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Inspra

Inspra

eplerenone

Manufacturer:

Viatris Pharmaceuticals

Distributor:

Viatris
Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing
Concise Prescribing Info
Contents
Eplerenone
Indications/Uses
HTN (alone or in combination w/ other antihypertensives). Addition to standard therapy to reduce the risk of CV mortality & morbidity in stable patients w/ left ventricular dysfunction [left ventricular ejection fraction (LVEF) ≤40%] & clinical evidence of heart failure after recent MI; in adults w/ NYHA class II (chronic) heart failure & left ventricular systolic dysfunction (LVEF ≤35%).
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Dosage/Direction for Use
HTN Initially 50 mg once daily, can be increased to 100 mg daily if BP is inadequately controlled. Max: 100 mg daily. Heart failure-post MI Initially 25 mg once daily & titrated in 1 step to the target dose of 50 mg once daily w/in 4 wk, taking into account the serum K level. Maintenance: 50 mg once daily. Max: 50 mg daily. NYHA class II (chronic) heart failure Initially 25 mg once daily & titrated to the target dose of 50 mg once daily preferably w/in 4 wk, taking into account the serum K level. Patient w/ moderate renal impairment (CrCl 30-60 mL/min) Initially 25 mg every other day, & dose should be adjusted based on K level.
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Overdosage
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Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Clinically significant hyperkalemia or w/ conditions associated w/ hyperkalemia. Serum K level >5 mmol/L (mEq/L) at initiation. Hypertensive patients w/ type 2 diabetes w/ microalbuminuria; serum creatinine >2 mg/dL (or >177 micromol/L) in males or >1.8 mg/dL (or >159 micromol/L) in females; & concomitant use w/ K supplements. Concomitant use w/ K-sparing diuretics or potent inhibitors of CYP3A4 (eg, ketoconazole, itraconazole, & ritonavir). Moderate to severe renal impairment (CrCl <50 mL/min) in post MI heart failure or CrCl <30 mL/min in NYHA class II (chronic) heart failure. Severe hepatic impairment (Child-Pugh class C).
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Special Precautions
Increased risk of hyperkalemia. Regularly monitor K levels in patients w/ impaired renal function (eg, elderly), including diabetic microalbuminuria. Combination w/ ACE inhibitors &/or ARBs. Co-administration w/ potent CYP3A4 inducers is not recommended. Do not use w/ K supplements or salt substitutes containing K. Caution when driving or operating machinery. Patients w/ mild to moderate hepatic impairment. Pregnancy. Decision should be made whether to discontinue nursing during treatment or discontinue the drug. Safety & efficacy have not been studied in childn w/ heart failure.
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Use In Pregnancy & Lactation
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Adverse Reactions
Hyperkalemia; dizziness; cough; diarrhea. HTN: Flu-like illness; hypertriglyceridemia, hypercholesterolemia; abdominal pain; increased γ-glutamyl transferase & ALT; albuminuria; fatigue. Heart failure post MI & NYHA class II (chronic heart failure): Infection; dehydration; syncope; MI; hypotension; nausea, constipation; pruritus; muscle spasms, musculoskeletal pain; renal impairment; increased blood urea.
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Drug Interactions
Risk of hyperkalemia w/ K-sparing diuretics; ACE inhibitors or ARBs. May result in hyperkalemia w/ NSAIDs in patients w/ impaired renal function. Reports of lithium toxicity in patients receiving lithium concomitantly w/ diuretics & ACE inhibitors. Increased AUC w/ potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, & ritonavir); mild to moderate CYP3A4 inhibitors (eg, erythromycin, saquinavir, verapamil, or fluconazole). Decreased AUC w/ potent CYP3A4 inducers (eg, St. John's Wort).
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Storage
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Description
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Action
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MIMS Class
Diuretics
ATC Classification
C03DA04 - eplerenone ; Belongs to the class of aldosterone antagonists. Used as potassium-sparing diuretics.
Regulatory Classification
Rx
Presentation/Packing
Form
Inspra FC tab 25 mg
Packing/Price
30's (P27.25/film-coated tab)
Form
Inspra FC tab 50 mg
Packing/Price
30's (P48/film-coated tab)