Pharmacy Diabetes

D-3.5 formulation-vildagliptin

Vildagliptin

Each Galvus tablet contains 50mg vildagliptin.

  • 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/3415R

  • Recommended dose of Galvus is 50 mg twice daily (morning and night) (100 mg daily dose) without regard to food.
  • Missed doses: If a dose of Galvus is missed, it should be taken as soon as remembered. Double doses should not be taken on the same day to make up for missed doses.
  • Hepatic impairment: Vildagliptin is not recommended in hepatic impairment.
  • Renal impairment: Glomerular filtration rate (GFR) is to be estimated prior to commencement of therapy. In moderate (eGFR30-59 mL/min/1.73 m) or severe (eGFR15-29 mL/min/1.73 m) renal impairment or end stage renal disease (ESRD), the recommended dose of vildagliptin is 50 mg once daily.

  • No dosage adjustment is required in this age population.

  • Acute pancreatitis - Use of DPP4 inhibitors have been associated with a risk of developing acute pancreatitis. If pancreatitis is suspected, vildagliptin should be discontinued: if acute pancreatitis is suspected vildagliptin should not be restarted. Caution should be used if there is a history of acute pancreatitis.

  • Dizziness
  • Headache
  • Pancreatitis
  • Peripheral Oedema (uncommon)
  • Constipation

  • Hypersensitivity to vildagliptin or any of the excipients.
  • Type 1 diabetes
  • Diabetic Ketoacidosis
  • Other: Vildagliptin tablets contain lactose. Those with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose/ galactose malabsorption should not take this medicine.

is rapidly absorbed with an absolute oral bioavailability of 85%, with peak plasma concentrations observed at 1.75 hours.

Metabolism is the major elimination pathway for vildagliptin

Vildagliptin distributes equally between plasma and red blood cells, with plasma protein binding low (9.3%).

Following an oral dose of vildagliptin, approximately 85%of the dose is excreted into the urine and 15% is recovered in the faeces. Renal excretion of unchanged vildagliptin accounts for 23% of the dose. Vildagliptin is not metabolized by cytochrome P450 enzymes to any reasonable extent.

For more detailed information on this product please consult the product information.
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-07768-3&d=202103211016933