Vildamet 500/50

Presentation:Each film-coated tablet contains 500 mg of metformin hydrochloride and 50 mg of vildagliptin.

Indications:Vildamet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with bothvildagliptin and metformin is appropriate.This includes:

• Patients not adequately controlled on metformin alone.
• Patients already treated with vildagliptin and metformin as separate tablets.
• Treatment-naïve patients with high initial glucose levels as initial therapy.

Dosage and Administration: The usual starting dose is one tablet twice daily with meals. Dosage should be individualized based on the patient's current regimen, effectiveness, and tolerability, while not exceeding the maximum daily dose of 100mg vildagliptin and 2000 mg metformin hydrochloride.

• Patients not controlled on metformin alone: Initiate with one tablet twice daily.
• Patients switching from separate vildagliptin and metformin: Initiate with the same daily dose of vildagliptin and metformin already being taken.
• Treatment-naïve patients: Initiate with one tablet twice daily.

Gradual dose escalation is recommended to reduce gastrointestinal side effects associated with metformin.Tablets should be swallowed whole and not crushed or chewed.⁶Renal function should be assessed prior to initiation and periodically thereafter.

Side Effects:

• Common:Nausea, vomiting, diarrhea, abdominal pain, headache, and tremor.  
• Uncommon: Hypoglycemia (when used in combination with sulfonylureas or insulin), dizziness.
• Rare: Lactic acidosis (potentially serious, requiring immediate medical attention), pancreatitis, and liver enzyme elevations.

Precautions:

Vildamet is contraindicated in patients with:

• Severe renal impairment (eGFR < 30 mL/min/1.73 m²).
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis.
• Known hypersensitivity to vildagliptin or metformin.

Caution should be exercised in patients with:

• Moderate renal impairment (eGFR 30 to < 45 mL/min/1.73 m²).
• Heart failure.
• History of pancreatitis.
• Excessive alcohol intake.
• Hepatic impairment.

Temporary discontinuation of Vildamet may be necessary for surgical procedures or iodinated contrast imaging. Monitor renal function regularly. Educate patients on the symptoms of lactic acidosis and pancreatitis.

Storage:Store below 30°C, protected from light and moisture.Keep out of reach of children.

Important Note: This information is for general knowledge and informational purposes only, and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication. They can assess your individual medical condition and provide the most appropriate advice.