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.
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 |
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.