Galvusmet 50Mg/850Mg Tablet

Description

GALVUSMET 50MG/850MG TABLET

Description : Per 50 mg/500 mg tab Vildagliptin 50 mg, metformin HCl 500 mg. Per 50 mg/850 mg tab Vildagliptin 50 mg, metformin HCl 850 mg. Per 50 mg/1,000 mg Vildagliptin 50 mg, metformin HCl 1,000 mg

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.