Jump to Site Navigation

Back to Top

BANNER: Instant Savings Program. Click to learn more.

Important Safety Information about GLUMETZA®

What is the most important information I should know about GLUMETZA?

Serious side effects can happen in people taking GLUMETZA, including:

Lactic Acidosis. Metformin hydrochloride, the medicine in GLUMETZA, can cause a rare, but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.

Stop taking GLUMETZA and call your doctor right away if you get any of the following symptoms of lactic acidosis:

  • Feel very weak or tired
  • Have unusual (not normal) muscle pain
  • Have trouble breathing
  • Have unusual sleepiness or sleep longer than usual
  • Have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea
  • Feel cold, especially in your arms and legs
  • Feel dizzy or lightheaded
  • Have a slow or irregular heartbeat

You have a higher chance of getting lactic acidosis with GLUMETZA if you :

  • Have kidney problems. People whose kidneys are not working properly should not take GLUMETZA.
  • Have liver problems
  • Have congestive heart failure that requires treatment with medicines
  • Drink a lot of alcohol (very often or short-term "binge" drinking)
  • Get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.
  • Have certain x-ray tests with injectable dyes or contrast agent
  • Have surgery
  • Have a heart attack, severe infection, or a stroke

Who should not take GLUMETZA?

Do not take GLUMETZA if you:
  • Have kidney problems
  • Are allergic to the metformin hydrochloride in GLUMETZA or any of the ingredients in GLUMETZA.
  • Are going to get an injection of dye or contrast agents for an x-ray procedure, GLUMETZA will need to be stopped for a short time. Talk to your doctor about when you should stop GLUMETZA and when you should start GLUMETZA again. See "What is the most important information I should know about GLUMETZA?"
  • Have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in your blood or urine).

What are the side effects of GLUMETZA?

GLUMETZA can cause serious side effects, including:
  • See "What is the most important information I should know about GLUMETZA?"
  • Low blood sugar (hypoglycemia). If you take GLUMETZA with another medicine that can cause low blood sugar, such as sulfonylureas or insulin, you have a higher risk of having low blood sugar. Tell your doctor if you take other diabetes medicines. If you have symptoms of low blood sugar, you should check your blood sugar and treat if low, then call your doctor.
  • Symptoms of low blood sugar include:
    • Shaking
    • Sweating
    • Rapid heartbeat
    • Change in vision
    • Hunger
    • Headache
    • Change in mood
  • Common side effects of GLUMETZA include:
    • Hypoglycemia
    • Diarrhea
    • Nausea
    • Upset stomach or stomach pain

Taking GLUMETZA with your evening meal can help lessen the common stomach side effects of metformin that usually happens at the beginning of treatment. If you have unexplained stomach problems, tell your doctor. Stomach problems that start later, during treatment may be a sign of something more serious.

Tell your doctor if these symptoms return, as they may be symptoms of lactic acidosis.

Tell your doctor if you have side effects that bother you or that do not go away.

These are not all of the possible side effects of GLUMETZA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Learn more about how to take GLUMETZA.

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