Trajenta Duo

Trajenta Duo

linagliptin + metformin

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
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 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 when treatment w/ both linagliptin & metformin is appropriate.
Dosage/Direction for Use
Individualised dosage. Max daily dose: Linagliptin 5 mg & metformin 2,000 mg. Patient currently not treated w/ metformin Initially 2.5 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/ the 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 & the 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.
Administration
Should be taken with food: Take w/ meals to reduce GI discomfort.
Contraindications
Hypersensitivity. Any type of metabolic acidosis (eg, lactic acidosis, diabetic ketoacidosis); diabetic pre-coma; 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, 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. Hepatic impairment, acute alcohol intoxication; alcoholism.
Special Precautions
Do not use in patients w/ type 1 diabetes or for the treatment of diabetic ketoacidosis. Acute pancreatitis; promptly discontinue if pancreatitis is suspected. Hypoglycaemia. Risk of lactic acidosis. Assess glomerular filtration rate before treatment initiation & regularly thereafter. Regular monitoring of cardiac & renal function in patients w/ stable chronic heart failure. Discontinue 48 hr before administration of iodinated contrast media in patients w/ moderate renal impairment. Discontinue at the time of surgery under general, spinal or epidural anaesth. Discontinue use if bullous pemphigoid 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 laboratory abnormalities or clinical illness. Combination w/ sulphonylurea & insulin. Avoid use during pregnancy. Do not use during lactation. Not recommended in childn & adolescents <18 yr. Elderly >75 yr.
Adverse Reactions
Nasopharyngitis; hypersensitivity, angioedema, urticaria; lactic acidosis, abnormal vit B12 absorption test, 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 liver function test, hepatitis; angioedema, pruritus, erythema, rash, bullous pemphigoid; increased lipase & amylase.
Drug Interactions
Linagliptin: Inhibits Pgp-mediated transport of digoxin (w/ low potency). Increased AUC & Cmax w/ ritonavir. Decreased steady-state AUC & Cmax & dipeptidyl peptidase 4 (DPP-4) inhibition at trough w/ rifampicin. Increased AUC & Cmax of simvastatin. Metformin: Increased risk of lactic acidosis w/ acute alcohol intoxication, iodinated contrast agents, NSAIDs including selective COX II inhibitors, ACE inhibitors, angiotensin II receptor antagonists & diuretics especially loop diuretics. Reduced efficacy w/ OCT1 inhibitors (eg, verapamil). Increased GI absorption & efficacy w/ OCT1 inducers (eg, rifampicin). Increased plasma conc w/ OCT2 inhibitors (eg, cimetidine, dolutegravir, ranozaline, trimethoprim, vandetanib, isavuconazole). Altered efficacy & renal elimination w/ OCT1 & OCT2 inhibitors (eg, crizotinib, olaparib).
MIMS Class
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 mg/1,000 mg FC tab
Packing/Price
60's
Form
Trajenta Duo 2.5 mg/500 mg FC tab
Packing/Price
60's
Form
Trajenta Duo 2.5 mg/850 mg FC tab
Packing/Price
60's
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