Pharmacologic class: Angiotensin II receptor blocker
Therapeutic class: Antihypertensive
Pregnancy risk category D
FDA Box Warning
• When pregnancy is detected, discontinue drug as soon as possible.
• Drugs that act directly on the renin-angiotensin system can cause injury and death to a developing fetus.
Inhibits the pressor effects of an angiotensin II infusion in a dose-related manner. Effects of angiotensin II, the principal pressor agent of the renin-angiotensin system, include vasoconstriction, aldosterone release, and sodium reabsorption from the kidneys.
Tablets: 40 mg, 80 mg
Indications and dosages
➣ Hypertension alone or in combination with other antihypertensives
Adults: 80 mg P.O. daily. Consider a starting dose of 40 mg for patients who are being treated with high-dose diuretics
Use cautiously in:
• renal impairment, renal artery stenosis
• hypotension in volume- or salt-depleted patients
• patients whose renal function may depend on activity of the renin-angiotensin system
• elderly patients
• pregnant or breastfeeding patients
• children younger than age 18 (safety and efficacy not established).
• Administer with or without food.
• Correct volume or salt depletion before starting drug.
CV: hypotension, orthostatic hypotension
GU: oliguria or progressive azotemia with acute renal failure (rare)
Other: death (rare)
Drug-drug. NSAIDs, including selective COX-2 inhibitors: deteriorated renal function, including possible acute renal failure in patients who are elderly, volume-depleted, or who have compromised renal function; attenuated azilsartan antihypertensive effect
Drug-diagnostic tests. Serum creatinine: small reversible increases
• Watch for hypotension in volume- or salt-depleted patients, such as those receiving high-dose diuretics.
• Observe for increasing serum creatinine level in patients with moderate to severe renal impairment and worsening renal function in elderly patients and those receiving NSAIDs, including COX-2 inhibitors.
☞ Watch for oliguria or progressive azotemia that could possibly lead to acute renal failure and death in patients whose renal function depends on the activity of the renin-angiotensin system (such as patients with severe congestive heart failure, renal artery stenosis, or volume depletion).
• Tell patient to take drug with or without food.
☞ Instruct patient to promptly report changes in urinary function.
• Advise female patient of childbearing age to immediately notify prescriber if she becomes pregnant.
• Because of the potential for adverse effects in the breastfeeding infant, a decision should be made whether to discontinue breastfeeding or discontinue drug, taking into account importance of drug to the mother.
• As appropriate, review all significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.