Finished product reference

Vildagliptin

Tablet · Oral · 50 mg

List code
52522
Pharmacologic class
Oral antidiabetic; dipeptidyl peptidase-4 (DPP-4) inhibitor

What it is and how it works

Vildagliptin selectively inhibits DPP-4, increasing endogenous levels of the incretin hormones GLP-1 and GIP. This enhances glucose-dependent insulin secretion and suppresses inappropriate glucagon release, lowering fasting and postprandial glucose with a low intrinsic risk of hypoglycaemia.

Indications

Type 2 diabetes mellitus in adults, as monotherapy when metformin is inappropriate, or in combination with metformin, a sulfonylurea, a thiazolidinedione or insulin when glycaemic control is inadequate.

Dosage and administration (summary)

Orally, 50 mg twice daily (morning and evening); 50 mg once daily when combined with a sulfonylurea and in moderate or severe renal impairment; maximum 100 mg daily.

Contraindications

Hypersensitivity to vildagliptin or excipients.

Warnings and precautions

Not recommended in hepatic impairment (including pre-treatment ALT or AST more than 3 times the upper limit of normal); liver function should be tested before treatment and periodically during the first year. Discontinue if acute pancreatitis or bullous pemphigoid is suspected. Not for type 1 diabetes or diabetic ketoacidosis; hypoglycaemia risk increases when combined with sulfonylureas or insulin, which may need dose reduction.

Pregnancy

Avoid in pregnancy; insulin is preferred.

Storage and supply

Store below 30 °C in the original package, protected from moisture.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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