Trajenta Duo

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. Patient not currently treated w/ metformin Initially 2.5 mg/500 mg bid. Patient inadequately controlled on maximal tolerated dose of metformin monotherapy Initially linagliptin 2.5 mg bid + the metformin dose already being taken. Patient switching from co-administration of linagliptin & metformin Initiate at the dose of linagliptin & metformin already being taken. Patient 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. Risk of hypoglycaemia 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. Preferable to avoid use during pregnancy. Not to be used during breast-feeding. Not recommended in childn <18 yr. Regularly monitor renal function in elderly. Metformin: Increased risk of lactic acidosis when accumulation occurs at acute worsening of renal function, cardioresp illness or sepsis. Temporarily discontinue use if dehydration (severe diarrhoea or vomiting, fever or reduced fluid intake) occurs. Medicinal products that can acutely impair renal function (eg, antihypertensives, diuretics & NSAIDs) should be initiated w/ caution. Discontinue treatment prior to or at the time of imaging procedure w/ intravascular iodinated contrast agent & do not restart until at least 48 hr after, provided that renal function has been re-evaluated & found to be stable. Discontinue treatment 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 metformin dose, treatment duration, &/or in patients w/ risk factors known to cause vit B₁₂ deficiency. Continue therapy for as long as tolerated & not contraindicated; provide appropriate corrective treatment for vit B₁₂ deficiency in line w/ current clinical guidelines.

Nasopharyngitis; hypersensitivity, urticaria; hypoglycaemia (when used w/ sulphonylurea); cough; decreased appetite, diarrhoea, constipation (when used w/ insulin), nausea, pancreatitis, vomiting; pruritus; increased lipase/amylase. Linagliptin: Angioedema; mouth ulceration; rash; bullous pemphigoid. Metformin: Lactic acidosis, vit B₁₂ decrease/deficiency; taste disturbance; abdominal pain; abnormal LFT, hepatitis; erythema.

Linagliptin: Decreased linagliptin steady-state AUC & C_max, & decreased DPP-4 inhibition at trough w/ rifampicin (potent inducer of P-gp & CYP3A4). Metformin: Increased risk of lactic acidosis w/ alcohol intoxication; iodinated contrast agents; NSAIDs including selective COX-2 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). Renal elimination may be decreased w/ OCT2 inhibitors (eg, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib & isavuconazole). Efficacy & renal elimination may be altered 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