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.