Medication info
Clopidogrel Tablets (Clopidogrel Bisulfate)

Clopidogrel Tablets (Clopidogrel Bisulfate)

Prescription medicationTablet
Ingredient · strength
Clopidogrel Bisulfate›97.875mg / 1 tablet
Manufacturer / importer
(주)다산제약
Appearance
Pink round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201802536 · Approved 2018.06.19 · Insurance code 678601050

Summary

Main use
Treatment for improvement of atherosclerotic symptoms such as ischemic stroke and myocardial infarction, and reduction of the risk of stroke and thromboembolism.
Who uses it
Adults
Adult dosage
For patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, administer clopidogrel 75 mg orally once daily. For patients with acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), initiate with a loading dose of 300 mg on the first day of therapy, followed by a maintenance dose of 75 mg orally once daily. At this time, aspirin 75-325 mg should be administered once daily alongside this medication.

Ingredients

Manufacturer
(주)다산제약

Efficacy & effects

Treatment for improvement of atherosclerotic symptoms such as ischemic stroke and myocardial infarction, and reduction of the risk of stroke and thromboembolism.

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

This medication is used to improve symptoms of atherosclerosis in adult patients with ischemic stroke, myocardial infarction, and peripheral arterial disease. Additionally, it helps alleviate symptoms in patients with acute coronary syndrome who have received medical treatment, coronary intervention, or coronary artery bypass grafting due to cardiovascular anomalies. This drug is effective in reducing the risk of stroke and thromboembolism in patients with atrial fibrillation who have one or more vascular risk factors. In summary, this medication is used to improve various atherosclerotic symptoms associated with cardiovascular diseases and to reduce the risk of thrombus formation.

Dosage and Administration

Adult dosage

For patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, administer clopidogrel 75 mg orally once daily. For patients with acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), initiate with a loading dose of 300 mg on the first day of therapy, followed by a maintenance dose of 75 mg orally once daily. At this time, aspirin 75-325 mg should be administered once daily alongside this medication.

Precautions

This medication helps prevent platelets from aggregating, allowing for better blood flow. However, individuals with a genetically impaired function of a specific enzyme (CYP2C19) may experience reduced effectiveness of this medication, and in such cases, alternative treatment options should be considered. Additionally, taking medications that increase the activity of this enzyme may elevate the concentration of this medication, which can increase the risk of bleeding, so it is advisable not to take them together. Patients who are allergic to this medication or its components, those with bleeding disorders, patients with severe liver damage, nursing women, and individuals with genetic issues such as lactose intolerance should not take this medication. Patients at high risk of bleeding, those with liver disease, patients with impaired renal function, individuals with acute stroke, patients taking certain medications, hypertensive patients, the elderly, and underweight patients should use this medication with caution. In particular, if bleeding is suspected, testing should be conducted immediately, and if surgery is planned, this medication should be stopped 5-7 days prior to the procedure and resumed after hemostasis has been achieved. As this medication may increase the risk of bleeding, caution is required when used in combination with aspirin, anticoagulants, nonsteroidal anti-inflammatory drugs, or selective serotonin reuptake inhibitors. During treatment with this medication, the time it takes for bleeding to stop may be longer than usual, so if there is a bleeding site or if bleeding persists, the physician should be notified immediately. Rarely, side effects such as thrombocytopenia, agranulocytosis, allergic reactions, skin rash, gastrointestinal disturbances, headaches, or dizziness may occur, and serious bleeding may happen, requiring immediate consultation with healthcare professionals if symptoms arise. During pregnancy, the risk to the fetus is not significant, but there is a risk of bleeding during delivery; hence, it should be considered to stop the medication before any nerve block or delivery. If nursing, careful consideration should be given as the drug may be excreted in breast milk. In cases of overdose, the risk of bleeding may increase, and since there is no antidote, platelet transfusion may be necessary to stop the bleeding. The safety and effectiveness of this medication have not been established in children, and older adults may have an increased risk of bleeding due to decreased bodily function, requiring dose adjustments and caution.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or breathing difficulty, asthma attacks, respiratory distress accompanied by cough and fever, jaundice, extreme lethargy, sudden and severe headaches, lightning-like headaches, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Chest pain
  • accidental injury
  • influenza-like illness
  • pain
  • fatigue
  • edema
  • hypertension
  • headache
  • dizziness
  • abdominal pain
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  • indigestion
  • diarrhea
  • nausea
  • hypercholesterolemia
  • arthralgia
  • low back pain
  • purpura/bruising
  • epistaxis
  • depression
  • upper respiratory tract infection
  • rhinitis
  • bronchitis
  • cough
  • pruritus
  • urinary tract infection
  • chest pain
  • weight loss
  • weight gain
  • facial flushing
  • weakness
  • stiffness
  • facial edema
  • syncope
  • diminished motor function
  • tremors
  • voice disorders

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, preferably at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain its effectiveness and ensure safe use.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets/bottle, 100 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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.