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 glycemic control in adults w/ type 2 DM when treatment w/ both linagliptin & metformin is appropriate, in patients inadequately controlled on metformin alone or those already being treated & well controlled w/ the free combination of linagliptin & metformin. In combination w/ sulphonylurea (ie, triple combination therapy) as adjunct to diet & exercise in adults inadequately controlled on their maximal tolerated dose of metformin & sulphonylurea. In combination w/ SGLT2 inhibitor (ie, triple combination therapy) as adjunct to diet & exercise in patients inadequately controlled on their max tolerated dose of metformin & SGLT2 inhibitor. As add-on to insulin (ie, triple combination therapy), as adjunct to diet & exercise to improve glycaemic control in adult patients when insulin & metformin alone do not provide adequate glycaemic control.

Adult w/ normal renal function (GFR ≥90 mL/min) 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1,000 mg bid. Max daily dose: 5 mg/2,000 mg. Patients not currently treated w/ metformin Initially 2.5 mg/500 mg bid. Patients inadequately controlled on maximal tolerated dose of metformin monotherapy Initially linagliptin 2.5 mg bid + the metformin dose already being taken. Patients switching from co-administration of linagliptin & metformin Initiate at the dose of linagliptin & metformin already being taken. Patients inadequately controlled on dual combination therapy w/ the maximal tolerated dose of metformin & sulphonylurea/insulin Linagliptin 2.5 mg bid & dose of metformin similar to the dose already being taken.

Should be taken with food.

Hypersensitivity. Any type of acute metabolic acidosis (eg, lactic acidosis, diabetic ketoacidosis). Diabetic pre-coma. Acute conditions w/ the potential to alter renal function (eg, dehydration, severe infection, shock, intravascular administration of iodinated contrast agents). Disease which may cause tissue hypoxia (especially acute disease or worsening of chronic disease) eg, decompensated heart failure, resp failure, recent MI, shock. Acute alcohol intoxication & alcoholism. Hepatic impairment & severe renal failure (CrCl <30 mL/min or eGFR <30 mL/min/1.73 m²).

Do not use in patients w/ type 1 diabetes. Discontinue if pancreatitis & bullous pemphigoid are suspected. Hypoglycaemia. Consider dose reduction when used in combination w/ sulphonylurea & insulin. Risk of hypoxia & renal insufficiency in patients w/ heart failure. Assess GFR before initiation & regularly thereafter. Temporarily discontinue in presence of conditions that alter renal function. Avoid use during pregnancy. Not to be used during breast-feeding. Not recommended in childn <18 yr. Elderly. Metformin: Increased risk of lactic acidosis when accumulation occurs at acute worsening of renal function. Temporarily discontinue use if dehydration (severe diarrhoea or vomiting, fever or reduced fluid intake) occurs. May acutely impair renal function when used concomitantly w/ antihypertensives, diuretics & NSAIDs. Intravascular administration of iodinated contrast agent. Discontinue prior to or at the time of the imaging procedure & not restarted until at least 48 hr after, provided that renal function has been re-evaluated & found to be stable; at the time of surgery under general, spinal or epidural anesth. 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. Increased risk of low vit B₁₂ levels w/ increasing dose, treatment duration, &/or in patients w/ risk factors known to cause vit B₁₂ deficiency. Continue therapy for as long as tolerated & not contra-indicated; provide appropriate corrective treatment for vit B₁₂ deficiency in line w/ current clinical guidelines.

Nasopharyngitis; hypersensitivity; cough; decreased appetite, diarrhoea, nausea, pancreatitis, vomiting; pruritus; increased lipase. Metformin: Urticaria; lactic acidosis, vit B₁₂ decrease/deficiency; taste disturbance; abdominal pain; abnormal LFT, hepatitis; erythema.

Linagliptin: Inhibits P-gp-mediated transport of digoxin w/ low potency. Increased AUC & C_max w/ ritonavir. Decreased steady-state AUC & C_max, & DPP-4 inhibition at trough w/ rifampicin. Increased plasma AUC & C_max of simvastatin. Metformin: Increased risk of lactic acidosis in alcohol intoxication; NSAIDs including selective COX-2 inhibitors, ACE inhibitors, AIIA & diuretics especially loop diuretics. May reduce efficacy w/ OCT1 inhibitors (eg, verapamil). May increase GI absorption & efficacy w/ OCT1 inducers (eg, rifampicin). May decrease renal elimination w/ OCT2 inhibitors (eg, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib & isavuconazole). May alter efficacy & renal elimination w/ both OCT1 & OCT2 inhibitors (eg, crizotinib & olaparib).

Antidiabetic Agents

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

Rx