History of serious hypersensitivity (eg, anaphylaxis, angioedema, exfoliative skin conditions, urticaria, bronchial hyperreactivity<2021/8/13>) to empagliflozin, linagliptin, or any component of the formulation; severe renal impairment (eGFR <30 mL/minute/1.73 m2), ESRD, or dialysis
懷孕分類
According to the manufacturer, use is not recommended during the second and third trimesters. Refer to individual monographs.
哺乳分類
It is not known if empagliflozin or linagliptin are excreted in breast milk. Breastfeeding is not recommended by the manufacturer. Refer to individual monographs.
副作用
Genitourinary: Urinary tract infection (11% to 13%)
Endocrine & metabolic: Hypoglycemia (2% to 4%)
Respiratory: Upper respiratory tract infection (7%), nasopharyngitis (6% to 7%)
Postmarketing: Acute pancreatitis, ketoacidosis(使用前需考量病人易發生酮酸中毒之因素)<20210209>, hypotension due to intravascular volume depletion, increased amylase<2021/8/13>
劑量和給藥方法
Oral: Initial: Empagliflozin 10 mg/linagliptin 5 mg once daily; may increase to empagliflozin 25 mg/linagliptin 5 mg once daily
小兒調整劑量
Safety and efficacy have not been established in pediatric patients
腎功能調整劑量
eGFR >30 mL/minute/1.73 m2: No dosage adjustment necessary. eGFR <30 mL/minute/1.73 m2: Use is not recommended. Discontinue therapy when eGFR is persistently <30 mL/minute/1.73 m2.<20210209>
End-stage renal disease (ESRD) or dialysis: Use is contraindicated.
肝功能調整劑量
No dosage adjustment necessary.
安定性
Store at controlled room temperature, 25 degrees C (77 degrees F); excursions permitted between 15 and 30 degrees C (59 and 86 degrees F)Close lid tightly