Medication info
Cheil Cilazapril Tablet 0.5 mg (Cilazapril Hydrate)

Cheil Cilazapril Tablet 0.5 mg (Cilazapril Hydrate)

Prescription medicationTabletOral
Ingredient · strength
Cilazapril Hydrate›0.522mg / 1 tablet
Manufacturer / importer
Cheil Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets (10 tablets/PTPX3)
Approval status
Active

MFDS item code 199300655 · Notified 1993.10.07 · Insurance code 645401360

Summary

Main use
Treatment of hypertension (essential hypertension and renal hypertension)
Who takes it
Adults
Adult dose
This medication should be administered once daily at the same time of day. Since food intake does not significantly affect absorption, it may be administered before or during a meal. Measure blood pressure after 4 weeks of treatment and adjust the dose if necessary. 1. Essential hypertension Adults: The usual dose is 2.5 ∼ 5 mg of cilazapril anhydrate orally once daily. For the first 2 days, a dose of 1 ∼ 1.25 mg once daily is recommended. The dose should be adjusted individually according to the blood pressure response. If blood pressure is not controlled with 5 mg daily, this medication may be administered in combination with a small dose of a potassium-sparing diuretic. In most cases, the full therapeutic effect is not achieved until 2 ∼ 4 weeks after treatment is started. 2. Renal hypertension Adults: Since the blood pressure-lowering effect of ACE inhibitors may be more pronounced in patients with renal hypertension than in those with essential hypertension, treatment should be initiated at a dose of 0.5 mg once daily or less, and the maintenance dose should be determined individually. 3. Special dosage instructions 1) Hypertensive patients taking diuretics Patients taking diuretics should be treated with caution when starting therapy, as they are often volume-depleted or susceptible to hypotension caused by ACE inhibition. If possible, discontinue all diuretics 2 ∼ 3 days before starting this medication. If the patient's condition prevents discontinuation, initiate treatment with 0.5 mg once daily and closely monitor blood pressure after the first dose until it stabilizes. The maintenance dose should be adjusted according to the individual patient's response. 2) Patients with renal impairment The following dosage regimen is recommended. Creatinine clearance (mL/min) > 40: Initial dose 1 mg once daily, maximum dose 2.5~5 mg once daily Creatinine clearance (mL/min) 10 ∼ 40: Initial dose 0.5 mg once daily, maximum dose 2.5 mg once daily Creatinine clearance (mL/min) < 10: Not recommended Patients requiring hemodialysis should take this medication on days when dialysis is not performed, and the dose should be adjusted according to the blood pressure response. 3) Elderly patients Initiate treatment with 0.5 mg ~ 1 mg once daily or less, depending on the patient's fluid status and general condition. The maintenance dose should be adjusted according to the individual response. 4) Patients with cirrhosis In patients with cirrhosis who do not have ascites, the dose of this medication should not exceed 0.5 mg daily. Since severe hypotension may occur when treating hypertension in these patients, prescribe with extreme caution and carefully monitor blood pressure.

Ingredients

Manufacturer
Cheil Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of hypertension (essential hypertension and renal hypertension)

  • Primary hypertension
  • renovascular hypertension
View approved original text

Primary hypertension and renovascular hypertension both refer to conditions in which blood pressure is abnormally high. Primary hypertension is high blood pressure of unknown origin, while renovascular hypertension is high blood pressure caused by kidney issues. Both of these conditions can impact heart and vascular health, making appropriate treatment necessary. This medication helps to manage such hypertension and maintain blood pressure within a normal range. Therefore, it is used for the treatment of primary hypertension and renovascular hypertension.

How to take

Adult dose

This medication should be administered once daily at the same time of day. Since food intake does not significantly affect absorption, it may be administered before or during a meal. Measure blood pressure after 4 weeks of treatment and adjust the dose if necessary. 1. Essential hypertension Adults: The usual dose is 2.5 ∼ 5 mg of cilazapril anhydrate orally once daily. For the first 2 days, a dose of 1 ∼ 1.25 mg once daily is recommended. The dose should be adjusted individually according to the blood pressure response. If blood pressure is not controlled with 5 mg daily, this medication may be administered in combination with a small dose of a potassium-sparing diuretic. In most cases, the full therapeutic effect is not achieved until 2 ∼ 4 weeks after treatment is started. 2. Renal hypertension Adults: Since the blood pressure-lowering effect of ACE inhibitors may be more pronounced in patients with renal hypertension than in those with essential hypertension, treatment should be initiated at a dose of 0.5 mg once daily or less, and the maintenance dose should be determined individually. 3. Special dosage instructions 1) Hypertensive patients taking diuretics Patients taking diuretics should be treated with caution when starting therapy, as they are often volume-depleted or susceptible to hypotension caused by ACE inhibition. If possible, discontinue all diuretics 2 ∼ 3 days before starting this medication. If the patient's condition prevents discontinuation, initiate treatment with 0.5 mg once daily and closely monitor blood pressure after the first dose until it stabilizes. The maintenance dose should be adjusted according to the individual patient's response. 2) Patients with renal impairment The following dosage regimen is recommended. Creatinine clearance (mL/min) > 40: Initial dose 1 mg once daily, maximum dose 2.5~5 mg once daily Creatinine clearance (mL/min) 10 ∼ 40: Initial dose 0.5 mg once daily, maximum dose 2.5 mg once daily Creatinine clearance (mL/min) < 10: Not recommended Patients requiring hemodialysis should take this medication on days when dialysis is not performed, and the dose should be adjusted according to the blood pressure response. 3) Elderly patients Initiate treatment with 0.5 mg ~ 1 mg once daily or less, depending on the patient's fluid status and general condition. The maintenance dose should be adjusted according to the individual response. 4) Patients with cirrhosis In patients with cirrhosis who do not have ascites, the dose of this medication should not exceed 0.5 mg daily. Since severe hypotension may occur when treating hypertension in these patients, prescribe with extreme caution and carefully monitor blood pressure.

