Enalapril Maleate Tablets 10 Milligrams

Adult dose

1. Hypertension 1) Patients not receiving diuretics Adults: Administer enalapril maleate 5㎎ once daily as the initial dose and adjust according to blood pressure. The maintenance dose is 10-40㎎ per day in 1-2 divided doses. If the antihypertensive effect decreases toward the end of the dosing interval in patients receiving the medicine once daily, increase the dose or administer it twice daily. 2) Patients receiving diuretics Adults: Hypotension may occur upon initial administration of this medicine in patients recently treated for hypertension with a diuretic. Therefore, discontinue the diuretic, if possible, 2-3 days before starting this medicine. If hypertension is not controlled after starting this medicine, the diuretic may be resumed. If the diuretic cannot be discontinued, administer this medicine 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 higher (serum creatinine up to 3㎎/㎗). ② Patients with creatinine clearance of 30㎖/min or lower (serum creatinine of 3㎎/㎗ or higher): 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 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㎎ Dialysis patients 2.5㎎ on the day of renal dialysis * If renal dialysis is not performed, determine the dose according to the blood pressure response. 2. Heart failure 1) This medicine is used as adjunctive therapy to diuretics and digitalis. 2) Initial dose Adults: Administer 2.5㎎ per dose 1-2 times daily. After the first dose, observe the patient carefully 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 of this medicine, continue to adjust the dose carefully and manage 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 trials administering the maximum daily dose of 40㎎ to most patients, once-daily administration was effective; however, twice-daily administration was generally used in many trials. In placebo-controlled trials in patients with severe heart failure (NYHA class Ⅳ) that confirmed a reduction in mortality, most patients received 2.5-40㎎ per day in 2 divided doses. The dose may be adjusted according to hemodynamic or clinical response. 4) Patients with heart failure accompanied by renal failure or hyponatremia In patients with heart failure and hyponatremia (serum sodium concentration 130mEq/ℓ or lower) or serum creatinine of 1.6㎎/㎗ or higher, administer 2.5㎎ per day as the initial dose with careful monitoring. If increasing the dose, administer 2.5-5㎎ 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 for 4 days or longer after the initial dose. The maximum dose is 40㎎ per day.

This medication should not be used in certain patients. For instance, it is contraindicated in patients with a history of allergic reactions to this drug, patients undergoing dialysis, patients with a history of angioedema, patients receiving specific blood purification treatments, patients with severely impaired liver or kidney function, pregnant women or women of childbearing potential, and children. Moreover, it should be used with caution in patients with severely compromised kidney function, renovascular hypertension, cerebrovascular disease, patients with significant proteinuria, patients with severe hypertension, patients with electrolyte imbalances, patients with immune disorders or collagen diseases, and the elderly. This drug may increase the risk of side effects when used with other blood pressure medications, hence it should be administered under the supervision of a specialist. While using this medication, renal function and electrolyte status must be monitored periodically, especially when beginning treatment, as blood pressure may drop suddenly; therefore, it is important to start at a low dose and increase it gradually. It is also advisable not to administer this drug within 24 hours before surgery. Side effects may include deterioration of renal function, reduction in blood cell counts, allergic reactions, skin rashes, dizziness, headaches, cardiac issues, gastrointestinal disturbances, liver function abnormalities, and respiratory symptoms; any unusual symptoms should be immediately discussed with healthcare professionals. This drug has numerous drug interactions, so caution is advised when taken with potassium-sparing diuretics, lithium, non-steroidal anti-inflammatory drugs, other antihypertensives, immunosuppressants, and alcohol. Pregnant or nursing women should not take this medication, and breastfeeding should be discontinued if necessary. The safety and efficacy of this drug in children have not been established, and it is preferable not to use it in this population. Elderly patients should start at a low dose to prevent excessive blood pressure drops, and any symptoms of neutropenia or premonitory symptoms should be reported to healthcare professionals immediately. Finally, this medication should be kept out of reach of children, and transferring it to other containers may lead to a decline in quality or accidents, so caution is necessary.

• BUN increase
• serum creatinine increase
• acute kidney failure
• hemoglobin decrease
• hematocrit decrease
• leukopenia
• thrombocytopenia
• eosinophilia
• positive antinuclear antibody
• angioedema

This medication should be stored in a tightly closed container to prevent exposure to air and moisture, preferably in a cool and dry place at or below 30 degrees Celsius. Proper storage can help maintain the effectiveness of the medication for a longer period.

Appearance

White octagonal tablets

Package unit

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