Clopidogrel Tablets (Clopidogrel Bisulfate)

Adult dose

1. For patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, administer clopidogrel 75 mg 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 drug, 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. For 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: Experience with treatment in patients with renal impairment is limited. ○ Patients with hepatic impairment: Experience with treatment in patients with moderate liver disease and a bleeding diathesis is limited. This drug may be taken with or without food.

This medicine helps to prevent platelets from aggregating, allowing blood to flow well. However, patients with genetic deficiencies in certain enzymes (CYP2C19) may experience reduced effectiveness of this drug, in which case it may be necessary to change treatment methods or use another medication. Taking this drug together with medications that increase the activity of the enzyme may raise drug concentration and increase bleeding risk, so it is advisable not to combine them. Patients with allergies to this drug or its components, patients with bleeding tendencies, patients with severe liver damage, nursing women, and patients with lactose intolerance should not take this medication. Patients at high risk of bleeding or those scheduled for surgery should exercise extreme caution when taking this medication and may need to discontinue it 5 to 7 days before the procedure. Additionally, taking this medication with other drugs that carry a bleeding risk can increase the risk of bleeding, so consultation with a physician is necessary. During treatment, the time it takes for bleeding to stop may be longer than usual, so if bleeding or bruising worsens, immediate medical attention is needed. Rarely, thrombocytopenia or serious blood disorder reactions may occur, requiring immediate investigation if symptoms of infection or bleeding appear. Side effects may include dyspepsia, diarrhea, headache, rash, fatigue, among others, and immediate treatment is needed for severe bleeding symptoms or allergic reactions. The effects on the fetus during pregnancy are unclear, but treatment should not be delayed in emergencies such as myocardial infarction or stroke. In nursing cases, consultation with a healthcare professional is required regarding the possibility of this drug being excreted in breast milk and whether to discontinue breastfeeding. Elderly patients or those with impaired kidney or liver function are at higher risk of bleeding, so careful observation and dosage adjustment are necessary. In case of overdose of this drug, the risk of bleeding may increase, and since there is no specific antidote, measures such as platelet transfusion may be required. This medication should be kept out of reach of children and should not be transferred to other containers.

Bleeding, gastrointestinal bleeding, bleeding requiring hospitalization, petechiae, contusion, hematoma, epistaxis, hematoma, hematuria, intraocular bleeding, intracranial hemorrhage, significant bleeding, minor bleeding, hemorrhagic stroke, thrombocytopenia, neutropenia, aplastic anemia, skin and skin appendage adverse reactions, rash, pruritus, chest pain, accidental injury, influenza-like illness, pain, fatigue, edema, hypertension, headache, dizziness, abdominal pain, dyspepsia, diarrhea, nausea, hypercholesterolemia, arthralgia, low back pain, depression, upper respiratory tract infection, dyspnea, rhinitis, bronchitis, cough, urinary tract infection, decreased motor function, tremor, voice disorder, abnormal gait, hyperkinesia, ataxia, sensory disturbance, constipation, vomiting, ulcer, abdominal pain, anorexia, thirst, dysphagia, tongue disease, insomnia, depression, forgetfulness, anxiety, tonic-clonic status, abnormal behavior, rigidity, weight loss, weight gain, flushing, weakness, facial edema, syncope, purpura, hematochezia, hematoma, thrombocytopenia, anemia, cough, dyspnea, rhinitis, visual disturbances, visual field defects, dry eye syndrome, transient blindness, congestion, tinnitus, dysuria, pollakiuria, hyperuricemia, uremia, increased blood urea nitrogen, hypoglycemia, hyperuricemia, increased liver enzymes, elevated ALT, liver dysfunction, leg edema, arrhythmia, bradycardia, palpitations, contact dermatitis, gynecomastia, elevated prostate-specific antigen, allergic symptoms, ischemic necrosis, generalized edema, gastritis, hemorrhagic gastroenteritis, duodenal ulcer, gastric ulcer, perforated gastric ulcer, upper gastrointestinal tract ulcer bleeding, distension, hyperbilirubinemia, infectious hepatitis, fatty liver, hemorrhagic arthropathy, hematuria, hemoptysis, retroperitoneal bleeding, surgical wound bleeding, ocular bleeding, pulmonary hemorrhage, vasculitis, hypotension, bronchospasm, interstitial pneumonia, eosinophilic pneumonia, colitis, pancreatitis, stomatitis, hepatitis, acute liver failure, petechial rash, erythematous skin rash, urticaria, pruritus, angioedema, vesicular dermatitis, drug-induced hypersensitivity syndrome, eosinophilia, drug rash, eczema, lichen planus, arthritis, myalgia, glomerulonephritis, gynecomastia, fever, abnormal liver function tests, increased blood creatinine, cholecystitis, hematemesis, spinal hematoma

This medicine should be stored in a tightly closed container to prevent exposure to air and moisture. It is best to keep the storage temperature between 1 degrees and 30 degrees Celsius.

Appearance

Pink round film-coated tablet

Package unit

Domestic use - 30 tablets/bottle, Domestic use - 100 tablets/bottle, Export use - 10 tablets/box [(10 tablets/blister x 1)], Export use - 20 tablets/box [(10 tablets/blister x 2)], Export use - 90 tablets/box [(10 tablets/blister x 9)], Export use - 100 tablets/box [(10 tablets/blister x 10)]