Paviklen Tablet (Clopidogrel Hydrogen Sulfate)

Adult dose

○ Adults 1. For patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, administer 75 mg of clopidogrel 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 of this medicine once daily, followed by a maintenance dose of 75 mg orally once daily. Aspirin 75 ～ 325 mg should be administered concomitantly with this medicine once daily. 3. For patients with atrial fibrillation, administer 75 mg of this medicine orally once daily. Aspirin 75 ～ 100 mg should be administered concomitantly with this medicine once daily. ○ Patients with renal impairment: Treatment experience in patients with renal impairment is limited. ○ Patients with hepatic impairment: Treatment experience in patients with moderate liver disease with a bleeding diathesis is limited. This medicine may be taken with or without food.

This medication inhibits platelet aggregation to prevent blood clotting. In patients with genetically reduced CYP2C19 enzyme function, less active metabolite of the drug will be produced, which may reduce its effectiveness, potentially increasing the risk of cardiovascular diseases; thus, treatment options should be carefully evaluated for these patients. Furthermore, if taken with drugs that activate CYP2C19 enzyme, the concentration of the medication may increase, heightening the risk of bleeding, hence co-administration should be avoided. Patients with hypersensitivity to this drug or those with bleeding disorders, severe liver damage, or who are breastfeeding should not take this medication. Patients at high risk of bleeding or with suspected bleeding symptoms should consult healthcare providers immediately, and if surgery is planned, this medication should be discontinued 5 to 7 days prior, and should be resumed only after hemostasis is achieved. Caution is needed when taken with other antiplatelet agents, anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs), or selective serotonin reuptake inhibitors (SSRIs) which can increase bleeding risk. During pregnancy, an increased risk of bleeding may occur, thus it should be used with caution, and during breastfeeding, it is advised to consult a physician regarding whether to discontinue nursing or the medication, as the drug may be secreted in breast milk. Elderly patients or those with impaired renal or liver function may have heightened risk of bleeding and side effects, therefore dose adjustments and monitoring may be necessary. In case of overdose, the risk of bleeding may increase, and it is necessary to visit a medical facility immediately, as there is currently no specific antidote available for this medication. This drug may also cause side effects other than bleeding abnormalities, such as headache, dizziness, dyspepsia, diarrhea, rash, etc., and any unusual symptoms should be reported to healthcare professionals. While taking this medication, it may take longer than usual for bleeding to stop, thus extra caution is needed in the event of trauma or surgery. Finally, this medication should be stored out of the reach of children, and transferring it to another container may compromise its quality.

• Hemorrhage
• gastrointestinal bleeding
• bleeding requiring hospitalization
• purpura
• contusion
• hematoma
• epistaxis
• hematoma
• hematuria
• intraocular hemorrhage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is recommended to maintain a storage temperature of between 1 and 30 degrees Celsius at room temperature. Proper storage will help maintain the medication's efficacy and safety for a longer period.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle