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brand edarbyclor 40-25 mg tablet

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Uses

Hypertension

Azilsartan medoxomil is used alone or in combination with other classes of antihypertensive agents in the management of hypertension. Angiotensin II receptor antagonists such as azilsartan are considered one of several preferred antihypertensive drugs for the initial management of hypertension; other options include angiotensin-converting enzyme (ACE) inhibitors, calcium-channel blockers, and thiazide diuretics. While there may be individual differences with respect to specific outcomes, these antihypertensive drug classes all produce comparable effects on overall mortality and cardiovascular, cerebrovascular, and renal outcomes. Angiotensin II receptor antagonists or ACE inhibitors may be particularly useful in the management of hypertension in patients with certain coexisting conditions such as diabetes mellitus or chronic kidney disease; angiotensin II receptor antagonists also may be preferred, generally as an alternative to ACE inhibitors, in hypertensive patients with heart failure or ischemic heart disease and/or postmyocardial infarction.

Efficacy of azilsartan in the treatment of hypertension has been established in 7 double-blind, randomized studies, including 5 placebo-controlled studies of 6 weeks to 6 months in duration in patients with mild, moderate, or severe hypertension. In these patients, azilsartan medoxomil dosages of 40-80 mg daily decreased placebo-corrected systolic blood pressure by about 12-15 mm Hg and diastolic blood pressure by about 6-9 mm Hg at 6 weeks. Rebound hypertension following abrupt withdrawal of the drug was not reported. Clinical studies have shown that the hypotensive effect of azilsartan is greater than that of placebo and comparable to or greater than that of olmesartan and valsartan. At maximum recommended dosages, the effect of azilsartan on clinic and 24-hour mean blood pressure measurements at 6 weeks was greater than that of olmesartan and valsartan.

Azilsartan has approximately its usual effects on blood pressure reduction when added to amlodipine or chlorthalidone treatment.

Like ACE inhibitors, angiotensin II receptor antagonists such as azilsartan may produce a smaller blood pressure response in hypertensive black patients compared with patients of other races. According to the manufacturer, the effect of monotherapy with azilsartan on blood pressure was reduced by about 50% in black patients compared with patients of other races.

For additional information on the management of hypertension, For information on overall principles and expert recommendations for treatment of hypertension,

Diabetic Nephropathy

Both angiotensin II receptor antagonists and ACE inhibitors have been shown to slow the rate of progression of renal disease in patients with diabetes mellitus and persistent albuminuria, and use of a drug from either class is recommended in such patients with modestly elevated (30-300 mg/24 hours) or higher (exceeding 300 mg/24 hours) levels of urinary albumin excretion. The usual precautions of angiotensin II receptor antagonist or ACE inhibitor therapy in patients with substantial renal impairment should be observed.(See Renal Effects under Warnings/Precautions: Other Warnings and Precautions, in Cautions.) For additional information on the use of angiotensin II receptor antagonists in the treatment of diabetic nephropathy, and in .

Heart Failure

Angiotensin II receptor antagonists have been used in the management of heart failure.

Current guidelines for the management of heart failure in adults generally recommend a combination of drug therapies to reduce morbidity and mortality, including neurohormonal antagonists (e.g., ACE inhibitors, angiotensin II receptor antagonists, angiotensin receptor-neprilysin inhibitors [ARNIs], β-adrenergic blocking agents [β-blockers], aldosterone receptor antagonists) that inhibit the detrimental compensatory mechanisms in heart failure. Additional agents (e.g., cardiac glycosides, diuretics, sinoatrial modulators [i.e., ivabradine]) added to a heart failure treatment regimen in selected patients have been associated with symptomatic improvement and/or reduction in heart failure-related hospitalizations. Experts recommend that all asymptomatic patients with reduced left ventricular ejection fraction (LVEF) (American College of Cardiology Foundation [ACCF]/American Heart Association [AHA] stage B heart failure) receive therapy with an ACE inhibitor and β-blocker to prevent symptomatic heart failure and reduce morbidity and mortality. In patients with prior or current symptoms of chronic heart failure with reduced LVEF (ACCF/AHA stage C heart failure), ACCF, AHA, and the Heart Failure Society of America (HFSA) recommend inhibition of the renin-angiotensin-aldosterone (RAA) system with an ACE inhibitor, angiotensin II receptor antagonist, or ARNI in conjunction with a β-blocker, and an aldosterone antagonist in selected patients, to reduce morbidity and mortality. While ACE inhibitors have been the preferred drugs for inhibition of the RAA system because of their established benefits in patients with heart failure and reduced ejection fraction, some evidence indicates that therapy with sacubitril/valsartan, an ARNI, may be more effective than ACE inhibitor therapy (enalapril) in reducing cardiovascular death and heart failure-related hospitalization. ACCF, AHA, and HFSA recommend that patients with chronic symptomatic heart failure and reduced LVEF (New York Heart Association [NYHA] class II or III) who are able to tolerate an ACE inhibitor or angiotensin II receptor antagonist be switched to therapy containing an ARNI to further reduce morbidity and mortality. However, in patients in whom an ARNI is not appropriate, continued use of an ACE inhibitor for all classes of heart failure with reduced ejection fraction remains strongly advised. In patients in whom an ARNI or ACE inhibitor is not appropriate, an angiotensin II receptor antagonist may be used. For additional information on the use of angiotensin II receptor antagonists in the management of heart failure, and in .

