Enalin 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, administered in 1-2 divided doses. If the blood pressure-lowering effect decreases toward the end of the dosing interval in patients receiving the drug once daily, 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 recently treated for hypertension with a diuretic, discontinue the diuretic 2-3 days before starting this drug whenever possible. If hypertension is not controlled while taking this drug, 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 creatinine clearance of 30㎖/min or greater (serum creatinine up to 3㎎/㎗). ② Patients with creatinine clearance of 30㎖/min or less (serum creatinine of 3㎎/㎗ or greater): 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 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㎎ Patients on dialysis / 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㎎ at a time, 1-2 times daily. After the first dose, observe the patient closely for at least 2 hours and until blood pressure is stable, and reduce the diuretic dose if possible to avoid 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 more often. In placebo-controlled trials that confirmed 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 For patients with heart failure who have hyponatremia (serum sodium concentration 130mEq/ℓ or less) or serum creatinine of 1.6㎎/㎗ or greater, administer an initial dose of 2.5㎎ daily under close observation. When increasing the dose, administer 2.5-5㎎ at a time 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 more after the first dose. The maximum daily dose is 40㎎.

This medication should not be administered to certain patients. For example, it should not be used in patients who have had an allergic reaction to this medicine, are undergoing specific types of dialysis, or have a history of angioedema. It is also not recommended for patients with severely impaired liver or kidney function, pregnant or nursing women, and children. Patients with weak kidney function, renovascular hypertension, cerebrovascular disorders, significant proteinuria, severe hypertension, etc., should be particularly cautious when using this medication, and dose adjustments or prolonged administration intervals may be necessary. Additionally, elderly patients or those with immune abnormalities should also receive this medication with caution. This medication may affect kidney function, so kidney function tests are necessary before and during treatment. At the initiation of treatment, blood pressure may drop sharply, so particularly in patients with hypertension or those taking diuretics, it is advised to start at a low dose and gradually increase it. While taking this medication, dizziness or drowsiness may occur, so activities such as driving or operating hazardous machinery should be avoided. Any concomitant medications may interact with this drug, so it is essential to consult with a doctor or pharmacist. This medication can elevate serum potassium levels, so caution is advised when using it with potassium supplements or medications high in potassium. The risk of side effects may also increase when used in combination with lithium, non-steroidal anti-inflammatory drugs, or other antihypertensives. Women who are pregnant or may become pregnant should not take this medication, and nursing mothers should either avoid it or stop breastfeeding. Possible side effects include deterioration of kidney function, changes in blood components, angioedema, skin rash, neurological symptoms, gastrointestinal issues, liver dysfunction, respiratory symptoms, etc., so any abnormal symptoms should be promptly discussed with a doctor. This medication is not recommended for use in children due to a lack of established safety and effectiveness. For the elderly, it should be started at a low dose and administered with caution. Finally, this medication should be stored out of the reach of children, and it is advisable not to transfer it to another container.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It should also be kept away from direct sunlight and stored at room temperature.

Appearance

Brownish-red round tablets

Package unit

30 tablets/bottle, 100 tablets/bottle