Can Udapa (dapagliflozin) be taken twice daily?

Dapagliflozin (Udapa) Dosing: Once Daily Only

Dapagliflozin must be taken once daily, not twice daily—the FDA-approved dosing is 5 mg or 10 mg orally once daily, and this regimen is supported by all major cardiovascular and renal outcome trials. 1

FDA-Approved Dosing Regimen

• The FDA label specifies that dapagliflozin is administered once daily for all approved indications, including type 2 diabetes, heart failure, and chronic kidney disease 1
• For glycemic control in adults and pediatric patients ≥10 years: start with 5 mg once daily, with the option to increase to 10 mg once daily if additional glucose lowering is needed 1
• For cardiovascular and renal protection (heart failure, chronic kidney disease): the fixed dose is 10 mg once daily with no titration required 1

Pharmacokinetic Evidence Supporting Once-Daily Dosing

• Dapagliflozin has a half-life of approximately 17 hours, which supports sustained 24-hour SGLT2 inhibition with once-daily administration 2
• Although a pharmacokinetic study demonstrated that 5 mg twice daily produces similar total drug exposure (AUC) and urinary glucose excretion compared to 10 mg once daily, the twice-daily regimen is not FDA-approved and offers no clinical advantage 3
• The maximum effect on renal glucose reabsorption inhibition is achieved with doses of 20–50 mg administered once daily, providing close-to-maximal SGLT2 blockade for at least 24 hours 2

Clinical Trial Evidence

• All pivotal cardiovascular and renal outcome trials—including DAPA-HF, DAPA-CKD, and DELIVER—used dapagliflozin 10 mg once daily, establishing this as the evidence-based dose for mortality and morbidity reduction 4
• A 16-week randomized trial comparing dapagliflozin 2.5 mg twice daily, 5 mg twice daily, and 10 mg once daily found that twice-daily dosing produced numerically similar HbA1c reductions but offered no superiority over once-daily administration 5
• The twice-daily regimen was explored solely to assess feasibility of a fixed-dose combination product with metformin, not because it provides better efficacy or safety 5

Why Twice-Daily Dosing Is Not Recommended

• No regulatory approval exists for twice-daily dapagliflozin dosing in any country 1
• The once-daily regimen simplifies adherence, reduces pill burden, and aligns with all guideline recommendations from the American Diabetes Association, American College of Cardiology, and Kidney Disease: Improving Global Outcomes 4, 6
• Twice-daily dosing creates unnecessary fluctuations in minimum and maximum plasma concentrations without improving urinary glucose excretion or clinical outcomes 3

Correct Administration

• Take dapagliflozin once daily in the morning or evening (timing does not affect efficacy) 3, 7
• The tablet may be taken with or without food 1
• If a dose is missed, take it as soon as remembered on the same day; do not double the dose the next day 1

In summary, dapagliflozin should never be prescribed twice daily—the approved and evidence-based regimen is once-daily administration at either 5 mg or 10 mg depending on the indication. 1, 4