Home FDA labels 3bbca54f-08ae-4ef7-8a8c-75a204f4df8a FDA label 3bbca54f-08ae-4ef7-8a8c-75a204f4df8a openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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SPL ID 3bbca54f-08ae-4ef7-8a8c-75a204f4df8a
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warnings and cautions 5 WARNINGS AND PRECAUTIONS Hyperkalemia: Patients with decreased renal function and diabetics with proteinuria are at increased risk. Proper patient selection and monitoring and avoiding certain concomitant medications can minimize the risk. (5.1) Eplerenone Tablets 50 mg contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. (5.4) 5.1 Hyperkalemia Minimize the risk of hyperkalemia with proper patient selection and monitoring and avoidance of certain concomitant medications [See 4 CONTRAINDICATIONS , ADVERSE REACTIONS , 6.2 Clinical Laboratory Test Findings ) and 7 DRUG INTERACTIONS ]. Monitor patients for the development of hyperkalemia until the effect of eplerenone is established. Patients who develop hyperkalemia (>5.5 mEq/L) may continue eplerenone therapy with proper dose adjustment. Dose reduction decreases potassium levels. [See DOSAGE AND ADMINISTRATION , 2.1 Congestive Heart Failure Post-Myocardial Infarction .] The rates of hyperkalemia increase with declining renal function. [See ADVERSE REACTIONS , 6.2 Clinical Laboratory Test Findings .] Patients with hypertension who have serum creatinine levels >2.0 mg/dL (males) or >1.8 mg/dL (females) or creatinine clearance ≤50mL/min should not be treated with eplerenone [See 4 CONTRAINDICATIONS ]. 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 eplerenone with caution. 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 Clinical Laboratory Test Findings .] 5.2 Impaired Hepatic Function 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 eplerenone in patients with severe hepatic impairment has not been evaluated. [See CLINICAL PHARMACOLOGY, 12 CLINICAL PHARMACOLOGY .] 5.3 Impaired Renal Function Patients with decreased renal function are at increased risk of hyperkalemia. [See 4 CONTRAINDICATIONS , WARNINGS AND PRECAUTIONS , 5.1 Hyperkalemia , ADVERSE REACTIONS , 6.1 Clinical Trials Experience .] 5.4 Allergic Reaction Eplerenone Tablets 50 mg contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
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adverse reactions table <table ID="id_415d76b6-4d59-4c27-99f3-c0c012a6fccc" border="single" width="228.000"> <caption ID="id_30ec6427-acf7-4163-bb8f-d28c5f0420ba">Table 5: Hypokalemia (<3.5 mEq/L) or Hyperkalemia (>5.5 or ≥6.0 mEq/L) in EPHESUS</caption> <col width="29.4%"/> <col width="33.3%"/> <col width="37.3%"/> <tbody> <tr ID="id_3ed71e2c-4173-4e39-908d-bf5feb5d5134"> <td align="center" styleCode="Botrule Toprule Rrule Lrule" valign="top"> <paragraph> <content styleCode="bold">Potassium</content> </paragraph> <content styleCode="bold">(mEq/L)</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <paragraph> <content styleCode="bold">Eplerenone (N=3,251)</content> </paragraph> <content styleCode="bold">n (%)</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <paragraph> <content styleCode="bold">Placebo</content> </paragraph> <paragraph> <content styleCode="bold">(N=3,237)</content> </paragraph> <content styleCode="bold">n (%)</content> </td> </tr> <tr ID="id_dc0b9466-a70e-4a92-9e9d-2b76ed392df9"> <td align="left" styleCode="Lrule Botrule Rrule" valign="top"><3.5</td> <td align="center" styleCode="Botrule Rrule" valign="top">273 (8.4)</td> <td align="center" styleCode="Botrule Rrule" valign="top">424 (13.1)</td> </tr> <tr ID="id_eb7556d9-ff74-4e5d-b629-460f1ea10b16"> <td align="justify" styleCode="Lrule Botrule Rrule" valign="top"> <paragraph>>5.5</paragraph> </td> <td align="center" styleCode="Botrule Rrule" valign="top">508 (15.6)</td> <td align="center" styleCode="Botrule Rrule" valign="top">363 (11.2)</td> </tr> <tr ID="id_894f4f99-3022-469c-bd28-c18e5dd08aa0"> <td align="justify" styleCode="Lrule Botrule Rrule" valign="top"> <paragraph>≥ 6.0</paragraph> </td> <td align="center" styleCode="Rrule" valign="top">180 (5.5)</td> <td align="center" styleCode="Botrule Rrule" valign="top">126 (3.9)</td> </tr> </tbody> </table>
