Indications
Dosage & Administration
Adult-
Metformin 500 mg tablet: Initial dosage is 500 mg tablet 2-3 times daily with or after meals, gradually increased if necessary to 2 to 3 gm daily.
Metformin 850 mg tablet: Initial dosage is 850 mg tablet once or twice daily with or after meals, gradually increased if necessary to 2 to 3 gm daily.
Metformin extended release or long acting tablet: The usual starting dose of Metformin extended release tablet 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 Metformin extended release tablet 2000 mg once daily, a trial of Metformin extended release tablet 1000 mg twice daily should be considered. The maximum recommended dose of metformin is 3 gm daily.
Transfer from other antidiabetic therapy: When transferring patients from standard oral hypoglycemic agents other than Chlorpropamide to Metformin HCl, no transition period generally is necessary. When transferring patients from Chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of Chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.
Children and adolescents-
Monotherapy and combination with insulin
- Metformin tablets can be used in children from 10 years of age and adolescents.
- The usual starting dose is one tablet of 500 mg or 850 mg once daily, given during meals or after meals.
After 10 to 15 days the should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability. The maximum recommended dose of metformin is 2 g daily, taken as 2 or 3 divided doses.
Elderly-
Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.
Contraindications
- Hypersensitivity to metformin hydrochloride or to any of the excipients of the medication.
- 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 or respiratory failure, recent myocardial
- infarction, shock
- Hepatic insufficiency, acute alcohol intoxication, alcoholism
- Lactation
Side Effects
Pregnancy & Lactation
Pregnancy Category B. Animal studies do not indicate harmful effects with respect to pregnancy, embryonic or fetal development, parturition or postnatal development. There are no adequate and well-controlled studies in pregnant women. Can be used in pregnancy for both preexisting and gestational diabetes. Women with gestational diabetes should discontinue treatment after giving birth.
Lactation: Metformin is excreted into milk in lactating rats. Similar data is not available in humans and a decision should be made whether to discontinue nursing or to discontinue metformin, taking into account the importance of the drug to the mother. May be used during breast-feeding in women with pre existing diabetes.
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