Vildi tablets

Dexa Medica

Composition

Vildagliptin50 mg

Each Pack Contains

3 blisters of 10 tablets

Dosage Form

tablet

Dosage formTablet; plain

Flavor

None

W.H.O. Classification

A10B

Available In

Indonesia

Warning

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.

Pregnancy

NOT RECOMMENDEDThis item is not safe for use during pregnancy.

Lactation

NOT RECOMMENDEDThis item is not safe for use during lactation.

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.

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.