Trajenta Duo

Trajenta Duo

linagliptin + metformin

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH

Marketer:

Boehringer Ingelheim
Concise Prescribing Info
Contents
Per 2.5 mg/500 mg FC tab Linagliptin 2.5 mg, metformin HCl 500 mg. Per 2.5 mg/850 mg FC tab Linagliptin 2.5 mg, metformin HCl 850 mg. Per 2.5 mg/1,000 mg FC tab Linagliptin 2.5 mg, metformin HCl 1,000 mg
Indications/Uses
Adjunct to diet & exercise to improve glycaemic control in adults w/ type 2 DM.
Dosage/Direction for Use
Individualized dosage. Max daily dose: Linagliptin 5 mg & metformin HCl 2,000 mg. Patient currently not treated w/ metformin Initially linagliptin 2.5 mg/metformin HCl 500 mg bd. Patient inadequately controlled on max tolerated metformin monotherapy dose Initially linagliptin 2.5 mg bd + metformin dose already being taken. Patient switching from co-administration of linagliptin & metformin Initiate at dose of linagliptin & metformin already being taken. Patient inadequately controlled on dual combination therapy w/ sulphonylurea or insulin & max tolerated metformin dose Linagliptin 2.5 mg bd & metformin dose similar to the dose already being taken.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. 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; disease causing tissue hypoxia eg, decompensated heart or resp failure, recent MI. Hepatic impairment, acute alcohol intoxication, alcoholism. Severe renal failure (CrCl <30 mL/min or eGFR <30 mL/min/1.73 m2).
Special Precautions
Not to be used in type 1 diabetes or diabetic ketoacidosis. Discontinue use if pancreatitis & bullous pemphigoid are suspected. Temporarily discontinue use if dehydration occurs. Increased risk of lactic acidosis. Patients w/ acute & unstable heart failure. Periodically monitor vit B12 serum levels if vit B12 deficiency is suspected. Evaluate serum electrolytes & ketones, blood glucose, pH, lactate, pyruvate & metformin levels. Avoid excessive alcohol intake. Discontinue use prior to, during & until 28 hr after administration of iodinated contrast agent; during surgery. Assess GFR prior to treatment & at least annually thereafter. Concomitant use w/ sulphonylurea & insulin; antihypertensives, diuretics & NSAIDs; drugs causing lactic acidosis. May affect ability to drive & use machines. Not recommended in hepatic impairment. Not to be used during pregnancy. Lactation. Childn. Elderly ≥80 yr.
Adverse Reactions
Hypoglycaemia; abdominal pain. Taste disturbance; diarrhoea; increased lipase.
Drug Interactions
Linagliptin: Increased AUC & Cmax w/ ritonavir. Decreased steady-state AUC & Cmax w/ rifampicin. Increased plasma AUC & Cmax of simvastatin. Metformin: Intrinsic hyperglycaemic activity w/ systemic & local glucocorticoids, β2-agonists & diuretics. Increased risk of lactic acidosis w/ alcohol; NSAIDs eg, selective COX-2 inhibitors; ACE inhibitors, AIIA, loop diuretics. Reduced efficacy w/ verapamil. Increased GI absorption & efficacy w/ rifampicin. Increased plasma conc w/ cimetidine, dolutegravir, ranozaline, trimethoprim, vandetanib, isavuconazole. Altered efficacy & renal elimination w/ 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 2.5/1,000 mg FC tab
Packing/Price
6 × 10's
Form
Trajenta Duo 2.5/500 mg FC tab
Packing/Price
6 × 10's
Form
Trajenta Duo 2.5/850 mg FC tab
Packing/Price
6 × 10's
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