Basopril Tablets 10mg (Enalapril Maleate)

Adult dose

1. Hypertension 1) Patients not receiving diuretics Adults: The initial dose of enalapril maleate is 5㎎ once daily, adjusted according to blood pressure. The maintenance dose is 10-40㎎ daily, given in 1-2 divided doses. If the antihypertensive effect decreases toward the end of the dosing interval in patients receiving once-daily treatment, increase the dose or administer it twice daily. 2) Patients receiving diuretics Adults: Hypotension may occur when this drug is first administered to patients recently treated for hypertension with a diuretic. If possible, discontinue the diuretic 2-3 days before starting this drug. If hypertension is not controlled with this drug, the diuretic may be restarted. If the diuretic cannot be discontinued, administer this drug orally at 2.5㎎ 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 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 / On the day of renal dialysis: 2.5㎎ * 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㎎ 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; 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 studies 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 in many studies, and in a placebo-controlled study that confirmed reduced 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 impairment or hyponatremia In patients with heart failure and hyponatremia (serum sodium concentration 130mEq/ℓ or less) or serum creatinine of 1.6㎎/㎗ or more, administer an initial dose of 2.5㎎ daily with careful monitoring. If increasing the dose, increase by 2.5-5㎎ per dose twice daily, or more if necessary, provided that no excessive hypotension or significant deterioration in renal function occurs for 4 days or longer after the first dose. The maximum daily dose is 40㎎.

This medication should not be used in certain patients. For example, patients with allergies to this drug or hypersensitivity, those undergoing specific blood dialysis, those with a history of angioedema, and patients with renal or hepatic dysfunction should not take this medication. Also, it should not be administered to pregnant or potentially pregnant women, nursing mothers, and children. This drug should be used cautiously in patients with severely impaired renal function, renovascular hypertension, or cerebrovascular disorders. Caution is also necessary for patients with very high blood pressure, electrolyte imbalances, immune system disorders, and the elderly. In particular, when used in combination with other drugs that have similar effects, adverse reactions may increase, so it should be administered under the direction of a specialist. While taking this medication, it is necessary to regularly monitor renal function, blood pressure, and electrolyte status. If symptoms such as dizziness, headache, skin rash, or difficulty breathing occur, healthcare providers should be informed immediately. Additionally, this medication may interact with various drugs, so if other medications are being taken, consultation with a physician or pharmacist is essential. Care is particularly needed when taken with potassium-increasing drugs, lithium, NSAIDs, and antihypertensives. It is safer for pregnant and nursing women not to take this medication, and if unavoidable, breastfeeding should be discontinued. The safety and efficacy of this medication in children have not been sufficiently established, so it is advisable not to use it in this population. In the elderly, to prevent excessively low blood pressure, treatment should start at a lower dose, and their condition should be closely monitored. Lastly, this medication should be stored out of reach of children, and transferring it to another container is not advised for maintaining its quality and safety.

Increased BUN, elevated serum creatinine, acute renal failure, decreased hemoglobin, decreased hematocrit, leukopenia, thrombocytopenia, increased eosinophils, positive antinuclear antibody, angioedema, psoriasis, photosensitivity, onycholysis, exfoliative dermatitis, mucous membrane syndrome, rash, itching, urticaria, hyperhidrosis, hair loss, dizziness, headache, anxiety, depression, sleep disorders, drowsiness, loss of consciousness, palpitations, hypotension, orthostatic hypotension, chest pain, tachycardia, bradycardia, angina, transient ischemic attack, myocardial infarction, abdominal pain, loss of appetite, nausea, vomiting, diarrhea, dyspepsia, constipation, stomatitis, dry mouth, glossitis, pancreatitis, bowel obstruction, jaundice, hepatitis, elevated AST, elevated ALT, liver failure, pharyngeal discomfort, cough, bronchitis, rhinitis, dyspnea, bronchospasm, syndrome of inappropriate antidiuretic hormone secretion, hyponatremia, hypotonic hyponatremia, increased urinary sodium excretion, hyperuricemia, seizures, altered consciousness, malaise, fatigue, agitation, erythema, heat sensation, fever, myalgia, thirst, dysgeusia, tinnitus, numbness of the tongue, lip numbness, finger numbness, cyanosis, elevated serum potassium, decreased serum sodium

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. Additionally, it is best to store it at room temperature, between 1 to 30 degrees Celsius, avoiding extremes of hot or cold. This helps to maintain the drug's effectiveness for a longer period.

Appearance

white, round tablet

Package unit

30 tablets/bottle, 500 tablets/bottle