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General Information

Important Safety Information

Warning: Lactic Acidosis

Lactic acidosis is a rare, but serious, complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment and acute congestive heart failure.

The onset of lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress.

Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate.

If acidosis is suspected, GLUMETZA (metformin hydrochloride, extended-release tablets), should be discontinued and the patient hospitalized immediately.

GLUMETZA is contraindicated in patients with:

Renal impairment (e.g., serum creatinine levels ≥ 1.5 mg/dL for men, ≥ 1.4 mg/dL for women or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS (5) of the Full Prescribing Information).

Known hypersensitivity to metformin hydrochloride.

Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.

Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use, but 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 (such as sulfonylureas and insulin) or ethanol. Elderly, debilitated, or malnourished patients, and those with adrenal or pituitary insufficiency or alcohol intoxication are particularly susceptible to hypoglycemic effects. Hypoglycemia may be difficult to recognize in the elderly, and in people who are taking beta-adrenergic blocking drugs.

In clinical trials, the most common side effects with GLUMETZA monotherapy were diarrhea, nausea, dyspepsia, and upper abdominal pain. In clinical trials of GLUMETZA combined with a sulfonylurea, the most common side effects included hypoglycemia, diarrhea, and nausea.

Dosage and Administration

Administer once daily with the evening meal.

Individualize the dose based on effectiveness and tolerability, while not exceeding the maximum recommended daily dose of 2000 mg.

If naïve to metformin treatment, initiate with 500 mg daily.

Swallow whole. Never split, crush or chew.

Dosage Forms and Strengths

Extended Release Tablets, 500 mg and 1000 mg

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.

To report a Product Adverse Event or Product Complaint: 1-888-778-0887, Monday-Friday, 9:00 am-7:00 pm Eastern Time

Note: You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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Glumetza^® and Smartcoat^® are registered trademarks of Biovail Laboratories International S.r.l. AcuForm^® is a registered trademark of Depomed. Inc.