Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Boehringer Ingelheim International GmbH, Binger Str. 173, D-55216 Ingelheim am Rhein, Germany
Trajenta is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control as:
The dose of linagliptin is 5 mg once daily. When linagliptin is added to metformin, the dose of metformin should be maintained, and linagliptin administered concomitantly.
When linagliptin is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin, may be considered to reduce the risk of hypoglycaemia (see section 4.4).
For patients with renal impairment, no dose adjustment for linagliptin is required.
Pharmacokinetic studies suggest that no dose adjustment is required for patients with hepatic impairment but clinical experience in such patients is lacking.
No dose adjustment is necessary based on age.
However, clinical experience in patients >80 years of age is limited and caution should be exercised when treating this population.
The safety and efficacy of linagliptin in children and adolescents has not yet been established. No data are available.
The tablets can be taken with or without a meal at any time of the day. If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.
During controlled clinical trials in healthy subjects, single doses of up to 600 mg linagliptin (equivalent to 120 times the recommended dose) were generally well tolerated. There is no experience with doses above 600 mg in humans.
In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g. remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring and institute clinical measures if required.
Shelf life: 3 years.
This medicinal product does not require any special storage conditions.
Perforated alu/alu unit dose blisters in cartons containing 10 × 1, 14 × 1, 28 × 1, 30 × 1, 56 × 1, 60 × 1, 84 × 1, 90 × 1, 98 × 1, 100 × 1 and 120 × 1 film-coated tablets.
Not all pack sizes may be marketed.
Any unused product or waste material should be disposed of in accordance with local requirements.
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