Management of type 2 diabetes mellitus.
Vildagliptin acts primarily by inhibiting DPP-4 (Dipeptidyl peptidase-4), the enzyme responsible for the degradation of the incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide). The administration of Vildagliptin results in a rapid and complete inhibition of DPP-4 activity resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 and GIP. By increasing the endogenous levels of these incretin hormones, Vildagliptin increases insulin secretion from the pancreatic beta cell and decreases glucagon secretion from alpha cell. The enhanced increase in the insulin/glucagon ratio during hyperglycaemia due to increased incretin hormone levels results in a decrease in fasting and postprandial hepatic glucose production, leading to reduced glycaemia.
Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Glucomin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
Adults : Starting dose of Comet (Metformin Hydrochloride tablet) is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. Starting dose of Comet XR (Metformin Hydrochloride extended release tablet) is 500 mg once daily with the evening meal. Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal. If glycemic control is not achieved on Comet XR 2000 mg once daily, a trial of Comet XR 1000 mg twice daily should be considered. Pediatrics : Starting dose of Comet is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
No clinically relevant pharmacokinetic interaction was observed when Vildagliptin (100 mg once daily) was co-administered with Metformin Hydrochloride (1,000 mg once daily). Vildagliptin has a low potential for drug interactions. Since Vildagliptin is not a cytochrome P (CYP) 450 enzyme substrate nor does it inhibit nor induces CYP 450 enzymes, it is not likely to interact with co-medications that are substrates, inhibitors or inducers of these enzymes. As a result of these studies no clinically relevant interactions with other oral antidiabetics (glibenclamide, pioglitazone, metformin hydrochloride), amlodipine, digoxin, ramipril, simvastatin, valsartan or warfarin were observed after co-administration with vildagliptin. On the other hand, furosemide, nifedipine and glyburide increase Cmax and blood AUC of Metformin with no change in renal clearance of Metformin.
Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels > 1.5 mg/ dL [males], > 1.4 mg/dL [females] or abnormal creatinine clearance), Congestive heart failure requiring pharmacologic treatment, Known hypersensitivity to metformin hydrochloride, Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Pregnant mothers: Pregnancy Category B. Metformin should not be used during pregnancy unless clearly needed. Nursing mothers : Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Diarrhea, nausea, vomiting, flatulence, asthenia, indigestion, abdominal discomfort, headache etc.
While it does cross the placenta, metformin has not been associated with an increased risk of birth defects or complications. Therefore, if you're already taking metformin before you get pregnant, your doctor may encourage you to continue using the drug throughout your pregnancy. The very limited amounts of metformin observed in breast milk are highly unlikely to lead to substantial exposure in the breastfed baby. Metformin can be considered a safe medication for the treatment of type 2 diabetes in a breastfeeding mother.
Keep in a dry place away from light and heat. Keep out of the reach of children.
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