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June 10: VDP Formulary, CAD, MCO Search Realignment Now Active

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1.2. Pediatrics

Candesartan is FDA-approved to manage hypertension in children 1 to less than 17 years of age [1,2,4]. In 2021, the FDA expanded approval of valsartan to include patients 1 to 5 years of age for treatment of hypertension [1,2,9]. Losartan, olmesartan, and valsartan oral solution are FDA-approved to manage hypertension in pediatric patients 6 years of age and older [1,2,6,7,10]. 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 of age and older [1,2,5]. The safety and efficacy of azilsartan and telmisartan in pediatric patients have not been established [1-3,8]. The safety and efficacy of ARBs in combination with hydrochlorothiazide, aliskiren, or amlodipine in pediatric patients have not been established.  Sacubitril/valsartan is FDA-approved to treat symptomatic heart failure with left ventricular systolic dysfunction in children 1 year and older [1,2,12]. 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 – Monotherapy [1,2,4,6,7,9,10]
DrugPatient CharacteristicsMaximum Daily Dosage
candesartan1 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
losartan6 to 17 years of age:1.4 mg/kg/day to a maximum of 100 mg/day
olmesartan6 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
DrugPatient CharacteristicsMaximum 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.