Vilpower M Tablets (Vildagliptin + Metformin)

• Composition :
  Each film coated tablet contains Vildagliptin 50 mg + Metformin hydrochloride IP 500/1000mg.
• Indications :
  For the treatment of type-II diabetes mellitus when single drug therapy along with diet, exercise do not result in adequate glycaemic control.
• Pharmacodynamics :
  Vildagliptin is a dipeptidyl peptidase-4 inhibitor. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
• Dosage and administration :
  Vildagliptin 50 mg + Metformin 500mg twice daily Should be given with meals.
• Contraindications :
  Hypersensitivity to the active substance or to any other excipients of the formulation.Acute or chronic metabolic acidosis including lactic acidosis or diabetic ketoacidosis with or without coma. Patients with creatinine clearance < 30 ml/min. Acute conditions with thepotential to alter renal function. Acute or chronic disease which may cause tissue hypoxia.Hepatic impairment. Acute alcohol intoxication, alcoholism. Breast-feeding.
• Precautions and warnings :
  Not recommended in hepatic impairment, moderate or severe renal impairment. Not recommend in paediatric patients. Risk of decreased vitamin B12 serum levels. Risk of hypoglycemia. Should not be used in patients with type 1 diabetes or for the treatment of diabetic lactic acidosis. Dosage adjustment may be required in patients with creatinine clearancebetween 30 and 90 mL/min. Hepatic impairment: should not be used in patientswith hepatic impairment, including those with pre-treatment aminotransferase (ALT) or aspartateaminotransferase (AST) > 3 times the upper limit of normal (ULN). Geriatric patients:Dosage should be adjusted based on renal function which needs to be monitored.
• Use in pregnancy, lactation & pediatrics :
  There are no adequate studies of vildagliptin in these populations. Vildagliptin should not be used during pregnancy or lactation. Not recommended for use in children under 18 years of age
• Drug interactions :
  Vildagliptin has a low potential for drug interactions. No clinically relevant interactions with oral antidiabetic drugs (glibenclamide, pioglitazone, metformin), amlodipine, digoxin, ramipril, simvastatin, valsartan or warfarin were observed after co-adminisatration with vildagliptin. Interaction with Metformin: furosemide, nifedepine, cationic drugs, drugs tending to produce hyperglycemia, alcohol.
• Adverse reactions :
  Most common adverse reactions are headache, dizziness, abdominal pain, constipation, peripheral oedema.
• Therapy Area :
  Anti-Diabetic agents