Vildagliptin - oral


Concise Prescribing Info
Indications/Uses
Type 2 DM.
Dosage/Direction for Use
Adult : PO 50 mg bid.
Dosage Details
Oral
Type 2 diabetes mellitus
Adult: 50 mg bid.
Renal Impairment
Moderate, severe and ESRD: 50 mg once daily.
Administration
May be taken with or without food.
Special Precautions
Patient w/ cardiac failure (NYHA functional class IV), type 1 DM; history of acute pancreatitis. Not intended for the treatment of diabetic ketoacidosis. Hepatic impairment, including patients w/ pre-treatment ALT or AST >3 times the upper limit of normal (ULN). Moderate or severe renal impairment, ESRD.
Adverse Reactions
Nausea, peripheral oedema, headache, tremor, asthenia, dizziness, constipation, hypoglycaemia, arthralgia, hepatic dysfunction, nasopharyngitis, upper resp tract infection, pancreatitis, exfoliative and bullous skin reactions.
MonitoringParameters
Monitor liver function.
Overdosage
Symptoms: Muscle pain, mild and transient paraesthesia, fever, oedema, transient increase in lipase levels; increases in creatine phosphokinase, AST, C-reactive protein and myoglobin levels. Management: Supportive treatment.
Drug Interactions
Decreased hypoglycaemic effect w/ thiazides, corticosteroids, thyroid products and sympathomimetics.
Food Interaction
Food slightly delays time to peak plasma concentration.
Action
Description: Vildagliptin rapidly and completely inhibits DPP-4 activity, resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 (glucagon-like peptide 1) and GIP (glucose dependent insulinotropic polypeptide).
Pharmacokinetics:
Absorption: Rapidly absorbed from the GI tract. Food slightly delays time to peak plasma concentration. Bioavailability: 85%. Time to peak plasma concentration: Approx 1.7 hr.
Distribution: Equally distributed in plasma and RBC. Plasma protein binding: 9.3%.
Metabolism: Undergoes hydrolysis in the kidney to its major metabolite (LAY 151).
Excretion: Via urine (approx 85% of a dose; 23% as unchanged drug) and faeces (15%). Elimination half-life: Approx 3 hr.
Chemical Structure

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Storage
Store below 30°C. Protect from moisture.
MIMS Class
Disclaimer: This information is independently developed by MIMS based on Vildagliptin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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