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Learn More about Metformin

What is metformin?

  • Metformin is a medication proven to help control your blood sugar.
  • It is usually prescribed as a tablet, and is taken 1 to 3 times a day with food. There is also a liquid metformin available for people who have trouble swallowing tablets.
  • Metformin is a first choice in drug treatment for type 2 diabetes, in combination with diet and exercise.
    • The experts at the American Diabetes Association recommend metformin for patients newly diagnosed with type 2 diabetes. Your doctor may ask you to start taking metformin as soon as you are diagnosed with type 2 diabetes, unless you have a health issue (such as kidney problems) that causes your doctor to think a different treatment might be right for you.
    • While metformin is the first choice in treatment of type 2 diabetes, there are a range of other drugs available that work in different ways to lower blood sugar. Over time, your doctor may ask you to continue metformin and add one or more drugs to your treatment, or take a drug that combines metformin with another active ingredient. Each patient is different.
  • Over 25 million U.S. adults have diabetes—that's more than 1 in every 10 Americans. So chances are, someone you know takes a metformin!

What are my choices in metformin treatment?

  • There are 2 available formulations of metformin in a tablet: immediate-release and extended-release.

What is the difference between immediate-release and extended-release metformin?

  • Immediate-release metformin, such as Glucophage®, is a tablet taken 1 to 3 times a day. With this formulation, the entire drug dose is released in your body within 30 minutes.
  • Extended-release metformin is a once-daily tablet that has been designed to slowly release the medication to your body over most of the day (about 8 hours).
    • Among extended-release metformins, there are different drug delivery technologies available. Extended-release metformins include GLUMETZA and Glucophage® XR.

What are the benefits of extended-release metformin?

  • Some patients taking metformin experience stomach-related side effects.
  • The slow, controlled delivery of metformin with an extended-release tablet may result in fewer stomach-related side effects, such as nausea, in the first week of taking your type 2 diabetes medication.
  • Being able to tolerate and stay on metformin may help you meet your diabetes goals.

What if I am currently taking metformin, and it upsets my stomach?

  • It is important to treat your type 2 diabetes. Don't give up! There are several different metformins available, and one might be right for you. Talk to your doctor for more information.
  • Read more about metformin side effects and GLUMETZA, an extended-release metformin that may help reduce your stomach upset.

Find out more about what GLUMETZA is and how it works.

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.

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

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