1.1. Adults

Angiotensin II receptor blockers (ARBs) as monotherapy are FDA-approved for use in hypertension (all available ARBs), diabetic nephropathy (irbesartan, losartan), heart failure (candesartan, valsartan), stroke prophylaxis (losartan), cardiovascular risk reduction in patients unable to take angiotensin-converting enzyme (ACE) inhibitors (telmisartan), and post-myocardial infarction (valsartan). ARB combination therapy is FDA-approved for use in hypertension and stroke risk reduction in hypertensive patients as well as patients with left ventricular hypertrophy (Hyzaar®). Sacubitril/valsartan (Entresto®) combination therapy is FDA-approved to reduce the risk of cardiovascular death and hospitalization in chronic heart failure with reduced ejection fraction. The maximum recommended daily doses assigned to ARBs as monotherapy and combination therapy for adult patients are summarized in Tables 1 and 2. Patient profiles containing ARB dosage regimens exceeding these recommendations will be reviewed.

Table 1: Maximum Daily Adult Dosages for Angiotensin II Receptor Blockers - Monotherapy1-10
Drug Name Dosage Form/Strength Treatment Indication Maximum Recommended Dosage
azilsartan (Edarbi®) 40 mg, 80 mg tablets hypertension 80 mg/day
candesartan (Atacand®, generics) 4 mg, 8 mg, 16 mg, 32 mg tablets heart failure 32 mg/day
    hypertension 32 mg/day
irbesartan (Avapro®, generics) 75 mg, 150 mg, 300 mg tablets diabetic nephropathy 300 mg/day
    hypertension 300 mg/day
losartan (Cozaar®, generics) 25 mg, 50 mg, 100 mg tablets diabetic nephropathy 100 mg/day
    hypertension 100 mg/day
    hypertension with left ventricular hypertrophy/ stroke prevention 100 mg/day
olmesartan (Benicar®, generics) 5 mg, 20 mg, 40 mg tablets hypertension 40 mg/day
telmisartan (Micardis®, generics) 20 mg, 40 mg, 80 mg tablets cardiovascular risk reduction/ stroke prevention/ myocardial infarction prevention 80 mg/day
    hypertension 80 mg/day
valsartan (Diovan®, generics) 40 mg, 80 mg, 160 mg, 320 mg tablets; 20 mg/5mL oral solution (generic only)* heart failure 320 mg/day in divided doses
    hypertension 320 mg/day
    left ventricular dysfunction/failure after myocardial infarction 320 mg/day in divided doses

Legend:

  • * Valsartan oral solution is not therapeutically equivalent to the tablet formulation and not substitutable on a mg-per-mg basis
Table 2: Maximum Daily Adult Dosages for Angiotensin II Receptor Blockers - Combination Therapy1,2,11-23
Drug Name Dosage Form/Strength Treatment Indication Maximum Recommended Dosage
amlodipine/ olmesartan (Azor, generics) 5 mg/20 mg, 10 mg/20 mg, 5 mg/40 mg, 10 mg/40 mg tablets hypertension 10 mg/40 mg/day
amlodipine/ valsartan (Exforge®, generics) 5 mg/160 mg, 5 mg/320 mg, 10 mg/160 mg, 10 mg/320 mg tablets hypertension 10 mg/320 mg/day
amlodipine/ valsartan/ hydrochlorothiazide (Exforge HCT, generics) 5 mg/160 mg/12.5 mg, 10 mg/160 mg/12.5 mg, 5 mg/160 mg/25 mg, 10 mg/160 mg/25 mg, 10 mg/320 mg/25 mg tablets hypertension 10 mg/320 mg/25 mg/day
azilsartan/ chlorthalidone (Edarbyclor) 40 mg/12.5 mg, 40 mg/25 mg tablets hypertension 40 mg/25 mg/day
candesartan/ hydrochlorothiazide (Atacand HCT, generic) 16 mg/12.5 mg, 32 mg/12.5 mg, 32 mg/25 mg tablets hypertension 32 mg/25 mg/day
irbesartan/ hydrochlorothiazide (Avalide, generic) 150 mg/12.5 mg, 300 mg/12.5 mg tablets hypertension 300 mg/25 mg/day
losartan/hydrochlorothiazide (Hyzaar®, generic) 50 mg/12.5 mg, 100 mg/12.5 mg, 100 mg/25 mg tablets hypertension 100 mg/25 mg/day
    stroke prevention in hypertension with left ventricular hypertrophy 100 mg/25 mg/day
olmesartan/amlodipine/hydrochlorothiazide (Tribenzor®, generics) 20 mg/5 mg/12.5 mg, 40 mg/5 mg/12.5 mg, 40 mg/5 mg/25 mg, 40 mg/10 mg/12.5 mg, 40 mg/10 mg/25 mg tablets hypertension 40 mg/10 mg/25 mg/day
olmesartan/ hydrochlorothiazide (Benicar HCT®, generics) 20 mg/12.5 mg, 40 mg/12.5 mg, 40 mg/25 mg tablets hypertension 40 mg/25 mg/day
sacubitril/valsartan (Entresto®) 24 mg/26 mg, 49 mg/51 mg, 97 mg/103 mg tablets heart failure 194 mg/206 mg/day in two divided doses
telmisartan/ amlodipine (generics) 40 mg/5 mg, 40 mg/10 mg, 80 mg/5mg, 80 mg/10 mg tablets hypertension 80 mg/10 mg/day
telmisartan/ hydrochlorothiazide (Micardis HCT®, generics) 40 mg/12.5 mg, 80 mg/12.5 mg, 80 mg/25 mg tablets hypertension 160 mg/25 mg/day
valsartan/ hydrochlorothiazide (Diovan HCT®, generic) 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, 320 mg/ 25 mg tablets hypertension 320 mg/25 mg/day

