SYNJARDYXR(empagliflozin and metformin hydrochloride extended-release) tablets(四)
based on the patient’s current regimen:
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In patients on metformin hydrochloride, switch to SYNJARDY XR containing a similar total daily dose of metformin hydrochloride and a total daily dose of empagliflozin 10 mg;
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In patients on empagliflozin, switch to SYNJARDY XR containing the same total daily dose of empagliflozin and a total daily dose of metformin hydrochloride extended-release 1000 mg;
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In patients already treated with empagliflozin and metformin hydrochloride, switch to SYNJARDY XR containing the same total daily doses of empagliflozin and a similar total daily dose of metformin hydrochloride.
Adjust dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of metformin hydrochloride 2000 mg and empagliflozin 25 mg [see DOSAGE AND ADMINISTRATION (2.2)].
The dose of metformin hydrochloride should be gradually escalated to reduce the gastrointestinal side effects due to metformin hydrochloride [see DOSAGE FORMS AND STRENGTHS (3)].
Take SYNJARDY XR orally once daily with a meal in the morning
Swallow SYNJARDY XR tablets whole. Do not split, crush, dissolve, or chew before swallowing. There have been reports of incompletely dissolved tablets being eliminated in the feces for other tablets containing metformin hydrochloride extended-release. If a patient reports seeing tablets in feces, the healthcare provider should assess adequacy of glycemic control.
SYNJARDY XR 10 mg/1000 mg and 25 mg/1000 mg tablets should be taken as a single tablet once daily. SYNJARDY XR 5 mg/1000 mg and 12.5 mg/1000 mg tablets should be taken as two tablets together once daily.
2.2 Recommended Dosage in Patients with Renal Impairment
Assess renal function prior to initiation of SYNJARDY XR and periodically, thereafter.
SYNJARDY XR is contraindicated in patients with an eGFR less than 45 mL/min/1.73 m2 [see CONTRAINDICATIONS (4) and WARNINGS AND PRECAUTIONS (5.1, 5.4)].
2.3 Discontinuation for Iodinated Contrast Imaging Procedures
Discontinue SYNJARDY XR at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 45 and 60 mL/min/1.73 m2; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-eva luate eGFR 48 hours after the imaging procedure; restart SYNJARDY XR if renal function is stable [see WARNINGS AND PRECAUTIONS (5.1)].
3 DOSAGE FORMS AND STRENGTHS
SYNJARDY XR (empagliflozin and metformin hydrochloride extended-release) oval-shaped, film-coated tablets are available in the following strengths:
5 mg empagliflozin/1000 mg metformin hydrochloride olive green tablets printed on one side in black ink with the Boehringer Ingelheim company logo and “S5” on the top line and “1000 M” on the bottom line.
10 mg empagliflozin/1000 mg metformin hydrochloride orange tablets printed on one side in black ink with the Boehringer Ingelheim company logo and “S10” on the top line and “1000 M” on the bottom line.
12.5 mg empagliflozin/1000 mg metformin hydrochloride blue tablets printed on one side in black ink with the Boehringer Ingelheim company logo and “S12” on the top line and “1000 M” on the bottom line.
25 mg empagliflozin/1000 mg metformin hydrochloride light green tablets printed on one side in black ink with the |
