Vildi tablets

Dexa Medica

Ingredients in every tablet

Vildagliptin 50 mg

Each package contains

3 blisters of 10 tablets

Other details

Dosage form:Tablet; plain
Flavour None

W.H.O. classification

ATC Level 1 A - Alimentary tract and metabolism
ATC Level 2 A10 - Drugs Used in Diabetes
ATC Level 3 A10B - Blood Glucose Lowering Drugs; excl. Insulins

Warnings

Pregnancy

NOT SAFEThis item is not safe for use during pregnancy.

Lactation

NOT SAFEThis item is not safe for use during lactation.

Alcohol

CONSULT YOUR DOCTORSafety of this item for use with alcohol has not been established. Please consult your doctor.

Machinery

CAUTIONThis item may not be safe for use while operating heavy machinery. Use with caution and after consultation with your doctor.

Available in

Indonesia

Dosage information

18 TO 65 YEARS OLD
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
Combination therapy with other antidiabetic drugs such metformin, an SU, a TZD or insulin may be given if a tighter glycemic control is required on the top of the maximum recommended daily dose of 100 mg vildagliptin monotherapy. 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.

Vildagliptin can be administered with or without meal.

65 YEARS OLD AND ABOVE
Elderly patients
In patients treated with vildagliptin ≥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.

Vildagliptin can be administered with or without meal.

0 TO 18 YEARS OLD
Not recommended

Vildagliptin can be administered with or without meal.

PATIENTS WITH HEPATIC OR RENAL 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. 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.
Vildagliptin is, however, not recommended in patients with end stage renal disease (ESRD) on hemodialysis. There is limited data on the use of combination therapy in patients with renal and hepatic impairment. Therefore, the use of vildagliptin in combination therapy is not recommended in these patients.

Indication

Vildagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus (T2DM).
– 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.