- Metformin is indicated in the treatment of type 2 diabetes mellitus in adults, children from 10 years of age and adolescents, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control.
- For adult patients, metformin may be used as initial treatment or in sulfonylurea failures either alone or in combination with a sulfonylurea and other oral agents or as adjuvant therapy in insulin requiring type 2 diabetes.
- Initially 500 mg should be taken once or twice a day and if necessary increased over a few weeks up to 1 g three times per day. The dose should be titrated with gradual dose increments until the desired effect is obtained. 500 mg three times a day is often sufficient to obtain diabetic control. If necessary, the dose can be increased to 1 g three times daily, which is the maximum recommended daily dose.
- The action of metformin is progressive and no final assessment of the patient’s real response should be made before the 21st day of treatment; blood sugar estimations are recommended during the initial 15 days of stabilization. Metformin will not produce a hypoglycemic state when used alone; however, due to its action in increasing insulin effectiveness, care must be taken when metformin is initially administered with parenteral doses of insulin.
- 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 HCl Tablets
(n=141) |
Placebo
(n=145) |
| Diarrhea |
53% |
12% |
| Nausea/Vomiting |
26% |
8% |
| Flatulence |
12% |
6% |
| Asthenia |
9% |
6% |
| Indigestion |
7% |
4% |
| Abdominal Discomfort |
6% |
5% |
| Headache |
6% |
5% |
Does not require any special storage conditions.
Formin 500 mg: 5×50’s
Formin 850 mg: 10×10’s
