Medication info
Cebiruka HCT Tablet 5/40/12.5 mg

Cebiruka HCT Tablet 5/40/12.5 mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletOlmesartan Medoxomil›40mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
Light yellow round film-coated tablet
Packaging
28 tablets (14 tablets/PTP X 2)/carton
Approval status
Active

MFDS item code 201904429 · Approved 2019.06.27 · Insurance code 694004380

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
Take one tablet once daily with water, regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning) if possible. The recommended dosage is as follows: - 5/20/12.5 mg: Administered to patients whose blood pressure is not adequately controlled with Amlodipine/Olmesartan Medoxomil 5/20 mg combination therapy. - 5/40/12.5 mg: Administered to patients whose blood pressure is not adequately controlled with Amlodipine/Olmesartan Medoxomil 5/40 mg combination therapy.
Child dose
The safety and efficacy of this drug in pediatric patients under 18 years of age have not been established; therefore, its use is not recommended.

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential Hypertension
View approved original text

The combination therapy of Amlodipine and Olmesartan Medoxomil is used to effectively control blood pressure in patients with essential hypertension, which is hypertension with unknown cause. These two components have different mechanisms of action that dilate blood vessels and lower blood pressure, helping to manage hypertension that is uncontrolled by a single medication. In particular, this combination is effective in improving blood pressure control and reducing the risk of complications. This treatment contributes to the prevention of cardiovascular diseases through continuous blood pressure management. Therefore, it is used to improve blood pressure control in patients with essential hypertension.

How to take

Adult dose

Take one tablet once daily with water, regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning) if possible. The recommended dosage is as follows: - 5/20/12.5 mg: Administered to patients whose blood pressure is not adequately controlled with Amlodipine/Olmesartan Medoxomil 5/20 mg combination therapy. - 5/40/12.5 mg: Administered to patients whose blood pressure is not adequately controlled with Amlodipine/Olmesartan Medoxomil 5/40 mg combination therapy.

Child dose

The safety and efficacy of this drug in pediatric patients under 18 years of age have not been established; therefore, its use is not recommended.

Precautions

This drug can cause serious damage to the fetus and newborn in the second and third trimesters of pregnancy; therefore, administration should be discontinued immediately if pregnancy is confirmed. Patients with allergies or hypersensitivity to any ingredients in this drug or similar medications should not take it. Patients with severe hypotension, unstable heart failure after acute myocardial infarction, or severe renal or liver dysfunction may also be at risk if they take this drug. Patients with reduced blood volume or electrolyte imbalances may experience hypotension, so their condition should be closely monitored and appropriate measures taken before administration. Attention is also needed when this drug is used in patients with renal impairment, those who have undergone kidney transplantation, patients with renovascular hypertension, and patients with severe liver dysfunction. This drug may increase the blood pressure-lowering effect when used with other antihypertensives, so it is important to inform your doctor if you are taking any other medications. In particular, there may be an increased risk of side effects when used concomitantly with lithium, non-steroidal anti-inflammatory drugs (NSAIDs), and some antihypertensives. While taking this drug, regular blood pressure, renal function, and electrolyte level checks are required, and if any abnormal symptoms appear, you should immediately consult a doctor. Skin may become sensitive to sunlight, so precautions against UV exposure should be taken, and if any skin abnormalities occur, administration should be stopped and the doctor informed. The safety of this drug has not been established in children; therefore, it is advisable not to use it in individuals under 18 years of age. In the elderly, consideration should be given to the possibility of decreased renal and liver function, starting with a low dose and carefully monitoring their condition. In case of overdose, symptoms such as hypotension, palpitations, and electrolyte imbalances may occur, so it is important to adhere to the prescribed dosage and visit a healthcare facility immediately if any abnormal symptoms arise. This drug should be stored in a tightly sealed container to protect it from air and moisture, and it is advisable not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination changes

Mild side effects

  • Peripheral edema
  • headache
  • dizziness
  • upper respiratory tract infection
  • nasopharyngitis
  • urinary tract infection
  • sialadenitis
  • leukopenia
  • thrombocytopenia
  • bone marrow suppression
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  • neutropenia/agranulocytosis
  • hemolytic anemia
  • aplastic anemia
  • drug hypersensitivity
  • hyperkalemia
  • hypokalemia
  • decreased appetite
  • diabetes
  • hypercalcemia
  • hyperglycemia
  • hypomagnesemia
  • hyponatremia
  • hypochloremia
  • hypertriglyceridemia
  • hypercholesterolemia
  • hyperuricemia
  • hypochloremic metabolic alkalosis

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

Storage

This drug should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is recommended to store the drug at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness and safety.

Appearance and packaging

Appearance

Light yellow round film-coated tablet

Package unit

28 tablets (14 tablets/PTP X 2)/carton

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.