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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The incidence of adverse drug reactions classified according to the concomitant antihypertensive medication is presented in the Supplementary Material Table S2 to S9. Eplerenone is the first selective aldosterone receptor antagonist.
By clicking Subscribe, I agree to the Drugs. The recommended starting dose of Eplerenone tablets are 50 mg administered once daily.
Dogs showed emesis, salivation, and tremors at a C max 41 times the human therapeutic C maxprogressing to sedation and convulsions at higher exposures. There are no adequate and well-controlled studies in pregnant women. Prospective postmarketing surveillance of Selara eplerenonea selective mineralocorticoid receptor antagonist, was performed to confirm its safety and efficacy for hypertension treatment in Japan.
There were no exclusion criteria for patient registration. In these two studies, patients were randomized to Eplerenone eplereone patients to placebo. All the deaths were judged as not attributable to eplerenone.
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eplerenone Entire Monograph – Epocrates Online
Patients with a serum potassium value over 5. The incidence of hypotension among patients prescribed antihypertensive drugs in addition to eplerenone was considered as not high and the symptoms were improved.
Despite these limitations, this PMS has provided important information regarding the effect of eplerenone in patients with essential hypertension in real-world settings. No active metabolites of Eplerenone have been identified in human plasma.
Mean peak plasma concentrations of Eplerejone are reached approximately 1. If symptomatic hypotension should occur, supportive treatment elerenone be instituted. Patients treated with Eplerenone 50 mg to mg daily experienced significant decreases in sitting systolic and diastolic blood pressure at trough with differences from placebo of 6 to 13 mm Hg systolic and 3 to 7 mm Hg diastolic.
In contrast, the percentage of patients with serum potassium values over 5.
Itraconazole clearance decreases at higher doses due to saturable hepatic metabolism. Medically reviewed on Oct 1, Mineralocorticoid receptor antagonists MRAs have been shown to exert antihypertensive effects by binding to mineralocorticoid receptors MRs and blocking MR-dependent signal transduction.
There inxert no significant difference in the type or incidence of ADRs in this surveillance compared to results reported prior to approval of the drug. In this study and in a 1-year pediatric safety study in patients epleremone range 5 to 17 yearsthe incidence of reported adverse events was eperenone to that of adults. Published studies of eplerenone for hypertension used doses up to mgd despite the package insert limiting doses to 50 mg twice daily, reflecting concerns over hyper kalemia in patients with.
Effects of eplerenone on heart and kidney in twokidney. The risk of hyperkalemia increases when Eplerenone is used in combination with an ARB.
The drug is indicated to eperenone the survival of stable patients with leftventricular systolic dysfunction ejection fraction eplerenone, a selective aldosteronereceptor antagonist, clinical therapeutics on deepdyve, the largest online rental service for scholarly research with thousands of academic publications available at your fingertips.
A drug interaction study of Eplerenone with lithium has not been conducted. Control of high blood pressure should be part of comprehensive CV risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.
Hyperkalemia or increased serum potassium was observed in 20 and 6 patients, respectively Table 2. Assess serum potassium periodically thereafter. The safety and efficacy of Eplerenone has been evaluated in clinical studies of hypertensive patients.
Eplerenone is not removed by hemodialysis [see Warnings eplerenonf Precautions 5. International Journal of Hypertension. Eplerenone has not been studied in hypertensive patients less than 4 years old because the study in older pediatric patients did not demonstrate effectiveness. A total of patients were treated for over 6 months and patients were treated for over 1 year.
Fourth, this PMS was conducted as a noninterventional study under real-world settings and the results should be interpreted within this context. The pharmacokinetics of Eplerenone did not differ significantly between males and females. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. Between May and Aprilwe conducted a PMS that targeted hypertensive patients in Japan who had not previously been treated with eplerenone.
Eplerenone package insert pdf file
Therefore, the results of this surveillance also suggest that patients with renal impairment are more prone to hyperkalemia and that serum potassium levels should be properly monitored according to the package insert. Monitor patients for the jnsert of hyperkalemia until the effect of Eplerenone is established.
In patients with hypertension taking a moderate CYP3A inhibitor, initiate at 25 mg once daily.