1.2. Pediatrics

Candesartan is FDA-approved to manage hypertension in children 1 to less than 17 years1,2,4. In 2021, the FDA expanded approval of valsartan to include patients 1 to 5 years for treatment of hypertension1,2,9. Losartan, olmesartan, and valsartan oral solution are FDA-approved to manage hypertension in pediatric patients 6 years of age and older1,2,6,7,10. Irbesartan is not FDA-approved for use in pediatric patients and has not demonstrated sustained efficacy in managing elevated blood pressure in patients 6 years and older1,2,5. Sacubitril/valsartan is FDA-approved to treat symptomatic heart failure with left ventricular systolic dysfunction in children 1 year and older1,2,12. Recommended dosages are summarized in Table 3. Dosages exceeding these recommendations will be reviewed.

Table 3: Pediatric Maximum Daily Angiotensin II Receptor Blocker Dosages for Hypertension – Monotherapy1,2,4,6,7,9,10
Drug Patient Characteristics Maximum Daily Dosage
candesartan 1 to less than 6 years of age:     
6 to less than 17 years of age:  
Less than 50 kg:
Greater than 50 kg:		 0.4 mg/kg/day
16 mg/day
32 mg/day
losartan 6 to 17 years of age: 1.4 mg/kg/day to a maximum of 100 mg/day
olmesartan 6 to 16 years of age:     
Less than 35 kg:  
Greater than or equal to 35 kg:  
17 years of age:		 20 mg/day
40 mg/day
40 mg/day
valsartan (oral tablet) 1 to 16 years of age:
17 years of age:		 4mg/kg/day to a maximum of 160 mg/day
320 mg/day
valsartan (oral solution) 6 to 16 years of age:
17 years of age:		 2.7 mg/kg/day in two divided doses to a maximum of 160 mg/day
320 mg/day
Table 4. Pediatric Maximum Daily Angiotensin II Receptor Blocker Dosages for Heart Failure – Combination Therapy1,2,12
Drug Patient Characteristics Maximum Daily Dosage
sacubitril/ valsartan (Entresto) 1 to 17 years of age:
Less than 40 kg:
40 to 49 kg:
Greater than 50 kg:		 6.2mg/kg/day in two divided doses
144/156 mg/day in two divided doses
194/206 mg/day in two divided doses

The safety and efficacy of azilsartan and telmisartan in pediatric patients have not been established1-3,8. The safety and efficacy of ARBs in combination with hydrochlorothiazide, aliskiren, or amlodipine in pediatric patients have not been established.