Medication info
Uribix Tablet (Clopidogrel Sulfate)

Uribix Tablet (Clopidogrel Sulfate)

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

MFDS item code 201602804 · Approved 2016.05.23 · Insurance code 670104040

Summary

Main use
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
For patients with ischemic stroke, myocardial infarction or peripheral artery disease, clopidogrel is administered orally once a day at a dosage of 75 mg. In patients with acute coronary syndrome (unstable angina or non-ST segment elevation myocardial infarction), therapy may begin with a loading dose of 300 mg once daily on the first day, followed by a maintenance dose of 75 mg once daily. Aspirin at a dosage of 75 to 325 mg should be co-administered once daily during this time.

Ingredients

Manufacturer
(주)팜젠사이언스

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-ST segment elevation myocardial infarction
  • cardiovascular abnormalities
  • stroke
  • refractory ischemia
  • vascular risk factors
  • atherothrombosis
  • thromboembolism
View approved original text

This medication is used for adult patients with vascular diseases. It improves symptoms caused by atherosclerosis in patients with ischemic stroke, myocardial infarction, and peripheral artery disease. Additionally, it reduces the risk of cardiovascular complications in patients with acute coronary syndrome. For patients with atrial fibrillation and low bleeding risk, it decreases the risk of stroke and thrombus formation. This medication is effective in enhancing overall vascular health and preventing cardiovascular complications, therefore it is used in the management of atherosclerotic diseases.

Dosage and Administration

Adult dosage

For patients with ischemic stroke, myocardial infarction or peripheral artery disease, clopidogrel is administered orally once a day at a dosage of 75 mg. In patients with acute coronary syndrome (unstable angina or non-ST segment elevation myocardial infarction), therapy may begin with a loading dose of 300 mg once daily on the first day, followed by a maintenance dose of 75 mg once daily. Aspirin at a dosage of 75 to 325 mg should be co-administered once daily during this time.

Precautions

This medication is an anticoagulant that prevents blood clot formation. It needs to be converted into its active form in the liver to be effective; therefore, individuals with genetically decreased enzyme function involved in this activation process may experience diminished drug efficacy. Additionally, concomitant use of drugs that activate certain enzymes may increase blood concentration and elevate bleeding risk, so such combinations should be avoided. Patients allergic to this medication or its components, those already experiencing bleeding, patients with severe liver damage, and nursing mothers should not take this medication. Patients at high risk for bleeding should use this medication cautiously. For instance, if bleeding symptoms occur, immediate medical attention is required, and it may be necessary to discontinue this medication for a period prior to surgery. Furthermore, extra caution is needed when using this medication alongside other bleeding risk medications. During treatment, various adverse reactions such as bleeding, thrombocytopenia, gastrointestinal disturbances, and skin rashes may occur. In particular, bleeding is the most common and significant side effect; thus, any bleeding symptoms must be reported to healthcare personnel immediately. Pregnant or nursing women should consult their physician regarding the effects of this medication on the fetus or newborn and make careful decisions about medication use during breastfeeding. This medication has not been adequately studied for safety and efficacy in children, and its use is not recommended in this population. Elderly individuals may have diminished bodily functions leading to a higher risk of bleeding, thus dosage adjustments and monitoring are necessary during use. Overdose may result in prolonged bleeding times and severe bleeding; currently, there is no antidote for this medication. Treatment for overdose may include platelet transfusions and other supportive measures. This medication should be stored out of reach of children and should not be transferred to other containers.

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, blistering, peeling skin, ulcers in the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, cough with fever accompanied by respiratory distress, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden severe headaches, thunderclap headaches, seizures, confusion, visual disturbances, paralysis, urinary incontinence

Mild side effects

  • Headache
  • dizziness
  • abdominal pain
  • dyspepsia
  • diarrhea
  • nausea
  • rash
  • pruritus
  • purpura/bruising
  • epistaxis
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  • fatigue
  • hematoma
  • fever
  • myalgia
  • arthralgia
  • low back pain
  • depression
  • insomnia
  • anxiety
  • cough
  • rhinitis
  • bronchitis
  • visual disturbances
  • visual impairment
  • dry eyes
  • congestion
  • tinnitus
  • urination disorders
  • polyuria
  • hypoglycemia
  • abnormal liver function tests
  • increased blood creatinine
  • gynecomastia
  • weight gain
  • weight loss
  • flushing
  • contact dermatitis

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to store it at room temperature, specifically between 1°C and 30°C.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

100 tablets, 30 tablets

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.