Angiotensin II receptor antagonists are considered reasonable alternative therapy in patients who are unable to tolerate ACE inhibitors (e.g., because of cough or angioedema).(See Sensitivity Reactions under Cautions: Warnings/Precautions.) No additional therapeutic benefit has been demonstrated with concomitant use of an angiotensin II receptor antagonist and an ACE inhibitor.

Dosage and Administration

General

Azilsartan medoxomil is administered orally without regard to meals.

Azilsartan medoxomil is commercially available as azilsartan kamedoxomil (the potassium salt of azilsartan medoxomil); dosage is expressed in terms of azilsartan medoxomil.

Azilsartan tablets must be dispensed and stored in the original manufacturer's container.

Hypertension

Azilsartan Therapy

The usual dosage of azilsartan medoxomil is 80 mg once daily in adults. In patients receiving high dosages of diuretics, a reduced initial azilsartan medoxomil dosage of 40 mg once daily should be considered. Azilsartan medoxomil dosages exceeding 40-80 mg daily do not appear to provide additional therapeutic benefit in the majority of patients. The panel members appointed to the Eighth Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8 expert panel) state that evidence-based dosing information (i.e., dosages shown in randomized controlled trials to reduce complications of hypertension) should be used when available to determine target dosages of antihypertensive agents. Target dosages generally can be achieved within 2-4 weeks, but it may take up to several months. The manufacturer states that most of the antihypertensive effect of azilsartan generally is evident within 2 weeks.

If blood pressure response to azilsartan monotherapy is inadequate, other antihypertensive agents may be added.

Antihypertensive therapy should be titrated until goal blood pressure is achieved. If an adequate blood pressure response is not achieved with azilsartan monotherapy, another antihypertensive agent with demonstrated benefit may be added; if goal blood pressure is still not achieved with the use of 2 antihypertensive agents at optimal dosages, a third drug may be added. In patients who experience intolerable adverse effects with azilsartan, dosage reduction should be considered; if adverse effects worsen or fail to resolve, it may be necessary to discontinue the angiotensin II receptor antagonist and initiate another class of antihypertensive agent.

Blood Pressure Monitoring and Treatment Goals

Careful monitoring of blood pressure during initial titration or subsequent upward adjustment in dosage of azilsartan medoxomil is recommended.

The goal of hypertension management and prevention is to achieve and maintain optimal control of blood pressure; specific target levels of blood pressure should be individualized based on consideration of multiple factors, including patient age and comorbidities, and the currently available evidence from clinical studies.

For additional information on initiating and adjusting azilsartan medoxomil dosage in the management of hypertension,

Special Populations

Volume or salt depletion should be corrected before initiating treatment with azilsartan medoxomil or a lower initial dose of the drug (40 mg once daily) should be used. The manufacturer states that adjustment in initial azilsartan medoxomil dosage is not necessary in geriatric patients or in those with mild to moderate hepatic impairment, mild to severe renal impairment, or end-stage renal disease. Data are lacking on the use of azilsartan in patients with severe hepatic impairment.

Cautions

Contraindications

Concomitant use of azilsartan and aliskiren in patients with diabetes mellitus.(See Drug Interactions: Drugs that Block the Renin-Angiotensin System.)

