Medication info

Lenaton Tablet 10 mg (Enalapril Maleate)

Prescription medicationApproval withdrawn
Ingredient · strength
Enalapril Maleate›Strength being verified
Manufacturer / importer
Korea United Pharmaceutical Co., Ltd.
Appearance
For domestic use: white round tablet, For export: yellowish round tablet
Packaging
For domestic use: 30 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 199301689 · Notified 1993.10.22

This product's status changed to Approval withdrawn on 2023.05.12. 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 is 5㎎ once daily as enalapril maleate, adjusted according to blood pressure. The maintenance dose is 10 ~ 40㎎ per day, administered in 1 ~ 2 divided doses. If the blood pressure-lowering effect decreases at the end of the dosing interval in patients receiving once-daily dosing, increase the dose or administer it twice daily. 2) Patients receiving diuretics Adults: Hypotension may occur when this medicine is first administered to patients recently treated for hypertension with a diuretic. Therefore, discontinue the diuretic, if possible, 2-3 days before starting this medicine. If hypertension is not controlled when this medicine is administered, the diuretic may be resumed. If the diuretic cannot be discontinued, administer this medicine 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 higher (serum creatinine up to 3㎎/㎗). ② Patients with a creatinine clearance of 30㎖/min or lower (serum creatinine of 3㎎/㎗ or higher): 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. ③ In patients not undergoing dialysis, determine the dose according to the blood pressure response. 2. Heart failure 1) This medicine 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 closely for at least 2 hours and until blood pressure is stable; reduce the diuretic dose, if possible, to prevent hypotension. If hypotension occurs after the first dose of this medicine, 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 dosing; however, twice-daily dosing has generally been used more often. In placebo-controlled trials involving patients with severe heart failure (NYHA class Ⅳ), in which reduced mortality was confirmed, 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 In patients with heart failure and hyponatremia (serum sodium concentration 130mEq/ℓ or lower) or serum creatinine of 1.6㎎/㎗ or higher, administer an initial dose of 2.5㎎ per day with close observation. If increasing the dose, administer 2.5 ~ 5㎎ per dose twice 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 longer after the initial dose. The dose may be increased to a maximum of 40㎎ per day.

Ingredients

Manufacturer
Korea United Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of hypertension; adjunctive treatment of heart failure

  • Hypertension
  • heart failure
View approved original text

This medication is used to treat hypertension. Additionally, it serves as an adjunct in patients with heart failure who are receiving diuretics and digitalis. Therefore, it is mainly used effectively for the treatment of hypertension and heart failure.

Dosage and Administration

Adult dosage

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, administered in 1 ~ 2 divided doses. If the blood pressure-lowering effect decreases at the end of the dosing interval in patients receiving once-daily dosing, increase the dose or administer it twice daily. 2) Patients receiving diuretics Adults: Hypotension may occur when this medicine is first administered to patients recently treated for hypertension with a diuretic. Therefore, discontinue the diuretic, if possible, 2-3 days before starting this medicine. If hypertension is not controlled when this medicine is administered, the diuretic may be resumed. If the diuretic cannot be discontinued, administer this medicine 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 higher (serum creatinine up to 3㎎/㎗). ② Patients with a creatinine clearance of 30㎖/min or lower (serum creatinine of 3㎎/㎗ or higher): 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. ③ In patients not undergoing dialysis, determine the dose according to the blood pressure response. 2. Heart failure 1) This medicine 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 closely for at least 2 hours and until blood pressure is stable; reduce the diuretic dose, if possible, to prevent hypotension. If hypotension occurs after the first dose of this medicine, 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 dosing; however, twice-daily dosing has generally been used more often. In placebo-controlled trials involving patients with severe heart failure (NYHA class Ⅳ), in which reduced mortality was confirmed, 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 In patients with heart failure and hyponatremia (serum sodium concentration 130mEq/ℓ or lower) or serum creatinine of 1.6㎎/㎗ or higher, administer an initial dose of 2.5㎎ per day with close observation. If increasing the dose, administer 2.5 ~ 5㎎ per dose twice 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 longer after the initial dose. The dose may be increased to a maximum of 40㎎ per day.

Precautions

This medication should not be taken by certain patients. For example, individuals who are allergic to this medication or have previously experienced an allergic reaction, patients undergoing hemodialysis, and individuals with a history of angioedema should not take this medication. It is also not recommended for patients with primary hyperaldosteronism, aortic stenosis, liver disease, kidney transplant recipients, women who are pregnant or breastfeeding, and children. Patients with reduced kidney function or renal artery hypertension, individuals with cerebrovascular disorders, patients with significant proteinuria, those with severe hypertension, individuals with serious electrolyte imbalances, immune disorders or collagen diseases, and elderly individuals should use this medication with extra caution. This medication may affect kidney function, so kidney function tests should be conducted before and during use. Additionally, blood pressure may drop suddenly when starting this medication, so it should be initiated at a low dose and the patient's condition should be closely monitored. During treatment, dizziness or lightheadedness may occur, so it is advisable to avoid driving or operating hazardous machinery. This medication may interact with other drugs, so caution should be taken when used in conjunction with potassium-sparing diuretics, lithium, non-steroidal anti-inflammatory drugs, other antihypertensives, immunosuppressants, alcohol, psychiatric medications, and hypoglycemic agents. Women who are pregnant or may become pregnant should not take this medication, and if breastfeeding, should either avoid it or cease breastfeeding. The safety in children has not been established, so it is advisable not to use it in pediatrics. Elderly patients should start at a low dose and use cautiously to prevent excessive blood pressure reduction that could lead to cerebrovascular issues. Patients receiving this medication who undergo venom desensitization treatment may need to be monitored carefully for serious allergic reactions. Finally, this medication should be stored out of reach of children, and transferring it to another container should be avoided to maintain its quality and safety.

Side effects

  • Increased BUN
  • increased serum creatinine
  • acute renal failure
  • decreased hemoglobin
  • decreased hematocrit
  • decreased white blood cells
  • decreased platelets
  • increased eosinophils
  • positive antinuclear antibody
  • angioedema
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  • psoriasis
  • photosensitivity
  • nail dystrophy
  • exfoliative dermatitis
  • mucocutaneous syndrome
  • rash
  • itching
  • urticaria
  • hyperhidrosis
  • hair loss
  • dizziness
  • headache
  • anxiety
  • depression
  • sleep disturbances
  • 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
  • hepatic failure
  • pharyngeal discomfort
  • cough
  • bronchitis
  • rhinitis
  • shortness of breath
  • bronchospasm
  • hyponatremia
  • hypotonic hypovolemia
  • polyuria
  • seizures
  • altered consciousness
  • malaise
  • fatigue
  • agitation
  • erythema
  • heat sensation
  • fever
  • myalgia
  • thirst
  • dysgeusia
  • tinnitus
  • sublingual paresthesia
  • lip paresthesia
  • fingertip paresthesia
  • 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 protect it from air and moisture exposure. This will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

For domestic use: white round tablet, For export: yellowish round tablet

Package unit

For domestic use: 30 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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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.