Description GALVUSMET 50MG/500MG TABLET Description : Three strengths are available: 50 mg vildagliptin and 500 mg metformin hydrochloride; 50 mg vildagliptin and 850 mg metformin hydrochloride; 50 mg vildagliptin and 1,000 mg metformin hydrochloride. Indications / Uses : Adjunct to diet & exercise to improve glycemic control in patients w/ type 2 DM whose diabetes is not adequately controlled on metformin HCl or vildagliptin alone or who are already treated w/ the combination of vildagliptin & metformin HCl as separate tab. In combination w/ a sulfonylurea (ie, triple combination therapy) as an adjunct to diet & exercise in patients inadequately controlled w/ metformin & a sulfonylurea. In combination w/ insulin as an adjunct to diet & exercise to improve glycemic control in patients when stable dose of insulin & metformin alone do not provide adequate glycemic control. Initial therapy in patients w/ type 2 DM whose diabetes is not adequately controlled by diet & exercise alone. Administration : Should be taken with food. Contraindications : Hypersensitivity. Renal impairment (CrCl <60 mL/min), CHF, acute or chronic metabolic acidosis including diabetic ketoacidosis w/ or w/o coma. Special Precautions : Not be used in treatment of type 1 DM & diabetic ketoacidosis. Risk of lactic acidosis & hypoglycemia; may be temporarily withheld in case of loss of glycemic control. Risk of decreased vit B12 serum levels. Concomitant use w/ drugs affecting renal function or metformin HCl disposition. Pre-treatment ALT or AST >2.5 x ULN. Perform liver function test prior to treatment initiation at 3-mth intervals during the 1st yr & periodically thereafter. Avoid excessive alcohol intake. Discontinue use in case of hypoxemia; undergoing surgical procedure & radiologic studies involving intravascular administration of iodinated contrast materials. W/draw use if an increase in AST/ALT =3 x ULN & do not reinitiate. Monitor renal function. Hepatic & renal impairment. Do not use in pregnancy & lactation. Not recommended in childn <18 yr. Elderly.