adverse reactions table <table ID="id_c739fb30-9b55-4d4d-8ddd-ca14c890e3c9" border="single" width="247.000"> <caption ID="id_aef7655c-40d8-4419-87f3-94fa7f8d2c50">Table 6: Rates of Hyperkalemia (>5.5 mEq/L)in EPHESUS by Baseline Creatinine Clearance </caption> <col width="38.1%"/> <col width="29.1%"/> <col width="32.8%"/> <tbody> <tr ID="id_c18d2545-6459-4eb7-920f-9c5d9a803bcb"> <td align="center" styleCode="Botrule Toprule Rrule Lrule" valign="top"> <content styleCode="bold">Baseline Creatinine Clearance</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <paragraph> <content styleCode="bold">Eplerenone (N=508)</content> </paragraph> <content styleCode="bold">n (%)</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <paragraph> <content styleCode="bold">Placebo</content> </paragraph> <paragraph> <content styleCode="bold">(N=363)</content> </paragraph> <content styleCode="bold">n (%)</content> </td> </tr> <tr ID="id_69321c5c-e3be-4e90-8033-9bea97d5d177"> <td align="center" styleCode="Lrule Botrule Rrule" valign="top"> <paragraph>≤30 mL/min</paragraph> </td> <td align="center" styleCode="Botrule Rrule" valign="top">160 (32)</td> <td align="center" styleCode="Botrule Rrule" valign="top">82 (23)</td> </tr> <tr ID="id_bbf67dbe-0df8-40e2-92f1-2843d5fb7b95"> <td align="center" styleCode="Lrule Botrule Rrule" valign="top"> <paragraph>31–50 mL/min</paragraph> </td> <td align="center" styleCode="Botrule Rrule" valign="top">122 (24)</td> <td align="center" styleCode="Botrule Rrule" valign="top">46 (13)</td> </tr> <tr ID="id_6b606acd-73ec-49d5-a9d1-81ff6c1d20c4"> <td align="center" styleCode="Lrule Botrule Rrule" valign="top">51–70 mL/min</td> <td align="center" styleCode="Botrule Rrule" valign="top">86 (17)</td> <td align="center" styleCode="Botrule Rrule" valign="top">48 (13)</td> </tr> <tr ID="id_f5719c0a-aba9-4e6a-9427-e52fbe32d7f2"> <td align="center" styleCode="Lrule Botrule Rrule" valign="top"> <paragraph>>70 mL/min</paragraph> </td> <td align="center" styleCode="Rrule" valign="top">56 (11)</td> <td align="center" styleCode="Botrule Rrule" valign="top">32 (9)</td> </tr> </tbody> </table>
adverse reactions table <table ID="id_0ace0d82-3ac2-430d-bb27-ae1096345087" border="single" width="197.000"> <caption ID="id_a7e44fc1-5954-4009-bbeb-ab14e7c8828c">Table 7: Rates of Hyperkalemia ( >5.5 mEq/L)in EPHESUS by Proteinuria and History of Diabetes </caption> <col width="38.6%"/> <col width="34.0%"/> <col width="27.4%"/> <tbody> <tr ID="id_6be95584-69c9-4f6c-96f6-27af6ef6753d"> <td align="left" styleCode="Botrule Toprule Rrule Lrule" valign="top"> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <paragraph> <content styleCode="bold">Eplerenone</content> </paragraph> <paragraph> <content styleCode="bold">(N=508)</content> </paragraph> <content styleCode="bold">n (%)</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <paragraph> <content styleCode="bold">Placebo</content> </paragraph> <paragraph> <content styleCode="bold">(N=363)</content> </paragraph> <content styleCode="bold">n (%)</content> </td> </tr> <tr ID="id_bacc5c8d-2169-4d03-9fea-780b89e2c8cb"> <td align="left" styleCode="Lrule Botrule Rrule" valign="top"> <paragraph>Proteinuria, no Diabetes</paragraph> </td> <td align="center" styleCode="Botrule