Galvusmet

Galvusmet

metformin + vildagliptin

Manufacturer:

Novartis Indonesia
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
Indications/Uses
Adjunct to diet & exercise to improve glycaemic control in patients w/ type 2 DM whose diabetes is not adequately controlled on metformin HCl or vildagliptin alone or who are previously treated w/ vildagliptin & metformin HCl in separate combination. Used in combination w/ insulin.
Dosage/Direction for Use
Individualized dosage. Max vildagliptin dose: 100 mg daily. Patient inadequately controlled w/ vildagliptin or metformin HCl monotherapy Initially vildagliptin 50 mg + current metformin dose twice daily, 1 tab in the morning & in the evening. Recommended dose: Vildagliptin 100 mg + metformin HCl 2,000 mg. In combination w/ insulin Should provide vildagliptin 50 mg twice daily (100 mg total daily dose) & a dose of metformin similar to the dose already being taken.
Administration
Should be taken with food: Take w/ meals to reduce GI discomfort.
Contraindications
Hypersensitivity. CrCl <60 mL/min, acute conditions w/ potential to alter renal function, CHF, acute or chronic metabolic acidosis including lactic acidosis or diabetic ketoacidosis w/ or w/o coma. Intravascular administration of iodinated contrast materials. Acute or chronic disease which may cause tissue hypoxia. Acute alcohol intoxication, alcoholism. Hepatic impairment. Lactation.
Special Precautions
Not to be used in patients w/ type 1 diabetes or for treatment of diabetic ketoacidosis. Risk of lactic acidosis; decreased vit B12 serum levels; hypoglycemia. Monitor renal function prior to initiation, at least once a yr w/ normal renal function, 2-4 times a yr w/ serum creatinine levels at the ULN, in elderly & regularly thereafter. Concomitant use of medications affecting renal function or metformin HCl disposition. Temporary discontinuation in patients undergoing radiologic studies involving intravascular administration of iodinated contrast agent; surgical procedure. Discontinue treatment in case of hypoxemia. Avoid excessive alcohol intake. Perform LFTs prior to initiation & during treatment at 3-mth interval for the 1st yr & periodically thereafter. W/draw therapy if an increase in AST or ALT ≥3 x the ULN persist. Should not be reinitiated following withdrawal of treatment & LFT normalization. Monitor for skin disorders. May be temporarily w/held in case of loss in glycemic control. Not to be used in patients w/ CrCl <60 mL/min. Not recommended in patients w/ hepatic impairment including w/ pre-treatment ALT or AST >2.5 x ULN. Not to be used during pregnancy & breast-feeding. Not recommended in childn & adolescents <18 yr. Elderly ≥75 yr.
Adverse Reactions
Headache, tremor, dizziness, nausea. Vildagliptin: Constipation, arthralgia. Metformin: Loss of appetite, flatulence, vomiting, diarrhoea, abdominal pain. Dysgeusia. In combination w/ insulin: GERD, chills, decreased blood glucose.
Drug Interactions
Metformin HCl: Furosemide, nifedipine, cationic drugs, drugs that may produce hyperglycemia, alcohol.
MIMS Class
Antidiabetic Agents
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
Galvusmet 50 mg/500 mg FC tab
Packing/Price
3 × 10's (Rp154,500/boks)
Form
Galvusmet 50 mg/850 mg FC tab
Packing/Price
3 × 10's (Rp154,500/boks)
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