From the Guidelines
The maximum recommended dose of dapagliflozin is 10 mg once daily. This dose is recommended for adults with type 2 diabetes, heart failure, or chronic kidney disease, as stated in the 2020 expert consensus decision pathway on novel therapies for cardiovascular risk reduction in patients with type 2 diabetes 1. The medication works by inhibiting sodium-glucose cotransporter 2 (SGLT2) in the kidneys, reducing glucose reabsorption and increasing glucose excretion in urine, thereby lowering blood glucose levels.
Some key points to consider when prescribing dapagliflozin include:
- Monitoring renal function before and during treatment, as dapagliflozin is not recommended for patients with severely impaired kidney function (eGFR less than 25 mL/min/1.73m²) or end-stage renal disease, as noted in the diabetes management in chronic kidney disease consensus report 1.
- Ensuring patients are adequately hydrated to reduce the risk of volume depletion and hypotension.
- Being aware of potential side effects, including genital mycotic infections, urinary tract infections, and the rare but serious risk of diabetic ketoacidosis, as outlined in the 2020 expert consensus decision pathway 1.
- Considering dose adjustments for patients with decreased renal function, with a maximum dose of 10 mg daily for patients with an eGFR of 25 to <45 mL/min/1.73m², as recommended in the diabetes management in chronic kidney disease consensus report 1.
It's also important to note that the glucose-lowering efficacy of dapagliflozin is reduced as eGFR declines, but kidney and cardiovascular benefits are preserved, as stated in the diabetes management in chronic kidney disease consensus report 1. Overall, dapagliflozin at a dose of 10 mg once daily is a recommended treatment option for eligible patients, with careful consideration of potential side effects and renal function monitoring.
From the FDA Drug Label
2.2 Recommended Dosage for Glycemic Control in Adults and Pediatric Patients Aged 10 Years and Older with Type 2 Diabetes Mellitus In adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus, the recommended starting dosage of DAPAGLIFLOZIN TABLETS is 5 mg orally once daily to improve glycemic control For additional glycemic control, the dosage can be increased to 10 mg orally once daily.
2.3 Recommended Dosage for Other Indications in Adults The recommended dosage of DAPAGLIFLOZIN TABLETS is 10 mg orally once daily in adults for the following indications: • To reduce the risk of sustained eGFR decline, end stage kidney disease (ESKD), cardiovascular (CV) death, and hospitalization for heart failure (hHF) in patients with chronic kidney disease at risk of progression • To reduce the risk of CV death, hHF, and urgent heart failure visit in patients with heart failure. • To reduce the risk of hHF in patients with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors
The maximum recommended dose of dapagliflozin is 10 mg orally once daily 2.
From the Research
Maximum Recommended Dose of Dapagliflozin
The maximum recommended dose of dapagliflozin varies depending on the patient population and the specific indication.
- For patients with type 2 diabetes, the maximum recommended dose is 10 mg once daily 3, 4.
- For patients with type 1 diabetes, the approved dose in the EU is 5 mg/day as an adjunct to insulin in adults with a body mass index (BMI) of ≥ 27 kg/m2 5.
Key Findings
- Dapagliflozin 10 mg once daily is expected to be appropriate in patients of Chinese ethnicity 3.
- Doses of approximately 20-50 mg provided close-to-maximal SGLT2 inhibition for at least 24 h 6.
- The incidence of diabetic ketoacidosis with dapagliflozin in patients with a BMI ≥ 27 kg/m2 was less than half that of the overall population who received dapagliflozin 5.
Pharmacokinetics and Pharmacodynamics
- Dapagliflozin was rapidly absorbed, with a median time to maximum concentration (Tmax) of ≤ 1.5 h 3.
- The elimination half-life of dapagliflozin was 10 to 12 h 3.
- Dapagliflozin reduced the rate of cardiovascular death or hospitalization for heart failure, and possibly reduced progression of renal disease relative to placebo in patients with established atherosclerotic cardiovascular disease or multiple risk factors for cardiovascular disease 4.