Galvus-Met 500 - Tablet Metformin Hydrochloride + Vildagliptin - 500mg+50mg 10 Tablet(s) / Strip Nevian Lifescience PLC Introduction: Galvus-Met 500 is a combination of two medicines that control high blood sugar levels in people with type 2 diabetes mellitus. This helps prevent serious complications of diabetes such as kidney damage and blindness and may reduce your chance of having a heart attack or stroke. Galvus-Met 500 can be prescribed alone or together with other diabetes medications. All diabetes medicines work best when used along with a healthy diet and regular exercise. The dose you are given will depend on your condition, blood sugar levels and what other medicines you are taking. Taking it with meals helps to reduce... Uses of Galvus-Met 500: Type 2 diabetes mellitus Side effects of Galvus-Met 500: NauseaVomitingDiarrheaStomach painLoss of appetiteDizzinessHeadacheTremblingMetallic tasteHypoglycemia (low blood glucose level) How to use Galvus-Met 500: 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. Galvus-Met 500 is to be taken with food. How Galvus-Met 500 works: Galvus-Met 500 is a combination of two antidiabetic medicines: Metformin and Vildagliptin. Metformin is an anti-diabetic medication (biguanide). It works by lowering glucose production in the liver, delaying glucose absorption from intestines and increasing the body's sensitivity to insulin. Vildagliptin is a DPP-4 inhibitor which works by increasing the release of insulin from the pancreas and decreasing the hormones that raise blood sugar levels. This reduces both fasting and postmeal sugar levels. Together, they provide better control of blood sugar. Indication: Type 2 DM Administration: Should be taken with or just after food. Adult Dose: Oral Type 2 DM Adults: Based on the patient's current dose of Metformin, Combination of Vildagliptin & Metformin may be initiated at either 50 mg/500 mg or 50 mg/850 mg twice daily, 1 tab in the morning and the other in the evening. The recommended maximum daily dose is 100 mg Vildagliptin plus 2000 mg Metformin HCl. Patients receiving Vildagliptin and Metformin from separate tablets may be switched to Combination of Vildagliptin & Metformin containing the same doses of each component. Hepatic impairment: This combination is not recommended in patients with hepatic impairment including patients with a pre-treatment ALT or... Child Dose: Not recommended in patients <18 years of age Renal Dose: Renal impairment: This combination should not be used in patients with renal failure or renal dysfunction, e.g. serum creatinine levels > 1.5 mg/dL (>135 micro mol/L) in males and > 1.4 mg/dL (>110 micro mol/L) in females. Contraindication: This combination is contraindicated in patients with known hypersensitivity to Vildagliptin or Metformin Hydrochloride or to any of the excipients. It is contraindicated in patients with renal disease or renal dysfunction, acute myocardial infarction, and septicaemia. It is also contraindicated in patients with congestive heart failure patients and in patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. It should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. Mode of Action: Metformin: Biguanide; acts by decreasing endogenous hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization; improves glucose tolerance and lowers both basal and postprandial plasma glucose . 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. Precaution: Lactic acidosis can occur due to Metformin accumulation. If metabolic acidosis is suspected, treatment should be discontinued and the patient should be hospitalized immediately. Patients with renal impairment & hepatic impairment. Serum creatinine should be monitored at least once a year in patients with normal renal function and 2–4 times a year in patients with serum creatinine levels at the upper limit of normal and in elderly patients. Special caution should be exercised in elderly patients where renal function may become impaired (e.g. when initiating antihypertensives, diuretics or NSAIDs). It is recommended that Liver Function Tests (LFTs) are monitored prior... Side Effect: Hypoglycaemia, delayed gastric emptying, nausea and vomiting. Flu-like symptoms, headache and dizziness may occur. Potentially Fatal: Stevens-Johnson syndrome. Interaction: Additive effect w/ sulfonylureas. Thiazide diuretics, corticosteroids, phenothiazines, OC, sympathomimetics, niacin, Ca channel blockers and isoniazid may exacerbate loss of glycaemic control. ACE inhibitors may reduce fasting blood glucose concentrations. May increase serum level w/ cimetidine. Potentially Fatal: Concurrent use w/ iodinated contrast agents may increase the risk of metformin-induced lactic acidosis.