SYNJARDYXR(empagliflozin and metformin hydrochloride extended-release) tablets(十七)
ric Use
Safety and effectiveness of SYNJARDY XR in pediatric patients under 18 years of age have not been established.
8.5 Geriatric Use
Because renal function abnormalities can occur after initiating empagliflozin, metformin is substantially excreted by the kidney, and aging can be associated with reduced renal function, renal function should be assessed more frequently in elderly patients [see DOSAGE AND ADMINISTRATION (2.2) and WARNINGS AND PRECAUTIONS (5.1, 5.4)].
Empagliflozin
No empagliflozin dosage change is recommended based on age [see DOSAGE AND ADMINISTRATION (2)]. In studies assessing the efficacy of empagliflozin in improving glycemic control in patients with type 2 diabetes, a total of 2721 (32%) patients treated with empagliflozin were 65 years of age and older, and 491 (6%) were 75 years of age and older. Empagliflozin is expected to have diminished glycemic efficacy in elderly patients with renal impairment [see USE IN SPECIFIC POPULATIONS (8.6)]. The risk of volume depletion-related adverse reactions increased in patients who were 75 years of age and older to 2.1%, 2.3%, and 4.4% for placebo, empagliflozin 10 mg, and empagliflozin 25 mg. The risk of urinary tract infections increased in patients who were 75 years of age and older to 10.5%, 15.7%, and 15.1% in patients randomized to placebo, empagliflozin 10 mg, and empagliflozin 25 mg, respectively [see WARNINGS AND PRECAUTIONS (5.2) and ADVERSE REACTIONS (6.1)].
Metformin hydrochloride
Controlled clinical studies of metformin hydrochloride did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients, although other reported clinical experience has not identified differences in responses between the elderly and young patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of lactic acidosis. Assess renal function more frequently in elderly patients [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.1), and CLINICAL PHARMACOLOGY (12.3)].
8.6 Renal Impairment
SYNJARDY XR is contraindicated in patients with moderate to severe renal impairment (eGFR less than 45 mL/min/1.73 m2).
Empagliflozin
The efficacy and safety of empagliflozin have not been established in patients with severe renal impairment, with ESRD, or receiving dialysis. Empagliflozin is not expected to be effective in these patient populations [see DOSAGE AND ADMINISTRATION (2.2), CONTRAINDICATIONS (4) and WARNINGS AND PRECAUTIONS (5.2, 5.4)].
The glucose lowering benefit of empagliflozin 25 mg decreased in patients with worsening renal function. The risks of renal impairment [see WARNINGS AND PRECAUTIONS (5.4)], volume depletion adverse reactions and urinary tract infection-related adverse reactions increased with worsening renal function.
Empagliflozin may be used in patients with an eGFR greater than or equal to 45 mL/min/1.73 m2[see CLINICAL PHARMACOLOGY (12.3)]. Empagliflozin is not recommended in patients with an eGFR less than 45 mL/min/1.73 m2.
Metformin hydrochloride
Metformin is substantially excreted by the kidney, and the risk of metformin accumulation and lactic acidosis increases with the degree of renal impairment. SYNJ |
