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Taking GLUMETZA®

What should I tell my doctor before taking GLUMETZA?

Before you take GLUMETZA, tell your doctor if you:

  • Have type 1 diabetes. GLUMETZA should not be used to treat people with type 1 diabetes.
  • Have a history or risk for diabetic ketoacidosis (high levels of certain acids, known as ketones, in the blood or urine). GLUMETZA should not be used for the treatment of diabetic ketoacidosis.
  • Have kidney problems.
  • Have liver problems.
  • Have heart problems, including congestive heart failure.
  • Drink alcohol very often, or drink a lot of alcohol in short-term (binge) drinking.
  • Are taking insulin.
  • Have any other medical conditions.
  • Are pregnant or planning to become pregnant. It is not known if GLUMETZA can harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.
  • Are breastfeeding or plan to breastfeed. It is not known if GLUMETZA passes into your breast milk. Talk with your doctor about the best way to feed your baby while you take GLUMETZA.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist. Talk to your doctor before you start any new medicine.

GLUMETZA may affect the way other medicines work, and other medicines may affect how GLUMETZA works.

How should I take GLUMETZA?

  • Take GLUMETZA exactly as your doctor tells you.
  • GLUMETZA should be taken one time per day with your evening meal.
  • Swallow GLUMETZA tablets whole. Do not crush, cut, dissolve, or chew GLUMETZA.
  • Tell your doctor if you cannot swallow tablets whole. Your doctor may prescribe a different medicine for you.
  • You may sometimes pass a soft mass in your stools (bowel movement) that looks like GLUMETZA tablets. It is normal to see this in your stool.
  • When your body is under some type of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of type 2 diabetes medicine that you need may change. Tell your doctor right away if you have any of these problems.
  • Your doctor should do blood tests to check how well your kidneys and liver are working before and during your treatment with GLUMETZA.
  • Your healthcare provider will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.
  • Follow your doctor's instructions for treating blood sugar that is too low (hypoglycemia). Talk to your doctor if low blood sugar is a problem for you. See "What are the possible side effects of GLUMETZA?"
  • Check your blood sugar regularly and as your doctor tells you to.
  • Stay on your prescribed diet and exercise program and test your blood sugar regularly while taking GLUMETZA.
  • If you miss a dose of GLUMETZA, resume dosing according to schedule.
  • If you take too much GLUMETZA, call your doctor, or go to the nearest hospital emergency room right away.

Next, learn more about the Instant Savings Program that provides two ways to save on each GLUMETZA prescription.

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.

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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.

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