Enal Tablet (Enalapril Maleate)

Adult dose

1. Hypertension 1) Patients not receiving diuretics Adults: Administer 5㎎ of enalapril maleate once daily as the initial dose and adjust according to blood pressure. The maintenance dose is 10-40㎎ daily in 1-2 divided doses. In patients receiving once-daily administration whose blood pressure-lowering effect decreases toward the end of the dosing interval, increase the dose or administer twice daily. 2) Patients receiving diuretics Adults: Because hypotension may occur when this drug is first administered to patients recently treated for hypertension with diuretics, discontinue the diuretic 2-3 days before starting this drug, if possible. If hypertension is not controlled when this drug is administered, the diuretic may be restarted. If the diuretic cannot be discontinued, administer 2.5㎎ of this drug orally once daily. 3) Patients with renal impairment ① The usual dose applies to patients with creatinine clearance of 30㎖/min or more (serum creatinine up to 3㎎/㎗). ② Patients with creatinine clearance of 30㎖/min or less (serum creatinine 3㎎/㎗ or more): Administer 2.5㎎ once daily as the initial dose. The dose may be increased to a maximum of 40㎎ daily 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 renal dialysis is not performed, determine the dose according to blood pressure response. 2. Heart failure 1) This drug is used as adjunctive therapy with diuretics and digitalis. 2) Initial dose Adults: Administer 2.5㎎ per dose 1-2 times daily. After the first dose, monitor 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 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 dose may be increased to a maximum of 40㎎ daily. In controlled trials in which most patients received the maximum daily dose of 40㎎, effective results were achieved with once-daily administration; however, twice-daily administration was generally used in trials. 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㎎ daily 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 and hyponatremia (serum sodium concentration 130mEq/ℓ or less) or serum creatinine of 1.6㎎/㎗ or more, administer 2.5㎎ daily as the initial dose under close observation. 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 first dose. The dose may be increased to a maximum of 40㎎ daily.

This medication should not be used in certain patients. For example, it should not be administered to patients with an allergy to this medication, patients undergoing dialysis, patients with a history of angioedema, patients with severely impaired liver or kidney function, pregnant women or women who may become pregnant, and children. Additionally, this medication should be used with caution in patients with severely impaired kidney function or renovascular hypertension, and in patients with cerebrovascular disorders, as there is a risk of rapid drops in blood pressure. This medication can affect kidney function, so renal function must be monitored before and during treatment. It is particularly important to start at a low dose and gradually increase the dosage for patients with severe hypertension, those undergoing dialysis, or those taking diuretics. Symptoms such as dizziness or lightheadedness may occur when taking this medication, so caution is advised when driving or operating dangerous machinery. Furthermore, this medication can interact with many other drugs. Caution is needed when taken alongside potassium-sparing diuretics, lithium, non-steroidal anti-inflammatory drugs, other antihypertensive medications, immunosuppressants, alcohol, psychiatric medications, and antihyperglycemic agents, and patients should consult a physician. Women who are pregnant or breastfeeding are advised not to take this medication, and if unavoidable, breastfeeding should be discontinued. For elderly patients, treatment should start at a lower dose to avoid excessive blood pressure lowering, and the condition should be monitored carefully. If any abnormal symptoms or side effects occur while taking this medication, immediate consultation with a healthcare professional is necessary, particularly for symptoms such as angioedema, severe skin reactions, or acute renal failure, which require prompt action. Lastly, this medication should be stored out of the reach of children and should not be transferred to other containers for safety.

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

This medication should be stored in a tightly sealed container to prevent the entry of air or moisture, and should be kept at room temperature between 1 degrees and 30 degrees.

Appearance

White round tablet

Package unit

30 tablets/bottle, 500 tablets/bottle