Trajenta Duo

Adjunct to diet & exercise to improve glycaemic control in adults w/ type 2 DM when treatment w/ both linagliptin & metformin is appropriate.

Individualised dosage. Max daily dose: Linagliptin 5 mg & metformin 2,000 mg. Patient currently not treated w/ metformin Initially 2.5/500 mg bd. Patient inadequately controlled on maximal tolerated dose of metformin monotherapy Initially linagliptin 2.5 mg bd (total daily dose of 5 mg) + dose of metformin already being taken. Patient switching from co-administration of linagliptin & metformin to the fixed dose combination Initiate at the dose of linagliptin & metformin already being taken. Patient inadequately controlled on dual combination therapy w/ maximal tolerated dose of metformin & a sulphonylurea Linagliptin 2.5 mg bd (total daily dose of 5 mg) + dose of metformin similar to the dose already being taken. If used in combination w/ a sulphonylurea, a lower dose of sulphonylurea may be required. Patient inadequately controlled on dual combination therapy w/ insulin & maximal tolerated dose of metformin Linagliptin 2.5 mg bd (total daily dose of 5 mg) + dose of metformin similar to the dose already being taken. If used in combination w/ insulin, a lower dose of insulin may be required.

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

Hypersensitivity. Any type of 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, decompensated heart failure, cardiac or resp failure, recent MI, shock). Acute alcohol intoxication; alcoholism. Severe renal failure (CrCl <30 mL/min or eGFR <30 mL/min/1.73 m²). Hepatic impairment.

Not to be used in patients w/ type 1 diabetes or for diabetic ketoacidosis. Acute pancreatitis; promptly discontinue use & initiate appropriate management if pancreatitis is suspected. Hypoglycaemia could occur when caloric intake is deficient, strenuous exercise is not compensated by caloric supplementation or during concomitant use w/ other glucose-lowering agents (eg, sulphonylureas & insulin) or ethanol. Risk of lactic acidosis. Temporarily discontinue use in case of dehydration. Not recommended in patients w/ known mitochondrial diseases eg, mitochondrial encephalopathy w/ lactic acidosis & stroke-like episodes (MELAS) syndrome & maternal inherited diabetes & deafness (MIDD); immediately w/draw use & promptly perform diagnostic evaluation in case of signs & symptoms suggestive of MELAS syndrome or MIDD after metformin intake. Regular monitoring of cardiac & renal function in patients w/ stable chronic heart failure. Discontinue use at the time of surgery under general, spinal or epidural anaesth. Discontinue use if bullous pemphigoid is suspected. Monitor vit B₁₂ serum levels if vit B₁₂ deficiency (eg, anaemia or neuropathy) is suspected. Evaluate serum electrolytes & ketones, blood glucose & if indicated, blood pH, lactate, pyruvate & metformin levels in patients w/ previously well controlled type 2 diabetes who develops lab abnormalities or clinical illness; stop immediately & initiate other appropriate corrective measures if acidosis of either form occurs. Discontinue use prior to or at time of imaging procedure in patients w/ eGFR >60 mL/min/1.73 m²; do not restart until at least 48 hr after, provided that renal function has been re-evaluated & found to be stable. Discontinue 48 hr before iodinated contrast media administration in patients w/ moderate renal impairment; do not reinstitute until at least 48 hr afterwards & only after renal function has been re-evaluated & not deteriorated further. Assess GFR before treatment initiation & regularly thereafter. Avoid use during pregnancy. Do not use during breast-feeding. Not recommended in childn & adolescents. Elderly >75 yr.

Nasopharyngitis; hypersensitivity, angioedema, urticaria; lactic acidosis, vit B₁₂ decrease/deficiency, hypoglycaemia (when linagliptin & metformin were combined w/ a sulphonylurea); taste disturbance; cough; decreased appetite, diarrhoea, constipation (when linagliptin & metformin were combined w/ insulin), nausea, pancreatitis, vomiting, abdominal pain, mouth ulceration; abnormal LFT, hepatitis; pruritus, erythema, rash, bullous pemphigoid; increased lipase & amylase.

Linagliptin: Inhibits P-gp mediated transport of digoxin (w/ low potency). Decreased steady-state AUC, C_max & dipeptidyl peptidase-4 inhibition at trough w/ rifampicin. Increased plasma AUC & C_max of simvastatin. Metformin: Increased risk of lactic acidosis w/ alcohol intoxication; iodinated contrast agents; NSAIDs including selective COX II inhibitors, ACE inhibitors, AIIA & diuretics especially loop diuretics. Efficacy may be reduced w/ OCT1 inhibitors (eg, verapamil). GI absorption & efficacy may be increased w/ OCT1 inducers (eg, rifampicin). Plasma conc may be increased w/ OCT2 inhibitors (eg, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole). Efficacy & renal elimination may be altered w/ 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.

POM