Vasobix Tablet (Clopidogrel Hydrogen Sulfate)

Adult dose

○ Adults 1. In patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, administer 75 mg of clopidogrel orally once daily. 2. In 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 drug 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 75 mg of this drug 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 liver disease and a bleeding diathesis is limited. This drug may be administered with or without food.

This medication is an agent that inhibits platelet aggregation to prevent thrombosis. Patients with genetically reduced function of the CYP2C19 enzyme may experience decreased effectiveness of this medication, and in such cases, treatment methods should be adjusted or alternative therapies considered. Co-administration with drugs that activate the CYP2C19 enzyme may increase the concentration of the active metabolite of this medication, raising the risk of bleeding, and such combinations are not recommended. This medication should not be administered to patients with allergies to this drug or its components, those with bleeding disorders, patients with severe liver impairment, nursing mothers, or patients with genetic issues like lactose intolerance. Caution should be exercised when administering to patients at high risk of bleeding, those with liver disease, severe renal impairment, acute stroke, hypertension, the elderly, and underweight patients; particularly, patients scheduled for surgery should discontinue this medication 5 to 7 days prior to the operation. As this medication may increase the risk of bleeding, patients experiencing symptoms of bleeding should immediately notify healthcare personnel and undergo appropriate tests, such as complete blood counts. Caution is needed when used in conjunction with other antiplatelet agents, anticoagulants, NSAIDs, and selective serotonin reuptake inhibitors (SSRIs), as these may elevate the risk of bleeding. The effects on the fetus during pregnancy are unclear; however, treatment should not be delayed in emergency situations like myocardial infarction or stroke. Additionally, due to increased risk of bleeding during childbirth, it is advised to stop this medication 5 to 7 days before delivery. Nursing mothers should carefully consider whether to discontinue breastfeeding as the drug may be excreted in breast milk. Safety and efficacy in pediatric patients have not been established. In the elderly, adverse reactions such as bleeding may occur more frequently due to decreased physiological function, necessitating dosage adjustment and monitoring. In case of overdose, there may be prolonged bleeding time and bleeding complications, requiring immediate visit to a medical facility, where platelet transfusion might reverse these effects. This medication should be stored out of reach of children, and it is safer not to transfer it to other containers.

Hemorrhage, gastrointestinal bleeding, hospitalization required for bleeding, purpura, contusion, hematoma, epistaxis, hematoma, hematuria, intraocular hemorrhage, intracranial hemorrhage, major hemorrhage, minor hemorrhage, severe hemorrhage, fatal hemorrhage, hemorrhagic stroke, thrombocytopenia, neutropenia, aplastic anemia, abdominal pain, dyspepsia, diarrhea, nausea, rash, pruritus, depression, upper respiratory tract infection, dyspnea, rhinitis, bronchitis, cough, urinary tract infection, chest pain, accidental injury, influenza-like illness, pain, fatigue, edema, hypertension, headache, dizziness, hypercholesterolemia, arthralgia, low back pain, depression, insomnia, anxiety, convulsions, behavioral abnormalities, abnormal behavior, reduced motor function, tremor, speech impairment, abnormal gait, hyperkinesia, ataxia, sensory disturbances, constipation, vomiting, ulcer, abdominal pain, loss of appetite, hiccups, dry mouth, dysphagia, tongue disorders, bloody stools, thrombocytopenia, anemia, pneumonia, sinusitis, visual disturbances, visual field defects, dry eyes, transient blindness, congestion, tinnitus, taste disturbances, urination disorders, polyuria, non-protein nitrogen increase, uremia, elevated blood urea nitrogen, hypoglycemia, hyperuricemia, elevated liver enzymes, ALT elevation, abnormal liver function, leg edema, arrhythmia, bradycardia, palpitations, rash, itching, contact dermatitis, gynecomastia, elevated prostate-specific antigen, allergic symptoms, ischemic necrosis, gastritis, hemorrhagic gastroenteritis, duodenal ulcer, gastric ulcer, perforated gastric ulcer, upper gastrointestinal tract bleeding, distension, hyperbilirubinemia, infectious hepatitis, fatty liver, hemorrhagic arthropathy, hematuria, hemoptysis, retroperitoneal hemorrhage, surgical wound bleeding, pulmonary hemorrhage, vasculitis, hypotension, bronchospasm, interstitial pneumonia, eosinophilic pneumonia, colitis, pancreatitis, stomatitis, hepatitis, acute liver failure, petechial rash, erythematous or desquamating skin rash, urticaria, angioedema, vesicular dermatitis, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms, eczema, lichen planus, arthritis, myalgia, glomerulonephritis, gynecomastia, fever, abnormal liver function tests, increased serum creatinine, cholecystitis, hematemesis, spinal hematoma

This medication should be stored in a tightly sealed container to protect it from air and moisture. The appropriate storage temperature is between 1 degree Celsius and 30 degrees Celsius at room temperature. Avoid storing in excessively hot or cold places.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle