Nalpril Tablet (Enalapril Maleate)

Adult dose

1. Hypertension 1) Patients not receiving diuretics Adults: The initial dose of enalapril maleate is 5㎎ once daily, adjusted according to blood pressure. The maintenance dose is 10-40㎎ daily in 1-2 divided doses. If the blood pressure-lowering effect decreases toward the end of the dosing interval in patients receiving once-daily administration, increase the dose or administer 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. Therefore, discontinue the diuretic 2-3 days before starting this medicine whenever possible. If hypertension is not controlled with this medicine, the diuretic may be restarted. 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 of 3㎎/㎗ or higher): The initial dose is 2.5㎎ once daily. A maximum of 40㎎ daily may be administered 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㎎ Dialysis patients / 2.5㎎ on the day of renal dialysis * If renal 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. Observe the patient carefully for at least 2 hours after the first dose and until blood pressure is stable, and reduce the diuretic dose if possible to prevent 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㎎ daily in 2 divided doses; up to 40㎎ daily 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 was generally used in trials, and in placebo-controlled trials demonstrating reduced mortality in patients with severe heart failure (NYHA class Ⅳ), most patients received 2.5-40㎎ daily in 2 divided doses. Adjust the dose according to the hemodynamic or clinical response. 4) Patients with heart failure accompanied by renal failure or hyponatremia In patients with heart failure who have hyponatremia (serum sodium concentration 130mEq/ℓ or lower) or serum creatinine of 1.6㎎/㎗ or higher, administer an initial dose of 2.5㎎ daily with careful 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. Up to 40㎎ daily may be administered.

This medication should not be used in certain patients. For instance, individuals with an allergy to this medication, those undergoing hemodialysis, or patients with a history of angioedema should not take it. It is also contraindicated for pregnant or potentially pregnant women, nursing mothers, and children. Patients who have undergone kidney transplantation or those receiving certain treatments should also avoid its use. Patients with severely impaired kidney function, renovascular hypertension, or severe hypertension should adjust the dosage or use this medication cautiously. Since this drug can affect kidney function, renal function tests must be performed before and during treatment. Additionally, because blood pressure may drop sharply, starting with a low dose and closely monitoring the patient’s condition is advisable. While taking this medication, symptoms like dizziness or drowsiness may occur, so it is best to avoid operating heavy machinery or driving. This drug may increase serum potassium levels; therefore, caution should be taken when used with potassium-sparing diuretics or potassium supplements. Moreover, interactions may occur when used with other antihypertensives, lithium, non-steroidal anti-inflammatory drugs, etc., so it is essential to consult a physician or pharmacist. During pregnancy or lactation, this medication should not be administered as it may pose risks to the fetus or newborn and breastfeeding should be discontinued if it is absolutely necessary to use the drug. Elderly patients should start with a lower dose to prevent excessive drops in blood pressure and closely observe their condition. Finally, this medication should be stored out of reach of children, and transferring it to another container can compromise its quality.

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

This medication should be stored in a tightly closed container to protect it from exposure to air or moisture. It is best kept at room temperature between 1 and 30 degrees Celsius.

Appearance

White round tablet

Package unit

30 tablets/bottle, 500 tablets/bottle