Pitt B(1), Remme W, Zannad F, Neaton J, Martinez F, Roniker B, Bittman R, Hurley S, Kleiman J, Gatlin M; Eplerenone Post-Acute Myocardial. Insights from an EPHESUS (Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study) substudy. Rossignol P(1), Ménard J, Fay R. Eur J Heart Fail. May;8(3) Epub Feb Evaluation of eplerenone in the subgroup of EPHESUS patients with baseline left ventricular.
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Periodic monitoring of serum potassium is recommended see section 4. Intravenous enoxaparin or unfractionated heparin in primary percutaneous coronary intervention for ST-elevation myocardial infarction: Co-administration of eplerenone and lithium should be avoided.
In one study, the addition of hydrochlorothiazide to eplerenone therapy has been shown to offset increases in serum potassium. Hyperkalaemia see sections 4. Renal Insufficiency The pharmacokinetics of eplerenone were evaluated in patients with varying degrees of renal insufficiency and in patients undergoing haemodialysis. Serum potassium should be assessed as needed periodically thereafter.
Warfarin No clinically significant pharmacokinetic interactions have been observed with warfarin. NYHA functional classification improved or remained stable for a statistically significant greater proportion of subjects receiving eplerenone compared to placebo.
Erratum in N Engl J Med. A close monitoring of serum potassium and renal function is recommended, especially in patients at risk for impaired renal function, e. Forrest plot on the primary composite endpoint with eplerenone vs. Both peak plasma levels C max and area under the curve AUC are dose proportional for doses of 10 mg to mg and less than proportional at doses ephesuus mg.
Eplerenone 50 mg film-coated tablets – Summary of Product Characteristics (SmPC) – (eMC)
Enter medicine name or company Start typing to retrieve search suggestions. Show table of contents Hide table of contents 1. Aldosterone receptor antagonist use after myocardial infarction. Eplerenone is not ephfsus by haemodialysis. Name of the medicinal product 2. Idiopathic Pulmonary Fibrosis for Cardiologists: Consistent with its mechanism of action, hyperkalaemia may occur with eplerenone.
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Comment in J Fam Pract. Marketing authorisation number s 9. Sensitivity analyses were also performed using unadjusted Cox models. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: Alpha 1 blockers e. The effect in each subgroup was analysed with the use of a Cox proportional-hazards model, without adjustment for epesus. Esteban Lopez de Sa.
Clinical monitoring for postural hypotension is recommended during alphablocker co-administration. It is unknown if eplerenone is excreted in human breast milk after oral administration.
Tricyclic anti-depressants, neuroleptics, amifostine, baclofen Co-administration of these drugs with eplerenone may potentially increase antihypertensive effects and risk of postural hypotension. View large Download slide. Eplerenone has been shown to bind extensively to charcoal. Eplerenone treatment was initiated at 25 mg ephessus daily in paediatric patients and increased to 25 mg twice daily after 2 weeks and eventually to 50 mg twice daily, if clinically indicated.
Lithium, cyclosporin, tacrolimus should be avoided during treatment with eplerenone see section 4.
Eplerenone 50 mg film-coated tablets
The trial was monitored by an independent data and safety monitoring committee. Temporal trends and predictors in the use of aldosterone antagonists post-acute myocardial infarction. There was however no statistical significant difference between the occurrence of stroke in the eplerenone eplerejone vs placebo 22 groups.
We conducted a double-blind, placebo-controlled study evaluating the effect of eplerenone, a selective aldosterone blocker, on morbidity and mortality among patients with acute myocardial infarction complicated by left ventricular dysfunction and heart failure.
Eplerenone was started at a dose of 25 mg once daily and was to be increased to 50 mg once daily starting on day 2 if serum potassium concentration was below 5. Patients were randomly assigned to eplerenone 25 ephesu per day initially, titrated to a maximum of 50 mg per day; patients or placebo patients [correction] in addition to optimal medical therapy.
If needed, close monitoring of serum potassium and renal function are recommended when cyclosporine and tacrolimus are to be administered during treatment with eplerenone see section 4. The tablets contain lactose and should not be administered in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. MedDRA system organ class. NT-proBNP testing for diagnosis and short-term prognosis in acute destabilized eplerejone failure: In this study and in a 1-year paediatric safety study in subjects, the safety profile was similar to that of adults.
Randomization had to take place as early as possible following diagnosis and the first dose of study drug administered within 24 h of the onset of symptoms of acute MI and preferably within 12 h.
Overall mortality was low with death reported in 3 of patients 0. Impaired renal function Potassium levels should be monitored regularly in patients with impaired renal function, including diabetic microalbuminuria. Company contact details Consilient Health Ltd. All patients provided written informed consent.
It should also be emphasized that there were eplerenons deaths associated with the development of hyperkalaemia in patients randomized to eplerenone.