Medication info
Elpidogrel Tablets (Clopidogrel Sulfate)

Elpidogrel Tablets (Clopidogrel Sulfate)

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

MFDS item code 201307935 · Approved 2013.06.28 · Insurance code 657502360

Summary

Main use
Improvement of atherosclerotic symptoms such as ischemic stroke and myocardial infarction, and reduction of the risk of thromboembolism such as stroke.
Who takes it
Adults
Adult dose
For patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, 75 mg of clopidogrel should be taken orally once daily. In acute coronary syndrome patients, a loading dose of 300 mg should be started once daily on the day of initiation, followed by a maintenance dose of 75 mg taken orally once daily. Aspirin at 75 to 325 mg should be co-administered once daily. For atrial fibrillation patients, 75 mg should be taken orally once daily.

Ingredients

Manufacturer
미래바이오제약(주)

Efficacy & effects

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

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

This medication is used to improve atherosclerotic symptoms in adult patients with ischemic stroke, myocardial infarction, or peripheral arterial disease. Additionally, it helps improve atherosclerotic symptoms due to cardiovascular anomalies in patients with acute coronary syndrome who have undergone medication treatment, coronary intervention, or coronary artery bypass surgery, including reducing the risk of death, myocardial infarction, stroke, and refractory ischemia. Furthermore, it reduces the risk of atherosclerotic thrombosis such as stroke and thromboembolism among patients with atrial fibrillation who have vascular risk factors and in whom vitamin K antagonists are not suitable and bleeding risk is low. Therefore, this medication is used to alleviate important symptoms and reduce the risk of complications in various vascular-related diseases.

How to take

Adult dose

For patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, 75 mg of clopidogrel should be taken orally once daily. In acute coronary syndrome patients, a loading dose of 300 mg should be started once daily on the day of initiation, followed by a maintenance dose of 75 mg taken orally once daily. Aspirin at 75 to 325 mg should be co-administered once daily. For atrial fibrillation patients, 75 mg should be taken orally once daily.

Precautions

This medication is an antiplatelet drug that prevents the aggregation of platelets in the blood, thereby preventing thrombosis. The effect of this medication is manifested after it is converted to an active form in the body, which involves a specific enzyme (CYP2C19). Therefore, people genetically deficient in the function of this enzyme may experience reduced efficacy of the drug, and alternative treatment methods should be considered in such cases. Taking this medication together with specific drugs (e.g., drugs that activate CYP2C19) can increase the concentration of this medication and heighten the risk of bleeding, so co-administration should be avoided. Patients with a high risk of bleeding, severe liver damage, lactose intolerance, or those who are nursing should not use this medication. Patients at risk of bleeding must be especially cautious when using this medication and should immediately inform healthcare personnel of any bleeding symptoms that appear. If surgery is planned, this medication should be discontinued 5 to 7 days before surgery and resumed after hemostasis is achieved. This medication increases the risk of bleeding when used with other bleeding risk medications (aspirin, non-steroidal anti-inflammatory drugs, anticoagulants, etc.), so caution is necessary. During the use of this medication, if bleeding symptoms, skin rashes, or signs of infection occur, the patient should immediately consult a physician. If pregnant or nursing, the decision to take this medication should be made after consulting a physician, especially due to the potential for bleeding risk before delivery. Elderly patients and those with impaired kidney or liver function require dosage adjustments and close monitoring while using this medication. In case of overdose, the risk of bleeding may increase significantly, so patients should adhere to the prescribed dosage and inform healthcare personnel immediately of any abnormal symptoms. This medication should be kept out of the reach of children, and transferring it to other containers should be avoided.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), bleeding (gastrointestinal bleeding, intracranial bleeding, hematoma, hematuria, intraocular bleeding), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa, severe allergic reactions, severe skin adverse reactions, respiratory problems, yellowing of the skin or eyes (jaundice), profound lethargy, liver problems (jaundice), sudden and severe

Mild side effects

  • Chest pain
  • accidental injury
  • influenza-like illness
  • pain
  • fatigue
  • headache
  • dizziness
  • abdominal pain
  • indigestion
  • diarrhea
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  • nausea
  • high cholesterol
  • joint pain
  • back pain
  • petechiae/bruising
  • epistaxis
  • depression
  • upper respiratory tract infection
  • rhinitis
  • bronchitis
  • cough
  • pruritus
  • urinary tract infection
  • decreased motor function
  • tremors
  • voice disorders
  • abnormal gait
  • hyperactivity
  • ataxia
  • sensory disturbances
  • constipation
  • nausea
  • vomiting
  • hiccups
  • dry mouth
  • dysphagia

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is best to maintain a storage temperature between 1°C and 30°C room temperature. Proper storage will help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 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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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.