Galvus

Galvus

vildagliptin

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
Vildagliptin
Indications/Uses
Type 2 DM as monotherapy or initial combination therapy w/ metformin when diabetes is inadequately controlled by diet & exercise alone. In combination w/ other antidiabetics including insulin when these do not provide adequate glycaemic control.
Dosage/Direction for Use
Adult Monotherapy, in combination w/ metformin, thiazolidinedione, metformin & sulphonylurea or insulin (w/ or w/o metformin) 100 mg daily as 1 dose of 50 mg in the morning & evening. Dual combination w/ sulphonylurea 50 mg once daily in the morning. Initial combination therapy w/ metformin 50 mg once or bd. Max: 100 mg. Moderate or severe renal impairment or end-stage renal disease 50 mg once daily.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue use if pancreatitis, severe & disabling arthralgia are suspected; jaundice or other signs of liver dysfunction develops. Not an insulin substitute. Not to be used in type 1 diabetes or diabetic ketoacidosis. Not recommended in NYHA class IV. Hypoglycaemia. Perform liver function tests prior to & during treatment at 3-mth intervals for the 1st yr & periodically thereafter. Routine care for diabetic patients & monitor for skin disorders. Not to be used in galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Renal impairment or end-stage renal disease on haemodialysis. Not to be used in hepatic impairment & if AST or ALT increased >3 x upper limit of normal. Not to be used in pregnancy & lactation. Not recommended in childn & adolescents <18 yr.
Adverse Reactions
Hypoglycaemia, increased wt, decreased blood glucose; peripheral oedema; tremor, dizziness, headache, asthenia, chills; nausea, GERD; hyperhidrosis.
Drug Interactions
Increased risk of angioedema w/ ACE inhibitors. Reduced hypoglycaemic effect w/ thiazides, corticosteroids, thyroid products & sympathomimetics.
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
1 × 7's;2 × 14's;4 × 14's
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