
Viglimet50 mg+500
Square Pharmaceuticals PLC.
Vildagliptin + Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus in the following settings:…
Vildagliptin + Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus in the following settings:
Vildagliptin + Metformin Hydrochloride is not indicated for type 1 diabetes mellitus or diabetic ketoacidosis, and is not a substitute for insulin in patients who require it.
The dose of Vildagliptin + Metformin Hydrochloride should be individualised based on the patient's current metformin dose, effectiveness, and tolerability, while keeping the vildagliptin component at an effective and safe dose.
| Clinical situation | Typical adult dosing |
|---|---|
| Inadequately controlled on metformin alone | One tablet containing 50 mg vildagliptin twice daily (morning and evening), combined with the metformin dose closest to the patient's current metformin dose, up to a total vildagliptin dose of 100 mg/day. |
| Switching from separate vildagliptin + metformin tablets | Vildagliptin + Metformin Hydrochloride tablet matching the doses of vildagliptin and metformin already being taken, given twice daily. |
| Combined with a sulfonylurea or insulin | Dose individualised; a lower sulfonylurea or insulin dose may be needed to reduce hypoglycaemia risk (see Precautions). |
The maximum recommended daily dose of the vildagliptin component is 100 mg. Tablets should be swallowed whole with a glass of water, taken with or just after food to reduce gastrointestinal side effects.
| Renal function (eGFR) | Dose adjustment |
|---|---|
| ≥60 mL/min | No adjustment required for either component. |
| 45–59 mL/min | Vildagliptin limited to 50 mg once daily; metformin dose reduced per prescriber assessment (maximum metformin dose typically limited to 2000 mg/day). |
| 30–44 mL/min | Vildagliptin limited to 50 mg once daily; metformin dose further reduced (maximum typically 1000 mg/day), used only if benefit outweighs risk. |
| <30 mL/min | Vildagliptin + Metformin Hydrochloride is contraindicated (see Contraindications). |
Vildagliptin + Metformin Hydrochloride should not be used in patients with hepatic impairment or elevated liver enzymes, due to the metformin lactic-acidosis risk and vildagliptin's rare hepatotoxicity risk.
If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next dose, in which case the missed dose should be skipped. Doses should not be doubled.
The most commonly reported side effects of Vildagliptin + Metformin Hydrochloride include:
Less common but important effects include peripheral oedema and, rarely, hepatic dysfunction (see Precautions and Warnings), acute pancreatitis, and skin reactions such as rash or urticaria. Long-term metformin use can be associated with reduced vitamin B12 absorption; periodic monitoring may be considered in patients with risk factors for deficiency.
Vildagliptin + Metformin Hydrochloride is contraindicated in the following situations:
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.