Description
GALVUS 50 MG TABLET
Description :Vildagliptin: 1-[(3-hydroxy-adamant-1-ylamino)-acetyl]-pyrrolidine-2(S)-carbonitrile.Each tablet contains 50 mg of vildagliptin. Excipients/Inactive Ingredients: Lactose anhydrous, microcrystalline cellulose, sodium starch glycolate, magnesium stearate.
Indications / Uses : 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.
Administration : May be taken with or without food.
Contraindications : Patients with known hypersensitivity to vildagliptin or to any of the excipients (see Description).
Special Precautions : Not for use in patients w/ type 1 diabetes & diabetic ketoacidosis. Not recommended in patients w/ NYHA class IV; hepatic impairment w/ pre-treatment ALT/AST >2.5 x the upper limit of normal (ULN). 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. Not to be used during pregnancy & lactation. Childn <18 yr.
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