Maximum Dose of Valsartan
The maximum dose of valsartan is 320 mg once daily for hypertension and 320 mg daily (160 mg twice daily) for heart failure and post-myocardial infarction. 1
Hypertension Dosing
For adult hypertension, valsartan may be used over a dose range of 80 mg to 320 mg daily, administered once a day, with 320 mg representing the maximum approved dose. 1
The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. 1
If additional antihypertensive effect is required beyond the starting dose range, the dose may be increased to a maximum of 320 mg, though adding a diuretic has a greater effect than dose increases beyond 80 mg. 1
The target dose of valsartan for hypertension is 160 mg twice daily (320 mg total daily dose) according to ACC guidelines for heart failure patients, though for uncomplicated hypertension the FDA-approved maximum is 320 mg once daily. 2, 3
Heart Failure Dosing
For heart failure with reduced ejection fraction (HFrEF), the target dose is 160 mg twice daily (320 mg total daily), which represents the maximum dose studied in clinical trials. 2, 1
The recommended starting dose is 40 mg twice daily, with uptitration to 80 mg and 160 mg twice daily or to the highest dose tolerated by the patient. 1
The maximum daily dose administered in clinical trials is 320 mg in divided doses. 1
In the VALIANT trial, the target dose was 160 mg twice daily (320 mg total daily) for post-MI patients with LV dysfunction, demonstrating equivalence to captopril in reducing mortality. 2
Post-Myocardial Infarction Dosing
For post-MI patients, the target maintenance dose is 160 mg twice daily (320 mg total daily), as tolerated. 1
Valsartan may be initiated as early as 12 hours after MI, starting at 20 mg twice daily, with uptitration within 7 days to 40 mg twice daily, then to the target of 160 mg twice daily. 1
If symptomatic hypotension or renal dysfunction occurs, consider dosage reduction. 1
Pediatric Dosing
For pediatric patients aged 1 to 16 years with hypertension, the maximum dose is 4 mg/kg once daily (maximum daily dose 160 mg). 1
The usual recommended starting dose is 1 mg/kg once daily (up to 40 mg total), with a higher starting dose of 2 mg/kg considered in selected cases when greater blood pressure reduction is needed. 1
Special Populations and Renal Impairment
No specific dose adjustment is provided in the FDA labeling for patients with renal impairment, though caution is advised when creatinine >221 μmol/L (>2.5 mg/dL) or eGFR <30 mL/min/1.73 m². 4
Monitor renal function and electrolytes 1-2 weeks after initiation and after each dose increase, particularly in patients with baseline renal impairment. 4
No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate <30 mL/min/1.73 m². 1
Important Safety Considerations
Do not combine valsartan with an ACE inhibitor, as this increases the risk of hyperkalemia and renal dysfunction. 2, 4
Monitor for hypotension, renal impairment, and hyperkalemia, especially when initiating therapy or increasing doses. 4
Significant hyperkalemia (K+ >5.0 mmol/L) requires caution and specialist advice, with monitoring of potassium within 1-2 weeks after initiation or dose increases. 4
Avoid NSAIDs unless essential, as they may attenuate diuretic effects and cause renal impairment. 4
Clinical Context
Higher doses of valsartan provide greater benefits than lower doses, with sustained AT1-receptor blockade over 24 hours achieved with the 160 mg dose. 4
Many physicians use doses of valsartan that are too low, which may not provide optimal benefits; underdosing is widespread in clinical practice, with less than 25% of patients ever titrated to target doses. 4
Doses as high as 640 mg/day have been studied in research settings and found to be efficacious and safe, though this exceeds FDA-approved maximum dosing. 5