Galvus Tablet 50mg

TABLET

**DOSAGE REGIMEN AND ADMINISTRATION** **Method of administration** For oral use Galvus can be administered with or without meals (see section PHARMACOKINETICS, absorption – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The 50 mg dose should be administered once daily in the morning. The 100 mg dose should be administered as two divided doses of 50 mg given in the morning and evening. If a dose of Galvus is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day. **Dosage Regimen** The management of antidiabetic therapy should be individualized. The recommended dose of Galvus is 50 mg once or twice daily. The maximum daily dose of Galvus is 100 mg. For monotherapy, and for combination with metformin or with a thiazolidinedione (TZD), the recommended dose of Galvus is 50 mg or 100 mg daily. The recommended dose of Galvus is 100mg daily in combination with insulin (with or without metformin). When used in dual combination with a sulfonylurea (SU), the recommended dose of vildagliptin is 50 mg once daily. In this patient population, vildagliptin 100 mg daily was no more effective than vildagliptin 50 mg once daily. For triple combination with metformin and a SU, the recommended dose of Galvus is 100 mg daily. When used in combination with a sulfonylurea, a lower dose of the sulfonylurea may be considered to reduce the risk of hypoglycaemia. If tighter glycemic control is required on top of the maximum recommended daily dose of vildagliptin, the addition of other antidiabetic drugs such as metformin, an SU, a TZD or insulin may be considered. The safety and efficacy of vildagliptin as triple oral therapy in combination with other antidiabetic drugs has not been established. Doses higher than 100mg are not recommended. Initial combination therapy or maintenance of combination therapy should be individualized and are left to the discretion of the health care provider. **General target population** Adults 18 years of age and above **Special populations** **Renal impairment** No dosage adjustment of Galvus is required in patients with mild renal impairment (creatinine clearance ≥ 50mL/min). In patients with moderate or severe renal impairment or End Stage Renal Disease (ESRD) on haemodialysis, the recommended dose of Galvus is 50 mg once daily (see section PHARMACOKINETICS under Special Populations – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Hepatic impairment** Galvus is not recommended in patients with hepatic impairment including patients with a pre-treatment ALT or AST >2.5x the upper limit of normal (ULN) (see section PHARMACOKINETICS under Special Populations – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Geriatric patients (65 years or above)** In patients treated with Galvus ≥ 65 years of age and ≥ 75 years of age, no differences were observed in the overall safety, tolerability, or efficacy between this elderly population and younger patients. No dosage adjustments are therefore necessary in the elderly patients (see section PHARMACOKINETICS under Special Populations – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Pediatric patients (below 18 years)** Galvus has not been studied in patients under 18 years of age; therefore, the use of Galvus is not recommended for use in children below 18 years. (see section PHARMACOKINETICS under Special Populations – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).