Vildalion-M 550/Vildalion-M 900/Vildalion-M 1050

Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM: In patients who are inadequately controlled w/ metformin HCl alone; in patients already being treated w/ combination of vildagliptin & metformin HCl, as separate tab; in combination w/ other medicinal products for treatment of diabetes, including insulin, when these do not provide adequate glycemic control.

Adult w/ normal renal function (GFR ≥90 mL/min) Individualized dosage. Max daily dose: Not to exceed vildagliptin 100 mg. May be initiated at 50 mg/850 mg or 50 mg/1,000 mg bid, 1 tab in the morning & the other in the evening. Patient inadequately controlled at maximal tolerated dose of metformin monotherapy Initially vildagliptin 50 mg bid (100 mg total daily dose) + metformin dose already being taken. Patient switching from co-administration of vildagliptin & metformin as separate tab Initiate at the dose already being taken. Patient inadequately controlled on dual combination w/ metformin & sulfonylurea Vildagliptin 50 mg bid (100 mg total daily dose) + metformin dose similar to the dose already being taken. Patient inadequately controlled on dual combination w/ insulin & maximal tolerated metformin dose Vildagliptin 50 mg bid (100 mg total daily dose) + metformin dose similar to the dose already being taken. Patient w/ renal impairment GFR 60-89 mL/min Metformin max daily dose: 3,000 mg divided into 2-3 daily doses. Consider dose reduction in declining renal function, GFR 45-59 mL/min Metformin max daily dose: 2,000 mg divided into 2-3 daily doses. Starting dose is at most ½ of the max dose. Vildagliptin max daily dose: 50 mg, GFR 30-44 mL/min Metformin max daily dose: 1,000 mg divided into 2-3 daily doses. Starting dose is at most ½ of the max dose. Vildagliptin max daily dose: 50 mg.

Should be taken with food: Take w/ or immediately after meals to reduce GI discomfort.

Hypersensitivity. Acute metabolic acidosis (eg, lactic acidosis, diabetic ketoacidosis); diabetic pre-coma; acute conditions w/ potential to alter renal function eg, dehydration, severe infection, shock, intravascular administration of iodinated contrast agents; acute or chronic disease which may cause tissue hypoxia eg, cardiac or resp failure, recent MI, shock; acute alcohol intoxication, alcoholism. Severe renal failure (GFR <30 mL/min). Hepatic impairment. Breastfeeding.

Not a substitute for insulin in insulin-requiring patients & should not be used in patients w/ type 1 diabetes. Assess GFR before treatment initiation & at least annually thereafter; assess more frequently (eg, every 3-6 mth) in patients at increased risk of further progression of renal impairment & in elderly. Perform LFTs prior to treatment initiation & monitor at 3-mth interval during 1st yr of treatment, then periodically thereafter. W/draw therapy if increase in AST or ALT ≥3 times ULN persist. Discontinue in patients who develop jaundice or other signs suggestive of liver dysfunction. Should not be used during pregnancy. Not recommended in childn & adolescents <18 yr. Vildagliptin: Reports of skin lesions, including blistering & ulceration. Monitor patients for skin disorders. Risk of developing acute pancreatitis. Discontinue treatment if pancreatitis is suspected. Risk of hypoglycemia w/ concomitant sulfonylurea. Metformin: Risk of lactic acidosis. Temporarily discontinue in case of dehydration & in the presence of conditions that alter renal function. Discontinue use prior to or at the time of imaging procedure w/ intravascular iodinated contrast agents & do not restart until 48 hr after the procedure, provided that renal function is stable. Discontinue use at the time of surgery under general, spinal or epidural anesth; may be restarted no earlier than 48 hr following surgery or resumption of oral nutrition & provided that renal function is stable.

URTI, nasopharyngitis; dizziness, headache, tremor; vomiting, diarrhea, nausea, GERD, flatulence, constipation, abdominal pain, including upper abdominal pain; hyperhidrosis, pruritus, rash, dermatitis; arthralgia; asthenia.

Vildagliptin: Increased risk of angioedema w/ ACE inhibitors. Hypoglycemic effect may be reduced by thiazides, corticosteroids, thyroid products & sympathomimetics. Metformin: Increased risk of lactic acidosis w/ alcohol intoxication, particularly in cases of fasting, malnutrition or hepatic impairment; iodinated contrast agents; medicinal products that can adversely affect renal function eg, NSAIDs, including selective COX II inhibitors, ACE inhibitors, AIIA & diuretics, especially loop diuretics. Glucocorticoids, β₂ agonists, & diuretics have intrinsic hyperglycemic activity. Blood glucose levels may be decreased w/ ACE inhibitors. Increased systemic exposure w/ medicinal products that interfere w/ common renal tubular transport systems involved in renal elimination of metformin [eg, organic cationic transporter-2 (OCT2)/multidrug & toxin extrusion (MATE) inhibitors eg, ranolazine, vandetanib, dolutegravir & cimetidine].

Antidiabetic Agents

A10BD08 - metformin and vildagliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

Rx