EPLERENONE PACKAGE INSERT PDF

Send the page " " to a friend, relative, colleague or yourself. We do not record any personal information entered above. Selective aldosterone receptor antagonist SARA Used to treat hypertension; also used to treat heart failure in post-myocardial infarction patients Metabolized by CYP3A4; associated with a risk of hyperkalemia. For inadequate blood pressure response after 4 weeks of treatment, may increase dosage to 50 mg PO twice daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

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Send the page " " to a friend, relative, colleague or yourself. We do not record any personal information entered above. Selective aldosterone receptor antagonist SARA Used to treat hypertension; also used to treat heart failure in post-myocardial infarction patients Metabolized by CYP3A4; associated with a risk of hyperkalemia.

For inadequate blood pressure response after 4 weeks of treatment, may increase dosage to 50 mg PO twice daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Initially, 25 mg PO once daily. Increase dosage to 50 mg PO once daily as tolerated within 4 weeks. Monitor serum potassium concentrations at baseline, within the first week of eplerenone therapy, and at 1 month after dosage initiation or adjustments; monitor more frequently in at-risk patients.

If the serum potassium concentration is 5. No initial dosage adjustments are necessary for patients with mild to moderate hepatic impairment; eplerenone has not been studied in severe hepatic impairment. Use with cautious electrolyte monitoring in patients with heart failure.

Intermittent hemodialysis See dosage for patients with renal impairment. Eplerenone is not removed by hemodialysis. May administer eplerenone without regard to food. Advise patients not to use dietary salt substitutes that contain potassium while taking eplerenone. Generic: - Protect from light - Protect from moisture - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F Inspra: - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F.

Eplerenone is contraindicated in any patient with hyperkalemia serum potassium greater than 5. Eplerenone-induced hyperkalemia can cause life-threatening cardiac arrhythmias, and it is more likely to occur in patients with renal impairment or renal failure, renal disease, proteinuria, diabetes mellitus, those who are receiving angiotensin-converting enzyme ACE inhibitors, angiotensin II receptor blockers ARBs , nonsteroidal anti-inflammatory drugs NSAIDs , moderate CYP3A4 inhibitors, or in elderly patients.

Eplerenone dose reduction is required for patients receiving moderate CYP3A4 inhibitors that cannot be avoided. Measure serum potassium before initiating eplerenone therapy, within the first week of therapy, and 1 month after the start of treatment or any dose adjustment. Monitor periodically thereafter. Patients receiving eplerenone should be informed not to use dietary salt substitutes containing potassium without consulting their prescribing health care professional.

Although eplerenone was not found to have any associated adverse effects in patients with mild to moderate hepatic impairment, it should be used cautiously in patients with severe hepatic disease; the use of eplerenone has not been evaluated in patients with severe hepatic impairment. Because eplerenone may cause dizziness, patients should use caution in driving or operating machinery until the effects of the drug are known.

Safety and efficacy of eplerenone in neonates, infants, children, and adolescents have not been established. Eplerenone has not been studied in pediatric heart failure patients or in those younger than 4 years. Data are insufficient with eplerenone use during pregnancy to establish a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

There are no human data available on whether eplerenone is present in human milk, or has effects on milk production or the breast-fed infant. Eplerenone is present in the milk of lactating rats. When a drug is present in animal milk, it is likely the drug will be present in human milk. Previous American Academy of Pediatrics AAP recommendations classified spironolactone as compatible with breast-feeding, and it may serve as a possible alternative.

Based on animal data, eplerenone may be associated with reproductive risk and male infertility. Reversibility of effects was not evaluated. Eplerenone-induced hyperkalemia can cause life-threatening cardiac arrhythmias; hyperkalemia is more likely to occur in certain patient populations such as the elderly. A subgroup analysis of the EPHESUS trial demonstrated that geriatric patients older than 75 years did not appear to benefit from the use of eplerenone for the treatment of heart failure post-MI and are at increased risk of hyperkalemia due to age-related decreases in creatinine clearance.

