Unipril Tablet 10 mg (Enalapril Maleate)

Adult dose

1. Hypertension 1) Patients not receiving diuretics Adults: Administer 5㎎ once daily as the initial dose of enalapril maleate, and adjust according to blood pressure. The maintenance dose is 10-40㎎ per day in 1-2 divided doses. If the antihypertensive effect wanes 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 medication is first administered to patients recently treated for hypertension with a diuretic, discontinue the diuretic, if possible, 2-3 days before starting this medication. If hypertension is not controlled when this medication is administered, the diuretic may be resumed. If the diuretic cannot be discontinued, administer this medication 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): Administer 2.5㎎ once daily as the initial dose. The dose may be increased up to a maximum of 40㎎ per day 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㎎ Dialysis patients 2.5㎎ on the day of hemodialysis * If hemodialysis is not performed, determine the dose according to the blood pressure response. 2. Heart failure 1) This medication is used as adjunctive treatment with diuretics and digitalis. 2) Initial dose Adults: Administer 2.5㎎ 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 medication, 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 dose is 40㎎ per day. In controlled trials in which most patients received the maximum daily dose of 40㎎, once-daily administration was effective; however, twice-daily administration was generally used in trials, and in placebo-controlled trials confirming reduced mortality in patients with severe heart failure (NYHA class Ⅳ), most patients received 2.5-40㎎ twice daily. Adjust the dose 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 2.5㎎ per day as the initial dose with careful monitoring. If increasing the dose, increase by 2.5-5㎎ per dose twice daily or more if needed, provided that excessive hypotension or significant deterioration in renal function has not occurred for 4 days or more after the initial dose. The maximum dose is 40㎎ per day.

This medication should not be used in certain patients. For example, patients with allergies to this medication, those undergoing dialysis, patients with a history of angioedema, certain liver diseases, or those who have had a kidney transplant, pregnant women or those who might become pregnant, and children should not take this medication. Caution is required for patients with severe renal impairment, renovascular hypertension, cerebrovascular disorders, severe hypertension, electrolyte imbalances, the elderly, etc. Especially when taken with other antihypertensives, blood pressure may drop too low and renal function may become challenged. While taking this medication, renal function, serum potassium levels, and blood pressure should be regularly monitored, and any abnormal symptoms should be immediately reported to healthcare professionals. Symptoms may include severe dizziness, signs of angioedema (swelling of face, tongue, and throat), severe rash, dyspnea, etc. Additionally, since this medication lowers blood pressure, it should be initiated at a low dose and titrated slowly. It is advisable not to take it within 24 hours of surgery. Caution is advised when undertaking hazardous tasks such as high-altitude work or driving, as dizziness or drowsiness may occur. This medication can interact with other drugs, particularly when taken with potassium-sparing diuretics, lithium, non-steroidal anti-inflammatory drugs, other antihypertensives, immunosuppressants, and alcohol. Consult healthcare professionals before combining medications and ensure regular check-ups are conducted. It is safe for pregnant or breastfeeding women to avoid taking this medication, and if unavoidable, breastfeeding should be discontinued. The safety and efficacy of this medication in children are not sufficiently proven, so its use is not recommended. Finally, keep this medication out of the reach of children, and do not transfer it to other containers.

• Increased BUN
• elevated serum creatinine
• acute renal failure
• decreased hemoglobin
• decreased hematocrit
• decreased leukocytes
• decreased platelets
• increased eosinophils
• positive antinuclear antibodies
• angioedema

This medication should be stored in a tightly sealed container to protect it from air and moisture. Also, it is safest to store the medication at room temperature between 1 and 30 degrees Celsius, avoiding extremes of heat or cold.

Appearance

White round tablets

Package unit

30 tablets/bottle, 300 tablets/bottle