May 24, 2017
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"The US Food and Drug Administration (FDA) has approved empagliflozin (Jardiance, Boehringer Ingelheim Pharmaceuticals Inc) for the new indication of improving survival in adults with type 2 diabetes and cardiovascular disease (CVD).




Physician Instructions

Patients should be informed of the potential risks and advantages of PrandiMet and of alternative modes of therapy. They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of blood glucose, HbA1c, renal function, and hematologic parameters. The risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development and concomitant administration of other glucose-lowering drugs should be explained to patients and family members. Medication requirements may change during periods of stress such as fever, trauma, infection, or surgery, due to loss of glycemic control. Patients should be advised to seek medical advice promptly.

The risks of lactic acidosis, its symptoms, and conditions that predispose to its development, as noted in the WARNINGS AND PRECAUTIONS, should be explained to patients. Patients should be advised to discontinue PrandiMet immediately and to promptly notify their health practitioner if unexplained hyperventilation, myalgia, malaise, unusual somnolence, or other nonspecific symptoms occur. Once a patient is stabilized on any dose level of PrandiMet, gastrointestinal symptoms, which are common during initiation of metformin HCl therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease.

Patients should be instructed to take PrandiMet with meals. Doses are usually taken within 15 minutes prior to the meal but the timing can vary from immediately preceding the meal up to 30 minutes before the meal. Patients who skip a meal should be instructed to skip the PrandiMet dose for that meal.

Patients should be counseled against excessive alcohol intake, either acute or chronic, while receiving PrandiMet.

Laboratory Tests

Initial and periodic monitoring of hematologic parameters (e.g., hemoglobin/hematocrit and red blood cell indices) and renal function (serum creatinine) should be performed, at least on an annual basis. Vitamin B12 deficiency should be excluded if megaloblastic anemia is detected.

Last reviewed on RxList: 11/29/2016
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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