Galvus

Galvus

vildagliptin

Manufacturer:

Novartis Indonesia
Concise Prescribing Info
Contents
Vildagliptin
Indications/Uses
Adjunct to diet & exercise to improve glycaemic control in type 2 DM. As monotherapy or in dual combination w/ metformin, sulfonylurea (SU) or thiazolidinedione (TZD) when diet, exercise & monotherapy do not result in adequate glycaemic control. In triple combination in patients w/ uncontrolled use of sulfonylurea (SU) & metformin when diet, exercise & dual therapy do not provide adequate glycaemic control. In combination w/ insulin when maximal tolerated dose of insulin as an adjunct to diet & exercise do not provide adequate glycemic control. It is not recommended as initial therapy.
Dosage/Direction for Use
Individualized dosage. Monotherapy 50 mg once daily in the morning or 100 mg in 2 divided doses in the morning & in the evening. Dual combination therapy 50 mg once daily in the morning or 100 mg in 2 divided doses in the morning & in the evening in combination w/ metformin, TZD or insulin. Triple combination therapy 50 mg twice daily w/ metformin & SU. Patient w/ mderate or severe renal impairment 50 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to vildagliptin or to any of the excipients.
Special Precautions
Not to be used in patients w/ type 1 diabetes or for treatment of diabetic ketoacidosis. W/draw therapy if an increase in AST/ALT ≥3 x the ULN persist. Should not be reinitiated following withdrawal of treatment & LFT normalization. Perform LFTs prior to initiation & during treatment at 3-mth interval for the 1st yr & periodically thereafter. Contains lactose. Not recommended in patients w/ NYHA class IV; ESRD on haemodialysis; hepatic impairment including patients w/ pre-treatment ALT or AST >2.5 x the ULN. Not to be used during pregnancy & breast-feeding. Not recommended in patients <18 yr.
Adverse Reactions
Dizziness, nasopharyngitis, HTN. Combination therapy: Dizziness, nasopharyngitis, HTN, tremor, headache, asthenia, increased wt, peripheral edema, nausea, GERD, chills, decreased blood glucose, asthesia, hypoglycemia, hyperhidrosis.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BH02 - vildagliptin ; Belongs to the class of dipeptidyl peptidase 4 (DPP-4) inhibitors. Used in the treatment of diabetes.
Presentation/Packing
Form
Galvus tab 50 mg
Packing/Price
2 × 14's (Rp137,200/boks)
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