Elponal Tablet 10 mg (Enalapril Maleate)

Adult dose

1. Hypertension 1) Patients not receiving diuretics Adults: Administer 5 mg once daily as the initial dose of enalapril maleate, and adjust according to blood pressure. The maintenance dose is 10-40 mg daily 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 twice daily. 2) Patients receiving diuretics Adults: Because 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, if possible. If hypertension is not controlled when this drug is administered, diuretic therapy may be resumed. If the diuretic cannot be discontinued, administer 2.5 mg of this drug orally once daily. 3) Patients with renal impairment A. The usual dosage applies to patients with creatinine clearance of 30 mL/min or greater (serum creatinine up to 3 mg/dL). B. Patients with creatinine clearance of 30 mL/min or less (serum creatinine of 3 mg/dL or greater): Administer 2.5 mg once daily as the initial dose. The dose may be increased to a maximum of 40 mg daily until blood pressure is controlled. Renal function status / Creatinine clearance (mL/min) / Initial dose (mg/day) Normal / >80 mL/min / 5 mg Mild impairment / >30, ≤80 mL/min / 5 mg Moderate-to-severe impairment / ≤30 mL/min / 2.5 mg Patients on dialysis / 2.5 mg on the day of dialysis * If 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 mg per dose 1-2 times daily. Observe the patient carefully for at least 2 hours after the first dose 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 mg daily in 2 divided doses; the dose may be increased to a maximum of 40 mg daily. In controlled trials in which most patients received the maximum daily dose of 40 mg, effective results were obtained with once-daily administration; however, twice-daily administration was generally used more often. In placebo-controlled trials confirming reduced mortality in patients with severe heart failure (NYHA class IV), most patients received 2.5-40 mg 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 impairment or hyponatremia In patients with heart failure and hyponatremia (serum sodium concentration of 130 mEq/L or less) or serum creatinine of 1.6 mg/dL or greater, administer 2.5 mg daily as the initial dose with careful monitoring. If the dose is increased, administer 2.5-5 mg per dose 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 first dose. The dose may be increased to a maximum of 40 mg daily.

This medication should not be used in certain patients. For example, patients who have previously had an allergic reaction to this drug, are undergoing dialysis, have a history of angioedema, are taking specific antihypertensive treatments, have primary liver disease, have had a kidney transplant, are pregnant or breastfeeding, and children should not be administered this medication. Additionally, patients with severely impaired kidney function, renal artery hypertension, cerebrovascular disease, significant proteinuria, elderly patients, etc., should use this medication with caution. In particular, when used with other antihypertensive medications, there is an increased risk of hypotension, electrolyte problems, and worsening kidney function. During the use of this medication, kidney function and blood test results should be monitored frequently, and care should be taken to ensure that blood pressure does not drop too low. There is also a risk of dizziness or fainting due to sudden drops in blood pressure, so driving or operating hazardous machinery should be avoided. Various side effects can occur while taking this medication, including worsening kidney function, changes in blood components, allergic reactions, skin rashes, dizziness, headaches, gastrointestinal symptoms, abnormal liver function, and respiratory symptoms; if any unusual symptoms occur, consult a doctor immediately. Women who are pregnant or may become pregnant should avoid this medication as it may pose serious risks to the fetus, and breastfeeding women should either avoid taking it or stop breastfeeding. This medication is not recommended for children as its safety and efficacy have not been established. In elderly patients, there is a risk of stroke due to excessive blood pressure lowering, so they should start at a lower dose and be administered carefully. This medication may interact with other drugs; caution is needed, especially when used with potassium-sparing diuretics, lithium, non-steroidal anti-inflammatory drugs, antihypertensives, immunosuppressants, alcohol, etc. Finally, this medication should be kept out of reach of children, and transferring it to another container may negatively affect quality and safety, so it should be avoided.

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

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

Appearance

Brownish-red round tablet.

Package unit

30 tablets/bottle, 100 tablets/bottle, 500 tablets/bottle