Enalapril Tablet (Enalapril Maleate)

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 once-daily administration, increase the dose or administer twice daily. 2) Patients receiving diuretics Adults: Hypotension may occur when this drug is first administered to patients who have recently been treated for hypertension with a diuretic. Where possible, discontinue the diuretic 2-3 days before starting this drug. If hypertension is not adequately controlled when this drug is administered, diuretic therapy 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 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 renal dialysis is not performed, 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 first dose, observe the patient 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 careful dose titration and manage the hypotension effectively. 3) Maintenance dose Adults: Administer 5-20㎎ daily in 2 divided doses; the maximum daily dose is 40㎎. 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 used in trials. In placebo-controlled trials that demonstrated 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 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 greater, administer an initial dose of 2.5㎎ daily with close monitoring. If the dose is increased, administer 2.5-5㎎ twice daily, or increase further if necessary. Increase the dose only after 4 days or more from the initial dose, provided that excessive hypotension or significant deterioration in renal function has not occurred. The maximum daily dose is 40㎎.

This medication should not be used in certain patients. For example, those with allergic reactions to this medication or with previous experiences of such reactions, patients undergoing specific types of hemodialysis, those with a history of angioedema, and women who are pregnant or may become pregnant, including nursing mothers, should not take this medication. Also, patients with severely impaired kidney or liver function, patients post-kidney transplant, children, and diabetic patients taking certain other medications should use this medication with caution. When using this medication, kidney function must be monitored, and especially for patients with severe hypertension or those on diuretics, it is advised to start with a low dose and gradually increase it. This medication lowers blood pressure and may cause dizziness or lightheadedness, hence caution is necessary when driving or operating dangerous machinery. While taking this medication, kidney function and electrolyte levels should be regularly monitored through blood tests, and if any abnormal symptoms appear, the patient should consult a doctor immediately. Various side effects may occur, including worsening kidney function, blood disorders, skin rash, difficulty breathing, gastrointestinal symptoms, and liver function abnormalities; these symptoms should be reported to healthcare personnel immediately. Also, many drug interactions are possible, so if the patient is taking other medications, they must inform their healthcare provider, particularly when used with potassium-sparing diuretics, lithium, non-steroidal anti-inflammatory drugs, or antihypertensives. Women who are pregnant or nursing should avoid using this medication, and in unavoidable cases, breastfeeding should be discontinued. Safety and efficacy in children have not been established, and it is advisable not to administer this medication to them. Elderly patients should start at a low dose to prevent excessively low blood pressure and should be closely monitored. Caution is necessary if a patient receiving this medication is undergoing venom immunotherapy, as severe allergic reactions may ensue.

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

This medication should be stored in a tightly sealed container that is air-tight, kept in a cool, dry place below 30 degrees Celsius. Proper storage can maintain the effectiveness of the medication for a longer period.

Appearance

Pinkish round tablet

Package unit

30 tablets/bottle, 100 tablets/bottle