azilsartan medoxomil

azilsartan medoxomil

Edarbi

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.

Action

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.

Availability

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

Contraindications

None

Precautions

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).

Administration

• 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)

Interactions

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.

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EDARBYCLOR (azilsartan medoxomil and chlorthalidone) is a fixed-dose combination therapy for the treatment of hypertension that combines azilsartan medoxomil and chlorthalidone in a single tablet.
5, 2012 /PRNewswire/ -- Results of a 10-week, phase 3 study published online in the American Journal of Medicine found the clinic systolic blood pressure (SBP) reductions of a fixed-dose combination of azilsartan medoxomil and chlorthalidone were significantly greater at six and ten weeks than those of azilsartan medoxomil co-administered with hydrochlorothiazide.
June 19, 2012 /PRNewswire/ -- Results of a 12-week, head-to-head, phase 3 study published online in the American Heart Association journal Hypertension found systolic blood pressure (SBP) reductions of a fixed-dose combination of azilsartan medoxomil and chlorthalidone 40/25 mg were statistically superior to those of the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide 40/25 mg.
Food and Drug Administration (FDA) for an investigational fixed-dose combination of azilsartan medoxomil plus chlorthalidone (CLD) for the treatment of hypertension, or high blood pressure.
The only innovative antihypertensive agent expected to launch by 2019 is Takeda's ARB; azilsartan medoxomil (TAK-491).
today announced results from a pivotal phase 3 study of azilsartan medoxomil (development code: TAK-491), an angiotensin II receptor blocker (ARB) that demonstrated greater 24-hour mean systolic blood pressure (SBP) and clinic SBP reduction at 24 weeks compared to the commonly prescribed ARB, valsartan.
today announced results from pivotal phase 3 studies of azilsartan medoxomil (development code: TAK-491), an angiotensin II receptor blocker (ARB), demonstrating greater 24-hour systolic blood pressure (SBP) reduction compared to commonly prescribed ARBs olmesartan medoxomil and valsartan.
submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for azilsartan medoxomil (development code: TAK-491), an angiotensin II receptor blocker (ARB) under investigation for the treatment of hypertension.