What is the maximum dose of valsartan (Angiotensin II Receptor Blocker)?

From the Guidelines

The maximum dose of valsartan is 160 mg twice daily (320 mg total daily) for heart failure patients, as recommended by the most recent guidelines 1.

Valsartan Dosing

The dosing of valsartan typically starts at a lower dose, such as 20-40 mg once daily, and is gradually increased based on blood pressure response and tolerability.

• For heart failure patients, the target dose is 160 mg twice daily (320 mg total daily) 1.
• It is essential to monitor blood pressure and kidney function regularly while taking valsartan.
• Patients should take valsartan consistently at the same time each day, with or without food, and should not stop taking it without consulting their healthcare provider.

Considerations

• Patients with liver impairment or those taking other medications that affect kidney function may require lower maximum doses.
• Common side effects of valsartan include dizziness, headache, and elevated potassium levels.
• The use of lower doses of HFrEF medications, where higher target doses could be tolerated, may not produce the same degree of clinical benefit as the target doses 1.

Guideline Recommendations

• The 2022 AHA/ACC/HFSA guideline for the management of heart failure recommends the use of valsartan as an angiotensin receptor blocker (ARB) for the treatment of heart failure with reduced ejection fraction (HFrEF) 1.
• The guideline emphasizes the importance of using evidence-based therapies, including ARBs, to improve outcomes in patients with HFrEF.

From the FDA Drug Label

Valsartan tablets may be used over a dose range of 80 mg to 320 mg daily, administered once a day The maximum daily dose administered in clinical trials is 320 mg in divided doses. The dosage should be adjusted according to blood pressure response and tolerability, up to a maximum dose of 4 mg/kg once daily (maximum daily dose 160 mg). Patients may be uptitrated within 7 days to 40 mg twice daily, with subsequent titrations to a target maintenance dose of 160 mg twice daily, as tolerated by the patient

The maximum dose of valsartan is 320 mg per day, administered either as a single dose or in divided doses 2. Key points to consider:

• The maximum daily dose for adult hypertension is 320 mg per day.
• The maximum daily dose for pediatric hypertension is 160 mg per day.
• The maximum daily dose for heart failure and post-myocardial infarction is 320 mg per day, administered in divided doses.

From the Research

Valsartan Maximum Dose

• The maximum dose of valsartan varies depending on the patient population and the specific condition being treated 3, 4, 5, 6, 7.
• In patients with hypertension, the maximum recommended dose of valsartan is 320 mg per day 3, 4, 5.
• In patients with heart failure, the maximum recommended dose of valsartan is 160 mg twice daily 3, 4.
• In some studies, higher doses of valsartan (up to 640 mg per day) have been used to achieve greater blood pressure reductions, particularly in African-American patients with type 2 diabetes and albuminuria 7.
• The antihypertensive effect of valsartan increases in a predictable fashion over a wide dose range (20-320 mg), with the 80-mg dose being enhanced by doubling it to 160 mg, and the tolerability profile remaining comparable to that of placebo over a broad dose range 3.
• The efficacy and tolerability of valsartan have been demonstrated in large-scale studies in hypertension, heart failure, and post-myocardial infarction, with doses as high as 640 mg/day being found to be efficacious and safe 4.

Dose-Dependent Efficacy

• Valsartan exhibits dose-dependent efficacy in reducing both systolic and diastolic blood pressure over the once-daily dose range of 80-320 mg 4, 5.
• The median time to achieve blood pressure goal is shorter with higher doses of valsartan, particularly when combined with hydrochlorothiazide (HCTZ) 5.
• In patients with stage 2 hypertension, the median time to achieve blood pressure goal is shorter with valsartan 160 mg/HCTZ and valsartan 320 mg/HCTZ compared to valsartan alone 5.

Special Populations

• In African-American patients with type 2 diabetes and albuminuria, higher doses of valsartan (up to 640 mg per day) may be necessary to achieve greater blood pressure reductions 7.
• In patients with heart failure, the dose of valsartan should be individualized based on the patient's response to therapy 3, 4.