RAPRIL Tablet (Enalapril Maleate)

Adult dose

1. Hypertension 1) Patients not receiving diuretics Adults: Administer 5㎎ once daily as an initial dose of enalapril maleate, 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 receiving a once-daily dose, increase the dose or administer it twice daily. 2) Patients receiving diuretics Adults: Because hypotension may occur when this drug is first administered to patients recently treated for hypertension with a diuretic, discontinue the diuretic, if possible, 2-3 days before starting this drug. If hypertension is not controlled after starting this drug, the diuretic may be resumed. If the diuretic cannot be discontinued, administer 2.5㎎ orally once daily. 3) Patients with renal impairment ① The usual dosage applies to patients with a creatinine clearance of 30㎖/min or more (serum creatinine up to 3㎎/㎗). ② Patients with a creatinine clearance of 30㎖/min or less (serum creatinine of 3㎎/㎗ or more): Administer 2.5㎎ once daily as the initial dose. The dose may be increased to a maximum of 40㎎ per day until blood pressure is controlled. Renal function status / Creatinine clearance (㎖/min) / Initial dose (㎎/day) Normal / >80㎖/min / 5㎎ Mild impairment / >30, ≤80㎖/min / 5㎎ Moderate-to-severe impairment / ≤30㎖/min / 2.5㎎ Patients on dialysis / 2.5㎎ on the day of hemodialysis * If the patient is not undergoing hemodialysis, determine the dose according to the blood pressure response. 2. Heart failure 1) This drug 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, observe the patient closely for at least 2 hours and until blood pressure is stable; if possible, reduce the diuretic dose to prevent hypotension. If hypotension occurs after the first dose, 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 trials in which most patients received the maximum daily dose of 40㎎, once-daily administration was effective. However, twice-daily administration has generally been studied more extensively, and in placebo-controlled trials 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 the hemodynamic or clinical response. 4) Patients with heart failure accompanied by renal impairment or hyponatremia In patients with heart failure and hyponatremia (serum sodium concentration of 130mEq/ℓ or less) or serum creatinine of 1.6㎎/㎗ or more, administer 2.5㎎ per day as the initial dose under close observation. If increasing the dose, administer 2.5-5㎎ per dose twice daily, or increase further if needed. Increase the dose only after 4 days or more from the initial dose if excessive hypotension or significant deterioration in renal function has not occurred. The maximum dose is 40㎎ per day.

This medication should not be taken by certain patients. For example, patients who are allergic to this medication or have had hypersensitivity reactions, patients undergoing certain types of dialysis, patients with a history of angioedema, patients receiving specific hypertension treatments, patients with liver or kidney function problems, pregnant women, breastfeeding women, and children may be at risk when taking this medication. Additionally, patients with severely impaired kidney function, renal artery stenosis, cerebrovascular disorders, severe proteinuria, elderly patients, etc., should exercise special caution when taking this medication and may need to adjust their dosage or increase their dosing intervals, as necessary. This medication may affect kidney function, so kidney function tests must be performed before and during treatment. When starting the medication, blood pressure may drop suddenly; therefore, it is recommended to start at a low dose and observe the condition closely. During treatment, unusual symptoms such as dizziness, drowsiness, skin rash, breathing difficulties, or gastrointestinal upset may occur, and if these symptoms arise, one should consult a doctor immediately. Special care must be taken as severe allergic reactions such as angioedema may occur. This medication may interact with other drugs; therefore, if you are taking other medications, inform your doctor or pharmacist. Caution is particularly needed when taking it with potassium-sparing diuretics, lithium, non-steroidal anti-inflammatory drugs, other antihypertensive medications, alcohol, antipsychotics, or antihyperglycemic agents. Women who are pregnant or may become pregnant should not take this medication, and those who are breastfeeding should either avoid its use or discontinue breastfeeding if possible. Elderly patients should start at a low dose to prevent blood pressure from dropping too low and should be monitored closely. Finally, the safety and efficacy of this medication have not been sufficiently confirmed in children, so it is not recommended for use in children. When storing this medication, keep it out of the reach of children and do not transfer it to another container.

• Increased BUN
• increased serum creatinine
• acute renal failure
• decreased hemoglobin
• decreased hematocrit
• leukopenia
• thrombocytopenia
• increased eosinophils
• positive antinuclear antibody
• angioedema

This medication should be stored at room temperature between 1 and 30 degrees Celsius, and it is important to keep it in a tightly sealed container to prevent air exposure. Storing it this way will help maintain the effectiveness of the medication and prevent degradation.

Appearance

White round tablets

Package unit

30 tablets/bottle, 500 tablets/bottle