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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Introduction Hypertension is a major public health issue in many countries. Eplerenone does not preferentially bind to red blood cells. To view content sources and attributions, please refer to our editorial policy.

Eplerenone metabolism is primarily mediated via CYP3A4. Recent studies have revealed that organ damage occurs in the cardiovascular system and kidneys when aldosterone coexists with high sodium. There was no significant change in average heart rate among patients treated with Eplerenone in the combined clinical studies. There have been concerns regarding a possible increase in serum potassium levels caused by the pharmacological actions of eplerenone. Therefore, it is important to provide guidance for lifestyle modifications and to administer strict treatment with antihypertensive drugs according to the target blood pressure BP levels, depending on the comorbidities [ 2 ].

Bumetanide trade names bumex or burinex is a loop diuretic of the sulfamyl category, most often used to treat heart failure. Aldosterone receptor antagonists Potassium-sparing diuretics.

Eplerenone package insert pdf file

For examination of changes in blood pressure, patients were excluded if eplerenone was packag or used off-label. When administered concomitantly with one of these drugs Eplerenone usually produced its expected antihypertensive effects. Online convert pdf to tiff application software utility.


A total of patients were treated for over 6 months and patients were treated for over 1 year.

No correlation was observed between plasma clearance of Eplerenone and creatinine clearance. The major ADRs of these patients were hyperkalemia 3. Absorption is not affected by food.

eplerenone Entire Monograph – Epocrates Online

Online convert pdf to tiff application software utility html. Among the 3, patients included in the safety analysis, Eplerenone is not removed by hemodialysis [see Warnings and Precautions 5.

Eplerenone is thought to suppress the adverse effects of aldosterone in in various organs including the endothelium by inhibiting aldosterone activity through binding to MRs [ 25 ]; thus, eplerenone is a pharmacologically promising drug to prevent end organ damage induced by aldosterone. Fourth, this PMS was conducted as a noninterventional study under real-world settings and the results should be interpreted within packgae context.

For hepatic function abnormality and renal impairment, categories determined by the physician in charge were adopted.

Eplerenone is cleared predominantly by cytochrome P CYP 3A4 metabolism, with an elimination half-life of 3 to 6 hours. Search drug package insert information on dailymed uptodate resource from nih with information from drug labels package inserts for fda approved drugs.

Among the 2, patients who were prescribed antihypertensive medications other than eplerenone at the time of initiation of eplerenone treatment, 2 cases developed hypotension.


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In particular, most patients had stage 3 CKD glomerular filtration rate: FDA alerts for all medications. For the prevention and control of bleeding in patients with factor ix deficiency due to hemophilia b. Concomitant diabetes was observed in Meyer III and N. An extensive list of all adverse drug events that occurred in patients receiving eplerenone can be found in the package insert.

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Serum lithium levels should be monitored frequently if Eplerenone is administered concomitantly with lithium. 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. Among the patients included in the safety analysis, ADRs were observed in 75, and the incidence was 2.

Despite these limitations, this PMS has provided important information regarding the effect of eplerenone in patients with essential hypertension in real-world settings.

Clinicians should pay careful attention to the contraindications listed on the package insert when prescribing drugs and conducting regular monitoring of serum potassium levels.