Trajenta Duo

Trajenta Duo

linagliptin + metformin

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 2.5 mg/500 mg FC tab Linagliptin 2.5 mg, metformin 500 mg. Per 2.5 mg/1,000 mg FC tab Linagliptin 2.5 mg, metformin 1,000 mg
Indications/Uses
Adjunct to diet & exercise to improve glycaemic 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/ a sulphonylurea (ie, triple combination therapy) as adjunct to diet & exercise in patients inadequately controlled on their max tolerated dose of metformin & a sulphonylurea. In combination w/ empagliflozin (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 patients when insulin & metformin alone do not provide adequate glycaemic control.
Dosage/Direction for Use
Patients never treated w/ metformin Individualized dosage. Recommended dose: Linagliptin 2.5 mg + metformin HCl 500 mg bid. Max: Linagliptin 2.5 mg + metformin 1,000 mg bid. Patients inadequately controlled on max tolerated dose of metformin monotherapy Initially linagliptin 2.5 mg bid + metformin dose already being taken. Patients switching from co-administration of linagliptin + metformin Initially at the dose of linagliptin & metformin already being taken. Patients inadequately controlled on dual combination therapy w/ the max tolerated dose of metformin & a sulphonylurea Linagliptin 2.5 mg bid (5 mg total daily dose) & a dose of metformin similar to the dose already being taken. When used in combination w/ a sulphonylurea, a lower dose of the sulphonylurea may be required. Patients inadequately controlled on dual combination therapy w/ insulin & max tolerated dose metformin Linagliptin 2.5 mg bid (5 mg total daily dose) & metformin dose similar to the dose already being taken. When in combination w/ insulin, a lower dose of insulin may be required. Renal impairment eGFR 60-89 mL/min Max daily dose: Metformin 3,000 mg, 45-59 mL/min Max daily dose: Metformin 2,000 mg. The starting dose is at most half of max dose, 30-44 mL/min Max daily dose: Metformin 1,000 mg. The starting dose is at most half of max dose.
Administration
Should be taken with food: Take w/ meals to minimise GI effects.
Contraindications
Hypersensitivity. Acute metabolic acidosis eg, lactic acidosis, diabetic ketoacidosis; diabetic pre-coma. Hepatic impairment & severe renal failure (CrCl <30 mL/min or eGFR <30 mL/min/1.73 m2). Acute conditions w/ the potential to alter renal function eg, dehydration, severe infection & shock; acute or chronic disease which may cause tissue hypoxia eg, decompensated heart failure, or resp failure, recent MI, shock. Acute alcohol intoxication, alcoholism.
Special Precautions
Not for patients w/ type 1 diabetes. Discontinue if acute pancreatitis, bullous pemphigoid; dehydration occurs or are suspected. Hypoglycaemia. Concomitant use w/ sulphonylureas & insulin; antihypertensives, diuretics, NSAIDs. Risk of lactic acidosis; hypoxia & renal insufficiency in patients w/ heart failure. Contraindicated in patients w/ GFR <30 mL/min, & acute & unstable heart failure. Discontinue prior to intravascular administration of iodinated contrast media or at the time of imaging procedure & do not restart until 48 hr afterwards & only after renal function has been re-evaluated & found to be stable; patients undergoing operation requiring diet of food & fluid/drinking water. Assess GFR before treatment initiation & regularly thereafter. Discontinue at the time of surgery under general, spinal or eperidural anesth & restart no earlier than 48 hr following surgery or resumption of oral nutrition w/ renal function, re-evaluated & is stable. Pregnancy & lactation. Childn <18 yr. Elderly.
Adverse Reactions
Nasopharyngitis; hypersensitivity, angioedema, urticaria; lactic acidosis, abnormal vit B12 absorption test, hypoglycaemia; taste disturbance; cough; decreased appetite, diarrhoea, constipation, nausea, pancreatitis, vomiting, abdominal pain, mouth ulceration; abnormal liver function test, hepatitis; angioedema, pruritus, erythema, rash, bullous pemphigoid; increased lipase, increased amylase.
Drug Interactions
Linagliptin: Decreased steady-state AUC, Cmax & dipeptidyl peptidase 4 (DPP-4) inhibition w/ rifampicin. Increased plasma AUC & Cmax of simvastatin. Metformin: Increased risk of lactic acidosis w/ alcohol & other medicinal products eg, NSAIDs including COX-2 inhibitors, ACE inhibitors, angiotensin II receptor antagonists & diuretics, especially loop diuretics. Iodinated contrast agents. 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 & lead to increase in plasma conc w/ OCT2 inhibitors eg, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole. Efficacy & renal elimination may be altered w/ OCT1 & OCT2 inhibitors (eg, crizotinib, olaparib).
MIMS Class
Antidiabetic Agents
ATC Classification
A10BD11 - metformin and linagliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.
Presentation/Packing
Form
Trajenta Duo FC tab 2.5 mg/1000 mg
Packing/Price
60's
Form
Trajenta Duo FC tab 2.5 mg/500 mg
Packing/Price
60's
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