QTERNMET XR(dapagliflozin, saxagliptin, and metforminhydrochloride)extended-release tablets(三十六)
exfoliative skin conditions, and stop taking QTERNMET XR and seek medicaladvice promptly.
Genital Mycotic Infections in Females (e.g., Vulvovaginitis)
•Inform female patients that vaginal yeast infections may occur and provide them with information onthe signs and symptoms of vaginal yeast infections. Advise them of treatment options and when toseek medical advice [see WARNINGS AND PRECAUTIONS (5.12)].
Genital Mycotic Infections in Males (e.g., Balanitis)
•Inform male patients that yeast infections of the penis (e.g., balanitis or balanoposthitis) may occur,especially in patients with prior history. Provide them with information on the signs and symptoms ofbalanitis and balanoposthitis (rash or redness of the glans or foreskin of the penis). Advise them oftreatment options and when to seek medical advice [see WARNINGS AND PRECAUTIONS (5.12)].
Bladder Cancer
•Inform patients to promptly report any signs of macroscopic hematuria or other symptoms potentiallyrelated to bladder cancer [see WARNINGS AND PRECAUTIONS (5.14)].
Severe and Disabling Arthralgia
•Inform patients that severe and disabling joint pain may occur with this class of drugs. The time toonset of symptoms can range from one day to years. Instruct patients to seek medical advice if severejoint pain occurs [see WARNINGS AND PRECAUTIONS (5.15)].
•Inform patients that bullous pemphigoid may occur with QTERNMET XR. Instruct patients to seekmedical advice if blisters or erosions occur [see WARNINGS AND PRECAUTIONS (5.16)].
Pregnancy
•Advise pregnant patients of the potential risk to a fetus with treatment with QTERNMET XR. Instructpatients to immediately inform their healthcare provider if pregnant or planning to become pregnant[see USE IN SPECIFIC POPULATIONS (8.1)].
Lactating Mothers
•Advise patients that use of QTERNMET XR is not recommended while breastfeeding [see USE IN
SPECIFIC POPULATIONS (8.2)].
Females and Males of Reproductive Potential
•Inform female patients that treatment with metformin may result in an unintended pregnancy in somepremenopausal anovulatory females due to its effect on ovulation [see USE IN SPECIFICPOPULATIONS (8.3)].
Laboratory Tests
•Inform patients that due to its mechanism of action, patients taking QTERNMET XR will testpositive for glucose in their urine.
Taking Dose
•Instruct patients that QTERNMET XR must be swallowed whole and not crushed or chewed, and thatthe inactive ingredients may occasionally be eliminated in the feces as a soft mass that may resemblethe original tablet.
Distributed by:
AstraZeneca Pharmaceuticals LP
Wilmington, DE 19850
QTERNMET XR is a trademark of the AstraZeneca group of companies.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210874s000lbl.pdf
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