Vildi
Indonesia • Dexa Medica
Indication
Vildagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in patients with Type-2 Diabetes mellitus.
As monotherapy:
- In dual combination with metformin, a sulphonylurea (SU), a thiazolidinedione (TZD) when diet, exercise and a single antidiabetic agent do not result in adequate glycemic control
- In triple combination in patients with uncontrolled use of sulphonylurea (at submaximal dose) and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycemic control. It is not recommended as initial therapy
Vildagliptin is also indicated for use in combination with insulin (with or without metformin), when maximal tolerated dose of insulin (without metformin or with maximal tolerated dose of metformin) as an adjunct to diet and exercise do not provide adequate glycemic control.
Composition
Vildagliptin 50 mg
Package
Dosage Forms
TabletATC Classification
Warning
Dosage
Up to 18 Years
Not recommended.
18 to 65 Years Old
Vildagliptin can be administered with or without meal.
Monotherapy:
The recommended dose of vildagliptin is 50 mg or 100 mg daily. 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.
Combination therapy:
The recommended dose of vildagliptin is 50 mg or 100 mg daily in dual combination with metformin, an SU, or a TZD or insulin. The 50 mg dose should be administered once daily in the morning. The 100 mg dose should be administered as two divided dose of 50 mg given in the morning and evening.
The recommended dose of vildagliptin is 50 mg twice daily for triple combination with metformin and a SU. When used in dual combination with a sulphonylurea, the recommended dose of vildagliptin is 50 mg once daily administered in the morning. In this patient population, vildagliptin 100 mg daily was no more effective than vildagliptin 50 mg once daily.
65 Years Old and Above
No dosage adjustments are therefore necessary in the elderly patients.
Patients with Renal Impairment
No dosage adjustment of vildagliptin is required in patients with mild renal impairment, in patients with moderate or severe renal impairment the recommended dose of vildagliptin is 50 mg once daily.
Patients with Hepatic Impairment
Vildagliptin is not recommended in patients with hepatic impairment including patients with a pre-treatment ALT or AST >2.5 x the upper limit of normal.