HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use GLUMETZA safely and effectively. See full prescribing information for GLUMETZA.

GLUMETZA®
(metformin hydrochloride extended-release tablets), 500mg and 1000mg
Initial U.S. Approval: 1995
 
WARNING: LACTIC ACIDOSIS

See full prescribing information for complete boxed warning

Lactic acidosis can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic insufficiency, renal impairment, and acute congestive heart failure. (5.1)
Symptoms include malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate. (5.1)
If acidosis is suspected, discontinue GLUMETZA and hospitalize the patient immediately. (5.1)
 
RECENT MAJOR CHANGES
Dosing and Administration: Inclusion of the 1000mg tablet (3) 12/2007

 
INDICATIONS AND USAGE
GLUMETZA is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type2 diabetes mellitus. (1)

Important limitations of use:

Not for treatment of type1 diabetes or diabetic ketoacidosis. (1)

 
DOSAGE AND ADMINISTRATION
Administer once daily with the evening meal. (2.1)
Individualize the dose based on effectiveness and tolerability, while not exceeding the maximum recommended daily dose of 2000mg. (2.1)
If naïve to metformin treatment, initiate with 500mg daily. (2.1)
Swallow whole. Never split, crush or chew. (2.1)

 
DOSAGE FORMS AND STRENGTHS
Extended Release Tablets, 500mg and 1000mg (3)

 
CONTRAINDICATIONS
Renal impairment (4)
Metabolic acidosis, including diabetic ketoacidosis (4)
Hypersensitivity to metformin hydrochloride (4)

 
WARNINGS AND PRECAUTIONS
Lactic acidosis: Warn against excessive alcohol intake. GLUMETZA is not recommended in hepatic impairment and is contraindicated in renal impairment. Ensure normal renal function before initiating and at least annually thereafter. (5.1)
Temporarily discontinue in patients undergoing radiologic studies with intravascular administration of iodinated contrast materials or any surgical procedures necessitating restricted intake of food and fluids. (5.2)
Vitamin B12 deficiency: Metformin may lower vitamin B12 levels. Monitor hematologic parameters annually. (5.6)
Macrovascular outcomes: No conclusive evidence of macrovascular risk reduction with GLUMETZA or any other antidiabetic drug. (5.8)

 
ADVERSE REACTIONS
The incidence and type of adverse reactions reported by >5% of patients for the combined GLUMETZA group versus placebo group are hypoglycemia, diarrhea, and nausea. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Depomed, Inc. at 1-866-458-6389 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 
DRUG INTERACTIONS
Cationic drugs: May reduce metformin elimination. Use with caution in patients who are taking cationic medications eliminated by renal tubular secretion. (7.2)

 
USE IN SPECIFIC POPULATIONS
Pediatric Use: Safety and effectiveness in children younger than 18years of age have not been established. (8.4)
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