See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling 

Revised: 04/2011
 

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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed 

RECENT MAJOR CHANGES
WARNING: Lactic Acidosis
1. INDICATIONS AND USAGE
2. DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
3. DOSAGE FORMS AND STRENGTHS
4. CONTRAINDICATIONS
5. WARNINGS AND PRECAUTIONS
5.1 Lactic Acidosis
5.2 Monitoring of Renal Function
5.3 Hypoxic States
5.4 Alcohol Intake
5.5 Impaired Hepatic Function
5.6 Vitamin B12 Levels
5.7 Hypoglycemia
5.8 Macrovascular Outcomes
6. ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Laboratory Tests
7. DRUG INTERACTIONS
7.1 Carbonic Anhydrase Inhibitors
7.2 Cationic Drugs
7.3 Drugs Affecting Glycemic Control
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10. OVERDOSAGE
11. DESCRIPTION
12. CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
12.4 Specific Populations
12.5 Drug Interactions
13. NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14. CLINICAL STUDIES
16. HOW SUPPLIED/STORAGE AND HANDLING
17. PATIENT COUNSELING INFORMATION
PATIENT INFORMATION
PRINCIPAL DISPLAY PANEL - 500mg Extended-Release Tablets
PRINCIPAL DISPLAY PANEL - 1000mg Extended-Release Tablets
 

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FULL PRESCRIBING 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. (See WARNINGS and PRECAUTIONS (5.1))

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

Important Limitations of Use

GLUMETZA should not be used in patients with type1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

2. DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
GLUMETZA should be taken once daily with the evening meal. The dosage of GLUMETZA must be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended daily dose of 2000mg. The starting dose of GLUMETZA in