Vildaxil-Plus

Adjunct to diet & exercise to improve glycaemic control in adults w/ type 2 DM in patients who are inadequately controlled w/ metformin HCl alone or 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 glycaemic control.

Adult w/ normal renal function (GFR ≥90 mL/min) Individualized dosage. Max daily dose: Not to exceed vildagliptin 100 mg. May initiate at 50 mg/500 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) plus 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 & sulphonylurea, or insulin & maximal tolerated metformin dose Provide vildagliptin 50 mg bid (100 mg total daily dose) & metformin dose similar to the dose already being taken.

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

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. Lactation.

Not a substitute for insulin in insulin-requiring patients & not to be used in patients w/ type 1 diabetes. Hepatic impairment, including pre-treatment ALT or AST >3x ULN. Not to be used during pregnancy. Metformin: Lactic acidosis. Temporarily discontinue in case of dehydration (severe diarrhoea or vomiting, fever or reduced fluid intake). Initiate medicinal products that can acutely impair renal function (eg, antihypertensives, diuretics & NSAIDs) w/ caution in metformin-treated patients. Risk factors for lactic acidosis eg, excessive alcohol intake, hepatic insufficiency, inadequately controlled diabetes, ketosis, prolonged fasting & any conditions associated w/ hypoxia, as well as concomitant use of medicinal products that may cause lactic acidosis. Discontinue in case of suspected symptoms of lactic acidosis. May lead to contrast-induced nephropathy w/ intravascular administration of iodinated contrast agents. Discontinue prior to or at the time of imaging procedure & do not restart until at least 48 hr after, provided that renal function has been re-evaluated & found to be stable. Assess GFR before treatment initiation & regularly thereafter; temporarily discontinue in the presence of conditions that alter renal function. Concomitant medicinal products that may affect renal function, result in significant haemodynamic change, or inhibit renal transport & increase systemic exposure. Discontinue at time of surgery under general, spinal or epidural anaesth. Restart therapy no earlier than 48 hr following surgery or resumption of oral nutrition & provided that renal function has been re-evaluated & found to be stable. Vildagliptin: Perform LFTs prior to initiation of treatment in order to know patient's baseline value. Monitor liver function during treatment at 3-mth intervals during the 1st yr & periodically thereafter. Monitor patients who develop increased transaminase levels w/ 2nd liver function evaluation to confirm finding & be followed thereafter w/ frequent LFTs until abnormalities return to normal. W/draw therapy if increase in AST or ALT of 3x ULN or greater persist. Discontinue in patients who develop jaundice or other signs suggestive of liver dysfunction; if pancreatitis is suspected. Skin lesions, including blistering & ulceration; monitor skin disorders in diabetic patient. Do not restart treatment if acute pancreatitis is confirmed. Patients w/ history of acute pancreatitis. Risk of hypoglycaemia in combination w/ sulphonylurea.

Hypoglycaemia. Vildagliptin: Rare cases of hepatic dysfunction (including hepatitis); angioedema (mostly when administered in combination w/ ACE inhibitor).

Vildagliptin: Increased risk of angioedema w/ ACE inhibitors. Hypoglycaemic effect may be reduced by thiazides, corticosteroids, thyroid products & sympathomimetics. Metformin: Increased risk of lactic acidosis, particularly in cases of fasting, malnutrition or hepatic impairment w/ alcohol intoxication. Iodinated contrast agents. Medicinal products that can adversely affect renal function which may increase risk of lactic acidosis eg, NSAIDs, including selective COX II inhibitors, ACE inhibitors, AIIA & diuretics, especially loop diuretics. Intrinsic hyperglycaemic activity w/ glucocorticoids, β-2-agonists, & diuretics. May decrease blood glucose levels w/ ACE inhibitors. Increased systemic exposure w/ medicinal products that interfere w/ common renal tubular transport systems involved in renal elimination (eg, organic cationic transporter-2 [OCT2]/multidrug & toxin extrusion [MATE] inhibitors including 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.

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