Elprin Tablet (Enalapril Maleate)

Adult dose

1. Hypertension 1) Patients not receiving diuretics Adults: The initial dose is 5㎎ once daily as enalapril maleate, adjusted 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: Hypotension may occur when this medicine is first administered to patients recently treated for hypertension with a diuretic. If possible, discontinue the diuretic 2-3 days before starting this medicine. If hypertension is not adequately controlled after starting this medicine, diuretic therapy 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 a creatinine clearance of 30㎖/min or greater (serum creatinine up to 3㎎/㎗). ② Patients with a creatinine clearance of 30㎖/min or less (serum creatinine of 3㎎/㎗ or greater): The initial dose is 2.5㎎ once daily. The dose may be increased 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 hemodialysis * If hemodialysis 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㎎ 1-2 times daily. Observe the patient for at least 2 hours after the first dose and until blood pressure is stable. If possible, reduce the diuretic dose to avoid 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; the maximum daily dose is 40㎎. In controlled studies in which most patients received the maximum daily dose of 40㎎, once-daily administration was effective. However, twice-daily dosing was generally used in studies, including placebo-controlled studies 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. 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 greater, administer an initial dose of 2.5㎎ per day with careful observation. If increasing the dose, increase by 2.5-5㎎ per dose twice daily, or more 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 daily dose is 40㎎.

This medication may not be suitable for certain patients. For example, individuals who have had an allergic reaction to this medicine or have experienced such in the past should not take it. Additionally, patients undergoing certain dialysis methods, those with a history of angioedema, and patients with primary hyperaldosteronism should not use this medication. It is also safest not to administer this drug to pregnant women, women who may become pregnant, nursing mothers, and children. Caution is advised when using this medication in patients with severely impaired renal function, renal artery stenosis, cerebrovascular disease, very high blood pressure, electrolyte imbalances, elderly patients, among others. Furthermore, when taking similar medications in the same class, the risk of side effects may increase, hence it should be administered under professional supervision. During the administration of this medication, kidney function should be checked periodically, and since blood pressure may drop sharply when first taking the medication, it is recommended to start with a low dose and monitor the condition closely. It is advisable not to take this medication within 24 hours before surgery. Moreover, this drug may cause a variety of side effects; therefore, if abnormal symptoms occur, healthcare professionals should be consulted immediately. Symptoms may include worsening kidney function, blood abnormalities, allergic reactions, skin rashes, dizziness, gastrointestinal problems, liver function abnormalities, and respiratory distress. This medication may interact with other drugs; thus, it is essential to inform healthcare providers if other medications are being taken, especially potassium-sparing diuretics, lithium, non-steroidal anti-inflammatory drugs, antihypertensive medications, and alcohol. It is safer for pregnant or nursing women not to use this medication, and if it is absolutely necessary, breastfeeding should be interrupted. The safety and efficacy of this drug in children have not been fully established, so it is advisable not to use it in this population. Elderly patients should start with a low dosage to avoid excessive blood pressure reduction, and their condition should be monitored closely. Finally, this medication should be kept out of reach of children, and transferring it to another container is important for maintaining its quality.

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

This medication should be stored in a tightly closed container that protects it from air and kept in a dry place without moisture. Additionally, to maintain the effectiveness of the drug, it is recommended to store it at room temperature, between 1°C to 30°C.

Appearance

White hexagonal tablet

Package unit

30 tablets/bottle, 500 tablets/bottle