This is indicated as an adjunct to diet and exercises to improve glycaemic control in patients with type 2 diabetes mellitus whose diabetes is not adequately controlled on Metformin Hydrochloride or Vildagliptin alone or who are already treated with the combination of Vildagliptin and Metformin Hydrochloride, as separate tablets.
Combination Oral hypoglycemic preparations
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.
Dosage & Administration
Adults: Based on the patient’s current dose of Metformin, Vildagliptin and Metformin may be initiated at either 50 mg/500 mg or 50 mg/850 mg twice daily, 1 tablet in the morning and the other in the evening. Patients receiving Vildagliptin and Metformin from separate tablets may be switched to Vildagliptin and Metformin containing the same doses of each component. Doses higher than 100 mg of vildagliptin are not recommended. There is no clinical experience of Vildagliptin and Metformin in triple combination with other antidiabetic agents. Taking Vildagliptin and Metformin with or just after food may reduce gastrointestinal symptoms associated with Metformin.
Pregnancy & Lactation
NURSING MOTHERS: It is not known whether Vildagliptin is excreted in human milk. Due to lack of human data, Vildagliptin & Metformin should not be used during lactation.