About Metformin Hydrochloride Extended-Release Tablets
Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Metformin hydrochloride extended-release tablets should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
Important Safety Information
WARNING: LACTIC ACIDOSIS. Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain.
Metformin hydrochloride extended-release tablets are contraindicated in patients with severe renal impairment, known hypersensitivity to metformin hydrochloride, or acute or chronic metabolic acidosis, including diabetic ketoacidosis.
Metformin may lower vitamin B12 levels. Hypoglycemia could occur when caloric intake is deficient, when strenuous exercise is not compensated by caloric supplementation, or during concomitant use with other glucose-lowering agents or ethanol. Elderly, debilitated, or malnourished patients, and those with adrenal or pituitary insufficiency or alcohol intoxication are particularly susceptible to hypoglycemic effects. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with metformin hydrochloride extended-release tablets or any other oral anti-diabetic drug.
In a controlled clinical trial, the adverse reactions reported by greater than 5% of patients for the combined metformin hydrochloride extended-release tablets group and greater than placebo were hypoglycemia, diarrhea, and nausea.
For more information, please see accompanying Full Prescribing Information, including Boxed Warning.