Precautions

This drug can cause serious harm to the fetus during pregnancy, so if pregnancy is confirmed, it should be discontinued immediately. Patients who are allergic to this drug or its components, or who have a history of angioedema should not take it. This drug should not be used by pregnant or breastfeeding women, children, and adolescents. Patients undergoing specific blood component collection procedures or those on dialysis, as well as patients with cirrhosis, may be at risk when taking this medication, and caution is required. Patients with severely impaired kidney function should adjust the dosage or use it carefully, and those with hyperkalemia should also take precautions. A sharp drop in blood pressure may occur with initial dosing, so starting with a low dose and closely monitoring the patient's condition is essential. Elderly patients or those with heart failure, angina, or cerebrovascular diseases should be administered this with caution, and extra care is needed when combined with other antihypertensives. This medication may cause various side effects, including dry cough, hypotension, dizziness, rash, fatigue, headache, indigestion, etc., so any unusual symptoms should be discussed with healthcare professionals immediately. In particular, serious side effects such as angioedema, acute renal failure, and hyperkalemia may occur, necessitating regular blood tests and kidney function checks. Because of the strong blood pressure-lowering effect, patients who are dehydrated or taking diuretics should be extra cautious, and diuretics may be temporarily discontinued if necessary. This drug can interact with several other medications, so patients must inform their doctor or pharmacist if they are taking any other medications. Dizziness or drowsiness may occur when driving or operating machinery, so caution is needed. When storing, keep it out of the reach of children, and do not transfer it to another container for safety.

Side effects

  • Dry cough
  • rash
  • hypotension
  • dizziness
  • fatigue
  • headache
  • nausea
  • dyspepsia
  • itching
  • angioedema
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  • anaphylactic reaction
  • lupus-like symptoms
  • proteinuria
  • elevated BUN
  • elevated creatinine
  • renal impairment
  • acute kidney failure
  • hyperkalemia
  • hyponatremia
  • nephrotic syndrome
  • nephritis
  • anemia
  • leukopenia
  • neutropenia
  • agranulocytosis
  • thrombocytopenia
  • drowsiness
  • unsteadiness
  • insomnia
  • tinnitus
  • oral paralysis sensation
  • cerebral ischemia
  • transient ischemic attack
  • ischemic stroke
  • peripheral neuropathy
  • myocardial ischemia
  • angina pectoris
  • tachycardia
  • palpitations
  • orthostatic hypotension
  • ventricular extrasystole
  • myocardial infarction
  • arrhythmia
  • diarrhea
  • loss of appetite
  • precordial pain
  • heartburn
  • dry mouth sensation
  • aphthous stomatitis
  • vomiting
  • glossitis
  • pancreatitis
  • elevated AST
  • elevated ALT
  • elevated ALP
  • elevated LDH
  • cholestatic hepatitis
  • cough
  • pharyngalgia
  • dyspnea
  • bronchospasm
  • rhinitis
  • interstitial lung disease
  • bronchitis
  • sinusitis
  • papular rash
  • psoriatic dermatitis
  • psoriasis
  • lichen planus
  • exfoliative dermatitis
  • urticaria
  • erythema multiforme
  • mucocutaneous syndrome
  • toxic epidermal necrolysis
  • vesiculobullous disease
  • bullous disease
  • Kaposi sarcoma
  • vasculitis
  • purpura
  • photoreactive response
  • hair loss
  • nail dystrophy
  • muscle cramps
  • myalgia
  • arthralgia
  • malaise
  • chest pain
  • foreign body sensation in the mouth
  • altered taste sensation
  • agitation
  • shoulder stiffness
  • flushing
  • weakness
  • sleep disorder
  • erectile dysfunction
  • elevated serum potassium
  • elevated total cholesterol
  • elevated uric acid
  • hypoglycemia
  • gynecomastia
  • erythema
  • edema
  • circulatory shock
  • electrolyte disturbance
  • hyperventilation
  • bradycardia
  • anxiety

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

Storage

This medication should be stored in a tightly sealed container that prevents air from entering, in a cool place between 1 to 25 degrees Celsius. This helps maintain the efficacy of the drug's components.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets (10 tablets/PTPX3)

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.

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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.