Jump to Site Navigation

Back to Top

BANNER: Instant Savings Program. Click to learn more.

Learn More about the Treatment of Type 2 Diabetes with GLUMETZA®

A treatment for type 2 diabetes in adults

What is GLUMETZA?

  • GLUMETZA is a prescription type 2 diabetes medicine that contains metformin hydrochloride used with diet and exercise to help control high blood sugar in adults with type 2 diabetes.
  • GLUMETZA is not for people with type 1 diabetes.
  • GLUMETZA is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).
  • It is not known if GLUMETZA is safe and effective in children younger than 18 years old.

How GLUMETZA may help control my blood sugar

  • GLUMETZA may help control your blood sugar in a number of ways, including:
    • Helping your body respond better to the insulin it makes naturally
    • Decreasing the amount of sugar your liver makes
    • Decreasing the amount of sugar your intestines absorb
  • If you have been diagnosed, GLUMETZA may be the appropriate type 2 diabetes drug for you.

What is the advanced technology of GLUMETZA?

GLUMETZA uses advanced technology that delivers the type 2 diabetes medicine slowly and steadily over several hours. This delay in the release of metformin may result in fewer stomach-related side effects, such as nausea, in the first week of taking your type 2 diabetes medication. Please see the illustration below for a step-by-step description.

DIAGRAM: GLUMETZA provides slow, gradual release of metformin*

GLUMETZA should be taken with the evening meal.

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.

Learn more about possible side effects of GLUMETZA.

What are the ingredients in GLUMETZA?

Active ingredient: metformin hydrochloride

Inactive ingredients: 500 mg tablet: coloring, hypromellose, magnesium stearate, microcrystalline cellulose and polyethylene oxide. 1000 mg tablet: colloidal silicon dioxide, polyvinyl alcohol, crospovidone, glyceryl behenate, polyacrylate dispersion, hypromellose, talc, polyethylene glycol, eudragit, titanium dioxide, simethicone emulsion, polysorbate and coloring.

Now, learn more about what to expect from GLUMETZA.

*GLUMETZA 500 mg utilizes patented AcuForm® gastric retention technology. GLUMETZA 1000 mg utilizes patented Smartcoat® gastric retention technology.

Indication

GLUMETZA is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

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.

Adobe® Acrobat® Reader is required to view these documents. Download now.

The content of this website is not a substitute for professional medical advice and should not be interpreted as treatment recommendations or relied on for medical diagnosis or treatment. Please see complete Legal Disclaimer.

This site is intended for the exclusive use of residents of the United States of America.

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

Back to Top

Back to Top