Medication info
Cheil Cilazapril Tablet 2.5 mg (Cilazapril Hydrate)

Cheil Cilazapril Tablet 2.5 mg (Cilazapril Hydrate)

Prescription medicationTabletOral
Ingredient · strength
Cilazapril Hydrate›2.61mg / 1 tablet
Manufacturer / importer
Cheil Pharmaceutical Co., Ltd.
Appearance
Pink round film-coated tablets
Packaging
30 tablets (10 tablets/PTPX3), 500 tablets/bottle
Approval status
Active

MFDS item code 199300654 · Notified 1993.10.07 · Insurance code 645401380

Summary

Main use
Treatment of hypertension (essential hypertension and renal hypertension)
Who takes it
Adults
Adult dose
This medicine should be administered once daily at the same time of day. As food intake does not significantly affect its 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 anhydrous 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 medicine may be administered with a small dose of a non-potassium-sparing diuretic. In most cases, an adequate therapeutic effect is not achieved until 2 ∼ 4 weeks after starting treatment. 2. Renal hypertension Adults: Because the blood pressure-lowering effect of ACE inhibitors may be more pronounced in patients with renal hypertension than in patients with essential hypertension, treatment should be started at a dose of 0.5 mg once daily or less, and the maintenance dose should be determined individually. 3. Special dosage and administration 1) Hypertensive patients taking diuretics Patients taking diuretics should be treated with caution when starting therapy, as they are often volume-depleted or prone to hypotension due to ACE inhibition. If possible, discontinue all diuretics 2 ∼ 3 days before administering this medicine. If discontinuation is not possible because of the patient's condition, start treatment with a dose of 0.5 mg once daily, and monitor blood pressure closely after the first dose until it stabilizes. The maintenance dose should be adjusted according to each patient's response. 2) Patients with renal impairment The following dosage and administration are 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 medicine on days when dialysis is not performed, and the dose should be adjusted according to the blood pressure response. 3) Elderly patients Start treatment with a dose of 0.5 mg ~ 1 mg once daily or less, depending on the patient's volume status and general condition. The maintenance dose should be adjusted according to the individual response. 4) Patients with cirrhosis In patients with cirrhosis (without ascites), the dose of this medicine should not exceed 0.5 mg daily. Since severe hypotension may occur when treating hypertension in these patients, prescribe with extreme caution and monitor blood pressure carefully.

Ingredients

Manufacturer
Cheil Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of hypertension (essential hypertension and renal hypertension)

  • Essential hypertension
  • renovascular hypertension
View approved original text

Essential hypertension and renovascular hypertension are representative types of hypertension, primarily used to control blood pressure and prevent cardiovascular diseases.

How to take

Adult dose

This medicine should be administered once daily at the same time of day. As food intake does not significantly affect its 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 anhydrous 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 medicine may be administered with a small dose of a non-potassium-sparing diuretic. In most cases, an adequate therapeutic effect is not achieved until 2 ∼ 4 weeks after starting treatment. 2. Renal hypertension Adults: Because the blood pressure-lowering effect of ACE inhibitors may be more pronounced in patients with renal hypertension than in patients with essential hypertension, treatment should be started at a dose of 0.5 mg once daily or less, and the maintenance dose should be determined individually. 3. Special dosage and administration 1) Hypertensive patients taking diuretics Patients taking diuretics should be treated with caution when starting therapy, as they are often volume-depleted or prone to hypotension due to ACE inhibition. If possible, discontinue all diuretics 2 ∼ 3 days before administering this medicine. If discontinuation is not possible because of the patient's condition, start treatment with a dose of 0.5 mg once daily, and monitor blood pressure closely after the first dose until it stabilizes. The maintenance dose should be adjusted according to each patient's response. 2) Patients with renal impairment The following dosage and administration are 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 medicine on days when dialysis is not performed, and the dose should be adjusted according to the blood pressure response. 3) Elderly patients Start treatment with a dose of 0.5 mg ~ 1 mg once daily or less, depending on the patient's volume status and general condition. The maintenance dose should be adjusted according to the individual response. 4) Patients with cirrhosis In patients with cirrhosis (without ascites), the dose of this medicine should not exceed 0.5 mg daily. Since severe hypotension may occur when treating hypertension in these patients, prescribe with extreme caution and monitor blood pressure carefully.

Precautions

This medication can cause serious harm to the fetus during pregnancy, so if pregnancy is confirmed, it should be discontinued immediately. Patients allergic to this drug or its components, or with a history of angioedema, should not use this medication. Women who are pregnant or might become pregnant, as well as nursing mothers, should not use this medication. Patients undergoing certain blood component collection procedures or hemodialysis may be at risk if they take this medication, so its use should be avoided. Patients with liver cirrhosis or children, adolescents, and those with certain kidney diseases should be cautious when using this medication. When starting, blood pressure can drop sharply, so treatment should begin with a low dose, monitoring the patient's condition closely. This medication may cause side effects such as dry cough, dizziness, fatigue, headache, and rash; severe cases require immediate medical attention. Regular blood tests to monitor kidney function and serum potassium levels are important. Caution is needed when combining with other antihypertensive agents or potassium-sparing diuretics, as the risk of side effects may increase. Dosage adjustment may be necessary before and after surgery, as the risk of blood pressure reduction increases when used with anesthetics. Dizziness or drowsiness may occur when driving or operating machinery, so caution is advised. Safety for use in children and adolescents has not been established, and elderly patients should start with a low dose and be administered with caution. In case of overdose, severe hypotension or shock may occur, thus strict adherence to the dosage is required. Store out of reach of children and do not transfer to another container.

Side effects

  • Dry cough
  • rash
  • hypotension
  • dizziness
  • fatigue
  • headache
  • nausea
  • indigestion
  • itching
  • angioedema
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  • anaphylactic reaction
  • lupus-like symptoms
  • proteinuria
  • elevated BUN
  • elevated creatinine
  • kidney impairment
  • acute kidney failure
  • hyperkalemia
  • hyponatremia
  • nephrotic syndrome
  • nephritis
  • anemia
  • leukopenia
  • neutropenia
  • agranulocytosis
  • thrombocytopenia
  • drowsiness
  • staggering
  • insomnia
  • tinnitus
  • oral paralysis
  • 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
  • retrosternal pain
  • heartburn
  • dry mouth
  • 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
  • hemispherical rash
  • psoriasis-like dermatitis
  • psoriasis
  • lichen planus
  • exfoliative dermatitis
  • urticaria
  • erythema multiforme
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • bullous pemphigoid
  • blistering
  • Kaposi's sarcoma
  • vasculitis
  • purpura
  • photosensitivity reaction
  • hair loss
  • nail detachment
  • muscle cramps
  • myalgia
  • arthralgia
  • lethargy
  • chest pain
  • foreign body sensation in the mouth
  • taste disturbance
  • agitation
  • shoulder stiffness
  • flushing
  • muscle weakness
  • sleep disturbances
  • erectile dysfunction
  • elevated serum potassium
  • increased total cholesterol
  • elevated uric acid
  • hypoglycemia
  • gynecomastia
  • erythema
  • edema
  • circulatory shock
  • electrolyte imbalance
  • hyperventilation
  • bradycardia
  • anxiety

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. The appropriate storage temperature is a cool place between 1 to 25 degrees Celsius. Proper storage will maintain the medication's efficacy and ensure safe use.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets (10 tablets/PTPX3), 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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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.