Leomin Tablets (Enalapril Maleate)

Adult dose

1. Hypertension 1) Patients not receiving diuretics Adults: The initial dose of enalapril maleate is 5㎎ once daily, adjusted 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 once-daily dosing, increase the dose or administer it twice daily. 2) Patients receiving diuretics Adults: Hypotension may occur when this drug is first administered to patients recently treated for hypertension with a diuretic. Therefore, 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 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 3㎎/㎗ or greater): The initial dose is 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 hemodialysis * If hemodialysis 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 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; 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 has generally been used more often, and in placebo-controlled trials that confirmed a reduction in mortality among patients with severe heart failure (NYHA class Ⅳ), most patients received 2.5-40㎎ per day in 2 divided doses. The dose may be adjusted according to the hemodynamic or clinical response. 4) Patients with heart failure accompanied by renal impairment 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㎎ per day under close observation. If increasing the dose, administer 2.5-5㎎ 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. The maximum daily dose is 40㎎.

This medication should not be administered to certain patients. For example, patients who are allergic to this medication or have hypersensitivity, patients undergoing certain types of dialysis, patients with a history of angioedema, patients receiving specific blood purification treatments, patients with primary hyperaldosteronism, patients with aortic stenosis or obstructive hypertrophic cardiomyopathy, patients with liver dysfunction, patients after kidney transplantation, women who are pregnant or may become pregnant, nursing mothers, and children should not receive this medication. Additionally, caution should be exercised when administering to patients with severe renal impairment, renal artery hypertension, cerebrovascular disorders, patients with significant proteinuria, severe hypertension, patients with severe electrolyte disturbances, patients with immune disorders or collagen diseases, and the elderly. In particular, when co-administering with other medications that have similar effects, the risk of hypotension, hyperkalemia, and renal dysfunction may increase, thus this should be administered under the supervision of a specialist. Kidney function should be monitored periodically during administration, and when starting treatment, blood pressure may drop suddenly, hence it is advisable to start with a low dose and closely monitor the patient's condition. Also, it is recommended not to administer this medication within 24 hours before surgery. As blood pressure may drop leading to dizziness or staggering, avoid hazardous tasks such as working at heights or operating vehicles. This medication can have various side effects, including renal dysfunction, decreased blood cell count, allergic reactions, skin rashes, dizziness, headaches, cardiac irregularities, gastrointestinal issues, liver dysfunction, and respiratory symptoms. Notably, serious allergic reactions such as angioedema may occur, and if any unusual symptoms arise, the patient should immediately consult a healthcare professional. This medication may interact with certain drugs, so caution is required when taken with potassium-sparing diuretics, lithium, non-steroidal anti-inflammatory drugs, other antihypertensive agents, immunosuppressants, alcohol, psychiatric medications, and hypoglycemic agents. In particular, when co-administered with medications affecting the renin-angiotensin system, the risk of serious side effects increases and should not be combined without expert advice. It is safest for pregnant women and nursing mothers to avoid this medication, and in unavoidable circumstances, breastfeeding should be discontinued. The safety and efficacy for children have not been established, so it is advisable not to administer this medication to them. Elderly patients should start with a low dose to prevent blood pressure from dropping too low and observe their condition carefully. Patients receiving venom immunotherapy while taking this medication may exhibit life-threatening anaphylactic reactions, so caution is warranted. Lastly, this medication should be stored out of the reach of children and it is best not to transfer it to another container to maintain its safety and quality.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is advisable to maintain the storage temperature between 1 degree and 30 degrees Celsius at room temperature. By storing it this way, the efficacy and safety of the medication can be preserved for a long time.

Appearance

White round tablets

Package unit

30 tablets/bottle, 100 tablets/bottle