Glucovance

Glucovance

glibenclamide + metformin

Manufacturer:

PT. Merck Tbk
Concise Prescribing Info
Contents
Per 1.25 mg/250 mg tab Glibenclamide 1.25 mg, metformin HCl 250 mg. Per 2.5 mg/500 mg tab Glibenclamide 2.5 mg, metformin HCl 500 mg. Per 5 mg/500 mg tab Glibenclamide 5 mg, metformin HCl 500 mg
Indications/Uses
Initial therapy, as an adjunct to diet & exercise, to improve glycemic control in patients w/ type 2 diabetes w/ HbA1c >8% whose hyperglycemia cannot be satisfactorily managed w/ diet & exercise alone. 2nd-line therapy when diet, exercise, & initial treatment w/ a sulfonylurea or metformin do not result in adequate glycemic control in patients w/ type 2 diabetes.
Dosage/Direction for Use
Initial therapy Recommended starting dose: 1.25 mg/250 mg 1-2 times daily. 2nd-line therapy Recommended starting dose: 5 mg/500 mg or 2.5 mg/500 mg twice daily, up to a max daily dose of 20 mg glibenclamide/2000 mg metformin.
Administration
Should be taken with food.
Contraindications
Renal disease or renal dysfunction, CHF requiring pharmacologic treatment, acute or chronic metabolic acidosis, including diabetic ketoacidosis w/ or w/o coma. Treatment should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials. Hepatic insufficiency, alcoholism, porphyria, lactation, in association w/ miconazole.
Special Precautions
Lactic acidosis is rare & may occur in significant renal insufficiency. Regular renal monitoring, especially in the elderly, is needed. Avoid use in patients w/ clinical or lab evidence of hepatic disease. Patients should be cautioned against excessive alcohol intake. Concomitant medications that may affect renal function or result in significant hemodynamic change or may interfere w/ the disposition of metformin. Suspend therapy during surgery & clinical investigations using IV iodinated contrast media.
Adverse Reactions
Upper resp infection, GI reactions eg, diarrhea, nausea/vomiting & abdominal pain, headache, dizziness, hypoglycemia.
Drug Interactions
Iodinated contrast media, alcohol, cationic drugs that are eliminated by renal tubular secretion, furosemide, nifedipine. Decreases vit B12 absorption. Thiazide & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OC, phenytoin, nicotinic acid, sympathomimetics, Ca-channel blockers & INH may produce hyperglycemia & lead to loss of glycemic control. The hypoglycemic action of sulfonylureas may be potentiated by NSAIDs & other highly protein-bound drugs, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, MAOIs, β-blockers, ciprofloxacin, oral miconazole & other oral hypoglycemic agents.
MIMS Class
ATC Classification
A10BD02 - metformin and sulfonylureas ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.
Presentation/Packing
Form
Glucovance 5 mg/500 mg FC tab
Packing/Price
100's (Rp397,320/pak)
Form
Glucovance 2.5 mg/500 mg FC tab
Packing/Price
100's (Rp327,210/pak)
Form
Glucovance 1.25 mg/250 mg FC tab
Packing/Price
100's (Rp189,778/pak)
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