INSPRA (eplerenone) Product Monograph. Page 2 of Table of This leaflet is a summary and will not tell you everything about INSPRA. X. Package leaflet: Information for the patient. Eplerenone 25 mg film-coated tablets. Eplerenone 50 mg film-coated tablets. Eplerenone. Read all of this leaflet . Easy to read FDA package insert, drug facts, dosage and administration, and adverse effects for Inspra (eplerenone).

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Eplerenone is thought to suppress the adverse effects of aldosterone in in various organs including the endothelium by inhibiting aldosterone activity through binding eplerehone MRs [ 25 ]; thus, eplerenone is a pharmacologically promising drug to prevent end organ damage induced by aldosterone.

ADRs that were unpredictable from the package insert of Selara tablets were observed in 11 patients and included renal impairmentshinglesacute myeloid leukemialymphadenitisloss of appetitespasmear fullnessgastric ulcer eplereenone, fecal incontinenceand photosensitivity reaction.

Inhibitors of CYP3A e. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce CV morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits.

Additionally, the antihypertensive effects of eplerenone were evaluated. The packagge of patients at each time point is indicated by the SBP levels under the chart. Effects of eplerenone on heart and kidney in twokidney, one. In a study in patients with low renin hypertension, blood pressure reductions in Blacks were smaller than those in whites during the initial titration period with Eplerenone.


This organ damage includes ventricular remodeling [ 1516 ], renal impairment [ 17 — 19 ], and vascular endothelial dysfunction eplereonne 20 ]. Repeat dose administration of Eplerenone to rats increases the hepatic conjugation and clearance of thyroxin, which results in increased levels of TSH by a compensatory mechanism. Clinicians should pay careful attention to the contraindications listed on the package insert when prescribing drugs eplerenome conducting regular monitoring of serum potassium levels.


Testicular weight and histology were not affected by Eplerenone in any test animal species at any dosage. The incidence of adverse drug reactions classified according to the concomitant antihypertensive medication is presented in the Supplementary Material Table S2 to S9. For patients with an inadequate blood packagee response to 50 mg once daily increase the dosage of Eplerenone tablets to 50 mg twice daily.

No significant changes in Eplerenone pharmacokinetics were observed when Eplerenone was administered with aluminum- and magnesium-containing antacids. The full therapeutic effect of Eplerenone tablet is apparent within 4 weeks. Although precise definitions of severity were not provided, the physicians in charge were asked to judge the severity in a comprehensive manner, considering the disease duration, complications, concomitant medications, and other relevant factors.

Many patients will require more than one drug to achieve blood pressure goals. Administration of any concomitant treatment including other antihypertensive drugs was not restricted. However, patients that did not meet the requirements for determining safety according to the selection criteria i.

Eplerenone selectively binds to human mineralocorticoid receptors relative to its binding to recombinant human glucocorticoid, progesterone, and androgen receptors. In these studies, assessments of hour ABPM data demonstrated that Eplerenone, administered once or twice daily, maintained antihypertensive efficacy over the entire dosing interval. For inadequate blood pressure response, dosing may be increased to a maximum of 25 mg twice daily [See Dosage and Administration 2.


Both were prescribed more than 2 antihypertensive drugs in addition to eplerenone. This surveillance has several limitations. Eplerenone Rating 4 User Reviews 8.

Eplerenone – FDA prescribing information, side effects and uses

The pharmacokinetics of Eplerenone mg has been investigated in patients with moderate Child-Pugh Class B hepatic impairment and compared with normal subjects.

Creatinine packsge was calculated using the Cockcroft-Gault formula. The reasons for discontinuation were AEs The elimination half-life of Eplerenone is approximately 3 to 6 hours. The most frequent serious adverse events were hyperkalemia 8 cases followed by renal impairment 3 cases.

Eplerenone package insert pdf file

The rates increased with increasing duration of therapy. Among the patients included in the safety analysis, serious ADRs were observed in 0. In the analysis of the binary data, the frequencies and incidence of AEs were calculated.

Serious adverse events were seen in 15 among 2, patients who were taking concomitant antihypertensive medications at the time of initiation of eplerenone. Gynecomastia and abnormal vaginal bleeding were reported with Eplerenone but not with placebo.

eplerenone Entire Monograph – Epocrates Online

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Assess serum potassium periodically thereafter. Entresto is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure nyha class iiiv and reduced ejection fraction. Prednisolone is a synthetic glucocorticoid, a derivative of cortisol, used to treat a variety of inflammatory and autoimmune conditions and some cancers.