Pharmacology: Metformin hydrochloride is a biguanide oral antihyperglycemic drug. Metformin hydrochloride does not affect insulin secretion nor the function of pancreatic β-cells. The proposed mechanisms include decreased hepatic glucose production and intestinal absorption of glucose, increased peripheral uptake and utilization of glucose by increasing peripheral tissue sensitivity to and/or receptor binding of insulin. At therapeutic dose, metformin does not cause hypoglycemia in both diabetic or nondiabetic individuals.
When given orally, the bioavailability of metformin is about 50-60% under fasting conditions. Food decreases the rate and extent of absorption. The protein-binding is negligible. Metformin is not metabolized in the body. The elimination t½ is about 6.2 hrs. Up to 90% of the dose is excreted unchanged in urine. Metformin crosses the placenta and appears in breast milk.
Treatment of type 2 diabetes, alone or with oral antidiabetic agents or with insulin, when hyperglycemia cannot be controlled by diet management or if patient is overweight.
Adults: Initial Dose: 1 tab 2 times daily in the morning and evening. Daily dosage may be increased by 1 tab at weekly intervals, as needed, up to a maximum of 6 tabs daily.
Reduction of blood glucose level may be achieved within a few days after initiation of metformin administration, however, the onset of full effects may be delayed for up to 2 weeks.
Maintenance Dose: 1 tab 2-3 times daily.
Metforex should be taken in divided doses, with or after meals to reduce nausea or diarrhea.
Hypersensitivity to metformin HCl.
Diabetic coma and ketoacidosis; active or history of lactic acidosis; severe hepatic disease; renal disease; conditions associated with hypoxemia eg, congestive heart failure and myocardial infarction; alcoholism.
Blood glucose level should be monitored more often during concomitant therapy with sulfonylurea and stabilization of diabetic patients with metformin and insulin should be carried out because of the possibility of hypoglycemia.
Annual monitoring of folic acid and vitamin B12 level are recommended during long-term metformin therapy because Metforex may decrease their absorption.
Regular monitoring of renal function is advised in all diabetic patients because metformin is excreted by the kidney.
Caution is recommended when concomitantly used with other drugs eg, alcohol, cimetidine and furosemide.
Metforex is not recommended for use during pregnancy and in nursing women and in children.
Metforex is not recommended for use during pregnancy and in nursing women.
Anorexia, dyspepsia, flatulence, metallic taste, nausea, vomiting, headache and weight loss are the most common side effects.
Lactic acidosis, a serious, potentially fatal side effect may occur rarely. Patients should be informed of the risks of lactic acidosis and its symptoms (diarrhea, fast and shallow breathing, unusual tiredness and weakness, sleepiness, muscle pain or cramping). If lactic acidosis does occur, immediate emergency hospitalization is required.
A10BA02 - metformin ; Belongs to the class of biguanides. Used in the treatment of diabetes.
Tab 500 mg x 10 x 10's. 850 mg x 10 x 10's.
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