CMG Maleate Enalapril Tablet 10mg

Adult dose

1. Hypertension 1) Patients not receiving a diuretic Adults: The initial dose of enalapril maleate is 5㎎ 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 toward the end of the dosing interval in patients taking the drug once daily, increase the dose or administer it 2 times daily. 2) Patients receiving a diuretic Adults: Hypotension may occur when this drug is first administered to patients who have recently been treated for hypertension with a diuretic. If possible, discontinue the diuretic 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 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㎎ Patients on dialysis / 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 drug is used as adjunctive therapy to diuretics and digitalis. 2) Initial dose Adults: Administer 2.5㎎ 1-2 times daily. After the first dose, observe the patient closely for at least 2 hours and until blood pressure is stable. If possible, reduce the diuretic dose to prevent 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; the maximum daily dose is 40㎎. In controlled trials in which most patients received the maximum daily dose of 40㎎, an effective response was obtained with once-daily administration. However, twice-daily administration has generally been used in many trials, 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 failure or hyponatremia In 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㎎ once daily with close observation. If the dose is increased, administer 2.5-5㎎ 2 times daily or increase it further if necessary. Increase the dose only if excessive hypotension or significant deterioration in renal function has not occurred during the 4 days or more after the initial dose. The maximum daily dose is 40㎎.

This medication should not be administered to certain patients. For example, patients with allergies or history of hypersensitivity to this medication, those undergoing specific dialysis, those with a history of angioedema, and patients with certain hypertension or liver disease, kidney transplant patients, etc. should not use this medication. Additionally, it is safe not to administer this medication to pregnant women, women who might become pregnant, nursing mothers, and children. Patients with severe renal impairment, renal vascular hypertension, or cerebrovascular disorders should use this medication with caution, observing the patient's condition closely during administration. Renal function must be monitored during the use of this medication; particularly in patients with severe hypertension or those undergoing dialysis or taking diuretics, initial administration can result in side effects such as hypotension; therefore, starting with a lower dose and gradually increasing is advisable. This medication may produce various side effects including decreased renal function, decreased blood cell count, allergic reactions, skin rashes, neurological symptoms, gastrointestinal issues, liver function abnormalities, respiratory symptoms, etc. If any abnormal symptoms appear, consult a healthcare professional immediately. This medication may interact with other drugs, so caution is needed when taken with potassium-sparing diuretics, lithium, non-steroidal anti-inflammatory drugs, antihypertensive agents, immunosuppressants, alcohol, psychiatric medications, hypoglycemic agents, and others. During pregnancy, it must never be administered as it can severely affect the fetus, and in nursing cases, possible administration should be avoided or breastfeeding should be stopped. Elderly patients should start with a lower dose to avoid excessive hypotension and should be closely monitored. Patients receiving specific treatments (e.g. venom desensitization) while on this medication may experience severe allergic reactions, so caution is warranted. Finally, this medication should be kept out of reach of children, and transferring it to another container should be avoided, as it can compromise quality and safety.

• Increased BUN
• increased serum creatinine
• acute kidney failure
• decreased hemoglobin
• decreased hematocrit
• decreased white blood cells
• decreased platelets
• increased eosinophils
• positive antinuclear antibody
• angioedema

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the medication’s efficacy.

Appearance

White round tablet

Package unit

30 tablets/bottle, 500 tablets/bottle