Medication info
Cheil Cilazapril Tablet 1.0 mg (Cilazapril Hydrate)

Cheil Cilazapril Tablet 1.0 mg (Cilazapril Hydrate)

Prescription medicationTabletOral
Ingredient · strength
Cilazapril Hydrate›1.044mg / 1 tablet
Manufacturer / importer
Cheil Pharmaceutical Co., Ltd.
Appearance
Pale yellow round film-coated tablet
Packaging
30 tablets (10 tablets/PTPX3)
Approval status
Active

MFDS item code 199300660 · Notified 1993.10.07 · Insurance code 645401370

Summary

Main use
Treatment of hypertension (essential and renal hypertension)
Who takes it
Adults
Adult dose
This medicine should be administered once daily at the same time each 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. Adults with essential hypertension: The usual dose is 2.5 ∼ 5 mg of anhydrous cilazapril 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 given in combination with a low dose of a non-potassium-sparing diuretic. An adequate therapeutic effect generally does not occur until 2 ∼ 4 weeks after starting treatment. Adults with renovascular hypertension: Since the blood pressure-lowering effect of ACE inhibitors may be more pronounced in patients with renovascular hypertension than in those with essential hypertension, treatment should be started at a dose of 0.5 mg once daily or a lower dose, and the maintenance dose should be determined individually. Hypertensive patients taking diuretics: Patients taking diuretics are often volume depleted or more susceptible to hypotension caused by ACE inhibition; therefore, treatment should be initiated with caution. If possible, discontinue all diuretics 2 ∼ 3 days before administering this medicine. If they cannot be discontinued 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. Patients with renal impairment: Creatinine clearance (mL/min) > 40: initial dose 1mg once daily, maximum dose 2.5~5mg once daily Creatinine clearance (mL/min) 10 ∼ 40: initial dose 0.5mg once daily, maximum dose 2.5mg 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. Older adults: Initiate treatment with 0.5mg ~ 1mg once daily or a lower dose, depending on the patient's fluid status and general condition. The maintenance dose should be adjusted according to the individual response. Patients with cirrhosis: In patients with cirrhosis who do not have 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 great caution and carefully monitor blood pressure.

Ingredients

Manufacturer
Cheil Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of hypertension (essential and renal hypertension)

  • Essential hypertension
  • renovascular hypertension
View approved original text

Essential hypertension and renovascular hypertension are both conditions that elevate blood pressure. Essential hypertension is high blood pressure with no clear cause, while renovascular hypertension is hypertension caused by kidney disease. Both conditions are important to manage as controlling blood pressure reduces the risk of cardiovascular disease. Therefore, this medication is used for essential hypertension and renovascular hypertension.

How to take

Adult dose

This medicine should be administered once daily at the same time each 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. Adults with essential hypertension: The usual dose is 2.5 ∼ 5 mg of anhydrous cilazapril 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 given in combination with a low dose of a non-potassium-sparing diuretic. An adequate therapeutic effect generally does not occur until 2 ∼ 4 weeks after starting treatment. Adults with renovascular hypertension: Since the blood pressure-lowering effect of ACE inhibitors may be more pronounced in patients with renovascular hypertension than in those with essential hypertension, treatment should be started at a dose of 0.5 mg once daily or a lower dose, and the maintenance dose should be determined individually. Hypertensive patients taking diuretics: Patients taking diuretics are often volume depleted or more susceptible to hypotension caused by ACE inhibition; therefore, treatment should be initiated with caution. If possible, discontinue all diuretics 2 ∼ 3 days before administering this medicine. If they cannot be discontinued 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. Patients with renal impairment: Creatinine clearance (mL/min) > 40: initial dose 1mg once daily, maximum dose 2.5~5mg once daily Creatinine clearance (mL/min) 10 ∼ 40: initial dose 0.5mg once daily, maximum dose 2.5mg 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. Older adults: Initiate treatment with 0.5mg ~ 1mg once daily or a lower dose, depending on the patient's fluid status and general condition. The maintenance dose should be adjusted according to the individual response. Patients with cirrhosis: In patients with cirrhosis who do not have 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 great caution and carefully monitor blood pressure.

