Generic name: EMPAGLIFLOZIN 5mg, METFORMIN HYDROCHLORIDE 500mg
Dosage form: tablet
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2.1 Recommended Dosage
- Individualize the starting dose of SYNJARDY based on the patient’s current regimen:
- In patients on metformin, switch to SYNJARDY containing empagliflozin 5 mg with a similar total daily dose of metformin;
- In patients on empagliflozin, switch to SYNJARDY containing metformin 500 mg with a similar total daily dose of empagliflozin;
- In patients already treated with empagliflozin and metformin, switch to SYNJARDY containing the same total daily doses of each component.
- Take SYNJARDY twice daily with meals; with gradual dose escalation to reduce the gastrointestinal side effects due to metformin [see Dosage Forms and Strengths (3)].
- In patients with volume depletion not previously treated with empagliflozin, correct this condition before initiating SYNJARDY [see Warnings and Precautions (5.2) and Patient Counseling Information (17)].
- Adjust dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of metformin 2000 mg and empagliflozin 25 mg [see Dosage and Administration (2.2)].
2.2 Recommended Dosage in Patients with Renal Impairment
2.3 Discontinuation for Iodinated Contrast Imaging Procedures
Discontinue SYNJARDY 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-evaluate eGFR 48 hours after the imaging procedure; restart SYNJARDY if renal function is stable [see Warnings and Precautions (5.1)].