API

Vildagliptin (50mg)

Drug classification

Antidiabetic agent; dipeptidyl peptidase-4 (DPP-4) inhibitor subclass.

Dosage form

Film-coated oral tablet containing 50 mg vildagliptin.

API strength per dosage

Dose

Galvus (vildagliptin) 50 mg is typically taken once or twice daily for adults with type 2 diabetes, with or without food. Not recommended in moderate or severe hepatic impairment. Dose adjustment is required in moderate or severe renal impairment. Safety and efficacy in children under 18 years have not been established. Always follow local prescribing guidelines.

Mechanism of action

Vildagliptin inhibits dipeptidyl peptidase-4 (DPP-4), an enzyme that degrades incretin hormones (GLP-1 and GIP). This inhibition increases incretin levels, enhancing glucose-dependent insulin secretion and suppressing glucagon release, resulting in improved glycemic control in patients with type 2 diabetes mellitus.

Indications

Treatment of Type 2 diabetes mellitus

Side effects

Hypoglycemia low blood glucose level Tremors Headache Dizziness Fatigue Nausea

Pregnancy category

Vildagliptin should be used during pregnancy only if clearly needed; data in pregnant women are limited, and potential risks to the fetus are unknown.

Precautions

Monitor liver function tests periodically, use with caution in hepatic impairment, assess renal function before and during treatment, risk of hypoglycemia when combined with sulfonylureas or insulin, monitor for signs of pancreatitis, not recommended in type 1 diabetes or for diabetic ketoacidosis, monitor for hypersensitivity reactions.

Contraindications

Hypersensitivity to vildagliptin or any excipients, type 1 diabetes mellitus, diabetic ketoacidosis, severe hepatic impairment.