Trajenta Duo

Per 2.5/500 mg FC tab Linagliptin 2.5 mg, metformin HCl 500 mg. Per 2.5/850 mg FC tab Linagliptin 2.5 mg, metformin HCl 850 mg. Per 2.5/1,000 mg FC tab Linagliptin 2.5 mg, metformin HCl 1,000 mg

Adjunct to diet & exercise to improve glycaemic control in adults w/ type 2 DM inadequately controlled on their maximally tolerated dose of metformin alone; or in combination w/ other antidiabetics, including insulin, in patients inadequately controlled w/ metformin & these medicinal products; or in patients already being treated w/ combination of linagliptin & metformin as separate tab.

Adult w/ normal renal function (GFR ≥90 mL/min) Should not exceed max recommended daily dose of 5 mg linagliptin plus 2,000 mg metformin. Patient inadequately controlled on metformin monotherapy Usual starting dose: Linagliptin 2.5 mg bd plus dose of metformin already being taken. Patient inadequately controlled on dual combination therapy w/ metformin & a sulphonylurea or insulin Linagliptin 2.5 mg bd plus dose of metformin already being taken. Lower dose of sulphonylurea or insulin may be required to reduce the risk of hypoglycaemia. Patient switching from co-administration of linagliptin & metformin as separate tab Initiate at dose of linagliptin & metformin already being taken. Adult w/ renal impairment, GFR 60-89 mL/min Max daily dose of metformin: 3,000 mg. Dose reduction may be considered in relation to declining renal function, GFR 45-59 mL/min Max daily dose of metformin: 2,000 mg. Starting dose is at most ½ of the max dose, GFR 30-44 mL/min Max daily dose of metformin: 1,000 mg. Starting dose is at most ½ of the max dose.

Should be taken with food.

Hypersensitivity. Any type of acute metabolic acidosis. Diabetic pre-coma. Acute conditions w/ the potential to alter renal function. Disease which may cause tissue hypoxia. Acute alcohol intoxication, alcoholism. Severe renal failure (GFR <30 mL/min). Hepatic impairment.

Should not be used in patients w/ type 1 diabetes. Consider dose reduction of sulphonylurea &/or insulin when used in combination. Metformin accumulation occurs at acute worsening of renal function & increases the risk of lactic acidosis. Temporarily discontinue in case of dehydration. Discontinue prior to or at the time of imaging procedure or surgery under general, spinal or epidural anaesth; do not restart until ≥48 hr after the imaging procedure or surgery or resumption of oral nutrition, provided w/ a stable renal function. Temporarily discontinue in the presence of conditions that alter renal function. Caution in initiating medicinal products that can acutely impair renal function (eg, antihypertensives, diuretics & NSAIDs). Regularly monitor cardiac & renal function in patients w/ stable chronic heart failure. Contraindicated in patients w/ acute & unstable heart failure. Promptly evaluate for evidence of ketoacidosis or lactic acidosis in patients w/ previously well-controlled type 2 diabetes on Trajenta Duo who develop lab abnormalities or clinical illness (especially vague & poorly defined illness). Discontinue in patients w/ suspected pancreatitis; should not be restarted if acute pancreatitis is confirmed. Caution in patients w/ history of pancreatitis. Discontinue if bullous pemphigoid is suspected. Monitor vit B₁₂ serum levels in case of suspicion of vit B₁₂ deficiency (eg, anaemia or neuropathy). Monitor vit B₁₂ periodically in patients w/ risk factors for vit B₁₂ deficiency. Not recommended in patients w/ hepatic impairment. Elderly ≥80 yr.

Hypoglycaemia, abdominal pain. Vit B₁₂ decrease/deficiency, taste disturbance, diarrhoea, nausea, increased lipase.

Linagliptin: Rifampicin. Metformin: Use w/ precaution w/ glucocorticoids, β₂-agonists, & diuretics w/ intrinsic hyperglycaemic activity; medicinal products that adversely affect renal function & may increase risk of lactic acidosis eg, NSAIDs, including selective COX II inhibitors, ACE inhibitors, AIIA & diuretics, especially loop diuretics; OCT1 inhibitors (eg, verapamil), OCT1 inducers (eg, rifampicin), OCT2 inhibitors (eg, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole), & inhibitors of both OCT1 & OCT2 (eg, crizotinib, olaparib). Not recommended w/ alcohol; iodinated contrast agents.

Antidiabetic Agents

A10BD11 - metformin and linagliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

P₁S₁S₃