Glumetza
Boxed Warning
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There is a black box warning associated with metformin products. Lactic acidosis due to metformin accumulation during treatment with GLUMETZA is a rare but potentially fatal occurrence. Lactic acidosis may also occur in association with a number of pathophysiologic conditions and whenever there is significant tissue hypoperfusion and hypoxemia. Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia, are at increased risk of lactic acidosis. The onset of lactic acidosis often is subtle, and can be accompanied only by nonspecific symptoms. The patient and the patient's physician must be aware of the possible importance of such symptoms and the patient should be instructed to notify the physician immediately if they occur. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient's age. Treatment should not be initiated in patients ≥ 80 years of age unless renal function is not reduced. The risk of lactic acidosis while on GLUMETZA therapy may be significantly decreased by: Initial and regular monitoring of renal and liver function; using the minimum effective dose of GLUMETZA; promptly withholding GLUMETZA in the presence of any condition associated with hypoxemia, dehydration, or sepsis; avoidance of GLUMETZA in patients with hepatic disease; cautioning patients against excessive alcohol intake, either acute or chronic; and temporarily discontinuing GLUMETZA prior to any intravascular radiocontrast study or surgical procedure. Lactic acidosis is a medical emergency requiring immediate discontinuation of GLUMETZA and prompt institution of general supportive measures. Because metformin is dialyzable, prompt hemodialysis is recommended to correct the acidosis and remove the accumulated metformin.
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For the Full Prescribing Information, including Black Box Warning, please click here. Please consult with your healthcare professional to see if GLUMETZA is right for you.
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GLUMETZA is contraindicated in patients with renal dysfunction, known hypersensitivity to metformin HCl or metabolic acidosis, including diabetic ketoacidosis. Use of concomitant medications that affect renal function or hemodynamic change may interfere with the disposition of metformin and should be used with caution.
Hypoglycemia does not occur in patients receiving GLUMETZA alone but could occur with deficient caloric intake or during concomitant use with other glucose-lowering agents or ethanol. Loss of glycemic control may occur when a stabilized patient is exposed to stress.
In clinical trials, the most common side effects with GLUMETZA monotherapy were diarrhea, nausea, dyspepsia, and upper abdominal pain. In a clinical trial of GLUMETZA combined with a sulfonylurea, the most common side effects included hypoglycemia, diarrhea, and nausea.
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