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity and Mortality

Drugs that act directly on the renin-angiotensin system (e.g., angiotensin-converting enzyme [ACE] inhibitors, angiotensin II receptor antagonists) reduce fetal renal function and increase fetal and neonatal morbidity and mortality when used in pregnancy during the second and third trimesters. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. ACE inhibitors also have been reported to increase the risk of major congenital malformations when administered during the first trimester of pregnancy. Potential neonatal effects include skull hypoplasia, anuria, hypotension, renal failure, and death.

Azilsartan should be discontinued as soon as possible when pregnancy is detected, unless continued use is considered life-saving. Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy. For additional information on the risk of such drugs during pregnancy, and in .

Sensitivity Reactions

Angioedema, pruritus, and rash have been reported during postmarketing experience in patients receiving azilsartan.

Other Warnings and Precautions

Hypotension

Because symptomatic hypotension may occur in patients with an activated renin-angiotensin system (e.g., patients with volume or salt depletion secondary to high doses of diuretics), azilsartan should be initiated in such patients after volume or salt depletion is corrected, or a lower initial dose of the drug should be used.(See Dosage and Administration: Special Populations.)

If hypotension occurs in patients receiving azilsartan, the patient should be placed in the supine position and, if necessary, an IV infusion of 0.9% sodium chloride injection should be administered. Transient hypotension is not a contraindication to additional doses of azilsartan medoxomil, and therapy with the drug can be cautiously reinstated after blood pressure has been stabilized (e.g., with volume expansion).

Malignancies

In July 2010, the US Food and Drug Administration (FDA) initiated a safety review of angiotensin II receptor antagonists after a published meta-analysis suggested a possible association between the use of these agents and an increased risk of cancer. The meta-analysis, which combined cancer-related findings from 5 randomized, controlled trials in over 60,000 patients, found a modest but significant increase in the risk of new cancer occurrence in patients receiving an angiotensin II receptor antagonist (mostly telmisartan) compared with those in control groups (7.2 versus 6%, respectively; risk ratio 1.08). However, because of several limitations of the study (e.g., trials included in the meta-analysis were not specifically designed to evaluate cancer outcomes, lack of individual patient data), the validity of these findings has been questioned.

Subsequent studies, including a larger, more comprehensive meta-analysis conducted by FDA, have not shown an increased risk of cancer in patients receiving angiotensin II receptor antagonists. FDA's meta-analysis, which included trial-level data from 31 randomized studies (total of approximately 156,000 patients), found no evidence of an increased risk of cancer in patients who received an angiotensin II receptor antagonist compared with those who received other treatments (placebo or active control). The overall rate of new cancer occurrence was essentially the same in both groups of patients (1.82 and 1.84 cases per 100 patient-years, respectively). In addition, there was no difference in the risk of cancer-related death, breast cancer, lung cancer, or prostate cancer between the groups. Based on these results and a review of all currently available data related to this potential safety concern, FDA has concluded that use of angiotensin II receptor antagonists is not associated with an increased risk of cancer.

Renal Effects

Because the renin-angiotensin-aldosterone (RAA) system appears to contribute substantially to maintenance of glomerular filtration in patients with severe heart failure, renal artery stenosis, or volume depletion, renal function may deteriorate markedly (e.g., oliguria, progressive azotemia, rarely with acute renal failure and death) in these patients during therapy with an ACE inhibitor or an angiotensin II receptor antagonist (e.g., azilsartan). Although reports received to date have involved patients treated with ACE inhibitors and other angiotensin II receptor antagonists, this adverse effect also would be expected to occur when azilsartan is used in a similar manner.

Increases in serum creatinine or blood urea nitrogen concentrations have been reported in patients with unilateral or bilateral renal artery stenosis receiving ACE inhibitors. This adverse effect also may be expected with the use of azilsartan.

Angioedema

Angioedema has been reported with the use of azilsartan during postmarketing experience.

Specific Populations

Pregnancy

Category D.

Azilsartan can cause fetal and neonatal morbidity and mortality when administered to a pregnant woman. Azilsartan should be discontinued as soon as possible when pregnancy is detected.(See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Warnings, in Cautions.)

Lactation

Azilsartan is distributed into milk in rats; it is not known whether azilsartan is distributed into human milk. Because of the potential for serious adverse reactions to azilsartan in nursing infants, a decision should be made to discontinue nursing or the drug.

