SYNJARDYXR(empagliflozin and metformin hydrochloride extended-release) tablets(三十三)
les (e.g., Balanitis or Balanoposthitis)
Inform male patients that yeast infection of penis (e.g., balanitis or balanoposthitis) may occur, especially in uncircumcised males and patients with chronic and recurrent infections. Provide them with information on the signs and symptoms of balanitis and balanoposthitis (rash or redness of the glans or foreskin of the penis). Advise them of treatment options and when to seek medical advice [see WARNINGS AND PRECAUTIONS (5.7)].
Monitoring of Renal Function
Inform patients about the importance of regular testing of renal function when receiving treatment with SYNJARDY XR.
Instruct patients to inform their doctor that they are taking SYNJARDY XR prior to any surgical or radiological procedure, as temporary discontinuation of SYNJARDY XR may be required until renal function has been confirmed to be normal [see WARNINGS AND PRECAUTIONS (5.1)].
Hypoglycemia
Inform patients that the risk of hypoglycemia is increased when SYNJARDY XR is used in combination with an insulin secretagogue (e.g., sulfonylurea), and that a lower dose of the insulin secretagogue may be required to reduce the risk of hypoglycemia [see WARNINGS AND PRECAUTIONS (5.6)].
Laboratory Tests
Inform patients that elevated glucose in urinalysis is expected when taking SYNJARDY XR.
Pregnancy
Advise pregnant women, and females of reproductive potential of the potential risk to a fetus with treatment with SYNJARDY XR [see USE IN SPECIFIC POPULATIONS (8.1)]. Instruct females of reproductive potential to report pregnancies to their physicians as soon as possible.
Lactation
Advise women that breastfeeding is not recommended during treatment with SYNJARDY XR [see USE IN SPECIFIC POPULATIONS (8.2)].
Females and Males of Reproductive Potential
Inform females that treatment with metformin may result in ovulation in some premenopausal anovulatory women which may lead to unintended pregnancy [see USE IN SPECIFIC POPULATIONS (8.3)].
Missed Dose
Instruct patients to take SYNJARDY XR only as prescribed. If a dose is missed, it should be taken as soon as the patient remembers. Advise patients not to double their next dose.
Administration Instructions
Inform patients that the tablets must be swallowed whole and never split, crushed, dissolved, or chewed and that incompletely dissolved SYNJARDY XR tablets may be eliminated in the feces. Patients should be told that, if they see tablets in feces, they should report this finding to their healthcare provider. The healthcare provider should assess adequacy of glycemic control if a patient reports observing tablets in feces [see DOSAGE AND ADMINISTRATION (2.1)].
Blood Glucose and A1C Monitoring
Inform patients that response to all diabetic therapies should be monitored by periodic measurements of blood glucose and HbA1c levels, with a goal of decreasing these levels toward the normal range. Hemoglobin A1c monitoring is especially useful for eva luating long-term glycemic control.
Inform patients that the most common adverse reactions associated with the use of SYNJARDY XR are hypoglycemia, urinary tract infection, and nasopharyngitis.
Distributed by:
Boehringer Ingelheim Pharmaceuticals, Inc.
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