Neovix Tablets (Clopidogrel Hydrogen Sulfate)

Adult dosage

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), begin treatment on the first day with a loading dose of 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 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.

This medication is an agent that prevents platelet aggregation in the blood, thereby preventing thrombus formation. This drug is converted into an active form by a specific enzyme, CYP2C19, in the liver, so caution is needed in individuals with diminished enzyme function as the drug's effectiveness may be reduced. Additionally, using this medication with drugs that activate the CYP2C19 enzyme may increase drug concentration and the risk of bleeding, so concomitant use is not recommended. This medication should not be administered to patients at high risk of bleeding, severely impaired liver function, nursing women, or specific genetically lactose intolerant patients. Caution should be exercised when using this drug in patients at risk of bleeding or with bleeding disorders, and if bleeding symptoms occur during treatment, consult a physician immediately. For patients scheduled for surgery, it is advisable to discontinue this medication 5 to 7 days prior to the surgery and to resume treatment after hemostasis has been achieved. Increased bleeding risk may occur when used in combination with other antiplatelet agents, anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs), selective serotonin reuptake inhibitors (SSRIs), so it should be used cautiously. Rarely, blood-related adverse reactions such as thrombocytopenia and neutropenia may occur, so if there are symptoms of infection or bleeding, testing should be conducted immediately. Gastrointestinal symptoms (abdominal pain, dyspepsia, diarrhea, etc.), skin rashes, headache, dizziness, and other side effects may occur; seek medical advice if unusual symptoms appear. The risks to the fetus during pregnancy have not been confirmed, but the risk of bleeding during delivery may increase, so it is recommended to discontinue administration before delivery. In nursing mothers, the drug may be secreted into breast milk, so it is advisable to discuss with a physician whether to continue nursing or to discontinue medication. Safety and efficacy in pediatric patients have not been established; therefore, it should be used with caution in children. Elderly patients may have a higher risk of bleeding due to decreased physiological functions, so dose adjustments and observation of the patient’s condition are necessary. In case of overdose, bleeding time may be prolonged, and since there is no specific antidote, treatment may be required for severe bleeding, such as platelet transfusion. This medication should be stored out of reach of children, and transferring it to another container should be avoided as it may cause accidents or reduce quality.

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

This medication can be sensitive to air and moisture, so it must be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1 to 30 degrees.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle