GildaGen-50 Dosage/Direction for Use

Dosage Regimen: The management of antidiabetic therapy should be individualized. The recommended dose is 50 mg once or twice daily. The maximum daily dose is 100 mg. For monotherapy, and for combination with metformin, with a thiazolidinedione (TZD) or with insulin (with or without metformin), the recommended dose is 50 mg or 100 mg daily.
When used in dual combination with a sulfonylurea, the recommended dose of vildagliptin is 50 mg once daily. In this patient population, vildagliptin 100 mg daily was no more effective that the vildagliptin 50 mg once daily.
For triple combination with metformin and a sulfonylurea (SU), the recommended dose is 100 mg daily.
If tighter glycemic control is required on the 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.
General target populations: Adults 18 years of age and above.
Special Populations: Renal Impairment: No dosage adjustment is required in patients with mild renal impairment. In patients with moderate or severe renal impairment or End Stage Renal Disease (ESRD), the recommended dose is 50 mg once daily.
Hepatic Impairment: Not recommended in patients with hepatic impairment including patients with a pre-treatment ALT or AST >2.5x the upper limit of normal (ULN).
Pediatric patients (below 18 years): Vildagliptin has not been studied in patients under 18 years of age; therefore, the use in pediatric patients is not recommended.
Geriatric patients (65 years or above): In treated patients of ≥65 years of age and ≥75 years of age, no differences were observed in overall safety, tolerability, or efficacy between this elderly population and younger patients.
Method of Administration: For oral use.
Administer with or without meals.
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 is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.