Eplerenona Pentafarma Drug Interactions

Overview: Inhibitors of CYP3A4: EPLERENONA PENTAFARMA TABLETS (eplerenone) metabolism is predominantly mediated via CYP3A4 and therefore, EPLERENONA PENTAFARMA TABLETS should not be used with drugs described as strong inhibitors of CYP3A4 in their labeling (see Table 13 as follows, Contraindications, and Dosage & Administration).
Caution should be used in patients treated with mild to moderate CYP3A4 inhibitors; dosing should not exceed 25 mg QD in patients with an eGFR ≥50 mL/min/1.73 m². For patients with moderate renal impairment (eGFR 30-49 mL/min/1.73 m²), EPLERENONA PENTAFARMA TABLETS is not recommended because a lower dose than 25 mg once daily has not been studied.
Inducers of CYP3A4: St. John's Wort was found to decrease exposure and to increase clearance of EPLERENONA PENTAFARMA TABLETS significantly indicating that concomitant use of strong inducers of CYP3A4 such as phenobarbital, phenytoin, rifampicin, carbamazepine should be avoided.
ACE Inhibitors and Angiotensin II Receptor Antagonists: In EPHESUS and EMPHASIS-HF, 3020 (91%) and 1282 (94%) patients, respectively, receiving eplerenone 25 to 50 mg, also received ACE inhibitors or angiotensin II receptor antagonists (ACEI/ARB). Rates of patients with maximum potassium levels >5.5 mmol/L were similar regardless of the use of ACEI/ARB. However, as ACEI/ARB can also increase serum potassium levels in some patients, concomitant use with EPLERENONA PENTAFARMA TABLETS dictates that greater caution should be exercised.
Lithium: A drug interaction study of EPLERENONA PENTAFARMA TABLETS with lithium has not been conducted. However, lithium toxicity has been reported in patients receiving lithium concomitantly with diuretics and ACE inhibitors and concomitant administration of EPLERENONA PENTAFARMA TABLETS may worsen lithium toxicity. Serum lithium levels should be monitored frequently if EPLERENONA PENTAFARMA TABLETS is administered concomitantly with lithium, as excretion may be altered as a result of modifications in sodium balance induced by the aldosterone antagonist. Lithium has also been reported to increase plasma renin activity and aldosterone levels.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): A drug interaction study of EPLERENONA PENTAFARMA TABLETS with an NSAID has not been conducted. The administration of potassium-sparing antihypertensive drugs with NSAIDs has been shown to reduce the antihypertensive effect in some patients and result in severe hyperkalemia in patients with impaired renal function. Therefore, when EPLERENONA PENTAFARMA TABLETS and NSAIDs including COX-2 Inhibitors, are used concomitantly, blood pressure, renal function and serum potassium should be closely monitored.
Herbal Preparations and Salt Substitutes: The full consequence of using EPLERENONA PENTAFARMA TABLETS in patients taking herbal preparations and/or salt substitutes has not been established, and caution should be exercised. Theoretically, patients who are taking herbal preparations that affect blood pressure or contain high levels of potassium may be at risk of hypotension/hypertension or hyperkalemia (see Precautions). Clinicians should consider discontinuing the herbal preparation or salt substitute or closely monitoring patients using such a combination. Such preparations may include (but not limited to): dandelion, potassium iodine, laminaria, morinda, oleander, phosphate salts and potassium preparations, cat's claw, cod liver oil, and licorice.
Drug-Drug Interactions: Drug-drug interaction studies were conducted with a 100 mg dose of eplerenone and the outcomes are summarized in Table 13. (See Table 13.)

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Drug-Food Interactions: EPLERENONA PENTAFARMA TABLETS may be administered with or without food.