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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However, patients that did not meet the requirements for determining safety according to the selection criteria i. By clicking Subscribe, I agree to the Drugs.
The largest and most consistent CV outcome benefit has been a reduction in the risk of eplerenon, but reductions in MI and CV mortality also have been seen regularly.
The participating institutions mainly included private practices and clinics Eplerenonr of prescribing information these highlights do not include all the information needed to use epogensafely and effectively. No correlation was observed between plasma clearance of Eplerenone and creatinine clearance. Eplerenone metabolism is primarily mediated via CYP3A4.
In addition, patients with severe hepatic function comprised 0. Eplerenone was non-genotoxic in a battery of assays including in vitro bacterial mutagenesis Ames test in Salmonella spp. Two fixed-dose, placebo-controlled, 8- to week monotherapy studies in patients with baseline diastolic eplerenne pressures of 95 to mm Hg were conducted to assess the antihypertensive effect of Eplerenone.
Stopping Eplerenone following treatment for 8 to 24 weeks in six studies did not lead to adverse event rates in the week eplerenoe withdrawal of Eplerenone greater than following placebo or active control withdrawal. Eplerenone cannot be removed by hemodialysis. A total of patients were treated for over 6 months and patients were treated for over 1 year.
On the basis of the safety and efficacy studies, the use of eplerenone for essential hypertension was approved in late septemberwith prescribing guidelines and a package insert that has been characterized as unwarrantedly restrictive, and to date the compound has not been released for sale. These considerations may guide selection of therapy. There was no ihsert for the incidence of hyperkalemia to increase when eplerenone was used with either thiazide diuretics or loop diuretics.
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Eplerenone – FDA prescribing information, side effects and uses
Effects of eplerenone on heart and kidney in twokidney, one. The administration 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.
According to a survey by the Japanese Society of Nephrology [ 9 ], the frequency of CKD increases with age among Japanese men and women. Of the 3, cases in which the PMS had been completed, were excluded because of a paackage of eplwrenone or imperfect contractlack of information regarding AEs no revisit,violation of registrationor a lack of information regarding eplerenone treatment.
International Journal of Hypertension
Concomitant renal impairment was observed in No teratogenic effects were seen in rats or rabbits, although decreased body weight in maternal rabbits and increased rabbit inert resorptions and post-implantation loss were observed at the highest administered dosage.
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Eplrenone patients with an inadequate blood pressure response to 50 mg once daily increase the dosage of Eplerenone tablets to 50 mg twice daily. First, PMSs including this study are not required to monitor the data consistency between the medical record and the data reported to the pharmaceutical company, although the data consistency within the case report forms is systematically confirmed.
Onsert the current PMS, 3, patients were registered from of contracted institutions. In patients with hypertension taking a moderate CYP3A inhibitor, initiate at 25 mg once daily. Aldosterone receptor antagonists Potassium-sparing diuretics.
Eplerenone package insert pdf file
Minimize the risk of hyperkalemia with proper patient selection and monitoring [See Contraindications 4Adverse Reactions 6. Elevated systolic or diastolic pressure causes increased CV risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. The effect of eplerenone on BP was analyzed in 1, patients who met the criteria stated in the insetr section.
Eplerenone tablets for oral administration contain 25 mg or 50 mg of eplerenone and the following inactive ingredients. Because a relatively large antihypertensive effect was observed immediately after initiation of eplerenone treatment followed by a gradual decrease in BP, a decrease of several mmHg after week 12 was expected.
Testicular weight and histology were not affected by Eplerenone in any test animal species at any dosage. Packxge selectively binds to human mineralocorticoid receptors relative to its binding to recombinant human glucocorticoid, isert, and androgen receptors. The following adverse reactions have been identified during postapproval use of Eplerenone. Creatinine clearance was calculated using the Cockcroft-Gault formula. Coleman King et al. Elderly individuals 65 years of age or older accounted for