Medication info
Okodorel Tablets (Clopidogrel Sulfate)

Okodorel Tablets (Clopidogrel Sulfate)

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

MFDS item code 201804935 · Approved 2018.12.06 · Insurance code 629701480

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 artery disease, 75 mg of clopidogrel is administered orally once daily. 2. For patients with acute coronary syndrome, start with a loading dose of 300 mg orally once on the day of initiation and subsequently administer 75 mg orally once daily as a maintenance dose. Aspirin 75–325 mg should be administered concurrently once daily. 3. For patients with atrial fibrillation,

Ingredients

Manufacturer
(주)오스코리아제약

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 artery disease
  • acute coronary syndrome
  • unstable angina
  • non-Q-wave myocardial infarction
  • cardiovascular abnormalities
  • stroke
  • refractory ischemia
  • atrial fibrillation
View approved original text

This medication is used to improve symptoms caused by atherosclerosis in adult patients with ischemic stroke, myocardial infarction, or peripheral artery disease. It is also effective in improving atherosclerotic symptoms such as cardiovascular death, myocardial infarction, stroke, and refractory ischemia in patients with acute coronary syndrome, including unstable angina or non-Q-wave myocardial infarction, who have undergone drug therapy or percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG). Furthermore, for adults with atrial fibrillation who have multiple vascular risk factors and for whom vitamin K antagonists are not appropriate and the risk of bleeding is low, it is effective in reducing the risk of atherothrombotic events and thromboembolism, including stroke. Thus, this medication is used to reduce various cardiovascular diseases and thrombotic risks and improve atherosclerotic symptoms.

How to take

Adult dose

1. For patients with ischemic stroke, myocardial infarction, or peripheral artery disease, 75 mg of clopidogrel is administered orally once daily. 2. For patients with acute coronary syndrome, start with a loading dose of 300 mg orally once on the day of initiation and subsequently administer 75 mg orally once daily as a maintenance dose. Aspirin 75–325 mg should be administered concurrently once daily. 3. For patients with atrial fibrillation,

Precautions

This medication prevents platelet aggregation in the blood, thus preventing blood clotting. The effectiveness of this medication may be reduced in patients with genetically impaired CYP2C19 enzyme function, so such patients may need to consider changing their treatment or using alternative medications. Additionally, taking this medication with drugs that activate the CYP2C19 enzyme may increase the concentration of the active substance, leading to a higher risk of bleeding, and therefore, concurrent use is not recommended. Patients who are allergic to this medication or its components, patients with bleeding disorders, patients with severe liver damage, breastfeeding women, patients with genetic issues such as lactose intolerance, and those allergic to soybean oil, soybeans, or peanuts should not take this medication. Patients at high risk of bleeding, those with poor liver or kidney function, patients who have recently experienced a stroke, hypertensive patients, and elderly patients should use this medication cautiously and undergo immediate examination when bleeding symptoms are suspected. In particular, patients scheduled for surgery should discontinue this medication 5 to 7 days before the operation and resume after hemostasis is achieved. This medication may cause various adverse reactions, including bleeding, reduction in blood cells, gastrointestinal disturbances, and skin rashes; therefore, consultation with a physician should be sought when abnormal symptoms occur. When taken with other bleeding risk medications, anticoagulants, selective serotonin reuptake inhibitors (SSRIs), non-steroidal anti-inflammatory drugs (NSAIDs), etc., the risk of bleeding may increase, so caution is needed. During pregnancy, the effects on the fetus are unclear, so it should only be used when treatment for severe cardiovascular disease is necessary, and care should be taken during delivery as the risk of bleeding may increase during delivery or neural blockade. Breastfeeding women should consider discontinuing breastfeeding or stopping the medication as it may be excreted in breast milk. The safety and efficacy of this medication in children have not been adequately confirmed, and elderly patients may have an increased risk of bleeding due to declining bodily functions, so caution is needed when taking it. In the case of overdose, bleeding may worsen, and since there are no specific antidotes, treatment should be pursued, such as platelet transfusion, for severe bleeding. This medication should be kept out of reach of children, and transferring it to another container should be avoided as it may affect the quality of the medication.

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 high fever, blisters, skin peeling, pain in the mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary retention

Mild side effects

  • Chest pain
  • accidental injuries
  • influenza-like illness
  • pain
  • fatigue
  • dizziness
  • dyspepsia
  • diarrhea
  • nausea
  • headache
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  • hypercholesterolemia
  • arthralgia
  • low back pain
  • petechiae
  • epistaxis
  • depression
  • upper respiratory tract infection
  • rhinitis
  • bronchitis
  • cough
  • pruritus
  • urinary tract infection
  • decreased motor function
  • tremor
  • voice disorders
  • abnormal gait
  • hyperactivity
  • ataxia
  • sensory abnormalities
  • insomnia
  • anxiety
  • hypersomnia
  • abnormal behavior
  • facial flushing

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pink, round, film-coated tablet

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.