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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Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular CV events, primarily strokes and MI. Interactions that may increase risk of arrhythmias with eplerenone8,9 mechanism of interaction medications potent inhibitors of cyp 3a4 ketoconazole, itraconazole, troleandomycin, clarithromycin, nefazodone, nelfinavir, ritonavir.
In total, 3, patients were therefore included in the safety analysis. There was no significant difference in the type or incidence of ADRs in this surveillance compared to results reported prior to approval of the drug.
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Adverse events AEs were assessed as a safety endpoint. In these studies, assessments of hour ABPM data demonstrated that Eplerenone, administered once or twice daily, maintained antihypertensive efficacy over the entire dosing interval. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug insret any changes in indications and dosage and for added warnings and precautions.
In addition, combination therapy consisting of drugs with different mechanisms of action has been recommended to further lower BP without causing adverse drug reactions ADRs [ 2 ].
The concentration packagr Eplerenone in human breast milk after oral administration is unknown. 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.
Eplerenone tablets for oral administration contain 25 mg or 50 mg of eplerenone and the following inactive ingredients. Itraconazole clearance decreases at higher doses due to saturable hepatic metabolism.
The major ADRs of these patients were hyperkalemia 3. As the leader in providing barcoded medications to hospitals and tlc facilities, ahp is the only industry supplier for these types of ud products.
The incidence of adverse drug reactions was 2. For examination of changes in blood pressure, patients were excluded if eplerenone was contraindicated or used off-label. View at Google Scholar W.
A total of patients were treated for over 6 months and patients were treated for over 1 year.
Eplerenone binds to the mineralocorticoid receptor and blocks the binding of aldosterone, a component of the renin-angiotensin-aldosterone-system RAAS. Highlights of prescribing information these highlights do not include all the information needed to use injectafer safely and effectively. There have been concerns regarding a possible increase in serum potassium levels caused by the pharmacological actions of inert.
eplerenone Entire Monograph – Epocrates Online
This postmarketing surveillance PMS was conducted to identify unknown ADRs that are not stated in the package insert of Selara tablets [ 7 ], estimate the incidence of ADRs including hyperkalemia in general practice, and elucidate the factors that affect the safety of the drug when it is used in Japanese hypertensive patients.
Assessments of Effectiveness The effectiveness of blood pressure reduction was assessed weeks after initiation of eplerenone treatment. Of these patients, eplerennone had moderate or mild hepatic function disorder, 8 had moderate or mild renal impairment, and 3 had functional class II heart failure according to the New York Heart Association NYHA classification system. Despite these limitations, this PMS has provided important information regarding the effect of eplerenone in patients with essential hypertension in real-world settings.
If symptomatic hypotension should occur, supportive treatment should be instituted. Find information about a drug food eplerenonf drug administration.
These effects were confirmed by assessments with hour ambulatory blood pressure monitoring ABPM. Its empirical formula is C 24 H 30 O 6 and it has a molecular weight of Eplerenone is cleared predominantly by cytochrome P CYP 3A4 metabolism, with an elimination half-life of 3 to 6 hours. 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.
They are supplied as follows:. For the prevention and control of bleeding in patients with factor ix deficiency due to hemophilia b. FDA alerts inseert all medications. On the basis of the safety and efficacy studies, the use of eplerenone for essential hypertension was approved in late septemberwith inwert guidelines and a package insert that has been characterized as unwarrantedly restrictive, and to date the compound has not been released for sale.
Eplerenone – FDA prescribing information, side effects and uses
The elimination half-life of Eplerenone is approximately 3 to 6 hours. This material is packsge for educational purposes only and is not intended for medical advice, diagnosis or treatment. Effects of eplerenone on heart and kidney in twokidney. These considerations may guide selection of therapy. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records.
The other institutions included national, public, and private university hospitals.
By packagee Subscribe, I agree to the Drugs. In this PMS, the occurrence of adverse events was more frequent in patients with renal impairment, and many of the events were hyperkalemia. Eplerenone selectively binds to human mineralocorticoid receptors relative to its binding to recombinant human glucocorticoid, progesterone, and androgen receptors.
Eplerenone tablets for oral administration contains 25 mg or 50 mg of Eplerenone and the following inactive ingredients: The following adverse reactions have been identified during postapproval use of Eplerenone. Meyer III and N. Mineralocorticoid receptor antagonists MRAs have been shown to exert antihypertensive effects by binding to mineralocorticoid receptors MRs and blocking MR-dependent signal transduction. A total of patients were treated for ineert 6 months and patients were treated for over 1 year.