Medication info
Clotex Tablets (Clopidogrel Sulfate)

Clotex Tablets (Clopidogrel Sulfate)

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

MFDS item code 201903699 · Approved 2019.06.03 · Insurance code 057600050

Summary

Main use
Treatment for improvement of atherosclerotic symptoms, such as ischemic stroke and myocardial infarction, and reduction of thromboembolic risk of stroke.
Who takes it
Adults
Adult dose
For patients with ischemic stroke, myocardial infarction, or peripheral artery disease, clopidogrel should be administered orally as a daily dose of 75 mg. For patients with acute coronary syndrome (unstable angina or non-Q myocardial infarction), start with a loading dose of 300 mg once daily on the first day of treatment, followed by a maintenance dose of 75 mg once daily. During this time, aspirin 75–325 mg should also be administered once daily.

Ingredients

Manufacturer
대원바이오텍주식회사

Efficacy & effects

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

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

This medication is used to improve symptoms related to atherosclerosis, such as ischemic stroke, myocardial infarction, and peripheral artery disease. It also helps to reduce the risk of death or recurrence related to cardiovascular events in patients with acute coronary syndrome, such as unstable angina or non-Q myocardial infarction who have undergone coronary interventional procedures or surgery. In patients with atrial fibrillation who have vascular risk factors and for whom vitamin K antagonists are not appropriate, this medication lowers the risk of stroke and thrombosis, thus improving health. This drug prevents complications from various vascular diseases effectively protecting the patients' cardiovascular health and improving symptoms.

How to take

Adult dose

For patients with ischemic stroke, myocardial infarction, or peripheral artery disease, clopidogrel should be administered orally as a daily dose of 75 mg. For patients with acute coronary syndrome (unstable angina or non-Q myocardial infarction), start with a loading dose of 300 mg once daily on the first day of treatment, followed by a maintenance dose of 75 mg once daily. During this time, aspirin 75–325 mg should also be administered once daily.

Precautions

This medication prevents platelets from aggregating and avoids excessive blood clotting. The efficacy of this medication may be diminished in individuals genetically predisposed to decreased function of a specific enzyme (CYP2C19), so in such cases, treatment methods should be adjusted in consultation with a doctor. Additionally, taking this medication with drugs that activate certain enzymes may increase drug concentration and elevate bleeding risk, so caution is necessary. Individuals allergic to this medication or its components, those with bleeding tendencies, those with severe liver damage, nursing mothers, and those with lactose intolerance should not take this medication. Patients who are at risk of bleeding or those who are scheduled for surgery should carefully monitor for signs of bleeding while taking this medication and may need to have blood tests if necessary. Particularly, taking this medication together with other antiplatelet or anticoagulant drugs, non-steroidal anti-inflammatory drugs (NSAIDs), and selective serotonin reuptake inhibitors (SSRIs) may increase the risk of bleeding and should be done with caution. This medication may prolong bleeding time, which means that even minor wounds may bleed for a longer duration, so if bleeding does not stop or is severe, immediate consultation with a doctor is required. While taking this medication, side effects such as headache, dizziness, dyspepsia, diarrhea, skin rashes, and others may occur, and in rare cases, blood disorders or serious bleeding may arise. If symptoms of infection (e.g., fever) develop during this medication course, prompt notification to a doctor and testing is necessary. During pregnancy, the risks to the fetus are low, but due to the possibility of bleeding during delivery, it is advisable to discontinue this medication about 5 to 7 days before the expected delivery date. Nursing mothers should consult with their doctor regarding whether to continue breastfeeding as this medication may be excreted in breast milk. Elderly patients and those with impaired kidney or liver functions may be at a higher risk of bleeding and should take this medication with caution. Excessive dosing may increase the risk of bleeding, and currently, there is no antidote for this medication; thus, severe bleeding may need treatment such as platelet transfusion. This medication should be kept out of reach of children and should not be transferred to another container for safety.

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 high fever, blisters, skin peeling, pain in the oral and ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormality accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe lethargy, sudden and intense headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, and urination issues.

Mild side effects

  • Headache
  • dizziness
  • abdominal pain
  • dyspepsia
  • diarrhea
  • nausea
  • rash
  • pruritus
  • purpura/ecchymosis
  • nasal bleeding
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  • depression
  • shortness of breath
  • rhinitis
  • bronchitis
  • cough
  • urinary tract infection
  • chest pain
  • fatigue
  • myalgia
  • arthralgia
  • low back pain
  • insomnia
  • anxiety
  • weight loss
  • weight gain
  • fever
  • voice disorder
  • reduced motor function
  • tremors
  • abnormal gait
  • hyperactivity
  • ataxia
  • hiccups
  • dysphagia
  • tongue disorders
  • abnormal behavior
  • rigidity
  • visual disturbance
  • and eye symptoms.

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

Storage

This medication should be stored in an airtight container and kept at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the medication's efficacy for an extended period.

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.