Description:
A fixed-dose oral combination of vildagliptin (50 mg) and metformin hydrochloride (500 mg), used to improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise.
Prescription:
Yes—prescription-only medication.
Therapeutic Category:
Antidiabetic agent, combining a DPP-4 inhibitor (vildagliptin) with a biguanide (metformin).
Active Ingredients / Composition:
- Vildagliptin 50 mg (DPP-4 inhibitor)
- Metformin hydrochloride 500 mg (biguanide)
Vitamins / Minerals:
None.
Variant:
This strength is 50/500 mg film-coated tablet. Other strengths (e.g., 50/850 mg, 50/1000 mg) also exist.
Consume Type:
Oral tablet.
Directions / Usage:
- Initial dose: Often one tablet twice daily (morning and evening) with meals; up to 100 mg vildagliptin + 2000 mg metformin daily is the recommended maximum.
- Can also be started as 50/500 mg once daily for treatment-naïve patients, then titrated.
- Should be taken with meals to reduce gastrointestinal side effects.
- Missed dose: take as soon as remembered, but do not double dose within the same day.
Common Side Effects:
- Gastrointestinal: nausea, vomiting, diarrhea, abdominal discomfort, loss of appetite.
Neurological / general: headache, dizziness, fatigue.
- Other: tremor, metallic taste, upper respiratory tract irritation.
- Rare but serious: lactic acidosis (metformin), hepatotoxicity or pancreatitis (vildagliptin), arthralgia, severe hypoglycemia when combined with sulfonylurea.
Package Type:
Typically available in blister packs/strips (e.g., 15 tablets).
Storage Advice:
Store in a cool, dry place—below about 30 °C, protected from heat and moisture.
Safety Advice:
- Monitor renal function before and during treatment; contraindicated if eGFR < 30 mL/min.
- Liver function tests (LFTs) before and during therapy; discontinue if ALT/AST > 3× ULN..
- Temporarily stop around iodinated contrast procedures, acute illness, surgery, or dehydration due to risk of lactic acidosis.
- Avoid excessive alcohol; increases risk of lactic acidosis.
Be cautious operating machinery or driving if dizziness or hypoglycemia occurs.
- For those on sulfonylureas, consider dose reduction to lower hypoglycemia risk.
Product Substitutes:
Other fixed-dose combinations of vildagliptin + metformin (e.g., 50/850 mg or 50/1000 mg), or use individual components separately. Other classes include DPP-4 inhibitors (e.g., sitagliptin), SGLT-2 inhibitors, sulfonylureas, and insulin depending on patient needs.
Manufacturer / Marketer:
In India, commonly manufactured by Novartis India Ltd (e.g., marketed versions under brand names like Eucreas).
Country of Origin:
In some markets (e.g., India), marketed tablets are manufactured in Turkey.
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