Renipril Tablet 10 mg (Enalapril Maleate)

Adult dose

1. Hypertension 1) Patients not receiving diuretics Adults: Administer an initial dose of 5㎎ once daily as 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 decreases toward the end of the dosing interval in patients receiving the medication once daily, increase the dose or administer it twice daily. 2) Patients receiving diuretics Adults: Hypotension may occur when this medication is first administered to patients who have recently been treated for hypertension with a diuretic. Therefore, discontinue the diuretic 2-3 days before starting this medication, if possible. If hypertension is not controlled when this medication is administered, diuretic treatment may be resumed. If the diuretic cannot be discontinued, administer 2.5㎎ of this medication orally once daily. 3) Patients with renal impairment ① The usual dose 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 less (serum creatinine of 3㎎/㎗ or higher): Administer an initial dose of 2.5㎎ once daily. The dose may be increased 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㎎ Patients on dialysis / 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 an adjunct to diuretics and digitalis. 2) Initial dose Adults: Administer 2.5㎎ per dose 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 prevent 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 dose may be increased to a maximum of 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 more often, and in placebo-controlled trials showing reduced mortality in patients with severe heart failure (NYHA class Ⅳ), most patients received 2.5-40㎎ per day 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 who have hyponatremia (serum sodium concentration 130mEq/ℓ or less) or serum creatinine of 1.6㎎/㎗ or higher, administer an initial dose of 2.5㎎ per day with close monitoring. If the dose is increased, increase by 2.5-5㎎ per dose twice daily, or more 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 patients with certain allergic reactions or a history of such reactions. It is not safe to administer to patients undergoing hemodialysis or using specific types of dialysis membranes. It may pose risks to patients with angioedema or a history of it, and should not be administered to patients undergoing specific LDL separation treatments. Patients with primary aldosteronism, aortic stenosis, or obstructive hypertrophic cardiomyopathy should not take this medication. Patients with liver dysfunction or primary liver disease, as well as those post-kidney transplant, should also avoid using this drug. It is best for pregnant women or those who may become pregnant, and nursing mothers to refrain from taking this medication. Safety and efficacy have not been established for children, hence it is recommended not to administer it. If patients with diabetes or severe renal impairment are taking certain other medications, they should not use this drug in conjunction. Patients with lactose intolerance or specific genetic issues should avoid this medication due to the lactose it contains. Patients with severely impaired renal function should use this medication cautiously with a reduced dose or increased dosing intervals. Caution is necessary for patients with renovascular hypertension or cerebrovascular disorders, as abrupt lowering of blood pressure may worsen their condition. Patients with severe hypertension, electrolyte imbalances, or immune disorders should also use this medication carefully. Older adults should start at a low dose and be closely monitored to prevent blood pressure from dropping too low. Caution is needed when used with other antihypertensive agents, as it may lower blood pressure too much. This medication can affect kidney function, so renal function tests must be conducted before and during treatment. It is advisable not to administer within 24 hours prior to surgery, and patients should avoid dangerous tasks if dizziness or unsteadiness occurs after administration. When taken with drugs that increase serum potassium levels, potassium levels may rise dangerously, so caution is required. When combined with lithium, lithium levels may increase, causing toxicity; therefore, blood levels should be monitored frequently. The antihypertensive effect may be reduced when used with non-steroidal anti-inflammatory drugs. Caution should be exercised with alcohol intake during treatment, as combining it with antipsychotic medications may increase the risk of orthostatic hypotension. Blood sugar levels should be carefully monitored when taken with hypoglycemic agents, as blood sugar may drop too low. Certain immunosuppressants may cause changes in blood cell counts when used concurrently, necessitating caution. During the course of using this medication, adverse reactions such as worsening kidney function, decreased blood cell counts, skin rashes, dizziness, low blood pressure, gastrointestinal symptoms, etc., may occur, and if symptoms arise, immediate consultation with healthcare personnel is necessary. Pregnant women or those who may become pregnant should not take this medication, and nursing mothers should avoid it or discontinue breastfeeding. Safety has not been verified in children, hence usage is not recommended, while older adults should start with a low dose and be monitored closely.

• Increased BUN
• elevated serum creatinine
• acute renal failure
• decreased hemoglobin
• reduced hematocrit
• leukopenia
• thrombocytopenia
• eosinophilia
• positive antinuclear antibody
• angioedema

This medication should be stored in a tightly closed container to prevent air or moisture from entering, and it is best stored at room temperature between 1 and 30 degrees Celsius. Doing so helps maintain the medication's effectiveness.

Appearance

Reddish-brown round tablet

Package unit

30 tablets (10 tablets/PTP packaging x 3), 100 tablets/bottle