Glumetza (metformin hydrochloride) is an oral diabetes medicine for people with type 2 (non-insulin-dependent) diabetes. Glumetza is sometimes used in combination with insulin or other medications, but it is not for treating type 1 diabetes. Glumetza is available in generic form.
An empty Glumetza tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication. Low blood sugar may occur if Glumetza is prescribed with other anti-diabetic medications. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet.
Dosage for Glumetza
Glumetza should be taken once daily. Dosage is individualized based on effectiveness and tolerance. The maximum recommended daily dose is 2000 mg.
What Drugs, Substances, or Supplements Interact with Glumetza?
Hyperglycemia (high blood sugar) may result if you take Glumetza with drugs that raise blood sugar, such as: isoniazid, diuretics (water pills), steroids, phenothiazines, thyroid medicine, birth control pills and other hormones, seizure medicines, and diet pills, or medicines to treat asthma, colds or allergies. Hypoglycemia (low blood sugar) may result if you take Glumetza with drugs that lower blood sugar, such as: alcohol, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, sulfa drugs, monoamine oxidase inhibitors (MAOIs), beta-blockers, or probenecid. It may also interact with furosemide, nifedipine, cimetidine or ranitidine, amiloride or triamterene, digoxin, morphine, procainamide, quinidine, trimethoprim, or vancomycin.
Glumetza During Pregnancy or Breastfeeding
During pregnancy, Glumetza should be used only when prescribed. Your doctor may direct you to use insulin instead of this product during your pregnancy. This medication can cause changes in the menstrual cycle (promote ovulation) and increase the risk of becoming pregnant. Consult your doctor about the use of reliable birth control. This medication passes into breast milk in small amounts. Consult your doctor before breastfeeding.
Additional Information
Our Glumetza (metformin hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Glumetza Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some people using metformin develop lactic acidosis, which can be fatal. Get emergency medical help if you have even mild symptoms such as:
unusual muscle pain;
feeling cold;
trouble breathing;
feeling dizzy, light-headed, tired, or very weak;
stomach pain, vomiting; or
slow or irregular heart rate.
Common side effects may include:
low blood sugar;
nausea, upset stomach; or
diarrhea.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials conducted in the U.S., over 1,000 patients with type 2 diabetes mellitus have been treated with GLUMETZA 1,500 to 2,000 mg/day in active-controlled and placebo-controlled studies with the 500 mg dosage form. In the add-on to sulfonylurea study, patients receiving background glyburide therapy were randomized to receive add-on treatment of either one of three different regimens of GLUMETZA or placebo. In total, 431 patients received GLUMETZA and glyburide and 144 patients received placebo and glyburide. Adverse reactions reported in greater than 5% of patients treated with GLUMETZA that were more common in the combined GLUMETZA and glyburide group than in the placebo and glyburide group are shown in Table 1. In 0.7% of patients treated with GLUMETZA and glyburide, diarrhea was responsible for discontinuation of study medication compared to no patients in the placebo and glyburide group.
Table 1: Adverse Reactions Reported by >5%* of Patients for the Combined GLUMETZA Groups Versus Placebo Group
Adverse Reaction
GLUMETZA + Glyburide (n=431)
Placebo + Glyburide (n=144)
Hypoglycemia
14%
5%
Diarrhea
13%
6%
Nausea
7%
4%
*Adverse reactions that were more common in the GLUMETZA-treated than in the placebo-treated patients.
Laboratory Tests
Vitamin B12 Concentrations
In clinical trials of 29-week duration with metformin HCl tablets, a decrease to subnormal levels of previously normal serum vitamin B12 levels was observed in approximately 7% of patients.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of GLUMETZA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cholestatic, hepatocellular, and mixed hepatocellular liver injury have been reported with postmarketing use of metformin.
&Copy; Glumetza Patient Information is supplied by Cerner Multum, Inc. and Glumetza Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
