Medication info

Antens Tablet (Enalapril Maleate)

Prescription medicationApproval withdrawn
Ingredient · strength
Enalapril Maleate›Strength being verified
Manufacturer / importer
DaeHwa Pharmaceutical Co., Ltd.
Appearance
White round tablets
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 199301977 · Notified 1993.12.17

This product's status changed to Approval withdrawn on 2023.06.08. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of hypertension; adjunctive treatment of heart failure
Who uses it
Adults
Adult dosage
1. Hypertension 1) Patients not receiving diuretics Adults: The initial dose of enalapril maleate is 5㎎ once daily; adjust according to blood pressure. The maintenance dose is 10-40㎎ daily, administered in 1-2 divided doses. If the antihypertensive effect wanes 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: Because hypotension may occur when this drug is first administered to patients recently treated for hypertension with a diuretic, discontinue the diuretic, if possible, 2-3 days before starting this drug. If hypertension is not controlled while taking this drug, diuretic therapy 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 creatinine clearance of 30㎖/min or more (serum creatinine up to 3㎎/㎗). ② Patients with 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 hemodialysis * If hemodialysis 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, monitor 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 most patients receiving the maximum daily dose of 40㎎, once-daily administration was effective. However, twice-daily dosing has generally been studied more extensively, and in placebo-controlled trials demonstrating reduced mortality in patients with severe heart failure (NYHA class Ⅳ), most patients received 2.5-40㎎ daily in 2 divided doses. Adjust the dose 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 of 130mEq/ℓ or less) or serum creatinine of 1.6㎎/㎗ or more, administer an initial dose of 2.5㎎ daily with close monitoring. If increasing the dose, administer 2.5-5㎎ per dose twice daily, or increase further if needed. Increase the dose only after 4 days or more from the first dose, provided that excessive hypotension or significant deterioration in renal function has not occurred. The maximum daily dose is 40㎎.

Ingredients

Manufacturer
DaeHwa Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of hypertension; adjunctive treatment of heart failure

  • High blood pressure
  • heart failure
View approved original text

This medication is used for the treatment of high blood pressure and heart failure. In heart failure, it is particularly effective when used in conjunction with diuretics and digoxin, providing supportive effects. It helps improve symptoms of high blood pressure and heart failure.

Dosage and Administration

Adult dosage

1. Hypertension 1) Patients not receiving diuretics Adults: The initial dose of enalapril maleate is 5㎎ once daily; adjust according to blood pressure. The maintenance dose is 10-40㎎ daily, administered in 1-2 divided doses. If the antihypertensive effect wanes 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: Because hypotension may occur when this drug is first administered to patients recently treated for hypertension with a diuretic, discontinue the diuretic, if possible, 2-3 days before starting this drug. If hypertension is not controlled while taking this drug, diuretic therapy 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 creatinine clearance of 30㎖/min or more (serum creatinine up to 3㎎/㎗). ② Patients with 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 hemodialysis * If hemodialysis 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, monitor 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 most patients receiving the maximum daily dose of 40㎎, once-daily administration was effective. However, twice-daily dosing has generally been studied more extensively, and in placebo-controlled trials demonstrating reduced mortality in patients with severe heart failure (NYHA class Ⅳ), most patients received 2.5-40㎎ daily in 2 divided doses. Adjust the dose 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 of 130mEq/ℓ or less) or serum creatinine of 1.6㎎/㎗ or more, administer an initial dose of 2.5㎎ daily with close monitoring. If increasing the dose, administer 2.5-5㎎ per dose twice daily, or increase further if needed. Increase the dose only after 4 days or more from the first dose, provided that excessive hypotension or significant deterioration in renal function has not occurred. The maximum daily dose is 40㎎.

Precautions

This medication should not be used in patients with certain conditions or diseases. For example, it is contraindicated in patients who have allergic reactions to this medication or have had such experiences in the past, patients undergoing specific types of dialysis, or those with a history of angioedema. It should also not be used in patients who have undergone kidney transplantation, are pregnant or may become pregnant, nursing mothers, and children. This medication should be used with caution in patients with severely impaired kidney function, certain cardiovascular diseases, very severe hypertension, electrolyte imbalances, and the elderly. In such cases, careful dosage adjustment or increased dosing intervals may be necessary. Regular monitoring of kidney function, blood pressure, and electrolyte levels is required during treatment to check for any adverse reactions. Since blood pressure can drop too low, immediate consultation with a physician is necessary if symptoms such as dizziness or fainting occur. This medication can cause various side effects, including worsening kidney function, a decrease in blood cell count, skin rash, headache, gastrointestinal disturbances, liver function abnormalities, and respiratory issues. If such symptoms occur, notify healthcare professionals immediately, and dosage adjustments or discontinuation may be needed. Additionally, this medication can interact with other drugs, so inform healthcare professionals about any medications currently being taken. Caution is particularly required when taken with potassium-sparing diuretics, lithium, non-steroidal anti-inflammatory drugs, blood pressure medications, immunosuppressants, and alcohol. Pregnant or nursing women should avoid this medication, and if necessary, consult a physician. Caution is advised when using this medication in children and the elderly, as its safety and effectiveness have not been adequately established in these populations. This medication should be kept out of reach of children and should not be transferred to other containers. Follow the physician's instructions accurately before and after use, and consult healthcare professionals immediately if any unusual symptoms occur.

Side effects

  • Increased BUN
  • elevated serum creatinine
  • acute renal failure
  • decreased hemoglobin
  • decreased hematocrit
  • leukopenia
  • thrombocytopenia
  • eosinophilia
  • positive antinuclear antibodies
  • angioedema
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  • psoriasis
  • photosensitivity
  • nail dystrophy
  • exfoliative dermatitis
  • mucocutaneous syndrome
  • rash
  • itching
  • hives
  • sweating
  • 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
  • intestinal obstruction
  • jaundice
  • hepatitis
  • elevated AST
  • elevated ALT
  • liver failure
  • pharyngodynia
  • cough
  • bronchitis
  • rhinitis
  • dyspnea
  • bronchospasm
  • hyponatremia
  • hypotonic hyponatremia
  • high urine output
  • seizures
  • altered consciousness
  • malaise
  • fatigue
  • excitement
  • erythema
  • heat sensation
  • fever
  • myalgia
  • thirst
  • taste disturbance
  • tinnitus
  • sublingual numbness
  • lip numbness
  • finger numbness
  • cyanosis
  • elevated serum potassium
  • decreased serum sodium

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White round tablets

Package unit

30 tablets/bottle, 500 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.