Name of Medicine
Vildagliptin
Presentation
Each Galvus tablet contains 50mg vildagliptin.
Key Practice Points
Therapeutic Indications:
- 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.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=&q=vildagliptin
Dose:
- 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.
Elderly:
- No dosage adjustment is required in this age population.
Precautions:
- 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.
Adverse Effects:
- Dizziness
- Headache
- Pancreatitis
- Peripheral Oedema (uncommon)
- Constipation
Contraindications:
- Hypersensitivity to vildagliptin or any of the excipients.
- Type 1 diabetes
- Ketoacidosis due to diabetes
- 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.
Pharmacokinetic Properties – Summary
Absorption:
is rapidly absorbed with an absolute oral bioavailability of 85%, with peak plasma concentrations observed at 1.75 hours.
Metabolism:
Metabolism is the major elimination pathway for vildagliptin
Distribution:
Vildagliptin distributes equally between plasma and red blood cells, with plasma protein binding low (9.3%).
Excretion:
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.
More Information
For more detailed information on this product please consult the product information.
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=PI&q=vildagliptin&r=/