Inspra

Inspra

eplerenone

Manufacturer:

Pfizer

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 the target dose of 50 mg once daily preferably w/in 4 wk.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to eplerenone. Hyperkalemia, serum K >5 mmol/L at initiation. Concomitant use w/ K-sparing diuretics, K supplements or potent CYP450 3A4 inhibitors. Hypertensive patients w/ type 2 diabetes w/ microalbuminuria & serum creatinine >2 mg/dL (males) or >1.8 mg/dL (females). Moderate to severe renal impairment; severe hepatic impairment.
Special Precautions
Hyperkalemia; monitor serum K leverls regularly. Concomitant CYP3A4 inducers & inhibitors. May affect ability to drive & use machines. Renal & hepatic impairment. Pregnancy & lactation. Elderly.
Adverse Reactions
Hyperkalemia, dehydration; infection; syncope, dizziness; MI; hypotension; cough; diarrhea, nausea, constipation; pruritus; muscle spasms, musculoskeletal pain; renal impairment; increased blood urea.
Drug Interactions
Potentiation of antihypertensive & diuretic effects w/ K-sparing diuretics & K supplements. Increased risk of hyperkalemia w/ ACE inhibitors, ARBs; cyclosporin, tacrolimus; trimethoprim. Monitor lithium plasma conc. May lead to acute renal failure w/ NSAIDs. Potential increased hypotensive effect &/or postural hypotension by α1-blockers. Increased antihypertensive effects w/ TCAs, neuroleptics, amifostine, baclofen. Decreased antihypertensive effect w/ glucocorticoids, tetracosactide. Increased AUC of digoxin. Increased AUC by mild to moderate & strong CYP3A4 inhibitors. Decreased AUC by strong CYP3A4 inducers.
MIMS Class
ATC Classification
C03DA04 - eplerenone ; Belongs to the class of aldosterone antagonists. Used as potassium-sparing diuretics.
Presentation/Packing
Form
Inspra FC tab 50 mg
Packing/Price
30's
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