Indication for GLUMETZA
GLUMETZA® (metformin hydrochloride extended-release tablets) is a prescription 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).
Important Safety Information about GLUMETZA
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.
Do not take GLUMETZA® (metformin hydrochloride extended-release tablets) 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.
- have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in your blood or urine).
Tell your healthcare provider if you drink alcohol very often, or drink a lot of alcohol in short-term.
Tell your healthcare provider if you are scheduled to have any tests that use radiocontrast or an injected dye or if you are having any surgical procedure that requires you to restrict your intake of food or liquids.
Your doctor should do blood tests to check how well your kidneys and liver are working before and during your treatment with GLUMETZA.
Tell your healthcare provider if you have problems with your liver. GLUMETZA may decrease your levels of Vitamin B12. Your doctor should monitor your blood levels on a yearly basis.
Tell your healthcare provider if you are taking insulin, or any of the following drugs as GLUMETZA may not be the right choice for you: amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin.
Safety and effectiveness in children younger than 18 years of age have not been established.
There have been no clinical studies that have been able to conclude a beneficial effect of GLUMETZA or any other oral anti-diabetic drug on reducing cardiovascular outcomes.
The most common adverse reactions (>5% of GLUMETZA-treated patients and at a rate greater than placebo) were low blood sugar (hypoglycemia). Symptoms of low blood sugar include: shaking, sweating, rapid heartbeat, change in vision, hunger, headache and change in mood. Other common adverse reactions include diarrhea, nausea, and upset stomach or stomach pain.
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.
For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
Please see complete Prescribing Information for GLUMETZA.
GLUMETZA® is a registered trademark of Valeant Pharmaceuticals International, Inc.
Smartcoat® is a registered trademark of Biovail Laboratories International S.r.l.
Acuform® is a registered trademark of Depomed, Inc.
Santarus, Inc, is a wholly owned subsidiary of Salix Pharmaceuticals, Inc.
The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.
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