Medication info
Aiprozen Clopidogrel Tablets (Clopidogrel Sulfate)

Aiprozen Clopidogrel Tablets (Clopidogrel Sulfate)

Prescription medicationTablet경구
Ingredient · strength
Clopidogrel Bisulfate›97.875mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
Pink round film-coated tablets
Packaging
30, 300 tablets/bottle
Approval status
Active

MFDS item code 200702138 · Approved 2007.02.16 · Insurance code 645201660

Summary

Main use
Improvement of atherosclerotic symptoms such as ischemic stroke and myocardial infarction, and reduction of risks for stroke and thromboembolism.
Who takes it
Adults
Adult dose
For patients with ischemic stroke, myocardial infarction, or peripheral artery disease, clopidogrel should be administered orally at a dose of 75 mg once daily. For patients with acute coronary syndrome (unstable angina or non-Q wave myocardial infarction), start with a loading dose of 300 mg once daily on the first day of treatment, then continue with a maintenance dose of 75 mg once daily. At this time, 75 to 325 mg of aspirin should be administered once daily in combination with this medication.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Improvement of atherosclerotic symptoms such as ischemic stroke and myocardial infarction, and reduction of risks for stroke and thromboembolism.

  • Ischemic stroke
  • myocardial infarction
  • peripheral artery disease
  • acute coronary syndrome
  • unstable angina
  • non-Q wave myocardial infarction
  • cardiovascular complications
  • stroke
  • refractory ischemia
  • vascular risk factors
  • bleeding risk
  • atrial fibrillation
View approved original text

This medication is used for symptom improvement in adult patients with atherosclerotic diseases, such as ischemic stroke, myocardial infarction, and peripheral artery disease. It is also helpful for alleviating symptoms such as cardiovascular complications, myocardial infarction, and stroke, particularly in patients with acute coronary syndrome who have undergone drug treatment, percutaneous coronary intervention, or coronary artery bypass surgery. Furthermore, this medication is used to reduce the risks of stroke and thromboembolism in patients with atrial fibrillation who have vascular risk factors and for whom vitamin K antagonists are not appropriate. Thus, this medication effectively improves symptoms and risks associated with various cardiovascular and cerebrovascular diseases.

How to take

Adult dose

For patients with ischemic stroke, myocardial infarction, or peripheral artery disease, clopidogrel should be administered orally at a dose of 75 mg once daily. For patients with acute coronary syndrome (unstable angina or non-Q wave myocardial infarction), start with a loading dose of 300 mg once daily on the first day of treatment, then continue with a maintenance dose of 75 mg once daily. At this time, 75 to 325 mg of aspirin should be administered once daily in combination with this medication.

Precautions

This medication helps prevent the clumping of platelets in the blood, aiding blood flow. The effectiveness of this medication may be reduced in individuals with genetic variations affecting a specific enzyme (CYP2C19), so alternative treatment options should be considered in such cases. Using this medication in conjunction with certain drugs (CYP2C19 inducers) may increase the concentration of the active substance, raising the risk of bleeding, and such combinations are not recommended. Patients with allergies to this medication or its components, those with bleeding tendencies, severe liver impairment, breastfeeding women, and individuals with lactose intolerance should not take this medication. Patients at high risk for bleeding or those suspected of having bleeding symptoms should undergo blood tests to assess their condition; caution is needed if used concurrently with anticoagulants like warfarin due to elevated bleeding risk. Patients scheduled for surgery should discontinue this medication 5-7 days prior to the procedure and should resume only after hemostasis. This medication may cause various bleeding symptoms such as gastrointestinal bleeding, bruising, nosebleeds, and hematuria, so it is essential to inform a physician immediately if such symptoms occur. Blood cell counts may be affected, so tests may be required when experiencing fever or signs of infection due to the possibility of bone marrow dysfunction. This medication may cause gastrointestinal disturbances such as heartburn, abdominal pain, diarrhea, as well as skin reactions such as rash and itching. During pregnancy, in emergencies like myocardial infarction or stroke, treatment takes precedence over risks to the fetus, but there may be an increased risk of bleeding during delivery, potentially requiring discontinuation of the medication prior to labor. In breastfeeding, since this medication may pass into breast milk, consultation with a physician regarding whether to continue or discontinue breastfeeding is necessary. There is insufficient evidence for safety and efficacy in children, hence it is not used in this population. Elderly patients may have decreased renal and liver function, elevating bleeding risk; therefore, dosage adjustments and close monitoring are required. Overdosage raises the bleeding risk, and although currently, there is no antidote for this medication, severe bleeding can be managed with platelet transfusion. While taking this medication, extreme caution is necessary when combining it with other drugs that increase bleeding risk, and it is crucial to inform healthcare providers about this medication when starting new medications or before surgery. This medication is known not to significantly affect driving or machine operation; however, individual variations may require caution.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe lethargy all over the body, sudden and severe headache, thunderclap headache, seizure, confusion, vision disturbances, paralysis, urination

Mild side effects

  • Chest pain
  • accidental injury
  • influenza-like illness
  • pain
  • fatigue
  • swelling
  • hypertension
  • headache
  • dizziness
  • abdominal pain
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  • dyspepsia
  • diarrhea
  • nausea
  • hypercholesterolemia
  • arthralgia
  • low back pain
  • purpura/bruising
  • epistaxis
  • depression
  • upper respiratory tract infection
  • dyspnea
  • rhinitis
  • bronchitis
  • cough
  • pruritus
  • urinary tract infection
  • decreased motor function
  • tremor
  • voice change
  • abnormal gait
  • hyperkinesia
  • ataxia
  • sensory disturbances
  • constipation
  • nausea

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly closed container. It is best to maintain the storage temperature between 1 and 30 degrees Celsius to preserve its efficacy for a long time.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30, 300 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.