Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control.
In patients treated with metformin at a dose 1 g or 2 g, switching to DH-METGLU XR to the daily dose being equivalent to the daily dose of metformin HCl. In patients treated with metformin at a dose > 2 g daily, switching to DH-METGLU XR is not recommended.
Starting treatment with metformin HCl: Initiating dose is 1 tablet of 500 mg once daily with the evening meal; dosage increases slowly to improve gastro-intestinal tolerability, increments of 500 mg every 10-15 days up to a maximum of 2 g once daily with the evening meal on the basis of blood glucose results; if glycaemic control is not achieved, DH-METGLU XR 1000 mg twice daily is considered with breakfast and the evening meal; If glycaemic control is still not achieved, switching to standard metformin tablets to a maximum dose of 3 g daily.
If transfer from another oral antidiabetic agent is intended: Initiate DH-METGLU XR 500 before switching to DH-METGLU XR 1000 at the dose previously indicated.
Combination with insulin: Initiate 500 mg once daily with the evening meal or use the dose being equivalent to the daily dose of metformin HCl used previously (maximum of 2 g once daily), insulin dosage is adjusted on the basis of blood glucose measurements.
Elderly, renal function: dosage is adjusted on renal function.
Children: should not be used.
ADMINISTRATION: Swallow the tablets whole with water. Do not chew, break in half or crush tablets.
Hypersensitivity to any of the compositions; diabetic ketoacidosis, diabetic pre-coma; moderate or severe renal failure or renal dysfunction (ClCr < 45mL/min or eGFR < 45mL/min/1.73m2); acute conditions with the potential to alter renal function such as dehydration, severe infection, shock; acute or chronic disease which may cause tissue hypoxia (decompensated heart failure, respiratory failure, recent myocardial infarction, shock); hepatic insufficiency, acute alcohol intoxication, alcoholism.
Lactic acidosis. In patients with renal failure, renal function should be assessed before and during treatment. Patients with heart failure are more at risk of hypoxia and renal insufficiency, in patients with stable chronic heart failure: metformin may be used with a monitoring of cardiac and renal function. Allergy to wheat starch. Metformin must be discontinued 48 hours before every surgery under general, spinal or epidural anaesthesia, before intravascular administration of iodinated contrast agents; the use of metformin needs to be re-evaluated. All patients should continue their diet and be monitored of blood glucose. Risk of hypoglycaemia when metformin is used in combination with insulin or other antidiabetics.
The most common adverse reactions are gastrointestinal disorders, these undesirable effects are dose-dependent, transient and occur during initiation of therapy. A slow increase of the dose and use during or shortly after meal may also improve gastrointestinal tolerability.
nausea, vomiting, diarrhoea, abdominal pain, loss of appetite.
metabolism and nutrition disorders (lactic acidosis, decrease of vitamin B12 absorption and decrease of serum levels during long-term use); abnormal liver function or reversible hepatitis; erythema, pruritus, urticaria.
Contraindications: iodinated contrast agents.
Not recommended: alcohol, preparations contains alcohol.
Precautions: medicines with intrinsic hyperglycaemic activity (glucocorticoids (systemic/local routes), sympathomimetics). Diuretics, especially loop diuretics.
A10BA02 - metformin ; Belongs to the class of biguanides. Used in the treatment of diabetes.
PR tab 500 mg x 1 x 10's, 3 x 10's, 5 x 10's, 10 x 10's. 1,000 mg x 1 x 10's, 3 x 10's, 5 x 10's, 10 x 10's.