Description
Contents
Vildagliptin
Indications/Uses
Galvus Met is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: as initial therapy when diabetes is not adequately controlled by diet and exercise alone; in patients who are inadequately controlled with metformin hydrochloride alone; in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets; in combination with other medicinal products for the treatment of diabetes, including insulin a when these do not provide adequate glycaemic control (see Precautions, Interactions and Pharmacology: Pharmacodynamics under Actions for available data on different combinations).
Dosage/Direction for Use
Posology: Adults with normal renal function (GFR ≥ 90 ml/min): The dose of antihyperglycaemic therapy with Galvus Met should be individualised on the basis of the patient’s current regimen, effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100 mg vildagliptin. Galvus Met may be initiated at either the 50 mg/500 mg, 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily, one tablet in the morning and the other in the evening.
For patients inadequately controlled at their maximal tolerated dose of metformin monotherapy: The starting dose of Galvus Met should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
For patients switching from co-administration of vildagliptin and metformin as separate tablets: Galvus Met should be initiated at the dose of vildagliptin and metformin already being taken.
For patients inadequately controlled on dual combination with metformin and a sulphonylurea: The doses of Galvus Met should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken. When Galvus Met is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin: The dose of Galvus Met should provide vildagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
For patients inadequately controlled at their maximal tolerated dose of metformin monotherapy: The starting dose of Galvus Met should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
For patients switching from co-administration of vildagliptin and metformin as separate tablets: Galvus Met should be initiated at the dose of vildagliptin and metformin already being taken.
For patients inadequately controlled on dual combination with metformin and a sulphonylurea: The doses of Galvus Met should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken. When Galvus Met is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin: The dose of Galvus Met should provide vildagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
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