Vildagliptin (vildagliptin)

Vildagliptin is approved for: EU (EMA / UK SmPC): treatment of type 2 diabetes mellitus in adults as monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate because of contraindications or intolerance.; EU: as dual oral therapy in combination with metformin, a sulphonylurea, or a thiazolidinedione; as triple oral therapy with metformin and a sulphonylurea; and in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not give adequate glycaemic control.; Not approved by the US FDA: Galvus has no FDA approval and is not marketed in the United States.; Approved as an oral treatment for adults with type 2 diabetes in more than 120 countries, including the EU, Japan, Latin America and Asia-Pacific (Novartis).. It is a vildagliptin (Dipeptidyl peptidase-4), originally marketed as Galvus (佳维乐); combination product Galvus Met / Eucreas by Novartis.

Vildagliptin (Dipeptidyl peptidase-4 (DPP-4) inhibitor of the islet enhancer class, oral antidiabetic. ATC A10BH02., originally Galvus (佳维乐); combination product Galvus Met / Eucreas by Novartis) Vildagliptin blocks the DPP-4 enzyme so the gut hormones GLP-1 and GIP stay active for longer. That makes the pancreas release more insulin when blood sugar is high and reduces glucagon release, lowering both fasting and after-meal glucose without causing weight gain. Adults: 100 mg daily given as 50 mg in the morning and 50 mg in the evening, when used as monotherapy or in combination with metformin, a thiazolidinedione, metformin plus a sulphonylurea, or insulin (with or without metformin). When used in dual combination with a sulphonylurea alone, the recommended dose is 50 mg once daily in the morning. Doses higher than 100 mg/day are not recommended. Can be

Standard dosing for vildagliptin: Adults: 100 mg daily given as 50 mg in the morning and 50 mg in the evening, when used as monotherapy or in combination with metformin, a thiazolidinedione, metformin plus a sulphonylurea, or insulin (with or without metformin). When used in dual combination with a sulphonylurea alone, the recommended dose is 50 mg once daily in the morning. Doses higher than 100 mg/day are not recommended. Can be taken with or without a meal. Dose adjustments: Renal: no dose adjustment needed if creatinine clearance >=50 mL/min; in moderate or severe renal impairment or end-stage renal disease the recommended dose is 50 mg once daily, and Galvus should be used with caution in ESRD patients on haemodialysis. Hepatic: Galvus should NOT be used in patients with hepatic impairment, including pre-treatment ALT or AST >3x ULN. Elderly (>=65 years): no dose adjustment. Paediatric (<18 years): not recommended.

Recommended monitoring for vildagliptin: Liver function tests before starting Galvus to establish a baseline, then at three-month intervals during the first year and periodically thereafter; Monitor for the characteristic symptoms of acute pancreatitis; discontinue vildagliptin if pancreatitis is suspected and do not restart if it is confirmed; Monitor for skin disorders such as blistering or ulceration; Blood glucose and HbA1c; watch for hypoglycaemia when used with a sulphonylurea or insulin; Renal function (dose must be reduced to 50 mg once daily in moderate/severe impairment and ESRD)

Vildagliptin (Dipeptidyl peptidase-4 (DPP-4) inhibitor of the islet enhancer class, oral antidiabetic. ATC A10BH02., originally Galvus (佳维乐); combination product Galvus Met / Eucreas by Novartis) Vildagliptin blocks the DPP-4 enzyme so the gut hormones GLP-1 and GIP stay active for longer. That makes the pancreas release more insulin when blood sugar is high and reduces glucagon release, lowering both fasting and after-meal glucose without causing weight gain. Adults: 100 mg daily given as 50 mg in the morning and 50 mg in the evening, when used as monotherapy or in combination with metformin, a thiazolidinedione, metformin plus a sulphonylurea, or insulin (with or without metformin). When used in dual combination with a sulphonylurea alone, the recommended dose is 50 mg once daily in the morning. Doses higher than 100 mg/day are not recommended. Can be

