What is the recommended dosing for Edarbi (azilsartan) in an adult patient with hypertension and potentially impaired renal function?

Edarbi (Azilsartan) Dosing

The recommended dose of Edarbi is 80 mg taken orally once daily, with a starting dose of 40 mg for patients on high-dose diuretics or those who are volume-depleted. 1

Standard Dosing Regimen

• Start with 80 mg once daily for most adult patients with hypertension 1
• Start with 40 mg once daily if the patient is currently treated with high doses of diuretics, as these patients are at higher risk for symptomatic hypotension 1
• Administer once daily without regard to meals 1
• Do not repackage or remove from original container – dispense in original packaging to protect from light and moisture 1

Dose Titration Strategy

• If blood pressure remains uncontrolled on 40 mg, increase to 80 mg once daily 1, 2
• The 80 mg dose provides superior blood pressure reduction compared to the 40 mg dose and has demonstrated greater efficacy than maximum doses of olmesartan 40 mg or valsartan 320 mg 2, 3
• Reassess blood pressure monthly after initiating or changing dose until target is achieved 4

Special Populations Requiring Dose Adjustment

Volume or Salt Depletion

• Correct volume or salt depletion prior to starting Edarbi, or initiate at 40 mg 1
• If symptomatic hypotension occurs, place patient supine and consider IV normal saline 1
• Once blood pressure stabilizes, treatment can usually continue without difficulty 1

Renal Impairment

• No specific dose adjustment required for mild to moderate renal impairment 1
• Exercise caution in patients with severe renal impairment or bilateral renal artery stenosis, as changes in renal function may occur due to renin-angiotensin system inhibition 1
• Monitor serum creatinine and potassium within 2-4 weeks of starting therapy, particularly in patients with chronic kidney disease 5
• Discontinue if serum creatinine rises >30% within 4 weeks or if uncontrolled hyperkalemia develops 5

Hepatic Impairment

• No specific dosing recommendations are provided in the FDA label for hepatic impairment 1

Combination Therapy Considerations

• May be used alone or combined with other antihypertensive agents, particularly thiazide diuretics or calcium channel blockers 4, 1
• Do NOT combine with ACE inhibitors or aliskiren (especially in diabetic patients), as this increases risk of hyperkalemia and renal dysfunction without additional benefit 4, 5, 1
• Fixed-dose combination with chlorthalidone (Edarbyclor) is available as 40/12.5 mg or 40/25 mg for patients requiring dual therapy 6, 7

Blood Pressure Targets

• Target <130/80 mmHg for most patients with hypertension and cardiovascular disease or high cardiovascular risk 4
• Target <140/90 mmHg for patients without comorbidities 4
• For patients with chronic kidney disease (stage 3 or higher, or albuminuria ≥300 mg/day), target <130/80 mmHg 4

Monitoring Requirements

• Check blood pressure monthly after initiation or dose changes until target achieved 4
• Monitor every 3-5 months once blood pressure is controlled 4
• Assess serum creatinine and potassium within 2-4 weeks of starting or increasing dose, especially in patients with CKD 5
• Continue monitoring renal function and electrolytes within first 3 months 8

Critical Contraindications and Warnings

• Absolutely contraindicated in pregnancy – discontinue immediately when pregnancy is detected, as drugs acting on the renin-angiotensin system cause fetal injury and death 1
• Do not coadminister with aliskiren in diabetic patients 1
• Avoid in patients with history of angioedema with ARBs 4
• Watch for hyperkalemia, particularly in patients with CKD or those on potassium supplements or potassium-sparing drugs 4

Clinical Efficacy Data

• Azilsartan 80 mg once daily produces significantly greater 24-hour blood pressure reduction than olmesartan 40 mg or valsartan 320 mg in head-to-head trials 2, 3
• Demonstrates sustained efficacy over 24 weeks with good tolerability profile similar to placebo 2
• The 80 mg dose achieves target blood pressure in approximately 88% of patients when combined with chlorthalidone 6