Synjardy Dosage

Recommended Dosage

• In patients with volume depletion not previously treated with empagliflozin, correct this condition before initiating SYNJARDY [see Warnings and Precautions (5.2)].
• Individualize the starting dose of SYNJARDY based on the patient’s current regimen:

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  In patients on metformin hydrochloride, switch to SYNJARDY containing empagliflozin 5 mg with a similar total daily dose of metformin hydrochloride;

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  In patients on empagliflozin, switch to SYNJARDY containing metformin hydrochloride 500 mg with a similar total daily dose of empagliflozin;

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  In patients already treated with empagliflozin and metformin hydrochloride, 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)].
• 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)].

Recommended Dosage in Patients with Renal Impairment

• Assess renal function prior to initiation of SYNJARDY and periodically, thereafter.
• SYNJARDY 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)].

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)].