Maximum Dose of Losartan
The maximum recommended dose of losartan is 100 mg once daily for both hypertension and diabetic nephropathy, as established by FDA labeling and supported by clinical trial evidence. 1
FDA-Approved Maximum Dosing
The FDA-approved maximum dose is 100 mg once daily for adult patients with hypertension, with a usual starting dose of 50 mg once daily that can be increased as needed to control blood pressure 1
For diabetic nephropathy specifically, the FDA recommends starting at 50 mg once daily and increasing to 100 mg once daily based on blood pressure response 1
Pediatric patients should not receive doses above 1.4 mg/kg or in excess of 100 mg daily, as higher doses have not been studied in this population 1
Evidence Supporting 100 mg as Optimal Dose
Clinical trial data demonstrates that 100 mg daily is the optimal dose for renoprotection in diabetic nephropathy, showing significantly greater reduction in albuminuria (48% reduction) compared to 50 mg daily (30% reduction), with no additional benefit observed at 150 mg daily 2
The 100 mg dose was more effective than 50 mg in reducing both systolic/diastolic blood pressure and mean arterial pressure, without differences between 100 mg and 150 mg doses 2
Major clinical trials (RENAAL and LIFE) that demonstrated cardiovascular and renal benefits in diabetic patients used a maximum losartan dose of 100 mg daily 3
Special Dosing Considerations
Patients with possible intravascular depletion (e.g., those on diuretic therapy) should start at 25 mg once daily 1
Patients with mild-to-moderate hepatic impairment require a reduced starting dose of 25 mg once daily, though the maximum dose can still be titrated upward as tolerated 1
Losartan has not been studied in patients with severe hepatic impairment 1
Important Clinical Context
While some pharmacokinetic reviews suggest that 50 mg may be suboptimal and advocate for routine use of 100 mg daily or consideration of higher doses, the FDA has not approved doses exceeding 100 mg daily 4
The renoprotective effects at 100 mg include a 28% reduction in end-stage renal disease and 16% reduction in the composite endpoint of doubling serum creatinine, ESRD, or death 3