Lenipril Tablet 5 mg (Enalapril Maleate)

Adult dose

1. Hypertension 1) Patients not receiving a diuretic Adults: The initial dose of enalapril maleate is 5㎎ once daily; 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 once-daily administration, increase the dose or administer twice daily. 2) Patients receiving a diuretic Adults: Hypotension may occur when this drug is first administered to patients recently treated for hypertension with a diuretic. Therefore, if possible, discontinue the diuretic 2-3 days before starting this drug. If hypertension is not controlled after starting this drug, diuretic treatment 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 more (serum creatinine up to 3㎎/㎗). ② Patients with creatinine clearance of 30㎖/min or less (serum creatinine 3㎎/㎗ or more): The initial dose is 2.5㎎ once daily. The dose may be increased up 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㎎ Patients on dialysis 2.5㎎ on the day of hemodialysis * If the patient is not undergoing hemodialysis, determine the dose according to the blood pressure response. 2. Heart failure 1) This drug is used as adjunctive treatment with diuretics and digitalis. 2) Initial dose Adults: Administer 2.5㎎ per dose 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㎎. Although a controlled trial in which most patients received the maximum daily dose of 40㎎ demonstrated efficacy with once-daily administration, twice-daily administration has generally been used in many trials. 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㎎ 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 failure 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 twice daily or more 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 used in certain patients. For instance, individuals who have had allergic reactions to this drug, patients receiving certain types of dialysis, patients with a history of angioedema, patients with certain kidney and liver diseases, women who are pregnant or may become pregnant, and children should not take this drug. Additionally, patients with severely impaired kidney function or renal artery hypertension, cerebrovascular disorders, and severe hypertension should exercise caution when using this medication and may require dose adjustments or increased intervals between doses. Since this medication can affect kidney function, kidney function tests must be conducted before and during treatment. Moreover, blood pressure may drop suddenly, so it is advisable to start treatment at a low dose and closely monitor the patient's condition. While taking this medication, regular blood tests should be conducted to check potassium levels, kidney function, and blood cell counts, and any unusual symptoms should be reported to healthcare providers immediately. This drug can cause various side effects, such as worsening kidney function, decreased blood cell counts, skin rash, dizziness, headaches, gastrointestinal disturbances, liver function abnormalities, and breathing difficulties, so it's crucial to inform healthcare providers if any of these symptoms occur. Furthermore, this medication may interact with other drugs, so patients should inform healthcare providers about any other medications they are taking, particularly potassium-sparing diuretics, lithium, non-steroidal anti-inflammatory drugs, antihypertensive agents, and immunosuppressants. Women who are pregnant or breastfeeding should preferably avoid this medication, and if it is necessary to take it, they should consult with a healthcare professional for guidance. Lastly, the safety and efficacy of this drug have not been established in children, so it is advisable not to use it. Elderly patients should start at a low dose and be carefully monitored.

• Increased BUN
• increased serum creatinine
• acute kidney 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 moisture. The storage temperature should maintain room temperature between 1°C and 30°C. This ensures the medication's effectiveness is preserved safely.

Appearance

White round tablet

Package unit

50 tablets (10 tablets/PTP packaging x 5)