API

Metformin (500mg) + Vildagliptin (50mg)

Drug classification

Oral antidiabetic; Metformin: biguanide, Vildagliptin: dipeptidyl peptidase-4 (DPP-4) inhibitor.

Dosage form

Film-coated tablet for oral administration.

API strength per dosage

Dose

Vilnip M 500 Tablet typically contains metformin 500 mg and vildagliptin 50 mg, taken once or twice daily with meals. Not recommended in patients with significant renal or hepatic impairment. Dose adjustments may be needed based on renal function. Safety and efficacy in children have not been established; use only in adults unless otherwise directed.

Mechanism of action

Metformin decreases hepatic glucose production and improves insulin sensitivity by activating AMP-activated protein kinase (AMPK). Vildagliptin inhibits dipeptidyl peptidase-4 (DPP-4), increasing endogenous incretin levels (GLP-1, GIP), which enhances glucose-dependent insulin secretion and suppresses glucagon release, resulting in improved glycemic control in type 2 diabetes mellitus.

Indications

Treatment of Type 2 diabetes mellitus

Side effects

Hypoglycemia low blood glucose level Trembling Headache Dizziness Nausea Weight gain

Pregnancy category

Metformin is generally considered safe in pregnancy; vildagliptin lacks sufficient human data, so use only if potential benefits justify potential risks.

Precautions

Renal function assessment, liver function monitoring, risk of lactic acidosis, hypoglycemia (especially with other antidiabetics), pancreatitis signs, heart failure history, gastrointestinal intolerance, vitamin B12 deficiency, discontinue before iodinated contrast studies, monitor for skin reactions, avoid in severe renal/hepatic impairment, regular blood glucose monitoring.

Contraindications

Hypersensitivity to metformin or vildagliptin, severe renal impairment, acute or chronic metabolic acidosis (including diabetic ketoacidosis), hepatic impairment, history of lactic acidosis, conditions predisposing to hypoxemia, severe infection, dehydration.