Viglaz Special Precautions

General: Vildagliptin is not a substitute for insulin in insulin-requiring patients. Vildagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Renal impairment: Patients with End Stage Renal Disease (ESRD) receiving hemodialysis have little experience. Vildagliptin should be used cautiously in these patients as a result.
Hepatic impairment: Vildagliptin is not recommended in patients with hepatic impairment, including patients with pre-treatment ALT or AST >2.5x ULN.
Liver enzyme monitoring: Hepatic dysfunction, including hepatitis, has only rarely been reported. When treatment was stopped, the patients' liver function test (LFT) results returned to normal and they were typically asymptomatic without any clinical sequelae. Before starting Vildagliptin therapy, LFTs should be carried out to determine the patient's baseline value. LFTs should be checked while taking Vildagliptin at three-month intervals for the first year and then at an event after that. Patients who develop increased transaminase levels should be followed up with a second liver functional evaluation to confirm the findings and be followed thereafter with frequent liver function tests until the abnormalities return to normal. Vildagliptin therapy should be stopped if an increase in AST or ALT of 3x ULN or more continues. Vildagliptin should be stopped by patients who develop jaundice or other symptoms of liver dysfunction and contact their physician immediately. Vildagliptin treatment shouldn't be started up again after stopping it and LFT normalization.
Cardiac failure: A clinical trial of Vildagliptin in patients with New York Heart Association (NYHA) functional classes I-III revealed that therapy with Vildagliptin was not related to changes in left ventricular function or worsening of pre-existing congestive heart failure (CHF) compared with placebo. Clinical experience in patients with NYHA functional class III treated with Vildagliptin is still limited and results are inconclusive. There is no experience of Vildagliptin use in clinical trials in patients with NYHA functional class IV and therefore use is not recommended in these patients.
Other: Vildagliptin should not be taken by those who have a rare hereditary condition called galactose intolerance, total lactase deficiency or glucose-galactose malabsorption because VIGLAZ (50 MG TABLET) contains lactose.