Rrule" valign="top">81 (16)</td> <td align="center" styleCode="Botrule Rrule" valign="top">40 (11)</td> </tr> <tr ID="id_73cac11e-ad83-46c2-b9f8-96c1ca8e8d48"> <td align="justify" styleCode="Lrule Botrule Rrule" valign="top"> <paragraph>Diabetes, no Proteinuria</paragraph> </td> <td align="center" styleCode="Botrule Rrule" valign="top">91 (18)</td> <td align="center" styleCode="Botrule Rrule" valign="top">47 (13)</td> </tr> <tr ID="id_659f9ef2-7882-423e-a852-4b0a88f31522"> <td align="left" styleCode="Lrule Botrule Rrule" valign="top"> <paragraph>Proteinuria and Diabetes</paragraph> </td> <td align="center" styleCode="Rrule" valign="top">132 (26)</td> <td align="center" styleCode="Botrule Rrule" valign="top">58 (16)</td> </tr> </tbody> </table>
adverse reactions table <table ID="id_d31f4f37-7f68-40ad-a603-996093b83a9d" border="single" width="233.000"> <caption ID="id_db7dffc5-615f-4385-9862-b0f7a7994f22">Table 8: Increases in Serum Potassium in the Placebo-Controlled, Fixed-Dose Hypertension Studies of Eplerenone</caption> <col width="24.0%"/> <col width="14.6%"/> <col width="34.8%"/> <col width="26.6%"/> <tbody> <tr ID="id_7b2d4f53-32b5-4b04-afa1-9360708740dc"> <td align="left" colspan="2" styleCode="Botrule Toprule Rrule Lrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"> <paragraph> <content styleCode="bold">Mean Increase</content> </paragraph> <content styleCode="bold">mEq/L</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">%> 5.5 mEq/L</content> </td> </tr> <tr ID="id_9cb9bed8-5690-4d9d-9058-b4f7d2a6baba"> <td align="left" styleCode="Lrule Botrule Rrule" valign="top"> <content styleCode="bold">Daily Dosage</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">n</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> </tr> <tr ID="id_9c30b625-0d03-4053-8bef-996fb660a716"> <td align="left" styleCode="Lrule Botrule Rrule" valign="top">Placebo</td> <td align="center" styleCode="Botrule Rrule" valign="top">194</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> <td align="center" styleCode="Botrule Rrule" valign="top">1</td> </tr> <tr ID="id_8dfcc3a8-36d4-47de-95e8-85256a29759f"> <td align="center" styleCode="Lrule Botrule Rrule" valign="top">25</td> <td align="center" styleCode="Botrule Rrule" valign="top">97</td> <td align="center" styleCode="Botrule Rrule" valign="top">0.08</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> </tr> <tr ID="id_293d5f81-0963-44fe-bb95-8336f39fe307"> <td align="center" styleCode="Lrule Botrule Rrule" valign="top">50</td> <td align="center" styleCode="Botrule Rrule" valign="top">245</td> <td align="center" styleCode="Botrule Rrule" valign="top">0.14</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> </tr> <tr ID="id_76b82ec0-6ca5-4913-b04a-023023aba8ee"> <td align="center" styleCode="Lrule Botrule Rrule" valign="top">100</td> <td align="center" styleCode="Botrule Rrule" valign="top">193</td> <td align="center" styleCode="Botrule Rrule" valign="top">0.09</td> <td align="center" styleCode="Botrule Rrule" valign="top">1</td> </tr> <tr ID="id_d8037f06-f29a-4955-81c2-d6abaeb78cad"> <td align="center" styleCode="Lrule Botrule Rrule" valign="top">200</td> <td align="center" styleCode="Botrule Rrule" valign="top">139</td> <td align="center" styleCode="Botrule Rrule" valign="top">0.19</td> <td align="center" styleCode="Botrule Rrule" valign="top">1</td> </tr> <tr ID="id_f8b00bae-9db0-45b2-97cf-4d8e212df5da"> <td align="center" styleCode="Lrule Botrule Rrule" valign="top">400</td> <td align="center" styleCode="Rrule" valign="top">104</td> <td align="center" styleCode="Rrule" valign="top">0.36</td> <td align="center" styleCode="Botrule Rrule" valign="top">8.7</td> </tr> </tbody> </table>
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