Pharmacy Diabetes

D-3.2 Formulations-Linagliptin

Linagliptin

  • 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.
    For the most up to date information on PBS indications please refer to
    https://www.pbs.gov.au/medicine/item/11280Q-3387G

  • 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.

  • Nasopharyngitis
  • Hypertriglyceridemia
  • Cough
  • Pancreatitis
  • Constipation

  • 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.
    For more detailed information on this product please consult the product information.
    https://www.pbs.gov.au/pbs/search?term=linagliptin&search-type=medicines&analyse=false