EPR Tablet 10mg (Enalapril Maleate)

Adult dose

1. Hypertension 1) Patients not receiving diuretics Adults: The initial dose is 5 mg once daily as enalapril maleate, adjusted 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 the drug once daily, 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. 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 2.5 mg orally once daily. 3) Patients with renal impairment ① The usual dosage applies to patients with creatinine clearance of 30 mL/min or more (serum creatinine up to 3 mg/dL). ② Patients with creatinine clearance of 30 mL/min or less (serum creatinine of 3 mg/dL or more): The initial dose is 2.5 mg once daily. 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 Dialysis patients 2.5 mg on the day of hemodialysis * If hemodialysis is not performed, determine the dose according to 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. After the first dose, observe the patient closely for at least 2 hours and until blood pressure is stable, and reduce the diuretic dose if possible 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 mg daily in 2 divided doses; the maximum daily dose is 40 mg. In controlled trials in which most patients received the maximum daily dose of 40 mg, once-daily administration was effective. However, twice-daily administration was generally used in trials, and in placebo-controlled trials demonstrating 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 hemodynamic or clinical response. 4) Patients with heart failure accompanied by renal impairment or hyponatremia For patients with heart failure who have hyponatremia (serum sodium concentration of 130 mEq/L or less) or serum creatinine of 1.6 mg/dL or more, administer an initial dose of 2.5 mg daily with close monitoring. If increasing the dose, increase by 2.5-5 mg per dose twice daily, or more if needed. 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 maximum daily dose is 40 mg.

This medication should not be used in certain patients. For example, it should not be administered to patients with an allergy or hypersensitivity to this drug, patients undergoing certain types of dialysis, or those with a history of angioedema. It should also be avoided in patients with primary aldosteronism, aortic stenosis, severe liver disease, kidney transplant recipients, pregnant or breastfeeding women, and children. Patients with severe renal impairment, renovascular hypertension, or cerebrovascular disorders should use this medication cautiously. In these cases, dose reduction or adjustment of the dosing interval may be necessary. This medication can affect kidney function; therefore, kidney function should be assessed before and during treatment. In particular, patients with hypertension, dialysis patients, or those taking diuretics should start at a low dose and be closely monitored. This drug can cause a sudden drop in blood pressure, leading to dizziness or fainting, so patients should avoid operating dangerous machinery or driving. This drug may have several side effects. Potential side effects include deterioration of kidney function, decreased blood cell counts, allergic reactions resulting in angioedema, skin rashes or itching, dizziness, headaches, nausea, vomiting, abdominal pain, liver function abnormalities, and respiratory difficulties. Patients should consult a doctor immediately if any unusual symptoms occur. This medication can interact with other drugs, particularly potassium-sparing diuretics, lithium, non-steroidal anti-inflammatory drugs, antihypertensives, immunosuppressants, and alcohol. Women who are pregnant or may become pregnant should not take this medication. Nursing mothers should also avoid taking it or discontinue breastfeeding if necessary. Elderly patients should start at lower doses due to the risk of excessive blood pressure reduction leading to stroke, and their condition should be closely monitored. This medication should not be used in children, as its safety and efficacy have not been established. Lastly, this medication should be stored out of reach of children, and transferring it to other containers is not advisable for quality maintenance and safety.

• Elevated BUN
• elevated serum creatinine
• acute renal failure
• decreased hemoglobin
• decreased hematocrit
• leukopenia
• thrombocytopenia
• increased eosinophils
• positive antinuclear antibody
• angioedema

Store this medication in a tightly closed container to prevent air and moisture from entering. It is best to keep the medication at room temperature between 1°C and 30°C, avoiding extremely hot or cold locations.

Appearance

White round tablet

Package unit

30 tablets/bottle, 500 tablets/bottle