Trajenta Duo Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Per 2.5/500 mg FC tab Linagliptin 2.5 mg, metformin HCl 500 mg. Per 2.5/850 mg FC tab Linagliptin 2.5 mg, metformin HCl 850 mg. Per 2.5/1,000 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.

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Dosage/Direction for Use

Individualized dosage. Max daily dose: Linagliptin 5 mg & metformin HCl 2,000 mg. Currently not treated w/ metformin Initially linagliptin 2.5 mg/metformin HCl 500 mg bd. Inadequately controlled on max tolerated metformin monotherapy Initially linagliptin 2.5 mg bd + current metformin dose. Switching from co-administration of linagliptin & metformin Initiate based on current linagliptin & metformin dose. Inadequately controlled on dual combination therapy w/ sulphonylurea or insulin & max tolerated metformin dose Linagliptin 2.5 mg bd & current metformin dose.

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Overdosage

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Administration

Should be taken with food.

Contraindications

Hypersensitivity. Lactic acidosis, diabetic ketoacidosis & 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. Acute alcohol intoxication, alcoholism. Severe renal failure (CrCl <30 mL/min or eGFR <30 mL/min/1.73 m²). Hepatic impairment.

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Special Precautions

Discontinue use if pancreatitis & bullous pemphigoid is suspected. Not to be used in type 1 diabetes or diabetic ketoacidosis. Temporarily discontinue use if dehydration occurs. Lactic acidosis; inadequately controlled diabetes, ketosis, prolonged fasting, conditions associated w/ hypoxia; stable chronic heart failure. Assess GFR prior to & at least annually thereafter. Evaluate serum electrolytes & ketones, blood glucose, pH, lactate, pyruvate & metformin levels. Avoid excessive alcohol intake. Discontinue use prior to, during or 48 hr after iodinated contrast agent administration; during surgery w/ general, spinal or epidural anaesth. 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. Paed. Elderly ≥80 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypoglycaemia; abdominal pain. Taste disturbance; diarrhoea; increased lipase.

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Drug Interactions

Linagliptin: Increased AUC & C_max w/ ritonavir. Decreased steady-state AUC & C_max w/ rifampicin. Increased plasma AUC & C_max of simvastatin. Metformin: Intrinsic hyperglycaemic activity w/ glucocorticoids, β₂-agonist & diuretics. Increased risk of lactic acidosis w/ alcohol intoxication, NSAIDs eg, COX2 inhibitors; ACE inhibitors, AIIA, 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. Not recommended in combination w/ iodinated contrast agents.

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Caution For Usage

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Storage

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Description

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Action

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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.

Regulatory Classification

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

Trajenta Duo

linagliptin + metformin

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH

Marketer:

Boehringer Ingelheim