According to OBRA, antihypertensive regimens should be individualized to achieve the desired outcome while minimizing adverse effects. Antihypertensives may cause dizziness, postural hypotension, fatigue, and there is an increased risk for falls. There are many drug interactions that can potentiate the effects of antihypertensives.

Some agents require a gradual taper to avoid adverse consequences caused by abrupt discontinuation. Acetaminophen; Dichloralphenazone; Isometheptene: Major Sympathomimetics can antagonize the antihypertensive effects of adrenergic agonists when administered concomitantly. Patients should be monitored for loss of blood pressure control.

Alemtuzumab: Moderate Alemtuzumab may cause hypotension. Careful monitoring of blood pressure and hypotensive symptoms is recommended especially in patients with ischemic heart disease and in patients on antihypertensive agents. Aliskiren; Amlodipine: Moderate Amlodipine can have additive hypotensive effects with other antihypertensive agents. This additive effect can be desirable, but the patient should be monitored carefully and the dosage should be adjusted based on clinical response.

Aliskiren; Valsartan: Major Monitor serum potassium and serum creatinine concentrations within 3 to 7 days of initiating coadministration of eplerenone and angiotensin II receptor antagonists ARBs. Hyperkalemia risk is increased when eplerenone is used with ARBs. Patients who develop hyperkalemia may continue eplerenone with proper dose adjustment; eplerenone dose reduction decreases potassium concentrations.

Alprostadil: Minor The concomitant use of systemic alprostadil injection and antihypertensive agents, such as eplerenone, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository MUSE or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely.

Use caution with in-clinic dosing for erectile dysfunction ED and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil. Ambrisentan: Moderate Although no specific interactions have been documented, ambrisentan has vasodilatory effects and may contribute additive hypotensive effects when given with other antihypertensive agents.

Patients receiving ambrisentan in combination with other antihypertensive agents should be monitored for decreases in blood pressure.

Amifostine: Major Patients receiving antihypertensive agents should be closely monitored during amifostine infusions due to additive effects. If possible, patients should not take their antihypertensive medication 24 hours before receiving amifostine. Patients who can not stop their antihypertensive agents should not receive amifostine or be closely monitored during the infusion and, possibly, given lower doses.

Amiloride: Severe Eplerenone should not be used concomitantly with potassium-sparing diuretics e. The combine use of these medications in patients with hypertension or renal impairment contraindicated. Amiodarone: Major Do not exceed an eplerenone dose of 25 mg PO once daily if given concurrently with a CYP3A4 inhibitor in a post-myocardial infarction patient with heart failure. In patients with hypertension receiving a concurrent CYP3A4 inhibitor, initiate eplerenone at 25 mg PO once daily; the dose may be increased to a maximum of 25 mg PO twice daily for inadequate blood pressure response.

In addition, measure serum creatinine and serum potassium within 3 to 7 days of initiating a CYP3A4 inhibitor and periodically thereafter.

Eplerenone is a CYP3A4 substrate. Amiodarone is a CYP3A4 inhibitor. Increased eplerenone concentrations may lead to a risk of developing hyperkalemia and hypotension. Amlodipine: Moderate Amlodipine can have additive hypotensive effects with other antihypertensive agents. Amlodipine; Atorvastatin: Moderate Amlodipine can have additive hypotensive effects with other antihypertensive agents. Amlodipine; Benazepril: Major Monitor serum potassium and serum creatinine concentrations within 3 to 7 days of initiating coadministration of eplerenone and angiotensin-converting enzyme ACE inhibitors.

Hyperkalemia risk is increased when eplerenone is used with ACE inhibitors. Moderate Amlodipine can have additive hypotensive effects with other antihypertensive agents. Amlodipine; Celecoxib: Major Monitor serum potassium and serum creatinine concentrations within 3 to 7 days of initiating coadministration of eplerenone and nonsteroidal antiinflammatory drugs NSAIDs , and monitor blood pressure.

