COMPOSITION:

Epliron 25 mg Tablets: Each Film Coated Tablet contain Eplerenone 25 mg.
Epliron 50 mg Tablets: Each Film Coated Tablet contains Eplerenone 50 mg.

INDICATIONS:

Congestive Heart Failure Post-Myocardial Infarction Hypertension.

DOSAGE & ADMINISTRATION:

Congestive Heart Failure Post-Myocardial Infarction:
It is given in an initial dose of 25 mg daily, increasing to 50 mg daily

Hypertension:
It is given in an initial dose of 50mg daily, increasing if necessary to a maximum of 50 mg twice daily

CONTRAINDICATIONS:

For all patients:
• Serum potassium >5.5 mEq/L at initiation
• Creatinine clearance ≤30 mL/min
• Concomitant use with strong CYP3A4 inhibitors

For the treatment of Hypertension:
• Type 2 diabetes with microalbuminuria
• Serum creatinine >2.0 mg/dL in males, >1.8 mg/dL in females
• Creatinine clearance <50 mL/min
• Concomitant use potassium supplements or potassium sparing diuretics.

UNDESIRABLE EFFECTS:

The following are the reported adverse event of the Eplerenone; hyperkalemia, increased creatinine, dizziness, coughing, fatigue, flu-like symptoms, headache, dizziness, angina pectoris/MI, increased GGT, Gynecomastia, abnormal vagina bleeding, angioneurotic edema, rash, drowsiness, gastrointestinal disturbance including cramp and diarrhea, ataxia, mental confusion, hirsutism, deepening of voice and impotence.

PRESENTATION:

Epliron 25mg & 50 mg are presented in the packing of 14’s

PREGNANCY & LACTATION:

Pregnancy Categories B. It is not known whether Eplerenone is excreted in human milk.