EPHESUS EPLERENONE PDF

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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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The safety and efficacy of eplerenone in children and adolescents have not been established. Overall mortality was low with death reported in 3 of patients 0.

Results of pharmacokinetic studies with CYP3A4 probe-substrates, i.

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Trimethoprim The epheus administration of trimethoprim with eplerenone increases the risk of hyperkalaemia. You must accept the terms and conditions. One patient in each group did not start study medication and was not included in the safety analysis. Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: Drug interaction studies of eplerenone have not been conducted with lithium.

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.

Eplerenone 50 mg film-coated tablets

Reporting suspected adverse reactions after authorisation of the medicinal product is important. The concomitant use of eplerenone and cyclosporin or tacrolimus should be avoided. Eplerenone is not removed by haemodialysis see section 4.

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. Each tablet contains 50 mg of eplerenone. Dosing should not exceed 25 mg OD see section 4. Therefore, these patients should be treated with caution. eplerehone

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Madrid, SpainC. In contrast, patients with hypokalaemia serum potassium concentration below 3.

Diarrhoea, nausea, constipation, vomiting. It furthers the University’s objective of excellence in research, scholarship, and education by publishing worldwide. No studies on the effect of eplerenone on the ability to drive or use machines have been performed. This medicinal product does not require any special storage conditions. During the course of the study, 28 patients 5. Eplerenone therapy should usually be started within days after an acute MI.

Reproductive system and breast disorders. The concomitant use of eplerenone with strong CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazadone, is contra-indicated see section 4. Lithium, cyclosporin, tacrolimus should be avoided during treatment with eplerenone see section 4.

Co-administration of these drugs with eplerenone may potentially ephesks antihypertensive effects and risk of postural hypotension. Sensitivity analyses were also performed using unadjusted Epheaus models.

Hyperkalaemia Consistent with its mechanism of action, hyperkalaemia may occur with eplerenone. Impaired renal function Potassium levels should be monitored regularly in patients with impaired renal function, including diabetic microalbuminuria. No initial dose adjustment is necessary for patients with mild-to-moderate hepatic impairment.

The concomitant administration of trimethoprim with eplerenone increases the risk of hyperkalaemia.

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The treatment-by-subgroup interaction was evaluated by means of a Cox proportional-hazards model with terms for treatment, subgroup, and their interaction. Frequencies are defined as: Paediatric population A population pharmacokinetic model for eplerenone concentrations from two studies in 51 paediatric hypertensive subjects of ages 4 to 16 years identified that patient body weight had a statistically significant effect on eplerenone volume of distribution but not on its clearance.

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Idiopathic Pulmonary Fibrosis for Cardiologists: Plasma aldosterone levels during hospitalization are predictive of survival post-myocardial infarction. Significant pharmacokinetic interactions may occur when eplerenone is co-administered with drugs that inhibit the CYP3A4 enzyme.

Metabolism and nutrition disorders. The pharmacokinetics of eplerenone mg have been investigated in patients with moderate Child-Pugh Class B hepatic impairment and compared with normal subjects.

However, lithium toxicity has been reported in patients receiving lithium concomitantly with diuretics and ACE inhibitors see section 4.

Renal and urinary disorders. The composite of CV mortality, re-hospitalization, or extended initial hospital stay due to diagnosis of HF, or sustained ventricular tachycardia or fibrillation was a secondary composite endpoint pre-specified in the statistical analysis plan. For the full list of excipients, see section 6.

Lactose 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. Juan Ramon Rey Blas. Dphesus reduction of eplerenone has been shown to decrease serum potassium levels. Electrolyte levels should be monitored in patients with mild to moderate hepatic impairment. Bad Nauheim, GermanyM. Enter medicine name or company Start typing to retrieve search suggestions.

General disorders and administration site conditions. More on eplerenonw topic Eplereone between C-reactive protein and generalized anxiety disorder in stable coronary heart disease patients. Hyperkalaemia see sections 4. The clinical relevance of these findings is unknown.