The concomitant use of other potassium-sparing antihypertensives with NSAIDs has been shown to reduce the antihypertensive effect in some patients and result in severe hyperkalemia in patients with impaired renal function. Amlodipine; Olmesartan: Major Monitor serum potassium and serum creatinine concentrations within 3 to 7 days of initiating coadministration of eplerenone and angiotensin II receptor antagonists ARBs.

Amlodipine; Telmisartan: Major Monitor serum potassium and serum creatinine concentrations within 3 to 7 days of initiating coadministration of eplerenone and angiotensin II receptor antagonists ARBs. Amlodipine; Valsartan: Major Monitor serum potassium and serum creatinine concentrations within 3 to 7 days of initiating coadministration of eplerenone and angiotensin II receptor antagonists ARBs.

Amobarbital: Moderate Concurrent use of amobarbital with antihypertensive agents may lead to hypotension. Monitor for decreases in blood pressure during times of coadministration.

Amoxicillin; Clarithromycin; Lansoprazole: Severe Coadministration of clarithromycin and eplerenone is contraindicated. Clarithromycin potently inhibits the hepatic CYP3A4 isoenzyme and can increase the serum concentrations of eplerenone. Amoxicillin; Clarithromycin; Omeprazole: Severe Coadministration of clarithromycin and eplerenone is contraindicated.

Amphetamine; Dextroamphetamine Salts: Minor Close monitoring of blood pressure or the selection of alternative therapeutic agents may be needed in patients receiving eplerenone and amphetamines. Amphetamines increase both systolic and diastolic blood pressure and may counteract the activity of some antihypertensive agents.

Amyl Nitrite: Moderate Concomitant use of nitrates with other antihypertensive agents can cause additive hypotensive effects. Dosage adjustments may be necessary. Angiotensin II receptor antagonists: Major Monitor serum potassium and serum creatinine concentrations within 3 to 7 days of initiating coadministration of eplerenone and angiotensin II receptor antagonists ARBs.

Angiotensin-converting enzyme inhibitors: Major Monitor serum potassium and serum creatinine concentrations within 3 to 7 days of initiating coadministration of eplerenone and angiotensin-converting enzyme ACE inhibitors. Apomorphine: Moderate Use of eplerenone and apomorphine together can increase the hypotensive effects of apomorphine.

Monitor blood pressure regularly during use of this combination. Apraclonidine: Minor Alpha blockers as a class may reduce heart rate and blood pressure.

While no specific drug interactions have been identified with systemic agents and apraclonidine during clinical trials, it is theoretically possible that additive blood pressure reductions could occur when apraclonidine is combined with the use of antihypertensive agents. Patients using cardiovascular drugs concomitantly with apraclonidine should have their pulse and blood pressure monitored periodically.

Aprepitant, Fosaprepitant: Major Do not exceed an eplerenone dose of 25 mg PO once daily if given concurrently with a CYP3A4 inhibitor in a post-myocardial infarction patient with heart failure. However, as a single mg intravenous dose, fosaprepitant only weakly inhibits CYP3A4 for a duration of 2 days. Aripiprazole: Minor Aripiprazole may enhance the hypotensive effects of antihypertensive agents. Asenapine: Moderate Secondary to alpha-blockade, asenapine can produce vasodilation that may result in additive effects during concurrent use of antihypertensive agents.

The potential reduction in blood pressure can precipitate orthostatic hypotension and associated dizziness, tachycardia, and syncope.

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Eplerenone

Medically reviewed by Drugs. Last updated on Aug 1, Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular CV events, primarily strokes and MI. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.

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Eplerenone, a mineralocorticoid receptor antagonist MRA , is available in Japan, but details of its use in clinical settings have not been thoroughly investigated. Data of , hypertensive patients who used the same drugs for six months or more were collected from an insurance database from January 1, , to December 31, Compared to patients on eplerenone or spironolactone, patients on neither drug had fewer comorbidities. Eplerenone was administered in combination with calcium channel blockers and angiotensin II receptor blockers in

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Database Analysis of Eplerenone Use in Japanese Hypertensive Patients in Clinical Practice

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