Hawon Enalapril Tablets

Adult dose

1. Hypertension 1) Patients not receiving diuretics Adults: The initial dose of enalapril maleate is 5㎎ once daily; adjust according to blood pressure. The maintenance dose is 10-40㎎ daily 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 twice daily. 2) Patients receiving diuretics Adults: Since hypotension may occur upon initial administration of this drug in patients who have recently been treated for hypertension with a diuretic, discontinue the diuretic, if possible, 2-3 days before starting this drug. If hypertension is not controlled when this drug is administered, the diuretic may be resumed. If the diuretic cannot be discontinued, administer this drug 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 up to a maximum of 40㎎ daily 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 the patient does not undergo renal dialysis, 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㎎ 1-2 times daily. After the initial 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 initial dose of this drug, continue to adjust the dose carefully and manage the hypotension effectively. 3) Maintenance dose Adults: Administer 5-20㎎ daily in 2 divided doses; the maximum daily dose is 40㎎. Although a controlled trial in which most patients received the maximum daily dose of 40㎎ demonstrated effective results with once-daily dosing, twice-daily dosing has generally been used more commonly. In placebo-controlled trials confirming a reduction in mortality in patients with severe heart failure (NYHA class Ⅳ), most patients received 2.5-40㎎ daily in 2 divided doses. The dose may be adjusted according to the hemodynamic or clinical response. 4) Patients with heart failure accompanied by renal failure 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㎎ daily with close monitoring. If increasing the dose, administer 2.5-5㎎ twice daily or increase further if necessary. Increase the dose only if excessive hypotension or significant deterioration in renal function has not occurred during the 4 days or longer after the initial dose. The maximum daily dose is 40㎎.

This medication should not be used in certain patients. For example, it should not be administered to patients with an allergy to this drug, those undergoing blood dialysis, patients with a history of angioedema, patients receiving specific blood purification treatments, or those with liver or kidney issues, pregnant or nursing women, and children. Additionally, caution is required for patients with significantly reduced kidney function, renovascular hypertension, cerebrovascular disorders, severe proteinuria, elderly patients, and it may be necessary to adjust the dosage or closely monitor their condition. Kidney function must be confirmed before using this medication; especially in patients with severe hypertension, those undergoing blood dialysis, or those taking diuretics should start at a low dose and gradually increase it. Blood pressure may drop rapidly, so if dizziness or lightheadedness occurs, it is advised to avoid dangerous activities such as working at heights or driving. This medication may interact with various other medications; caution is needed if taken with other antihypertensives, diuretics, lithium, non-steroidal anti-inflammatory drugs, or alcohol. Side effects may include deterioration of kidney function, changes in blood components, skin rashes, dizziness, gastrointestinal issues, liver dysfunction, and respiratory problems, so if any abnormal symptoms occur, immediate consultation with medical personnel is advised. Pregnant or nursing women should avoid using this medication unless unavoidable, in which case consult with a healthcare professional first. Safety and effectiveness have not been sufficiently verified for children, so it is best not to use it in this population. Elderly patients should start at a low dose and be carefully monitored to prevent blood pressure from dropping excessively.

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

This medication should be stored in a tightly sealed container to prevent air or moisture ingress. The storage temperature should be maintained at room temperature between 1°C and 30°C, preferably in a cool, dry place. Export medications should also be stored in a tightly sealed container at room temperature.

Appearance

For domestic use: reddish-brown round tablets; for export: white round tablets

Package unit

30 tablets/bottle, 500 tablets/bottle