Product Dossier
ESPLER
Product Dossier for ESPLER (eplerenone, Arrotex Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Arrotex Pharmaceuticals
- Active ingredient: eplerenone
- Therapeutic area: Cardiology
- Related brand: INPLER
- Related brand: INSPRA
- Related brand: APO-EPLERENONE
- Same area: ATOZET
- Same area: OPSUMIT
What it is
ESPLER is a brand of eplerenone tablets. Each tablet contains either 25 mg or 50 mg of eplerenone. Eplerenone is supplied as film-coated tablets.
Approved indications
— To reduce the risk of cardiovascular death in combination with standard therapy in patients who have evidence of heart failure and left ventricular impairment within 3–14 days of an acute myocardial infarction. — To reduce the risk of cardiovascular mortality and morbidity in adult patients with NYHA Class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF ≤30% or LVEF ≤35% in addition to QRS duration of >130 msec), in addition to standard optimal therapy.
Dosing overview
Serum potassium should be measured before initiating eplerenone therapy, within the first week and at 1 month after the start of treatment or dosage adjustment, then assessed periodically thereafter, with dose adjusted based on serum potassium level.
Regulatory history
ESPLER eplerenone 50 mg tablets (ARTG 231446) and 25 mg tablets (ARTG 231454) were first listed on the ARTG on 21 October 2015.