Drug Detail:Synjardy (Empagliflozin and metformin [ em-pa-gli-floe-zin-and-met-for-min ])
Generic Name: EMPAGLIFLOZIN 5mg, METFORMIN HYDROCHLORIDE 500mg
Dosage Form: tablet
Drug Class: Antidiabetic combinations
Recommendations Prior to Initiation of SYNJARDY
- Assess renal function before initiating SYNJARDY and as clinically indicated [see Warnings and Precautions (5.1, 5.3)].
- In patients with volume depletion, correct this condition before initiating SYNJARDY [see Warnings and Precautions (5.3) and Use in Specific Populations (8.5, 8.6)].
Recommended Dosage and Administration
- When switching to SYNJARDY from:
- Metformin HCl: initiate SYNJARDY at a similar total daily dosage of metformin HCl and a total daily empagliflozin dosage of 10 mg.
- Empagliflozin: initiate SYNJARDY 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 at the same total daily dosages of each component.
- Recommended dosage of SYNJARDY:
- 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.
Dosage Recommendations in Patients with Renal Impairment
- Initiation of SYNJARDY is not recommended in patients with an eGFR less than 45 mL/min/1.73 m2, due to the metformin component.
- SYNJARDY 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 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 if renal function is stable [see Warnings and Precautions (5.1)].