- TRAJENTA are film-coated tablets for oral administration containing 5 mg linagliptin.
- Treatment of type 2 diabetes in adults where physical activity and dietary management has not resulted in adequate glycaemic targets.
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- The recommended dose of Trajenta is 5 mg once daily, without regard to food as add-on dual combination therapy or triple oral therapy. It can be taken at any time of the day.
- Missed doses: If a does is missed, it should be taken as soon as the person remembers. A double dose should not be taken on the same day.
- Renal impairment: There is no adjustment required in renal impairment.
- Liver impairment. There is no adjustment required in liver impairment.
- There is no dosage adjustment required in this population.
- Acute pancreatitis: Use of DPP4 inhibitors have been associated with a risk of developing acute pancreatitis. If pancreatitis is suspected, linaglipton should be discontinued.
- Bullous pemphigoid: Post-marketing cases of bullous pemphigoid requiring hospitalisation have been reported with DPP-4 inhibitor use.
- Arthralgia: Joint pain, which may be severe, has been reported in post marketing reports for DPP4 inhibitors.
- GLP1 analogues: Lingliptin has not been studied in combination with GLP1 analogues.
- Hypersensitivity to linagliptin or any of the excipients.
- Type 1 diabetes
- Diabetic Ketoacidosis
The absolute bioavailability of linagliptin is approximately 30%
Following a [14C]-linagliptin oral 10 mg dose, approximately 5% of the radioactivity was excreted in urine.
linagliptin extensively distributes to the tissues. Plasma protein binding of linagliptin is concentration-dependent, decreasing from about 99% at 1 nmol/L to 75-89% at ≥ 30 nmol/L.
- Following administration of an oral [14C]-linagliptin dose to healthy subjects, approximately 85% of the administered radioactivity was eliminated in faeces (80%) or urine (5%) within 4 days of dosing.
Renal clearance at steady state was approximately 70 mL/min.
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