EPNAL Tablet (Enalapril Maleate)

Adult dose

1. Hypertension 1) Patients not receiving diuretics Adults: Administer enalapril maleate 5㎎ 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 receiving the drug once daily, increase the dose or administer it twice daily. 2) Patients receiving diuretics Adults: Because hypotension may occur when this medicine is first administered to patients recently treated for hypertension with diuretics, discontinue the diuretic, if possible, 2-3 days before starting this medicine. If hypertension is not controlled when this medicine is administered, the diuretic may be resumed. If the diuretic cannot be discontinued, administer this medicine orally at 2.5㎎ once daily. 3) Patients with renal impairment ① The usual dosage applies to patients with creatinine clearance of 30㎖/min or higher (serum creatinine up to 3㎎/㎗). ② Patients with creatinine clearance of 30㎖/min or less (serum creatinine 3㎎/㎗ or higher): Administer 2.5㎎ once daily as the initial dose. The dose may be increased up to a maximum of 40㎎ per day until blood pressure is controlled. Renal function / Creatinine clearance (㎖/min) / Initial dose (㎎/day) 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 * On days when dialysis is not performed, determine the dose according to the 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, observe the patient closely for at least 2 hours and until blood pressure is stable. If possible, reduce the diuretic dose 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. The maximum dose is 40㎎ per day. In controlled trials in which most patients received the maximum daily dose of 40㎎, effective results were obtained with once-daily administration. However, twice-daily administration was generally studied more extensively, and in placebo-controlled trials that demonstrated reduced mortality in patients with severe heart failure (NYHA class Ⅳ), most patients received 2.5-40㎎ per day in 2 divided doses. Adjust the dose 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 less) or serum creatinine of 1.6㎎/㎗ or higher, administer 2.5㎎ per day as the initial dose with close monitoring. If increasing the dose, administer 2.5-5㎎ per dose twice daily or increase further if necessary. Increase the dose only if excessive hypotension or significant deterioration in renal function has not occurred for 4 days or longer after the initial dose. The maximum dose is 40㎎ per day.

This medication should not be administered to certain patients. For example, individuals who are allergic or have hypersensitivity to this medication, patients undergoing certain types of dialysis, those with a history of angioedema, as well as patients with liver or kidney function issues should not use this product. It is also not recommended for women during pregnancy or breastfeeding, and children. Furthermore, caution is warranted for some diabetic patients who may be at risk when taking certain other medications together. Patients with severe renal impairment, renovascular hypertension, cerebrovascular disorders, and the elderly should use this medication cautiously, starting from a low dose and monitoring their condition closely because of the risk of a rapid drop in blood pressure. The medication may affect renal function, so renal function should be checked before and during administration. Additionally, if blood pressure falls too low, it may result in dizziness or fainting; therefore, caution should be exercised while performing dangerous tasks or driving. When used in conjunction with drugs that can raise serum potassium levels, certain diuretics, lithium, non-steroidal anti-inflammatory drugs, and others, the risk of side effects may increase, so it is essential to consult a healthcare professional. Particularly in the second and third trimesters of pregnancy, this medication may have serious effects on the fetus; thus, women of childbearing potential should refrain from using it, and it is also advisable to avoid it while breastfeeding. For children, it is prudent not to administer this medication as safety and efficacy have not been established. In elderly patients, the risk of excessively low blood pressure can lead to complications such as stroke; therefore, administration should begin with a low dose and be done cautiously. During the course of taking this medication, if any abnormal symptoms or side effects occur, immediate notification to a healthcare provider is necessary, especially if symptoms of angioedema, such as difficulty breathing, swelling of the face, tongue, or throat arise, as immediate action is required. Finally, this medication should be kept out of reach of children, and transferring it to another container should be avoided as it can harm the quality of the product.

• BUN elevation
• serum creatinine elevation
• acute renal failure
• hemoglobin decrease
• hematocrit decrease
• leukopenia
• thrombocytopenia
• eosinophilia
• positive antinuclear antibody
• angioedema

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, it should be kept in a cool, dry place below 30 degrees Celsius to maintain its efficacy.

Appearance

White round tablet

Package unit

30 tablets/bottle, 500 tablets/bottle