Precautions

This medication can cause serious harm to the fetus during pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. Individuals who have had an allergic reaction to this medication or its ingredients should not take it. Patients with a history of angioedema, those undergoing blood component collection, patients undergoing certain types of dialysis, patients with liver cirrhosis, children, adolescents, and those with specific kidney diseases may be at risk when taking this medication, so caution is necessary. Patients with severe kidney disease, renal artery stenosis, or hyperkalemia should use this medication with caution as it may cause deterioration of kidney function or hypotension. Patients with severe hypertension, those with depleted fluids, heart failure patients, the elderly, patients with liver cirrhosis, and nursing mothers are at risk of hypotension and should start with a low dose and gradually increase while monitoring closely. This medication can cause various side effects including dry cough, rash, hypotension, dizziness, fatigue, headache, dyspepsia, among others, and serious allergic reactions, deterioration of kidney function, blood abnormalities, liver function abnormalities, and skin reactions can occur; therefore, one should consult a doctor immediately if any unusual symptoms arise. In particular, if there is a rapid drop in blood pressure or symptoms of angioedema appear, the medication should be discontinued immediately and emergency care should be sought. This medication may have increased side effects or effects when combined with other antihypertensives, potassium-sparing diuretics, certain antibiotics, or immunosuppressants. If you are taking any other medications, it is essential to inform your doctor or pharmacist. Women who are pregnant or planning to become pregnant, as well as nursing women, should avoid using this medication, and if unavoidable, they should discontinue breastfeeding. Safety in children and adolescents has not been established, so it is recommended not to use it. Elderly individuals should periodically test kidney function and serum potassium levels, and treatment should start at a low dose and be given cautiously. During the course of treatment, regular checks on blood pressure, kidney function, and electrolyte status should be conducted, taking appropriate action if abnormalities are found. In case of overdose, symptoms such as hypotension, shock, or acute kidney failure may occur, so immediate medical attention is needed, and if necessary, the drug may be removed via dialysis. This medication should be stored out of reach of children and should not be transferred to another container, as this is important for maintaining quality.

Side effects

  • Dry cough
  • rash
  • hypotension
  • dizziness
  • fatigue
  • headache
  • nausea
  • indigestion
  • itching
  • angioedema
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  • anaphylaxis
  • lupus-like symptoms
  • proteinuria
  • elevated BUN
  • elevated creatinine
  • kidney impairment
  • acute renal failure
  • hyperkalemia
  • hyponatremia
  • nephrotic syndrome
  • nephritis
  • anemia
  • leukopenia
  • neutropenia
  • agranulocytosis
  • thrombocytopenia
  • drowsiness
  • unsteadiness
  • insomnia
  • tinnitus
  • oral paresthesia
  • cerebral ischemia
  • transient ischemic attack
  • ischemic stroke
  • peripheral neuropathy
  • myocardial ischemia
  • angina
  • tachycardia
  • palpitations
  • orthostatic hypotension
  • ventricular extrasystole
  • myocardial infarction
  • arrhythmia
  • diarrhea
  • loss of appetite
  • precordial pain
  • heartburn
  • dry mouth
  • aphthous stomatitis
  • vomiting
  • stomatitis
  • pancreatitis
  • elevated AST
  • elevated ALT
  • elevated ALP
  • elevated LDH
  • cholestatic hepatitis
  • cough
  • pharyngitis
  • dyspnea
  • bronchospasm
  • rhinitis
  • interstitial lung disease
  • bronchitis
  • sinusitis
  • urticaria
  • psoriasis-like dermatitis
  • psoriasis
  • lichen planus
  • exfoliative dermatitis
  • hives
  • erythema multiforme
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • blister-like dermatitis
  • bullous pemphigoid
  • Kaposi's sarcoma
  • vasculitis
  • purpura
  • photosensitivity reaction
  • alopecia
  • onycholysis
  • muscle spasms
  • myalgia
  • arthralgia
  • lethargy
  • chest pain
  • oral foreign body sensation
  • dysgeusia
  • excitement
  • shoulder stiffness
  • flushing
  • asthenia
  • sleep disturbances
  • 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 sealed container to prevent air exposure and kept in a cool place between 1 and 25 degrees Celsius. Proper storage will help maintain the effectiveness of the medication and prevent degradation.

Appearance and packaging

Appearance

Pale yellow 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.