JAMP EPLERENONE

JAMP

73 m2]; • 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).

73 m2] WARNINGS AND PRECAUTIONS Hyperkalemia The principal risk of JAMP Eplerenone is hyperkalemia. Hyperkalemia, if not recognized in a timely manner, can cause serious, sometimes fatal, arrhythmias. All patients prescribed JAMP Eplerenone must have their serum potassium level measured before initiating JAMP 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 JAMP Eplerenone has been established. For patient selection and medications which should not be prescribed concomitantly with JAMP Eplerenone or prescribed with caution, see CONTRAINDICATIONS, DRUG INTERACTIONS; and ADVERSE REACTIONS.

73 m2. The incidence of hyperkalemia increases with declining renal function (see ADVERSE EVENTS, Tables 6 and 9). 73 m2. In patients with hypertension who have reduced eGFR, serum potassium concentrations should be closely monitored when treated with JAMP Eplerenone, especially when co-administrated with other antihypertensive drugs.

JAMP Eplerenone (Eplerenone Tablets) Page 5 of 49 Even in hypertensive patients with normal renal function, hyperkalemia may occur when treated with eplerenone (see ADVERSE REACTIONS, Table 11). 5 mmol/L). Diabetic patients with heart failure (HF) who are treated with JAMP 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.