Product/Composition:- | Metformin + Vildagliptin Tablets |
---|---|
Strength:- | 50/500 mg/850mg/1000mg |
Form:- | Tablets |
Reference Brands:- | Eucreas®(EU) |
MOQ | As per the manufacturer batch size |
Get Quote Send Enquiry on WhatsApp |
Metformin reduces hepatic glucose production and improves insulin sensitivity. Vildagliptin (DPP-4 inhibitor) enhances incretin action, stimulating insulin secretion and suppressing glucagon. Together, they provide dual glycemic control, weight neutrality, and low hypoglycemia risk for type 2 diabetes. Benefits include improved HbA1c with complementary mechanisms.
EMA (EU): Approved as Eucreas® (Novartis) in fixed-dose combinations (50mg vildagliptin + 500/850/1000mg metformin). Key requirements: Boxed warnings: None, but pancreatitis risk requires discontinuation if suspected Hepatic monitoring: Mandatory (rare hepatitis reports) Renal restrictions: Contraindicated if eGFR <30; dose adjustment for eGFR 30-60 Storage: <30°C (protect from moisture) FDA (US): Not approved - Vildagliptin development discontinued in 2009 due to hepatotoxicity concerns in Phase III trials. Shared Requirements: Lactic acidosis warnings (metformin) Pregnancy Category B (avoid unless essential). For regulatory support: PharmaTradz.com