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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 & titrated to target dose: 50 mg once daily preferably w/in 4 wk. Moderate renal impairment (CrCl 30-60 mL/min) Start at 25 mg every other day.
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. Monitor serum K levels prior to, w/in 1st wk, 1 mth after treatment & periodically thereafter. Not to be administered w/ K supplements, K-containing salt substitutes. Not recommended to be co-administered w/ potent CYP3A4 inducers. Concomitant use w/ ACE inhibitors or ARBs. May affect ability to drive & use machines. 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 systemic exposure to digoxin. Increased AUC by mild to moderate (eg, erythromycin, saquinavir, amiodarone, diltiazem, verapamil, fluconazole) & strong (eg, ketoconazole, itraconazole, ritonavir, nelfinavir, 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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