Pediatric Use

If oliguria or hypotension occurs in neonates with a history of in utero exposure to azilsartan, blood pressure and renal function should be supported; exchange transfusions or dialysis may be required.(See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Warnings, in Cautions.)

Safety and efficacy of azilsartan have not been established in children younger than 18 years of age. For information on overall principles and expert recommendations for treatment of hypertension in pediatric patients,

Geriatric Use

A higher incidence of elevated serum creatinine concentrations has been reported in patients 75 years of age or older receiving azilsartan compared with younger patients. No other differences in safety and efficacy relative to younger adults have been reported, but increased sensitivity cannot be ruled out.

Hepatic Impairment

Data are lacking on the use of azilsartan in patients with severe hepatic impairment.

Renal Impairment

An increased incidence of abnormally high serum creatinine concentrations has been reported in patients with moderate to severe renal impairment receiving azilsartan.

Effect of Race

Blood pressure reduction was approximately 50% smaller in black patients, who may have low renin levels, compared with patients of other races.

Common Adverse Effects

Diarrhea was reported in up to 2% of patients receiving azilsartan compared with 0.5% of patients receiving placebo. Less common adverse effects occurring in 0.3% or more of patients receiving azilsartan and with a greater incidence than in patients receiving placebo include hypotension/orthostatic hypotension, nausea, asthenia, fatigue, muscle spasm, dizziness, postural dizziness, and cough.

Drug Interactions

Drugs that Block the Renin-Angiotensin System

Increased risk of hypotension, hyperkalemia, and changes in renal function (e.g., renal impairment) with concomitant use of other angiotensin II receptor blockers or other drugs that block the renin-angiotensin system (e.g., angiotensin-converting enzyme [ACE] inhibitors, aliskiren); blood pressure, renal function, and serum electrolyte concentrations should be monitored closely when azilsartan is used concomitantly with such drugs. Concomitant use of azilsartan and aliskiren is contraindicated in patients with diabetes mellitus; in addition, concomitant use of these drugs should be avoided in patients with renal impairment (glomerular filtration rate [GFR] less than 60 mL/minute).

Amlodipine

Pharmacokinetic interactions unlikely.

Antacids

Pharmacokinetic interactions unlikely.

Chlorthalidone

Pharmacokinetic interactions unlikely.

Reversible increases in serum creatinine, which may occur in patients receiving azilsartan, may be larger in patients also receiving chlorthalidone.

Digoxin

Pharmacokinetic interactions unlikely.

Fluconazole

Pharmacokinetic interactions unlikely.

Glyburide

Pharmacokinetic interactions unlikely.

Hydrochlorothiazide

Reversible increases in serum creatinine, which may occur in patients receiving azilsartan, may be larger in patients also receiving hydrochlorothiazide.

Ketoconazole

Pharmacokinetic interactions unlikely.

Lithium

Increased serum lithium concentrations and lithium toxicity has been reported with concomitant angiotensin II receptor antagonist therapy. Monitoring of serum lithium concentrations is recommended during such concomitant use.

Metformin

Pharmacokinetic interactions unlikely.

Nonsteroidal Anti-inflammatory Agents (NSAIAs)

Concomitant treatment with NSAIAs, including selective cyclooxygenase-2 (COX-2) inhibitors, and angiotensin II receptor antagonists may result in deterioration of renal function, including possible acute renal failure, in patients who are geriatric, volume-depleted (including those on diuretic therapy), or have compromised renal function. These effects usually are reversible. Renal function should be periodically monitored in patients receiving azilsartan and NSAIA therapy.

The antihypertensive effect of azilsartan may be attenuated in patients receiving NSAIAs, including selective COX-2 inhibitors.

Pioglitazone

Pharmacokinetic interactions unlikely.

Potassium-sparing Diuretics

Since the use of potassium-sparing diuretics (i.e., amiloride, spironolactone, triamterene) with an angiotensin II receptor antagonist (i.e., azilsartan) can increase the potential for hyperkalemia, some clinicians have suggested that concomitant administration of these drugs with azilsartan should be avoided.

Potassium Supplements and Potassium-containing Salt Substitutes

Since the use of potassium supplements and potassium-containing salt substitutes with an angiotensin II receptor antagonist (e.g., azilsartan) can increase the potential for hyperkalemia, some clinicians have suggested that concomitant administration of these agents with azilsartan should be avoided.

Warfarin

Pharmacokinetic interactions unlikely.

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