Fril Tablet (Enalapril Maleate)

Adult dose

1. Hypertension 1) Patients not receiving diuretics Adults: The initial dose is 5㎎ once daily as enalapril maleate, adjusted 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 a once-daily dose, increase the dose or administer it twice daily. 2) Patients receiving diuretics Adults: Hypotension may occur when this product is first administered to patients who have recently been treated for hypertension with a diuretic. Therefore, discontinue the diuretic, if possible, 2-3 days before starting this product. If hypertension is not controlled when this product is administered, the diuretic may be resumed. If the diuretic cannot be discontinued, administer 2.5㎎ of this product 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㎎ 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 the patient does not undergo hemodialysis, determine the dose according to the blood pressure response. 2. Heart failure 1) This product is used as adjunctive therapy to 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 prevent hypotension. If hypotension occurs after the first dose of this product, 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㎎, effective results were obtained with once-daily administration; however, twice-daily administration was generally used more often. In placebo-controlled trials that confirmed reduced mortality in patients with severe heart failure (NYHA class Ⅳ), most patients received 2.5-40㎎ per day in 2 divided doses. Adjust the dose according to the hemodynamic or clinical response. 4) Patients with heart failure accompanied by renal failure or hyponatremia In patients with heart failure who have hyponatremia (serum sodium concentration 130mEq/ℓ or less) or serum creatinine of 1.6㎎/㎗ or more, administer an initial dose of 2.5㎎ per day with careful observation. If increasing the dose, increase by 2.5-5㎎ per dose twice daily or more if necessary, provided that at least 4 days or more have passed after the initial dose without excessive hypotension or significant deterioration in renal function. The dose may be increased to a maximum of 40㎎ per day.

This medication should not be administered to certain patients. For instance, individuals who have an allergy to this medication or a history of hypersensitivity should not take it. Patients undergoing dialysis or with a history of angioedema should also avoid this medication, and caution is required in patients undergoing specific treatments or with liver or kidney dysfunction. It is advisable not to use this medication in pregnant women, women who may become pregnant, nursing mothers, and children. Patients with severely impaired kidney function may need to adjust the dose or extend the dosing interval, and individuals with renovascular hypertension or cerebrovascular disorders should use this medication with caution. Additionally, patients with severe hypertension or electrolyte imbalances, as well as individuals with immune system disorders, also require caution. This medication can affect kidney function, so kidney function tests must be conducted before and during treatment. Blood pressure may suddenly drop upon initial administration, so patients with severe hypertension or those taking diuretics should start with a low dose and gradually increase the dosage. It is recommended to refrain from taking this medication within 24 hours prior to surgery, and due to the risk of low blood pressure, dizziness, or fainting, driving or engaging in hazardous activities should be avoided. This medication may interact with other drugs, especially potassium-sparing diuretics, lithium, non-steroidal anti-inflammatory drugs, other antihypertensive medications, immunosuppressants, alcohol, psychiatric medications, and antihyperglycemic agents, so please consult a doctor or pharmacist when using them together. During the use of this medication, various side effects such as rare skin rashes, blood abnormalities, worsening of kidney function, respiratory difficulties, and liver function abnormalities may occur, and if abnormal symptoms arise, promptly inform a healthcare professional. Use during pregnancy can cause serious side effects in the fetus, so women who are pregnant or planning to become pregnant should avoid taking this medication, and nursing mothers should also avoid it if possible or discontinue breastfeeding. Elderly patients should start at a low dose to prevent excessively low blood pressure and be closely monitored. Finally, the safety of this medication has not been established in children, so it is preferable not to use it, and during storage, it should be kept out of reach of children. Transferring the medication to another container may adversely affect its quality, so caution is advised.

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

This medication should be stored in a sealed container to prevent exposure to air and moisture. This helps to maintain the effectiveness of the medication for a longer period.

Appearance

Dark reddish-brown round tablet

Package unit

30 tablets/bottle, 500 tablets/bottle