Clofidogrel Tablet (Clopidogrel Hydrogen Sulfate)

Adult dose

○ Adults 1. For patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, administer clopidogrel 75 mg orally once daily. 2. For patients with acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), start treatment on the first day with a loading dose of 300 mg once daily, followed by an oral maintenance dose of 75 mg once daily. Aspirin 75 ～ 325 mg must be coadministered with this medicine once daily. 3. For patients with atrial fibrillation, administer this medicine 75 mg orally once daily. Aspirin 75 ～ 100 mg must be coadministered with this medicine once daily. ○ Patients with renal impairment : There is limited treatment experience in patients with renal impairment. ○ Patients with hepatic impairment : There is limited treatment experience in patients with moderate liver disease and a bleeding diathesis. This medicine may be administered with or without food.

This drug prevents the formation of thrombi by inhibiting the aggregation of platelets in the blood. Individuals with genetically reduced function of a specific enzyme (CYP2C19) may have decreased efficacy of this drug, so therapy adjustment or switching to another drug should be considered. It is advisable not to take this drug in combination with drugs that increase enzyme activity, as this may raise the risk of bleeding. Patients with allergies to this drug, those with bleeding disorders, patients with severe liver damage, nursing mothers, and individuals with certain genetic disorders should not take this drug. Patients at high risk of bleeding or with certain diseases should use this drug cautiously, and should consult a doctor immediately if bleeding symptoms appear. If surgery is planned, this drug should be discontinued 5–7 days prior to surgery, and caution should be exercised when using it with other medications that pose a bleeding risk. This drug may cause various side effects including bleeding, gastrointestinal disorders, skin rashes, headaches, and dizziness, with bleeding-related side effects being the most common and severe. During treatment with this drug, patients should always be vigilant for signs of bleeding and report any unusual symptoms to healthcare professionals immediately. Pregnant women are reported to have a low risk to the fetus; however, it is recommended to discontinue this drug prior to delivery due to the risk of bleeding during childbirth. Nursing mothers should consult their doctor about whether to continue breastfeeding, as this drug may be secreted in breast milk. The safety and efficacy of this drug in children have not been established, so its use in children is not recommended. Elderly patients or those with impaired renal and liver function may have an increased risk of bleeding when taking this drug, requiring dosage adjustments and careful monitoring of their condition. Overdosage may lead to an increased risk of bleeding; thus, doses should be strictly adhered to, and platelet transfusions may shorten bleeding times if necessary. This drug may interact with several medications; therefore, patients taking other medications should inform their physician or pharmacist. During treatment with this drug, bleeding may take longer to stop than usual, so if there are any changes in bleeding sites or times, healthcare professionals should be notified immediately. Store out of reach of children and do not transfer to other containers for safety.

• Hemorrhage
• gastrointestinal bleeding
• purpura
• contusion
• hematoma
• epistaxis
• hematuria
• intraocular hemorrhage
• intracranial hemorrhage
• neutropenia

This drug should be stored in a tightly closed container to prevent exposure to air and moisture. Avoid extremely hot or cold places, and store it at a normal temperature between 1 to 30 degrees Celsius.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle