Epirin Tablet (Enalapril Maleate)

Adult dose

1. Hypertension 1) Patients not receiving diuretics Adults: Administer 5㎎ of enalapril maleate once daily as the initial dose, and adjust according to blood pressure. The maintenance dose is 10-40㎎ per day in 1-2 divided doses. If the antihypertensive effect decreases toward the end of the dosing interval in patients taking the medicine once daily, increase the dose or administer it twice daily. 2) Patients receiving diuretics Adults: Since hypotension may occur when this medicine is first administered to patients who have recently received diuretic treatment for hypertension, discontinue the diuretic, if possible, 2-3 days before starting this medicine. If hypertension is not controlled when this medicine is administered, diuretic treatment may be resumed. If the diuretic cannot be discontinued, administer 2.5㎎ of this medicine orally once daily. 3) Patients with renal impairment ① The usual dosage applies to patients with a creatinine clearance of 30㎖/min or higher (serum creatinine up to 3㎎/㎗). ② Patients with a creatinine clearance of 30㎖/min or lower (serum creatinine of 3㎎/㎗ or higher): Administer 2.5㎎ once daily as the initial dose. Up to a maximum of 40㎎ per day may be administered until blood pressure is controlled. Normal, >80㎖/min: 5㎎ Mild impairment, >30, ≤80㎖/min: 5㎎ Moderate to severe impairment, ≤30㎖/min: 2.5㎎ Dialysis patients: 2.5㎎ on the day of renal dialysis * If renal dialysis is not performed, determine the dose according to blood pressure response. 2. Heart failure 1) This medicine is used as adjunctive therapy to diuretics and digitalis. 2) Initial dose Adults: Administer 2.5㎎ per dose 1-2 times daily. After the first dose, monitor the patient closely for at least 2 hours and until blood pressure is stable; reduce the diuretic dose, if possible, to avoid hypotension. If hypotension occurs after the first dose of this medicine, continue to adjust the dose carefully and manage the hypotension effectively. 3) Maintenance dose Adults: Administer 5-20㎎ per day in 2 divided doses; up to a maximum of 40㎎ per day may be administered. In controlled studies in which most patients received the maximum daily dose of 40㎎, once-daily administration was effective; however, twice-daily administration was generally more commonly studied. In placebo-controlled studies in patients with severe heart failure (NYHA class Ⅳ), in which a reduction in mortality was confirmed, most patients received 2.5-40㎎ per day in 2 divided doses. The dose may be adjusted according to hemodynamic or clinical response. 4) Patients with heart failure accompanied by renal failure or hyponatremia In patients with heart failure accompanied by hyponatremia (serum sodium concentration 130mEq/ℓ or lower) or serum creatinine of 1.6㎎/㎗ or higher, administer 2.5㎎ per day as the initial dose with close monitoring. If the dose is increased, increase by 2.5-5㎎ per dose twice daily or more if necessary, provided that excessive hypotension or significant deterioration in renal function has not occurred for 4 days or longer after the initial dose. Up to a maximum of 40㎎ per day may be administered.

This medication should not be administered to certain patients. For example, patients who are allergic to this medication, undergoing dialysis, have a history of angioedema, are pregnant or potentially pregnant women and nursing mothers, and children should not use this medication. Additionally, patients with severely impaired kidney function, those with very high blood pressure, electrolyte imbalances, and the elderly should be more cautious when using this medication, as dose adjustments or changes in administration intervals may be necessary. This medication may affect kidney function, so kidney function tests must be done before and during treatment. Additionally, blood pressure may drop rapidly after the initial dose, so treatment should start at low doses, and the patient's condition should be closely monitored. During the use of this medication, dizziness or drowsiness may occur, necessitating caution when driving or operating hazardous machinery. This medication can interact with several other medicines. When taken with potassium-sparing diuretics, lithium, non-steroidal anti-inflammatory drugs, or other antihypertensives, blood pressure or electrolyte levels should be closely monitored. Side effects can include worsening kidney function, blood abnormalities, skin rashes, angioedema, gastrointestinal issues, liver dysfunction, and respiratory symptoms; therefore, if any unusual symptoms arise, immediate consultation with a physician is necessary. It is safer not to use this medication during pregnancy or lactation, and particularly during the second trimester of pregnancy, as it may significantly affect the fetus. The safety and efficacy of this medication in children and the elderly have not been sufficiently proven, and special caution is needed when administering it to these groups.

• Increased BUN
• increased serum creatinine
• acute kidney failure
• decreased hemoglobin
• decreased hematocrit
• decreased white blood cells
• decreased platelets
• increased eosinophils
• positive antinuclear antibody
• angioedema

This medication should be stored in a well-closed container that protects it from air and kept in a dry place without humidity at below 30 degrees Celsius to maintain its effectiveness.

Appearance

Brownish-red round tablets

Package unit

30 tablets/bottle, 100 tablets/bottle