azilsartan medoxomil

azilsartan medoxomil


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.

Adverse reactions

CV: hypotension, orthostatic hypotension

GI: diarrhea

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

Patient monitoring

• 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).

Patient teaching

• 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.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved
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(7) Amlodipine, chlorthalidone, and azilsartan medoxomil, all of which have long half-lives, are approximately 50% more potent than other antihypertensive agents.
The initial drug classes were thiazide-type diuretics (chlorthalidone was preferred unless advanced CKD was present, and then loop diuretics), calcium channel blockers (amlodipine preferred), ACE inhibitors (lisinopril was preferred), and ARBs (losartan or azilsartan medoxomil preferred).
Hooshmand et al., "The novel angiotensin II receptor blocker azilsartan medoxomil ameliorates insulin resistance induced by chronic angiotensin II treatment in rat skeletal muscle," Cardiorenal Medicine, vol.
This edition includes new drugs, including Azilsartan Medoxomil, Boceprevir, Clobazam, Ezogabine, Fidaxomicin, Linagliptin, Rilpivirine, Rivaroxaban, Telaprevir, Roflumilast, Ticagrelor, and Vilazodone; updated bisphosphonate, antipsychotic, carbapenem, and proton pump inhibitor group monographs; new combinations such as Emtricitabine/Rilpivirine/Tenofovir; and a revised ophthalmic/otic chapter with additions like glaucoma combinations, mast cell stabilizers, ophthalmic antihistamines, and otic corticosteroids.
Food and Drug Administration has approved azilsartan medoxomil with chlorthalidone (Edarbyclor, Takeda) for the treatment of hypertension.
announced last month that the Food and Drug Administration approved Edarbyclor (azilsartan medoxomil and chlorthalidone) for the treatment of hypertension to lower blood pressure in adults.
Azilsartan medoxomil, marketed as Edarbi in the United States, reduces blood pressure by blocking the action of angiotensin II, a vasopressor hormone that is present naturally within the body.
21 December 2011 - Japan's Takeda Pharmaceutical Company Limited (TYO:4502) said today that its high blood pressure treatment EDARBYCLOR (azilsartan medoxomil and chlorthalidone) had been approved by the US Food and Drug Administration (FDA).
The committee opinion was based on data from nine Phase III clinical trials, involving some 7,000 patients with hypertension.The studies showed that the highest approved dose of azilsartan medoxomil (80 mg/day) resulted in significantly greater reduction in systolic blood pressure than the highest approved doses of olmesartan medoxomil (40 mg/day) and valsartan (320 mg/day) and the ACE inhibitor ramipril (10 mg/day) in lowering both clinic and 24-hour mean blood pressure measurements.
28 February 2011 - Japanese Takeda Pharmaceutical Company Limited (TYO: 4502) and its wholly-owned subsidiary, Takeda Pharmaceuticals North America Inc, said on Friday that the US Food and Drug Administration (FDA) has approved EDARBI (azilsartan medoxomil) for the treatment of hypertension in adults.
M2 PHARMA-February 24, 2011-Takeda submits NDA to FDA for azilsartan medoxomil plus chlorthalidone(C)2011 M2 COMMUNICATIONS
M2 PHARMA-October 20, 2010-Takeda submits marekting application for azilsartan medoxomil for treatment of essential hypertension(C)2010 M2 COMMUNICATIONS