Medication info
Probit Tablets (Clopidogrel Sulfate)

Probit Tablets (Clopidogrel Sulfate)

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

MFDS item code 201503157 · Approved 2015.05.26 · Insurance code 641805920

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
In patients with ischemic stroke, myocardial infarction, or peripheral artery disease, clopidogrel is administered orally at a dose of 75 mg once daily. In patients with acute coronary syndrome, start with a loading dose of 300 mg on the day of treatment and continue with a maintenance dose of 75 mg orally once daily. At this time, aspirin 75 to 325 mg should be co-administered once daily. In patients with atrial fibrillation, administer 75 mg orally once daily.

Ingredients

Manufacturer
광동제약(주)

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 artery disease
  • acute coronary syndrome
  • unstable angina
  • non-ST elevation 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 suffering from ischemic stroke, myocardial infarction, or peripheral artery disease. It also effectively improves atherosclerotic symptoms such as mortality due to cardiovascular anomalies, myocardial infarction, and stroke in patients with acute coronary syndrome, particularly in those with unstable angina or non-ST elevation myocardial infarction, after drug treatment, procedures, or surgery. Additionally, it helps reduce the risk of stroke and thromboembolism in patients with atrial fibrillation who have one or more vascular risk factors. This medication is widely used for the prevention and improvement of various cardiovascular events associated with vascular disease.

Dosage and Administration

Adult dosage

In patients with ischemic stroke, myocardial infarction, or peripheral artery disease, clopidogrel is administered orally at a dose of 75 mg once daily. In patients with acute coronary syndrome, start with a loading dose of 300 mg on the day of treatment and continue with a maintenance dose of 75 mg orally once daily. At this time, aspirin 75 to 325 mg should be co-administered once daily. In patients with atrial fibrillation, administer 75 mg orally once daily.

Precautions

This drug is prescribed to prevent the formation of blood clots by inhibiting blood coagulation. This drug must be converted into an active metabolite in the liver to be effective; thus, individuals with genetically impaired liver enzyme function may experience reduced efficacy. Therefore, alternative treatment should be considered in such cases. This drug should not be taken with medications that activate certain liver enzymes, as this may increase drug concentrations and elevate bleeding risk, so co-administration should be avoided. This drug should not be administered to the following patients: - Individuals allergic to this drug or its components - Individuals with active bleeding (e.g., gastrointestinal bleeding, intracranial hemorrhage, hemophilia, etc.) - Individuals with severe liver dysfunction - Women who are nursing - Individuals with genetic metabolic disorders such as lactose intolerance Caution should be exercised when administering this drug to patients at high risk of bleeding. If bleeding symptoms are suspected, a blood test should be performed immediately, and special caution is needed when taking with other bleeding risk medications. Patients scheduled for surgery should discontinue this drug 5 to 7 days prior to the surgery and resume it once hemostasis is confirmed. This drug may prolong bleeding time, so caution should be taken if there are lesions that may bleed or if the individual is in a high-risk bleeding state. While taking this drug, various side effects may occur including headache, dizziness, abdominal pain, diarrhea, rash, and more. Especially, if there are bleeding symptoms (bruising, nosebleeds, hematuria, etc.), consult a doctor immediately. This drug is not confirmed to pose risks to the fetus in pregnant women, but caution is needed as there may be an increased risk of bleeding during childbirth. In nursing mothers, it is unclear if this drug is excreted in breast milk, necessitating a decision to either discontinue breastfeeding or the drug itself. The safety and efficacy in children have not been established. Elderly patients may be at higher risk of bleeding due to decreased body function, so dosage adjustment and monitoring are necessary. In cases of overdose, the risk of bleeding may increase and since there is no specific antidote, platelet transfusions may be necessary if the bleeding is severe. This drug should be kept out of reach of children, and transferring it to another container may degrade its quality.

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, mucosal pain in mouth/eyes, difficulty breathing or shortness of breath, asthma attack, respiratory distress accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Headache
  • dizziness
  • dyspepsia
  • diarrhea
  • nausea
  • abdominal pain
  • back pain
  • joint pain
  • fatigue
  • rash
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  • itching
  • rhinitis
  • cough
  • upper respiratory tract infections
  • depression
  • anxiety
  • insomnia
  • weight gain
  • weight loss
  • reduced motor function
  • memory loss
  • abnormal thoughts
  • visual disturbances
  • dry eyes
  • congestion
  • gynecomastia
  • increased blood urea nitrogen
  • abnormal liver function tests
  • myalgia
  • constipation
  • vomiting
  • appetite loss
  • hiccups
  • dysphagia
  • tongue disorders
  • contact dermatitis

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

Storage

This drug is sensitive to air and moisture, so it should be stored in a tightly closed container. Additionally, it is important to avoid direct sunlight and store at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Pink round film-coated tablets

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.