Galvus is centrally authorised in the EU (Novartis) and is the reference product; there is no FDA approval, so no US ANDA route exists. Generic vildagliptin and vildagliptin/metformin products are authorised in the EU through Article 10(1) generic procedures (decentralised / mutual recognition) after demonstrating bioequivalence to the originator - for example the Vildagliptin/Metformin Krka public assessment report and published bioequivalence studies of new generic vildagliptin formulations. In India, Cipla co-markets vildagliptin with Novartis under Vysov and Vysov M and has since acquired the brand/trademark rights, while Cipla's own generic listing is Cipvildin/Cipvildin-M. Manufacturers supplying vildagliptin generic versions include ACI Limited, Aristopharma Ltd, Cipla Ltd, Drug International Ltd, Eris Lifesciences Ltd, Eskayef Pharmaceuticals Ltd, Natco Pharma Ltd, Nevian Lifescience PLC. Brands registered in Bangladesh include Aptin, Dialiptin, Diavil, Edvila, Galet, Galvid.

Bangladesh benchmark: 22 manufacturers sell generic vildagliptin 50 mg; unit prices range from BDT 12 (US$0.10) to BDT 25 (US$0.20), i.e. about US$2.93–US$6.10 per 30 units. Cheapest listed brand: Vildaglip (Concord Pharmaceuticals Ltd.) at BDT 12 per unit. Originator comparison: Galvus (Nevian Lifescience PLC) is listed at BDT 32 per unit — roughly 167% more than the cheapest generic. Prices move with pack size, pharmacy and the exchange rate — confirm current stock and price with a licensed importer before ordering.

Vildagliptin (Dipeptidyl peptidase-4 (DPP-4) inhibitor of the islet enhancer class, oral antidiabetic. ATC A10BH02., originally Galvus (佳维乐); combination product Galvus Met / Eucreas by Novartis) Vildagliptin blocks the DPP-4 enzyme so the gut hormones GLP-1 and GIP stay active for longer. That makes the pancreas release more insulin when blood sugar is high and reduces glucagon release, lowering both fasting and after-meal glucose without causing weight gain. Adults: 100 mg daily given as 50 mg in the morning and 50 mg in the evening, when used as monotherapy or in combination with metformin, a thiazolidinedione, metformin plus a sulphonylurea, or insulin (with or without metformin). When used in dual combination with a sulphonylurea alone, the recommended dose is 50 mg once daily in the morning. Doses higher than 100 mg/day are not recommended. Can be

Vildagliptin (Dipeptidyl peptidase-4 (DPP-4) inhibitor of the islet enhancer class, oral antidiabetic. ATC A10BH02., originally Galvus (佳维乐); combination product Galvus Met / Eucreas by Novartis) Vildagliptin blocks the DPP-4 enzyme so the gut hormones GLP-1 and GIP stay active for longer. That makes the pancreas release more insulin when blood sugar is high and reduces glucagon release, lowering both fasting and after-meal glucose without causing weight gain. Adults: 100 mg daily given as 50 mg in the morning and 50 mg in the evening, when used as monotherapy or in combination with metformin, a thiazolidinedione, metformin plus a sulphonylurea, or insulin (with or without metformin). When used in dual combination with a sulphonylurea alone, the recommended dose is 50 mg once daily in the morning. Doses higher than 100 mg/day are not recommended. Can be

Vildagliptin (Dipeptidyl peptidase-4 (DPP-4) inhibitor of the islet enhancer class, oral antidiabetic. ATC A10BH02., originally Galvus (佳维乐); combination product Galvus Met / Eucreas by Novartis) Vildagliptin blocks the DPP-4 enzyme so the gut hormones GLP-1 and GIP stay active for longer. That makes the pancreas release more insulin when blood sugar is high and reduces glucagon release, lowering both fasting and after-meal glucose without causing weight gain. Adults: 100 mg daily given as 50 mg in the morning and 50 mg in the evening, when used as monotherapy or in combination with metformin, a thiazolidinedione, metformin plus a sulphonylurea, or insulin (with or without metformin). When used in dual combination with a sulphonylurea alone, the recommended dose is 50 mg once daily in the morning. Doses higher than 100 mg/day are not recommended. Can be