Enagrap Tablets (Enalapril Maleate)

Adult dose

1. Hypertension 1) Patients not receiving diuretics Adults: Administer an initial dose of 5㎎ once daily as enalapril maleate and adjust according to blood pressure. The maintenance dose is 10-40㎎ per day in 1-2 divided doses. If the antihypertensive effect decreases toward the end of the dosing interval in patients receiving the drug once daily, increase the dose or administer it 2 times daily. 2) Patients receiving diuretics Adults: In patients recently treated for hypertension with a diuretic, hypotension may occur with the first dose of this drug. If possible, discontinue the diuretic 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 dose applies to patients with a creatinine clearance of 30㎖/min or more (serum creatinine up to 3㎎/㎗). ② Patients with a creatinine clearance of 30㎖/min or less (serum creatinine 3㎎/㎗ or more): Administer an initial dose of 2.5㎎ once daily. The dose may be increased to a maximum of 40㎎ per day 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㎎ per dose 1-2 times daily. After the first dose, monitor the patient carefully 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㎎ per day in 2 divided doses; up to a maximum of 40㎎ per day may be administered. In controlled trials in which most patients received the maximum daily dose of 40㎎, once-daily administration was effective; however, twice-daily administration was generally used in trials, and in placebo-controlled trials confirming reduced mortality in patients with severe heart failure (NYHA class Ⅳ), most patients received 2.5-40㎎ per day in 2 divided doses. Adjust the dose according to the hemodynamic or clinical response. 4) Patients with heart failure accompanied by renal impairment or hyponatremia For patients with heart failure and hyponatremia (serum sodium concentration 130mEq/ℓ or less) or serum creatinine of 1.6㎎/㎗ or more, administer an initial dose of 2.5㎎ per day with careful monitoring. If increasing the dose, increase by 2.5-5㎎ per dose 2 times daily or more if necessary, provided that no excessive hypotension or significant deterioration in renal function has occurred for 4 days or longer after the first dose. The maximum dose is 40㎎ per day.

This medication should not be administered to certain patients. For example, patients who are allergic or hypersensitive to this medication, those undergoing specific dialysis methods, patients with a history of angioedema, and women who are pregnant or may become pregnant and breastfeeding should not take it. Furthermore, it is advisable not to use this medication in patients with severely impaired kidney or liver function, patients with aortic stenosis or obstructive valvular disease, as well as in children. Caution is also necessary for diabetic patients with certain kidney function issues or those taking other specific medications. Patients with severely decreased kidney function, patients with renovascular hypertension, patients with cerebrovascular disorders, patients with significant proteinuria, severely hypertensive patients, those with electrolyte imbalances, immune disorders or collagen diseases, and the elderly should have their dosage carefully adjusted or their conditions closely monitored while using this medication. This drug may affect kidney function, so renal function tests must be performed before and during administration. Particularly, in patients with severe hypertension or those on diuretics, blood pressure may drop sharply upon initial administration, so it is important to start at a low dose and gradually increase it. During the use of this medication, dizziness or drowsiness may occur, so it is advisable to avoid driving or operating potentially hazardous machinery. Additionally, interactions may occur when used with certain drugs such as potassium-sparing diuretics, lithium, non-steroidal anti-inflammatory drugs, antihypertensives, and alcohol, so it is essential to consult with healthcare professionals. Pregnant or breastfeeding women should not take this medication, and if unavoidable, breastfeeding should be discontinued. Safety in children has also not been established, hence use in children is not recommended. Lastly, this medication should be kept out of reach of children, and transferring it to other containers is not advisable for quality preservation.

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

This medication is susceptible to air and moisture, so it must be stored in a tightly closed container. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius, and it is best to keep it in a dry place with low humidity.

Appearance

Reddish-brown round tablets

Package unit

30 tablets/bottle, 100 tablets/bottle