What is the dose of Synjardy (empagliflozin and metformin)?

From the Guidelines

The dose of Synjardy, which is a combination of empagliflozin and metformin, is 10 mg of empagliflozin per day, as this is the recommended dose for improving glycemic control in adults with type 2 diabetes as an adjunct to diet and exercise, and for reducing the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease 1.

Key Points

• The recommended dose of empagliflozin is 10 mg per day, and no further dose titration is needed for cardiovascular or renal risk reduction, although dose increases may provide further glucose reduction benefits if indicated 1.
• Metformin dosing is not specified in the provided evidence, but it is typically started at a low dose and gradually increased to minimize gastrointestinal side effects.
• The dose of empagliflozin should be adjusted based on the patient's estimated glomerular filtration rate (eGFR), with a maximum dose of 10 mg per day in patients with an eGFR of 45 mL/min/1.73 m2 or higher, and use is not recommended for glycemic control in patients with an eGFR below 45 mL/min/1.73 m2 1.
• It is essential to monitor patients for potential adverse effects, such as genital fungal infections, urinary tract infections, and euglycemic diabetic ketoacidosis, when using empagliflozin 1.

From the FDA Drug Label

DOSAGE AND ADMINISTRATION Assess renal function before initiating and as clinically indicated. Correct volume depletion before initiating (2.1) Recommended dosage is 10 mg once daily in the morning, taken with or without food (2. 2) For additional glycemic control, dosage may be increased to 25 mg in patients tolerating JARDIANCE (2. 2)

The dose of empagliflozin is 10 mg once daily, which may be increased to 25 mg for additional glycemic control. However, the question asks for the dose of Synjardy (empagliflozin and metformin), which is not directly addressed in the provided drug label for JARDIANCE (empagliflozin). The FDA drug label does not answer the question.

From the Research

Dosing Information for Synjardy (Empagliflozin and Metformin)

• The dose of Synjardy (empagliflozin and metformin) can vary based on the specific formulation and the patient's response to treatment 2.
• In one study, patients were randomized to receive empagliflozin 12.5 mg twice daily + metformin 1,000 mg twice daily, empagliflozin 12.5 mg twice daily + metformin 500 mg twice daily, empagliflozin 5 mg twice daily + metformin 1,000 mg twice daily, or empagliflozin 5 mg twice daily + metformin 500 mg twice daily 2.
• Another study found that the combination of empagliflozin and metformin was effective in improving glycemic control, with a dose of empagliflozin 25 mg daily and metformin 2,000 mg daily 3.
• A network meta-analysis found that empagliflozin 25 mg daily was the most effective dose for lowering HbA1c and FPG, while also considering safety 4.
• The available doses of empagliflozin are 5 mg, 10 mg, 12.5 mg, 25 mg, and 50 mg, and the available doses of metformin are 500 mg and 1,000 mg 2, 4.

Special Considerations

• The dose of Synjardy may need to be adjusted in patients with renal impairment or other special populations 5.
• The combination of empagliflozin and metformin may be suitable for patients with type 2 diabetes who are inadequately controlled by metformin, particularly those who would benefit from modest reductions in blood pressure and body weight or who have risk factors for cardiovascular disease or declining renal function 6.