Metforlip: Each film coated tablet contains Metformin Hydrochloride BP 500 mg.
Metforlip SR: Each extended-release tablet contains Metformin hydrochloride BP 500 mg.
System Components and Performance: Metforlip SR is an extended-release pill, available in 500 mg tablets, that provides long-lasting blood sugar control and can be taken once daily.
Pharmacology: Mechanism of Action: Metformin is a biguanide antihyperglycemic agent, which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Unlike sulfonylurea, metformin does not produce hypoglycemia in either patient with type 2 diabetes or normal subjects and does not cause hyperinsulinemia.
Metforlip (metformin hydrochloride) or Metforlip SR (metformin hydrochloride extended-release tablets) is an oral antihyperglycemic drug that is indicated in the following cases: Non-insulin dependent diabetes mellitus (NIDDM) or type 2 diabetes as an adjunct to diet & exercise to improve glycemic control.
May be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults.
Metforlip: Insulin dependent diabetes mellitus (IDDM), as adjuvant therapy in combination with insulin
Metforlip SR: Insulin dependent diabetes mellitus (IDDM), as adjuvant therapy in combination with insulin to patients who are often obese.
Metformin (Metforlip) should be given in divided doses (2-3 times/day) with meals while metformin hydrochloride extended-release tablets (Metforlip SR) should generally be given once daily with the evening meal. In both cases it should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient.
Recommended Dosing Schedule: Metforlip: Adults: The usual starting dose of Metforlip is 500 mg twice a day, given with meals. Dosage increments should be made by 500 mg weekly, up to a total of 2000 mg per day, given in divided doses. Patients can also be titrated from 500 mg twice a day to 850 mg twice a day after 2 weeks.
Pediatrics: The usual starting dose of Metforlip is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
Metforlip SR: Adults: The usual starting dose of Metforlip SR (Metformin hydrochloride extended-release tablets) is 500 mg once daily with the evening meal. Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal. If glycemic control is not achieved on Metforlip SR 2000 mg once daily, a trial of Metforlip SR 1000 mg twice daily should be considered.
In a randomised trial, patients currently treated with Metformin were switched to Metformin extended-release tablets (Metforlip SR). Results of this trial suggest that patients receiving Metformin treatment may be safely switched to Metformin extended-release tablets (Metforlip SR) once daily at the same total daily dose, up to 2000 mg once daily. Following a switch from Metformin to Metformin extended-release tablets (Metforlip SR), glycemic control should be closely monitored and dosage adjustments made accordingly.
Children: not recommended.
Hypersensitivity to the drug, renal impairment, diabetic coma and ketoacidosis, chronic renal diseases, congestive heart failure (Metforlip), cardiac failure & recent myocardial infarction (Metforlip SR), trauma, dehydration, alcohol dependence, pregnancy, breast-feeding etc.
Metforlip: Metformin is known to be substantially excreted by the kidney, and the risk of Metformin accumulation and lactic acidosis is increased with the degree of impairment of renal function. Thus, patients with serum creatinine levels above the upper limit of normal should not receive Metformin. In patients with advanced age, Metformin should be carefully titrated to establish minimum dose for adequate glycemic control, because aging is associated with reduced renal function. Metformin therapy should be temporarily suspended for any surgical procedure and should not be restarted until the patient's oral intake has resumed and renal function has been evaluated as normal. During concomitant therapy with sulfonylurea, blood glucose should be monitored. Metformin & insulin therapy should be carried out in hospital until the correct ratio of the two drugs has been established.
Metforlip SR: Monitoring renal function regularly is advised in all patients taking Metformin. Therapy should be stopped 2-3 days before surgery and clinical investigations such as intravenous urology, angiography and reinstated only after control of renal function has been regained. Patients receiving continuous therapy should have an annual estimation of vitamin B12 levels. During concomitant therapy with sulfonylurea, blood glucose should be monitored. Metformin & insulin therapy should be carried out in hospital until the correct ratio of the two drugs has been established.
Usually well tolerated but minor GI disturbances sometimes occur which can be avoided easily by taking the drug with or after food. Some patients may experience a metallic taste. Lactic acidosis may occur but its incidence is very low (approximately 0.03 cases/1000 patient-year). It may induce malabsorption of vitamin B12 & folic acid.
Cimetidine reduces the renal clearance of Metformin. Alcohol potentiates the antihyperglycemic & hyperlactataemic effect of Metformin. It may enhance the effects of anti-coagulants. As such patients receiving the two drugs may need adjustment of the anti-coagulant dosage. Nifedipine appears to enhance the absorption of Metformin but Metformin has minimal effects on Nifedipine.
Store below 30°C in a cool and dry place. Protect from light.
A10BA02 - metformin ; Belongs to the class of biguanides. Used in the treatment of diabetes.
Metforlip: FC tab 500 mg x 5 x 10's.
Metforlip SR: ER tab 500 mg x 10 x 5's.
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