Samnam Enalapril Tablet 10 mg (Enalapril Maleate)

Adult dose

1. Hypertension 1) Patients not receiving diuretics Adults: The initial dose is 5㎎ of enalapril maleate once daily; adjust according to blood pressure. The maintenance dose is 10-40㎎ daily in 1-2 divided doses. If the blood pressure-lowering effect decreases at 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: Since hypotension may occur when this drug is first administered to patients recently treated for hypertension with a diuretic, discontinue the diuretic, if possible, 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㎎ of this drug orally 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 of 3㎎/㎗ or more): The initial dose is 2.5㎎ once daily. The dose may be increased to a maximum of 40㎎ daily until blood pressure is controlled. Renal function / 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 renal dialysis * If the patient does not undergo renal dialysis, 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. Observe the patient closely 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㎎ daily in 2 divided doses; up to a maximum of 40㎎ daily may be administered. In controlled trials in which most patients received the maximum daily dose of 40㎎, once-daily administration was effective. However, twice-daily administration has generally been used more often, and 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㎎ 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 For patients with heart failure and hyponatremia (serum sodium concentration of 130mEq/ℓ or less) or serum creatinine of 1.6㎎/㎗ or more, administer an initial dose of 2.5㎎ daily under close observation. If the dose is increased, administer 2.5-5㎎ per dose twice daily, or increase it further if needed. Increase the dose only if excessive hypotension or significant deterioration in renal function has not occurred for 4 days or longer after the initial dose. The maximum daily dose is 40㎎.

This medication should not be used in certain patients. For example, individuals with a known allergy or history of hypersensitivity to this medication, patients receiving certain types of dialysis, those with a history of angioedema, patients with primary hyperaldosteronism, and those with impaired liver or kidney function, as well as pregnant or breastfeeding women, and children may be at risk if they take this medication. Additionally, patients with severely impaired kidney function or renal artery stenosis, patients with cerebrovascular disorders, patients with severely elevated blood pressure, patients with electrolyte imbalances, and elderly individuals should use this medication with caution, and may require dose adjustments or changes in dosing intervals. This medication can affect kidney function, so kidney function tests must be performed before and during treatment. There is a risk of a sudden drop in blood pressure, so patients with severe hypertension, those on diuretics, or patients undergoing dialysis should start at a low dose and gradually increase the dose. During treatment, symptoms such as dizziness or drowsiness may occur, so caution is required when driving or operating dangerous machinery. Additionally, if symptoms such as sore throat or fever occur while taking this medication, immediate medical attention should be sought. This medication can interact with various other drugs, so caution is advised when used in combination with potassium-sparing diuretics, lithium, non-steroidal anti-inflammatory drugs, other antihypertensives, immunosuppressants, alcohol, psychotropic medications, or hypoglycemic agents. During pregnancy, it can have severe effects on the fetus, so women who are pregnant or may become pregnant should not take it, and breastfeeding should also be avoided or breastfeeding discontinued. The safety and efficacy in children have not been established, so it is preferable not to administer it to them. In elderly patients, dosing should start at a low dose with careful monitoring to prevent excessively low blood pressure. Finally, this medication should be kept out of reach of children, and care should be taken not to transfer it to another container as this may affect its quality.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is best to keep it at room temperature, between 1 degree and 30 degrees Celsius.

Appearance

White round tablets

Package unit

30 tablets/bottle, 200 tablets/bottle