Galvus Met保胰健加

Galvus Met

metformin + vildagliptin

Manufacturer:

Novartis

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Per 50 mg/500 mg Vildagliptin 50 mg, metformin HCl 500 mg. Per 50 mg/850 mg Vildagliptin 50 mg, metformin HCl 850 mg. Per 50 mg/1,000 mg Vildagliptin 50 mg, metformin HCl 1,000 mg
Indications/Uses
Adjunct to diet & exercise in patients w/ type 2 DM whose blood glucose is not adequately controlled on metformin HCl or vildagliptin alone or who are already being treated w/ a free combination of metformin HCl & vildagliptin. In combination w/ sulphonylurea ie, triple combination therapy, as an adjunct to diet & exercise in patients inadequately controlled w/ metformin & sulphonylurea alone. In combination w/ insulin to improve glycemic control in patients whose blood glucose cannot be adequately controlled by diet, exercise & treatment w/ a stable dose of insulin & metformin.
Dosage/Direction for Use
Inadequately controlled on vildagliptin monotherapy Initially 50 mg/500 mg or 50 mg/850 mg bd. Inadequately controlled on metformin monotherapy Initially 50 mg/500 mg, 50 mg/850 mg or 50 mg/1,000 mg bd. Switching from free combination of metformin & vildagliptin Initiate based on the current dose of metformin or vildagliptin. In combination w/ insulin or sulphonylurea Based on current dose of metformin, 50 mg/500 mg, 50 mg/850 mg or 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; severe renal impairment (CrCl <30 mL/min); acute conditions which may alter renal function eg, dehydration, severe infection, shock, intravascular administration of iodinated contrast agents; acute or chronic disease which may cause tissue hypoxia eg, heart & resp failure, recent MI & shock; hepatic impairment; acute alcohol intoxication, alcoholism. Lactation.
Special Precautions
Should not be used in type 1 diabetes or diabetic ketoacidosis. Hypoglycemia. Pregnancy & lactation. Childn. Elderly. Vildagliptin: Hepatic impairment. Perform liver function test prior to & during treatment at 3-mth intervals during the 1st yr & periodically thereafter. Discontinue use if AST/ALT ≥3 x ULN persists, or if jaundice & pancreatitis develop. Cardiac failure (NYHA class III-IV). Monitor for skin disorders eg, blistering & ulceration. Metformin: Discontinue if lactic acidosis is suspected. Renal impairment. Assess GFR before treatment initiation & regularly thereafter. Discontinue prior to or at the time of IV administration of iodinated contrast media & not restarted until at least 48 hr after. Discontinue at the time of surgery under general, spinal & epidural anesth; restart until at least 48 hr after. Avoid alcohol intake. Decreased serum vit B12 levels.
Adverse Reactions
Nausea; dizziness, tremor. Combination w/ insulin: Decreased blood glucose; headache, chills; nausea, GERD. Combination w/ a sulphonylurea: Hypoglycaemia; dizziness, tremor; hyperhidrosis; asthenia.
Drug Interactions
Metformin: Increased blood glucose levels w/ glucocorticoids, β2-agonists, diuretics, phenothiazines, thyroid hormones, oestrogens, OCs, hormone replacement therapy, phenytoin, nicotinic acid, Ca channel blockers, INH & tetracosactide. Increased plasma levels w/ furosemide & nifedipine. Increased Cmax & AUC w/ cimetidine. Decreased blood glucose w/ β-blockers & ACE inhibitors. Increased hypoglycaemic effect w/ MAOIs & oral antidiabetics. Potentiated hypoglycaemic effect w/ alcohol. Increased or reduced hypoglycaemic effect w/ H2-antagonists, clonidine & reserpine, quinolones. Increased risk of lactic acidosis w/ diuretics, iodinated contrast media, alcohol, NSAIDs, ACE inhibitors, angiotensin II receptor antagonists. Lowered plasma levels of furosemide. Reduced effect of phenprocoumon. Less perceptible warning signs of hypoglycaemia w/ sympatholytics.
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
Galvus Met 50 mg/1,000 mg film-coated tab
Packing/Price
60's
Form
Galvus Met 50 mg/500 mg film-coated tab
Packing/Price
60's
Form
Galvus Met 50 mg/850 mg film-coated tab
Packing/Price
60's
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