Elapril Tablets 10 mg (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 at the end of the dosing interval in patients receiving once-daily dosing, increase the dose or administer twice daily. 2) Patients receiving diuretics Adults: Hypotension may occur when this drug is first administered to patients recently treated for hypertension with diuretics. If possible, discontinue the diuretic 2-3 days before starting this drug. If hypertension is not controlled with 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 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): 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㎎ 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 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, 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 dose may be increased to a maximum of 40㎎ per day. In controlled studies in which most patients received the maximum daily dose of 40㎎, once-daily administration was effective; however, twice-daily administration was generally used in studies, including a placebo-controlled study that confirmed reduced mortality in patients with severe heart failure (NYHA class Ⅳ), in which 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 more, administer an initial dose of 2.5㎎ per day with close monitoring. If the dose is increased, 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 for 4 days or longer after the first dose. The maximum dose is 40㎎ per day.

This medication should not be used in certain patients. For example, those who are allergic or hypersensitive to this drug should not take it. Patients undergoing hemodialysis or those with a history of angioedema should also avoid this medication. Additionally, it is not indicated for patients with liver or kidney dysfunction, those who have received kidney transplants, pregnant or breastfeeding women, and children. This drug should be used with caution in patients with severely impaired kidney function, significantly elevated blood pressure, or electrolyte imbalances. Elderly patients and those with immune-related disorders also require careful monitoring. When used in conjunction with other antihypertensive medications, there is an increased risk of hypotension or renal function deterioration, hence it should be supervised by a specialist. During treatment with this medication, kidney function should be closely monitored, and a low dose should be initiated, as there may be a rapid drop in blood pressure during the initial dosing. It is advisable not to take this medication within 24 hours prior to surgery, and caution is advised when driving or operating dangerous machinery as dizziness may occur. This medication may cause various side effects. These can include renal function impairment, blood abnormalities, skin rashes, dizziness, headaches, hypotension, gastrointestinal issues, etc. If any abnormal symptoms arise, it is vital to consult a doctor immediately. Furthermore, caution is necessary when taking this drug with medications that can increase potassium levels, as well as with lithium, non-steroidal anti-inflammatory drugs, and alcohol due to possible interactions. During pregnancy, it can severely affect the fetus, so women who are likely to become pregnant should avoid this medication, and it is also advisable to refrain from use while breastfeeding. The safety and efficacy of this medication in children have not been established, so it is preferable not to use it in this population. Elderly patients should start on a low dose and be monitored closely thereafter. Finally, when storing this medication, it should be kept out of the reach of children and not transferred to other containers.

• Elevated BUN
• elevated serum creatinine
• acute renal failure
• decreased hemoglobin
• decreased hematocrit
• reduced white blood cell count
• reduced platelet count
• increased eosinophils
• positive antinuclear antibodies
• angioedema

This medication is sensitive to air and moisture, therefore it should be stored in a tightly sealed container. Additionally, it should be kept in a cool, dry place below 30 degrees Celsius to maintain its efficacy.

Appearance

White rectangular tablets (export version: white round tablets)

Package unit

30 tablets/bottle, 500 tablets/bottle