Vildagliptin Tablets

1. Indications and Usage
Monotherapy: Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Combination Therapy: Can be used in combination with metformin, pioglitazone, or a sulfonylurea.
2. Dosage and Administration
Recommended Dose: The usual dose is 50 mg twice daily, taken orally without regard to meals.
Renal/Hepatic Impairment: In patients with moderate or severe renal impairment or those on dialysis, and in patients with hepatic impairment, the dose should be limited to 50 mg once daily.
Missed Dose: If a dose is missed, it should be taken as soon as possible. If it is not remembered until the next day, the dose should be skipped.
3. Mechanism of Action
DPP-4 Inhibition: Vildagliptin is a potent, selective, and reversible inhibitor of dipeptidyl peptidase-4 (DPP-4).
Incretin Regulation: It inhibits the inactivation of incretin hormones (GLP-1 and GIP).
Glucose-Dependent Effects: Elevated incretin levels enhance glucose-dependent insulin secretion and suppress glucagon release, thereby lowering blood glucose levels.
4. Safety and Warnings
Heart Failure: Post-marketing cases of heart failure have been reported with DPP-4 inhibitors. Patients should be monitored for signs and symptoms.
Pancreatitis: Acute pancreatitis, including fatal and non-fatal cases, has been reported. If suspected, discontinue immediately.
Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis, angioedema, and exfoliative skin conditions, have been reported.
Hepatotoxicity: Cases of hepatic dysfunction, including fatal and non-fatal hepatic failure, have been reported.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Headache, hypoglycemia (especially when combined with sulfonylureas), and dizziness.
Hypoglycemia: Low risk as monotherapy, but the risk increases when used in combination with sulfonylureas or insulin.
Other Adverse Effects: Hypersensitivity reactions, rash, arthralgia, and insomnia have been reported.
Clinical Findings: Clinical trials have demonstrated significant reductions in HbA1c and fasting plasma glucose with a low incidence of hypoglycemia.
6. Drug Interactions
Hypoglycemic Agents: Concomitant use with insulin or sulfonylureas increases the risk of hypoglycemia.
Metabolism: Vildagliptin is not extensively metabolized by CYP450 enzymes and is unlikely to cause interactions with drugs metabolized by these enzymes.
Renal Elimination: Dosage adjustment is required in renal impairment, but no specific interaction with renal transporters has been identified.
7. Pharmaceutical Information
Active Ingredient: Vildagliptin.
Strengths: Typically available as 50 mg tablets.
Appearance: Film-coated tablets, typically pink or white to off-white.
Storage: Store below 30°C in a dry place.