- Reduction in the risk or delay of the onset of type 2 diabetes mellitus in adult, overweight patients with Impaired glucose tolerance (IGT) and/or Impaired Fasting Glucose (IFG), and/or increased HbA1C who are:
- at high risk for developing overt type 2 diabetes mellitus and
- still progressing towards type 2 diabetes mellitus despite implementation of intensive lifestyle change for 3 to 6 months
- Treatment with Metformin SR sustained release tablet must be based on a risk score incorporating appropriate measures of glycemic control and including evidence of high cardiovascular risk.
- Lifestyle modifications should be continued when metformin is initiated, unless the patient is unable to do so because of medical reasons.
- Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycemic control.
- Metformin SR sustained release tablets may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.
- The usual starting dose is one tablet of Metformin SR 500 mg once daily.
- After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastro-intestinal tolerability. The maximum recommended dose is 4 tablets of Metformin SR 500 mg daily.
- Dosage increases should be made in increments of 500 mg every 10-15 days, up to a maximum of 2000 mg once daily with the evening meal. If glycaemic control is not achieved on Metformin SR 2000 mg once daily, Metformin SR 1000 mg twice daily should be considered, with both doses being given with food. If glycaemic control is still not achieved, patients may be switched to standard metformin tablets to a maximum dose of 3000 mg daily.
- In patients already treated with metformin tablets, the starting dose of Metformin SR sustained release tablet should be equivalent to the daily dose of metformin immediate release tablets. In patients treated with metformin at a dose above 2000 mg daily, switching to Metformin SR prolonged release tablet is not recommended.
- If transfer from another oral antidiabetic agent is intended: discontinue the other agent and initiate Metformin SR sustained release tablet at the dose indicated above.
- The initial and maintenance dosing of metformin should be conservative in elderly patients, due to the potential for decreased renal function in this population. Any dosage adjustment should be based on a careful assessment of renal function. Generally, elderly patients should not be titrated to the maximum dose of metformin.
- Juvenile diabetes mellitus that is uncomplicated and well-regulated on insulin.
- Diabetes mellitus regulated by diet alone.
- During or immediately following surgery where insulin is essential. APO-Metformin 500/850/1000 should not be given to patients who have experienced hypersensitivity to the product or any of its ingredients.
- Hypersensitivity to biguanides.
- Diabetic ketoacidosis, diabetic pre-coma.
- Renal failure or renal dysfunction (creatinine clearance < 60 mL/min). Acute conditions with the potential to alter renal function such as:
- Dehydration
- Severe infection
- Shock
- Intravascular administration of iodinated contrast agents
- Acute or chronic disease which may cause tissue hypoxia such as:
- Cardiac failure
- Recent myocardial infarction
- Respiratory failure
- Pulmonary embolism
- Shock
- Acute significant blood loss
- Sepsis
- Gangrene
- Pancreatitis
- Severe hepatic insufficiency
- Acute alcohol intoxication
- Alcoholism
- Lactation
- Lactic Acidosis
- Lactic Acidosis
- Vitamin B 12 Deficiency
- Hypoglycemia with concomitant use with insulin and insulin secretagogues
- Macrovascular Outcomes
- Lactic Acidosis
- Vitamin B 12 Deficiency
- Hypoglycemia
| GI Side Effects |
Metformin IR |
Metformin SR |
| Diarrhea |
18.05% |
8.29% |
| Nausea |
2.93% |
1.95% |
| Dyspepsia |
3.41% |
1.46% |
| Abdominal Distention |
2.44% |
0.49% |
| Tympanism |
2.44% |
0% |
Does not require any special storage conditions.
FORMIN SR 500 mg Sustained Release Tablets: 10×10’s
FORMIN SR 1000 mg Sustained Release Tablets: 10×10’s
