Novartis Healthcare


Novartis Healthcare
Concise Prescribing Info
Adjunct to diet & exercise to improve glycemic control in patients w/ type 2 DM as monotherapy. In combination w/ metformin/sulfonylurea (SU)/thiazolidinedione (TZD) alone when diet & exercise do not result in adequate glycemic control. In triple combination w/ SU & metformin when diet & exercise plus dual therapy do not provide adequate glycemic control. In combination w/ insulin (w/ or w/o metformin) when diet, exercise & stable dose of insulin do not result in adequate glycemic control. Initial combination w/ metformin in patients w/ type 2 DM whose diabetes is not adequately controlled by diet & exercise alone.
Dosage/Direction for Use
Adult Monotherapy & in combination w/ metformin/TZD/insulin (w/ or w/o metformin) 50 mg or 100 mg daily. Combination w/ SU 50 mg once daily. Triple combination w/ metformin & SU 100 mg daily. Max: 100 mg/day (2 divided doses of 50 mg). Patients w/ moderate to severe renal impairment or end stage renal disease 50 mg once daily.
May be taken with or without food.
Special Precautions
Not for use in patients w/ type 1 diabetes & diabetic ketoacidosis. Not recommended in patients hepatic impairment w/ pre-treatment ALT/AST >2.5 x the upper limit of normal (ULN); w/ NYHA class IV. Perform liver function test prior to treatment initiation at 3-mth intervals during the 1st yr & periodically thereafter. W/draw therapy if an increase in AST/ALT ≥3 x ULN persist; do not reinitiate after w/drawal & LFT normalization. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Dizziness; tremor, headache; asthenia; increased wt; peripheral edema; nausea, GERD; chills; decreased blood glucose; hypoglycemia; hyperhidrosis.
MIMS Class
ATC Classification
A10BH02 - vildagliptin ; Belongs to the class of dipeptidyl peptidase 4 (DPP-4) inhibitors. Used in the treatment of diabetes.
Galvus tab 50 mg
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