Synjardy Dosage

Testing Prior to Initiation of SYNJARDY or SYNJARDY XR

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

Recommended Dosage and Administration of SYNJARDY or SYNJARDY XR in Adults

• When switching to SYNJARDY or SYNJARDY XR from:
  • Metformin HCl: initiate SYNJARDY or SYNJARDY XR at a similar total daily dosage of metformin HCl and a total daily empagliflozin dosage of 10 mg.
  • Empagliflozin: initiate SYNJARDY or SYNJARDY XR at the same total daily dosage of empagliflozin and a total daily metformin HCl dosage of 1,000 mg.
  • Empagliflozin and metformin HCl: initiate SYNJARDY or SYNJARDY XR at the same total daily dosages of each component.
• Recommended dosage of SYNJARDY or SYNJARDY XR:
  • The recommended total daily dosage of empagliflozin is 10 mg.
  • ​For additional glycemic control, empagliflozin may be increased to a maximum total daily dosage of 25 mg in patients tolerating 10 mg daily and metformin may be increased to a maximum total daily dosage of 2,000 mg, with gradual escalation to reduce gastrointestinal adverse reactions with metformin [see Adverse Reactions (6.1)].
• Take SYNJARDY orally twice daily with meals.
• Take SYNJARDY XR orally once daily with a meal in the morning. Swallow each tablet whole. Do not split, crush, dissolve, or chew.

Recommended Dosage and Administration of SYNJARDY in Pediatric Patients Aged 10 Years and Older

• ​Individualize the dosage of SYNJARDY based on the patient's current regimen.
• ​Monitor effectiveness and tolerability, and adjust dosage as appropriate, not to exceed the maximum total daily dosage of empagliflozin 25 mg and metformin HCl 2,000 mg.
• ​Take SYNJARDY orally twice daily with meals; with gradual dose escalation to reduce gastrointestinal adverse reactions with metformin [see Adverse Reactions (6.1)].

Dosage Recommendations in Patients with Renal Impairment

• Initiation of SYNJARDY or SYNJARDY XR is not recommended in patients with an eGFR less than 45 mL/min/1.73 m2, due to the metformin component.
• SYNJARDY and SYNJARDY XR are 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 or 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 or SYNJARDY XR if renal function is stable [see Warnings and Precautions (5.1)].

Temporary Interruption for Surgery

​Withhold SYNJARDY or SYNJARDY XR for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. Resume SYNJARDY or SYNJARDY XR when the patient is clinically stable and has resumed oral intake [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.2)].

Recommendations Regarding Missed Dose

• ​If a dose is missed, instruct patients to take the dose as soon as possible.
• ​Do not double up the next dose.