Trajenta Duo Dosage/Direction for Use

Adults with normal renal function (GFR ≥ 90 ml/min): For patients never treated with metformin: The recommended dose is 2.5/500 mg twice daily.
The dosage should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability. TRAJENTA DUO should be given twice daily with meals. Dose escalation should be gradual to reduce the gastrointestinal undesirable effects associated with metformin (see Table 5 for additional dosing information).
Maximum recommended dose of TRAJENTA DUO is 2.5 mg of linagliptin and 1000 mg of metformin twice daily.
For patients inadequately controlled on maximal tolerated dose of metformin monotherapy: For patients not adequately controlled on metformin alone, the usual starting dose of TRAJENTA DUO should provide linagliptin dosed as 2.5 mg twice daily plus the dose of metformin already being taken.
For patients switching from co-administration of linagliptin and metformin: For patients switching from co-administration of linagliptin and metformin to the fixed dose combination, TRAJENTA DUO should be initiated at the dose of linagliptin and metformin already being taken.
For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea: The dose of TRAJENTA DUO should provide linagliptin dosed as 2.5 mg twice daily (5 mg total daily dose) and a dose of metformin similar to the dose already being taken. When TRAJENTA DUO is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see Precautions).
For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin: The dose of TRAJENTA DUO should provide linagliptin dosed as 2.5 mg twice daily (5 mg total daily dose) and a dose of metformin similar to the dose already being taken. When TRAJENTA DUO is used in combination with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycaemia (see Precautions).
For the different doses on metformin, TRAJENTA DUO is available in strengths of 2.5 mg linagliptin plus 500 mg metformin hydrochloride or 1000 mg metformin hydrochloride.
Renal impairment: A GFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter.
In patients at an increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
If no adequate strength of Trajenta Duo is available, individual monocomponents should be used instead of the fixed dose combination.
Factors that may increase the risk of lactic acidosis (see Precautions) should be reviewed before considering initiation of metformin in patients with GFR<60 ml/min. (See Table 5.)

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Hepatic impairment: TRAJENTA DUO is contraindicated in patients with hepatic impairment due to the metformin component (see Contraindications).
Elderly: As metformin is excreted via the kidney, and elderly patients have a tendency for decreased renal function, elderly patients taking TRAJENTA DUO should have their renal function monitored regularly (see Precautions).
Children and adolescents: TRAJENTA DUO is not recommended for use in children below 18 years due to lack of data on safety and efficacy.
Missed dose: If a dose is missed, it should be taken as soon as the patient remembers.
However, a double dose should not be taken at the same time. In that case the missed dose should be skipped.