Enaprin Tablet 5 mg (Enalapril Maleate)

Adult dose

1. Hypertension 1) Patients not receiving diuretics Adults: The initial dose is 5㎎ once daily of enalapril maleate, adjusted according to blood pressure. The maintenance dose is 10-40㎎ daily, administered 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: Since hypotension may occur when this drug is first administered to 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, 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 higher (serum creatinine up to 3㎎/㎗). ② Patients with a creatinine clearance of 30㎖/min or lower (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 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 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; up to a maximum of 40㎎ daily may be administered. In controlled trials in which most patients received the maximum daily dose of 40㎎, once-daily administration was effective in most patients. However, twice-daily administration was generally used in many trials, and in placebo-controlled trials in patients with severe heart failure (NYHA class Ⅳ) that confirmed a reduction in mortality, 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 who have hyponatremia (serum sodium concentration of 130mEq/ℓ or lower) or serum creatinine of 1.6㎎/㎗ or higher, administer an initial dose of 2.5㎎ daily with close 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 during the 4 days or longer after the initial dose. A maximum of 40㎎ daily may be administered.

This medication should not be used in certain patients. For example, it should not be administered to patients who are allergic to this medication, those undergoing dialysis, patients with a history of angioedema, those with certain kidney and liver diseases, pregnant women or women who may become pregnant, and children. Additionally, patients with severely impaired kidney function, those with vascular hypertension, patients with cerebrovascular disorders, those with severe hypertension, and the elderly should be especially careful when using this medication. The risk of side effects may increase if this medication is used in combination with other antihypertensive medications, so it should be used under the supervision of a healthcare professional. During treatment with this medication, kidney function and serum electrolyte levels should be monitored regularly, and symptoms such as dizziness or fainting due to rapid drops in blood pressure may occur, so driving or engaging in hazardous activities should be avoided. This medication can cause various side effects, including decreased kidney function, reduced blood cell counts, allergic reactions, skin rash, digestive disorders, liver function abnormalities, respiratory issues, and electrolyte imbalances. If any of these symptoms occur, medical consultation should be sought immediately. It is safest for pregnant or breastfeeding women not to take this medication, and in unavoidable circumstances, breastfeeding should be discontinued. The safety and efficacy of this medication in children have not been established, so its use is not recommended in pediatric patients. For the elderly, the initial dose should start low to prevent excessively low blood pressure, and their condition should be closely monitored during administration. Furthermore, this medication may interact with certain drugs, so if other medications are being taken, the healthcare provider should be informed, and one should not abruptly stop or change the medication regimen. Finally, this medication should be kept in a safe place out of the reach of children, and transferring it to another container should be avoided.

• Increased BUN
• increased 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 air and light exposure. The storage temperature should be maintained between 1 to 30 degrees Celsius, avoiding extremely hot or cold conditions.

Appearance

Light orange round tablet

Package unit

30 tablets/bottle, 100 tablets/bottle