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.
| 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
| 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 |