Synjardy XR Dosage

Prior to Initiation of SYNJARDY XR

• ​Assess renal function before initiating SYNJARDY XR and as clinically indicated [see Warnings and Precautions (5.1, 5.3)].
• ​In patients with volume depletion, correct this condition before initiating SYNJARDY XR [see Warnings and Precautions (5.3) and Use in Specific Populations (8.5, 8.6)].

Recommended Dosage and Administration

• Individualize the starting dose of SYNJARDY XR based on the patient's current regimen:
  • In patients on metformin HCl, switch to SYNJARDY XR containing a similar total daily dose of metformin HCl and a total daily dose of empagliflozin 10 mg;
  • In patients on empagliflozin, switch to SYNJARDY XR containing the same total daily dose of empagliflozin and a total daily dose of metformin HCl extended-release 1000 mg;
  • In patients already treated with empagliflozin and metformin HCl, switch to SYNJARDY XR containing the same total daily doses of empagliflozin and a similar total daily dose of metformin HCl.
• Monitor effectiveness and tolerability, and adjust dosing as appropriate, not to exceed the maximum recommended daily dose of empagliflozin 25 mg and metformin HCl 2000 mg.
• The dose of metformin HCl should be gradually escalated to reduce the gastrointestinal side effects due to metformin.
• Take SYNJARDY XR orally once daily with a meal in the morning
• Swallow SYNJARDY XR tablets whole. Do not split, crush, dissolve, or chew.
• 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.

Dosage Recommendations in Patients with Renal Impairment

• ​Initiation of SYNJARDY XR is not recommended in patients with an eGFR less than 45 mL/min/1.73 m2, due to the metformin component.
• ​SYNJARDY XR is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m2 or in patients on dialysis [see Contraindications (4), Warnings and Precautions (5.1) and Use in Specific Populations (8.6)].

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 less than 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 XR if renal function is stable [see Warnings and Precautions (5.1)].