文档介绍：HIGHLIGHTS OF PRESCRIBING INFORMATION
• Metabolic acidosis, including diabetic ketoacidosis (4)
These highlights do not include all the information needed to use
GLUMETZA safely and effectively. See full prescribing information for • Hypersensitivity to metformin hydrochloride (4)
GLUMETZA. ______________ _______________
WARNINGS AND PRECAUTIONS
®
GLUMETZA • Lactic acidosis: Warn against excessive alcohol intake. GLUMETZA is not
(metformin hydrochloride extended-release tablets), 500 mg and 1000 mg
recommended in hepatic impairment and is contraindicated in renal
Initial . Approval: 1995 impairment. Ensure normal renal function before initiating and at least
annually thereafter. ()
WARNING: LACTIC ACIDOSIS
See full prescribing information for complete boxed warning • Temporarily discontinue in patients undergoing radiologic studies with
• Lactic acidosis can occur due to metformin accumulation. The risk intravascular administration of iodinated contrast materials or any surgical
increases with conditions such as sepsis, dehydration, excess alcohol procedures necessitating restricted intake of food and fluids. ()
intake, hepatic insufficiency, renal impairmen