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| __NOTOC__
| | #REDIRECT [[Eplerenone#Warnings]] |
| {{Eplerenone}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Warnings and Precautions==
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| ===5.1 Hyperkalemia===
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| Minimize the risk of [[hyperkalemia]]with proper patient selection and monitoring, and avoidance of certain concomitant medications [See CONTRAINDICATIONS (4),ADVERSE REACTIONS (6.2), and DRUG INTERACTIONS (7)]. Monitor patients for the development of [[hyperkalemia]]until the effect of INSPRA is established. Patients who develop [[hyperkalemia]](>5.5 mEq/L) may continue INSPRA therapy with proper dose adjustment. Dose reduction decreases potassium levels. [SeeDOSAGE AND ADMINISTRATION (2.1).]
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| The rates of [[hyperkalemia]]increase with declining renal function. [See ADVERSE REACTIONS (6.2).] Patients with hypertension who have serum creatinine levels >2.0 mg/dL (males) or >1.8 mg/dL (females) or creatinine clearance ≤50 mL/min should not be treated with INSPRA. [See CONTRAINDICTIONS (4).] Patients with CHF post-MI who have serum creatinine levels >2.0 mg/dL (males) or >1.8 mg/dL (females) or creatinine clearance ≤50mL/min should be treated with INSPRA with caution.
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| Diabetic patients with CHF post-MI should also be treated with caution, especially those with [[proteinuria]]. The subset of patients in the EPHESUS study with both diabetes and proteinuria on the baseline urinalysis had increased rates of [[hyperkalemia]]compared to patients with either diabetes or [[proteinuria]]. [See ADVERSE REACTIONS (6.2).]
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| The risk of [[hyperkalaemia]] may increase when eplerenone is used in combination with an angiotensin converting enzyme (ACE) inhibitor and/or an [[angiotensin receptor blocker]] (ARB). [See DRUG INTERACTIONS (7.2)]
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| ===5.2 Impaired Hepatic Function===
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| Mild-to-moderate hepatic impairment did not increase the incidence of [[hyperkalemia]]. In 16 subjects with mild-to-moderate hepatic impairment who received 400 mg of eplerenone, no elevations of serum potassium above 5.5 mEq/L were observed. The mean increase in serum potassium was 0.12 mEq/L in patients with hepatic impairment and 0.13 mEq/L in normal controls. The use of INSPRA in patients with severe [[hepatic impairment]] has not been evaluated. [See CLINICAL PHARMACOLOGY (12.3).]
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| ===5.3 Impaired Renal Function===
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| Patients with decreased renal function are at increased risk of [[hyperkalemia]]. [See CONTRAINDICATIONS (4),WARNINGS AND PRECAUTIONS (5.1), ADVERSE REACTIONS (6.1).]<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a55a39ff-1bd5-428b-a64f-c44262e2f3ed | publisher = | date = | accessdate = 28 February 2014 }}</ref>
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| ==References==
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| {{Reflist}}
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| [[Category:Aldosterone antagonists]]
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| [[Category:Pfizer]]
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| [[Category:Lactones]]
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| [[Category:Epoxides]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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