HIGHLIGHT
Galvus Met

Galvus Met

metformin + vildagliptin

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
Per 50 mg/500 mg FC tab Vildagliptin 50 mg, metformin HCl 500 mg. Per 50 mg/850 mg FC tab Vildagliptin 50 mg, metformin HCl 850 mg. Per 50 mg/1,000 mg FC tab Vildagliptin 50 mg, metformin HCl 1,000 mg
Indications/Uses
Type 2 DM inadequately controlled on metformin alone or who are already treated w/ combination of vildagliptin & metformin as separate tab. In triple combination therapy w/ sulphonylurea as an adjunct to diet & exercise in patients inadequately controlled w/ metformin & sulphonylurea. In triple combination therapy w/ insulin as an adjunct to diet & exercise to improve glycaemic control in adult patients when stable dose of insulin & metformin alone do not provide adequate glycaemic control. Initial therapy in patients w/ type 2 DM whose diabetes is inadequately controlled by diet & exercise alone.
Dosage/Direction for Use
Max vildagliptin dose: 100 mg daily. Inadequately controlled on metformin monotherapy or dual combination therapy w/ insulin Initially vildagliptin 50 mg bd + current metformin dose. Switching from co-administration of vildagliptin & metformin as separate tab Initiate based on current vildagliptin & metformin dose. Inadequately controlled on dual combination therapy w/ metformin & sulphonylurea Vildagliptin 50 mg bd & current metformin dose. Treatment-naive patient Initially 50 mg/500 mg once daily & gradually titrated to max dose: 50 mg/1,000 mg bd.
Administration
Should be taken with food: Take w/ or immediately after meals to reduce GI discomfort.
Contraindications
Hypersensitivity. Acute or chronic metabolic acidosis including lactic acidosis or diabetic ketoacidosis w/ or w/o coma. Acute conditions w/ potential to alter renal function. Acute or chronic disease which may cause tissue hypoxia. Acute alcohol intoxication, alcoholism. Patients w/ CrCl <30 mL/min. Hepatic impairment. Lactation.
Special Precautions
Discontinue use in case of hypoxemia. Not to be used in type 1 diabetes or diabetic ketoacidosis. Risk of lactic acidosis; decreased vit B12 serum levels; skin lesions including blistering & ulceration; acute pancreatitis; hypoglycemia. Severe & disabling arthralgia in patients taking DPP-4 inhibitors. Monitor renal function prior to initiation & regularly thereafter. Temporary discontinuation in patients undergoing radiologic studies involving intravascular administration of iodinated contrast agent; surgical procedure. Concomitant use of medications affecting renal function or metformin HCl disposition. Avoid excessive alcohol intake. Not to be used in hepatic impairment including patients w/ pre-treatment ALT or AST >3 times upper limit of normal. Renal impairment (CrCl between 30 & 90 mL/min). Not recommended in childn <18 yr. Elderly.
Adverse Reactions
Nausea, vomiting, diarrhoea, abdominal pain, loss of appetite. Dizziness, metallic taste, headache, tremor, hypoglycemia, chills, GERD, decreased blood glucose, asthenia, hyperhidrosis.
Drug Interactions
Vildagliptin: Increased risk of angioedema w/ ACE inhibitors. Reduced hypoglycaemic effect w/ thiazides, corticosteroids, thyroid products & sympathomimetics. Metformin: Increased risk of lactic acidosis in acute alcohol intoxication. Increased systemic exposure w/ cimetidine. Intrinsic hyperglycaemic activity w/ glucocorticoids, β2-agonists & diuretics. Decreased blood glucose levels w/ ACE inhibitors.
MIMS Class
ATC Classification
A10BD08 - metformin and vildagliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.
Presentation/Packing
Form
Galvus Met 50 mg/850 mg FC tab
Packing/Price
30's;60's
Form
Galvus Met 50 mg/1000 mg FC tab
Packing/Price
30's;60's
Form
Galvus Met 50 mg/500 mg FC tab
Packing/Price
30's;60's
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