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APO-EPLERENONE is a brand name for Eplerenone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
73m2]; concomitant use with potassium-sparing diuretics, potassium supplements or strong CYP3A4 inhibitors such as ketoconazole, itraconazole, nefazodone, telithromycin, clarithromycin, ritonavir, and nelfinavir (see DRUG INTERACTIONS and DOSAGE AND ADMINISTRATION).
73m2] WARNINGS AND PRECAUTIONS Hyperkalemia The principal risk of eplerenone is hyperkalemia. Hyperkalemia, if not recognized in a timely manner, can cause serious, sometimes fatal, arrhythmias. All patients prescribed APO-EPLERENONE must have their serum potassium level measured before initiating APO-EPLERENONE therapy, within one week and at one month after the first dose or after a dose adjustment, and measured periodically thereafter, as clinically warranted (see DOSAGE AND ADMINISTRATION).
Hyperkalemia can be minimized by appropriate patient selection, avoidance of certain concomitant treatments, thoroughly informing the patient and periodic monitoring until the effect of eplerenone has been established. For patient selection and medications which should not be prescribed concomitantly with eplerenone or prescribed with caution, see CONTRAINDICATIONS, DRUG INTERACTIONS; and ADVERSE REACTIONS.
73m2. The incidence of hyperkalemia increases with declining renal function (see ADVERSE EVENTS, Tables 6 and 9). 73m2. In patients with hypertension who have Page 5 of 49 reduced eGFR, serum potassium concentrations should be closely monitored when treated with eplerenone, especially when co-administrated with other antihypertensive drugs.
Even in hypertensive patients with normal renal function, hyperkalemia may occur when treated with eplerenone (see ADVERSE REACTIONS, Table 11). 5mmol/L). Diabetic patients with heart failure (HF) who are treated with eplerenone, especially those with proteinuria or renal impairment, should also be treated with caution as they have an increased risk of hyperkalemia.
Patients with either diabetes or renal impairment / proteinuria also have an increased risk of hyperkalemia, however the incidence remains lower than in patients with both of these comorbidities (see ADVERSE REACTIONS, Tables 7 and 10).
5 mmol/L were observed. Cmax was not significantly changed but AUC was increased by 42% and eplerenone clearance 30% lower compared to matched controls. The dose recommended is 8 times smaller and, therefore, no dose adjustment is necessary in patients with mild to moderate hepatic impairment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Eplerenone in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The use of eplerenone in patients with severe hepatic impairment has not been evaluated and therefore, APO-EPLERENONE is contraindicated in these patients (see CONTRAINDICATIONS, DOSAGE AND ADMINISTRATION and ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions).
Impaired Renal Function See CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS – Hyperkalemia, ADVERSE REACTIONS. Carcinogenesis, Mutagenesis Preclinical studies of safety pharmacology, genotoxicity, carcinogenic potential and toxicity to reproduction revealed no special hazard for humans.
In repeat dose toxicity studies, prostate atrophy was observed in rats and dogs at exposure levels several-fold above clinical exposure levels. The prostatic changes were not associated with adverse functional consequences. The clinical relevance of these findings is unknown.
Studies in rats and rabbits showed no teratogenic effects, although decreased body weight in maternal rabbits and increased rabbit fetal resorptions and post-implantation loss were observed at the highest administered dosage. Special Populations Pregnant Women There are no eplerenone studies in pregnant women.
Eplerenone did not impair fertility and was not teratogenic in animals but the risk to the fetus of pregnant women is not known. Therefore, eplerenone should be used during pregnancy only if the potential benefit to the mother justifies Page 6 of 49 the potential risk to the fetus (see TOXICOLOGY).
85. Because many drugs are excreted in human milk and because of the unknown potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother (see TOXICOLOGY).
Pediatrics The safety and effectiveness of eplerenone have not been established in pediatric patients and eplerenone is not recommended in this patient population. 6%) were 75 and over. Patients greater than 75 years did not appear to benefit from the use of eplerenone (see CLINICAL TRIALS – EPHESUS […]