Medication info
Daewon Clopidogrel Tablets (Clopidogrel Sulfate)

Daewon Clopidogrel Tablets (Clopidogrel Sulfate)

Prescription medicationTablet경구
Ingredient · strength
Clopidogrel Bisulfate›97.875mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
Pink round film-coated tablet
Packaging
Domestic use: 30 tablets/bottle, 300 tablets/bottle; Export use: 100 tablets (10 tablets/PTP×10), 30 tablets (10 tablets/PTP×3)
Approval status
Active

MFDS item code 200501593 · Notified 2005.07.26 · Insurance code 671800940

Summary

Main use
Improvement of atherosclerotic symptoms such as ischemic stroke and myocardial infarction, and reduction of the risk of stroke and thromboembolism
Who takes it
Adults
Adult dose
1. For patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, administer clopidogrel 75 mg once daily orally. 2. For patients with acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), begin with 300 mg as a loading dose on the first day of medication, and then continue with 75 mg once daily as a maintenance dose. In this case, aspirin 75 to 325 mg should also be given once daily with this drug.

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

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
  • atrial fibrillation
  • atherothrombosis
View approved original text

This medicine improves symptoms related to atherosclerosis in adult patients with ischemic stroke, myocardial infarction, or peripheral arterial disease. Furthermore, in patients with acute coronary syndrome who experience unstable angina or non-Q-wave myocardial infarction, it reduces the risk of cardiovascular complications before and after drug therapy, percutaneous interventional procedures, or coronary artery bypass surgery. Additionally, in patients with atrial fibrillation who have one or more vascular risk factors, and where vitamin K antagonists are inappropriate or where the risk of bleeding is low, it assists in reducing the risk related to stroke and thrombosis. Effectively improves important atherosclerotic symptoms across various cardiovascular diseases.

How to take

Adult dose

1. For patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, administer clopidogrel 75 mg once daily orally. 2. For patients with acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), begin with 300 mg as a loading dose on the first day of medication, and then continue with 75 mg once daily as a maintenance dose. In this case, aspirin 75 to 325 mg should also be given once daily with this drug.

Precautions

This drug inhibits the aggregation of platelets in the blood and prevents the formation of clots. This drug may have reduced efficacy in individuals genetically deficient in a specific enzyme (CYP2C19), and alternative treatment options should be considered in such instances. Moreover, concurrent use with drugs that activate CYP2C19 may enhance efficacy and increase bleeding risk, so combination use is not recommended. Persons allergic to this drug or its components, those with bleeding conditions, severe liver impairment, breastfeeding women, and those with genetic issues such as lactose intolerance should not take this medication. Patients at high risk of bleeding, those with impaired liver or kidney function, recent stroke patients, hypertensive patients, elderly individuals, and underweight patients should use this medication with caution, and discontinue 5-7 days prior to any scheduled surgery. As this drug can increase the risk of bleeding, any bleeding symptoms should be immediately discussed with a doctor, and special care should be taken when using with other drugs that also have bleeding risks. This drug can rarely cause serious side effects such as a rapid decrease in white blood cell count; therefore, any fever or signs of infection should be reported to healthcare providers immediately. While taking this medication, side effects such as headache, dizziness, dyspepsia, diarrhea, skin rash may occur, and if symptoms are severe or persistent, a doctor should be consulted. During pregnancy, as there might be an increased risk of bleeding during delivery, it is recommended to discontinue this drug 5-7 days before the expected delivery date. If breastfeeding, as this medication may be passed into breast milk, advice from a doctor should be sought on whether to continue breastfeeding or discontinue the medication. The safety and efficacy of this drug in children have not been established; therefore, it should not be administered to children. Overdose may increase the risk of bleeding, and currently, there are no antidotes available for this drug; thus, in cases of severe bleeding, treatments such as platelet transfusion may be necessary. This drug should be kept out of reach of children and should not be transferred to other containers. Due to the bleeding risk while on this medication, it is essential to inform healthcare providers about its use when starting new medications or undergoing surgery.

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 fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough + fever, jaundice (yellowing of the skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual 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
  • petechiae/bruising
  • epistaxis
  • depression
  • upper respiratory tract infections
  • rhinitis
  • bronchitis
  • cough
  • rash
  • pruritus
  • urinary tract infection
  • decreased motor function
  • tremor
  • speech disturbance
  • abnormal gait
  • hyperactivity
  • ataxia
  • sensory disturbance
  • constipation
  • nausea
  • ulcer

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

Storage

This medication should be stored in a tightly sealed container to protect it from air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius (room temperature) to keep the effectiveness and safety of the medication intact.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

Domestic use: 30 tablets/bottle, 300 tablets/bottle; Export use: 100 tablets (10 tablets/PTP×10), 30 tablets (10 tablets/PTP×3)

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.