Inspra

Inspra

eplerenone

Manufacturer:

Viatris

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Eplerenone
Indications/Uses
Reduce risk of CV mortality & morbidity in stable patients w/ left ventricular dysfunction & clinical evidence of heart failure after recent MI.
Dosage/Direction for Use
Initially 25 mg once daily & titrate to target dose of 50 mg once daily preferably w/in 4 wk.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Clinically significant hyperkalemia or conditions associated w/ hyperkalemia, serum K level >5 mmol/L at initiation. Concomitant use w/ K-sparing diuretics or potent CYP450 3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir. Moderate to severe renal impairment (CrCl <50 mL/min) in post-MI heart failure. Severe hepatic impairment (Child-Pugh class C).
Special Precautions
Hyperkalemia. Periodically monitor serum K levels. Not to be used w/ K supplements, K-containing salt substitutes. Not recommended to be used concomitantly w/ potent CYP3A4 inducers. Concomitant use w/ ACE inhibitors or ARBs. May affect ability to drive & use machines. Renal & mild to moderate hepatic impairment. Pregnancy & lactation. Childn. Elderly.
Adverse Reactions
Infection; hyperkalemia, dehydration; syncope, dizziness; MI; hypotension; cough; diarrhoea, nausea, constipation; pruritus; muscle spasms, musculoskeletal pain; renal impairment; increased blood urea.
Drug Interactions
Potentiated antihypertensive & diuretic effects w/ K-sparing diuretics & K supplements. Increased risk of hyperkalemia w/ ACE inhibitors, ARBs, trimethoprim. Monitor lithium plasma conc. Renal impairment & increased risk of hyperkalaemia w/ cyclosporin, tacrolimus. Acute renal failure w/ NSAIDs. Increased hypotensive effect &/or postural hypotension by α1-blockers eg, prazosin, alfuzosin. Increased antihypertensive effects & risk of postural hypotension w/ TCAs, neuroleptics, amifostine, baclofen. Decreased antihypertensive effects w/ glucocorticoids, tetracosactide. Increased AUC of digoxin. Increased AUC by mild to moderate (eg, erythromycin, saquinavir, amiodarone, diltiazem, verapamil, fluconazole) & strong (eg, ketoconazole, itraconazole, ritonavir, clarithromycin, telithromycin, nefazodone) CYP3A4 inhibitors. Decreased AUC by strong CYP3A4 inducers eg, St. John's wort, rifampicin, carbamazepine, phenytoin, phenobarb.
MIMS Class
Diuretics
ATC Classification
C03DA04 - eplerenone ; Belongs to the class of aldosterone antagonists. Used as potassium-sparing diuretics.
Presentation/Packing
Form
Inspra FC tab 25 mg
Packing/Price
30's
Form
Inspra FC tab 50 mg
Packing/Price
30's
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