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For patients currently not treated with metformin: In patient currently not treated with metformin, initiate treatment with 2.5mg linagliptin/500mg metformin hydrochloride 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 (5 mg total daily dose) 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, 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 linagliptin plus metformin hydrochloride 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 2.5mg twice daily (5mg total daily dose) and a dose of metformin similar to the dose already being taken. When linagliptin plus metformin hydrochloride 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 of metformin, Trajenta Duo is available in strengths of 2.5 mg linagliptin plus 500 mg metformin hydrochloride, 2.5 mg linagliptin plus 850 mg metformin hydrochloride and 2.5 mg linagliptin plus 1000 mg metformin hydrochloride.
Special populations: Elderly: As metformin is excreted by the kidney, Trajenta Duo should be used with caution as age increases. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly (see Contraindications and Precautions).
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. 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.
If no adequate strength of Trajenta Duo is available, individual monocomponents should be used instead of the fixed dose combination. (See Table 5.)
Click on icon to see table/diagram/imageHepatic impairment: Trajenta Duo is not recommended in patients with hepatic impairment due to the active substance metformin (see Contraindications and Pharmacology: Pharmacokinetics under Actions). Clinical experience with Trajenta Duo in patients with hepatic impairment is lacking.
Paediatric population: The safety and efficacy of Trajenta Duo in paediatric population have not been established. No data are available.
Method of administration: Trajenta Duo should be taken twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
All patients should continue their diet with an adequate distribution of carbohydrate intake during the day.
Overweight patients should continue their energy-restricted diet.
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.
