity to vildagliptin

Common - Headache - Common cold - Cough - Constipation - Dizziness - Sweating - Hypoglycaemia (low blood sugar level) in combination with insulin or sulphonylurea Nausea, peripheral oedema, headache, tremor, asthenia, dizziness, constipation, hypoglycaemia, arthralgia, hepatic dysfunction, nasopharyngitis, upper resp tract infection, pancreatitis, exfoliative and bullous skin reactions.

Pregnancy: There are no adequate data on the use of Vildagliptin in pregnant women; hence the potential risk for human is unknown.Lactation: It is not known whether Vildagliptin is excreted in human milk. Due to lack of human data, Vildagliptin should not be used during lactation.

Precaution: Patient w/ cardiac failure (NYHA functional class IV), type 1 DM; history of acute pancreatitis. Not intended for the treatment of diabetic ketoacidosis. Hepatic impairment, including patients w/ pre-treatment ALT or AST >3 times the upper limit of normal (ULN). Moderate or severe renal impairment, ESRD. Monitoring Parameters Monitor liver function.

Store below 30°C temperature & keep away from light & moisture. Keep out of reach of children.

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Vildagliptin is a dipeptidylpeptidase-4 (DPP-4) inhibitor that improves glycaemic control by preventing DPP-4 from inactivating the incretin hormones glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide, thus prolonging incretin activity in response to ingestion of nutrients. This increases insulin sensitivity, decreases glucagon secretion and improves ?-cell function.

Vildagliptin should not be used in pregnancy. Vildagliptin should not be used during lactation.