Anavix Tablets (Clopidogrel Hydrogen Sulfate)

Adult dose

○ Adults 1. Patients with ischemic stroke, myocardial infarction, or peripheral arterial disease should take clopidogrel 75 mg orally once daily. 2. Patients with acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) should start with a loading dose of 300 mg of this medicine once daily on the day treatment is initiated, 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. Patients with atrial fibrillation should take 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 and a bleeding diathesis is limited. This medicine may be taken with or without food.

This medication prevents blood clots by inhibiting platelet aggregation and is primarily used to prevent the recurrence of cardiovascular diseases. It is converted to its active form in the liver, and in patients with impaired CYP2C19 enzyme function, its efficacy may be reduced, indicating that alternative treatment methods should be considered in such cases. Taking this medication with drugs that increase the concentration of active metabolites may elevate the risk of bleeding, thus coadministration with such drugs is not recommended. Patients with an allergy to this drug or its ingredients, patients with severe bleeding, patients with severe liver damage, nursing mothers, and those with lactose intolerance should not take this drug. Patients at risk for bleeding, those with blood coagulation disorders, patients scheduled for surgery, the elderly, and underweight individuals should use this drug with caution, and if bleeding symptoms occur, they should consult healthcare professionals immediately. This drug may cause bleeding; therefore, careful monitoring for signs of bleeding or prolonged bleeding time is essential, especially when taken with other antiplatelet agents, anticoagulants, or nonsteroidal anti-inflammatory drugs. During the use of this medication, the risk of bleeding may increase; thus, before undergoing surgical or dental treatments, it is crucial to inform healthcare professionals about the use of this drug. This drug may rarely cause thrombocytopenia or severe hematological adverse reactions; therefore, if symptoms of infection or bleeding appear, immediate testing is necessary. During pregnancy, the risk to the fetus is low; however, the risk of bleeding during delivery may increase, and it should be discontinued before labor or nerve block. In nursing mothers, the potential for medication secretion and the risk of adverse reactions in infants should be carefully considered before continuing use. The safety in children has not been established, and elderly individuals may have an increased risk of bleeding due to decreased bodily functions; therefore, dose adjustment and caution are necessary. In case of overdose, prolonged bleeding time may occur, and bleeding complications could arise, necessitating immediate treatment. Platelet transfusion may be used to reverse the effects of this drug.

Hemorrhage, gastrointestinal bleeding, purpura, contusion, hematoma, epistaxis, hematoma, hematuria, intraocular hemorrhage, intracranial bleeding, neutropenia, agranulocytosis, aplastic anemia, thrombocytopenia, abdominal pain, dyspepsia, diarrhea, nausea, rash, pruritus, urinary tract infection, chest pain, accidental injury, influenza-like illness, pain, fatigue, edema, hypertension, headache, dizziness, vomiting, depression, dyspnea, rhinitis, bronchitis, cough, urinary tract infection, syncope, palpitations, asthenia, fever, hernia, heart failure, atrial fibrillation, leg cramps, sensory impairment, neuralgia, sensory abnormality, vertigo, constipation, elevated liver enzymes, gout, hyperuricemia, arthralgia, arthritis, anxiety, insomnia, anemia, hematochezia, hematoma, thrombocytopenia, pneumonia, sinusitis, eczema, skin ulcer, cystitis, cataract, conjunctivitis, reduced motor function, tremors, speech disorders, abnormal gait, hyperkinesia, ataxia, perceptual disturbances, insomnia, depression, forgetfulness, tremors, abnormal thoughts, abnormal behavior, arthralgia, myalgia, lumbago, gynecomastia, weight loss, weight gain, facial flushing, rigidity, facial edema, hematochezia, thrombocytopenia, anemia, cough, dyspnea, visual disturbances, field defects, dry eye syndrome, transient blindness, congestion, tinnitus, urination disorders, polyuria, hypoglycemia, hyperuricemia, liver dysfunction, leg edema, arrhythmia, bradycardia, palpitations, rash, pruritus, contact dermatitis, gynecomastia, elevated PSA, cholecystitis, hematemesis, spinal hematoma, allergic symptoms, ischemic necrosis, gastritis, hemorrhagic gastroenteritis, duodenal ulcer, gastric ulcer, perforated gastric ulcer, upper gastrointestinal tract ulcer hemorrhage, distension, bilirubinemia, infectious hepatitis, fatty liver, hemorrhagic arthropathy, hematuria, hemoptysis, retroperitoneal hemorrhage, surgical wound hemorrhage, pulmonary hemorrhage, vasculitis, hypotension, bronchospasm, interstitial pneumonia, eosinophilic pneumonia, colitis, pancreatitis, stomatitis, hepatitis, acute liver failure, maculopapular rash, erythematous skin rash, urticaria, angioedema, vesicular dermatitis, drug-induced hypersensitivity syndrome, eosinophilia, drug rash, lichen planus, arthritis, glomerulopathy, gynecomastia, fever, abnormal liver function tests, elevated blood creatinine, confusion, hallucinations, taste disturbance, taste loss, angioedema, thrombocytopenia, prolonged bleeding time, aplastic anemia, hypochromic anemia, agranulocytosis, granulocytopenia, leukemia, leukopenia, neutropenia, eosinophilia, menorrhagia, hemothorax, herpes simplex.

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is recommended to maintain storage temperatures between 1°C and 30°C at room temperature. Doing so will help maintain the medication's efficacy safely over time.

Appearance

Pink round film-coated tablet

Package unit

300 tablets/bottle, 30 tablets/bottle