Vildagliptin

Registered South African indications:

• Diabetes mellitus

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hepatic impairment
• Pre-treatment ALT or AST > 2.5 X the upper limit of normal

Cautions

• Pregnancy
• Breastfeeding
• Moderate to severe renal impairment
• Not to be used as a substitute for insulin
• NYHA class IV cardiac failure
• History of acute pancreatitis
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption

Forms avail. in SA and covered in this monograph: tab

Non insulin-dependant diabetes mellitus

• Oral (tab): 50mg, 12hlry; Max: 100mg/24hrs

Non insulin-dependant diabetes mellitus - coadministration with sulphonylurea

• Oral (tab): 50mg, dly

When coadministered with a sulphonylurea: lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia

Not established for use in children below 18 years

Pregnancy

• Caution
• There are no adequate data from the use of vildagliptin in pregnant women. Studies in animals have shown reproductive toxicity at high doses. The potential risk for humans is unknown. Due to lack of human data, vildagliptin should not be used during pregnancy

Breastfeeding

• Caution; not recommended
• It is unknown whether vildagliptin is excreted in human milk. Animal studies have shown excretion of vildagliptin in milk. Vildagliptin should not be used during breastfeeding

Renal Impairment

• CrCl >50 ml/min: No dose adjustment recommended
• CrCl <50 ml/min: Caution; dose adjustment recommended
  Recommended dose: 50mg daily

Hepatic Impairment

• Contraindicated
  Vildagliptin should not be used in patients with hepatic impairment, including patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x the upper limit of normal (ULN)

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Dizziness

Cardiovascular Disorders

• Peripheral oedema

Gastrointestinal Disorders

• Constipation
• Pancreatitis

Hepatobiliary Disorders

• Hepatitis
• Abnormal hepatic function tests

Endocrine and Metabolic Disorders

• Hypoglycaemia

Musculoskeletal Disorders

• Arthralgia
• Myalgia

Skin and Subcutaneous Tissue Disorders

• Urticaria
• Bullous skin lesions
• Exfoliative skin lesions

• Angiotensin converting enzyme inhibitors
• Thiazide diuretics
• Corticosteroids
• Thyroid treatment
• Sympathomimetics

Hepatic function

Vildagliptin acts by inhibiting dipeptidyl peptidase-4 activity which results in increased fasting and postprandial endogenous levels of the incretin hormones glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide. Increased levels of these incretin hormones sensitize beta cells to glucose, resulting in improved glucose-dependent insulin secretion from the pancreas. Increased levels of incretin hormones also suppress glucagon secretion from pancreatic alpha cells when blood glucose is normal or elevated.

Tablet 50mg 

• Galvus (Novartis) originator
• Jalra (Norvartis)
• Zomvil 50 (Trinity Pharma)

COMBINATION PREPARATIONS

Vidagliptin/ Metformin

Tablet 50mg/850mg

• Galvus Met (Novartis) originator

Vidagliptin/ Metformin

Tablet 50mg/1000mg

• Galvus Met (Novartis) originator