Serenade Tablets (Clopidogrel Hydrogen Sulfate)

Adult dose

○ Adults 1. In patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, administer clopidogrel 75 mg orally once daily. 2. In patients with acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), initiate treatment on the first day with a loading dose of this drug 300 mg once daily, followed by a maintenance dose of 75 mg orally once daily. Aspirin 75 ～ 325 mg should be administered concomitantly with this drug once daily. 3. In patients with atrial fibrillation, administer this drug 75 mg orally once daily. Aspirin 75 ～ 100 mg should be administered concomitantly with this drug 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 hepatic disease and bleeding diathesis is limited. This drug may be administered with or without food.

This medication is an antiplatelet agent that prevents the aggregation of platelets to avoid thrombosis. The effectiveness of this medication may be reduced in individuals genetically deficient in a specific enzyme (CYP2C19), in which case other treatment options should be considered. Additionally, concurrent use with medications that activate this enzyme may increase the concentration of this medication and elevate the risk of bleeding; hence, co-administration should be avoided. This medication is not administered to patients with allergies or bleeding, those with severe liver damage, breastfeeding women, or individuals with lactose intolerance. Caution should be exercised when using this medication in patients at high risk for bleeding, those with decreased liver or kidney function, recent stroke patients, hypertensive patients, and the elderly. Particularly, patients about to undergo surgery should discontinue this medication 5-7 days prior to the operation and must notify healthcare providers immediately if bleeding symptoms are suspected. The risk of bleeding can be elevated when this medication is taken with other medications associated with bleeding risks, such as aspirin, warfarin, nonsteroidal anti-inflammatory drugs, thrombolytics, and selective serotonin reuptake inhibitors (SSRIs). This medication may rarely cause thrombocytopenia or serious hematological abnormal reactions, so if fever or infection symptoms arise during treatment, immediate examination and consultation are necessary. During pregnancy, the risk to the fetus is not significant; however, due to the risk of bleeding at delivery, it is recommended to discontinue this medication before childbirth. If breastfeeding, it is not precisely known if this medication is excreted in breast milk, so it is advised to consult with a doctor regarding whether to continue breastfeeding or discontinue the medication. In the event of overdose, bleeding time may be prolonged, and bleeding complications may arise with no specific antidote; thus, platelet transfusions may be necessary. The safety and effectiveness of this medication in children have not been established. Elderly patients, due to reduced bodily function, have a higher risk of bleeding and thus require dosage adjustment and careful monitoring. Patients taking this medication should immediately inform their healthcare provider if any bleeding symptoms or adverse reactions occur, and must notify that they are currently taking this medication prior to surgery or starting new medications.

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

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is essential to maintain a storage temperature between 1 to 30 degrees Celsius to ensure the effectiveness and safety of the medication.

Appearance

Pink round film-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle