Trombix Tablets (Clopidogrel Hydrogen Sulfate)

Adult dose

○ Adults 1. Patients with ischemic stroke, myocardial infarction, or peripheral arterial disease: Administer clopidogrel 75 mg orally once daily. 2. Patients with acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): On the day treatment with this drug is initiated, start 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 drug once daily. 3. 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 hepatic disease and bleeding diathesis is limited. This drug may be administered with or without food.

This medication prevents platelets in the blood from aggregating, thereby preventing the formation of blood clots. Before taking this medication, patients with a genetic deficiency in the CYP2C19 enzyme that activates the drug in the liver may have reduced efficacy, so in such cases, the treatment strategy should be reconsidered. Additionally, taking this medication with drugs that increase the activity of CYP2C19 could raise the concentration of the active ingredient and may increase the risk of bleeding, so it is advisable to avoid such combinations. Patients who are allergic to this drug or its components, those with severe bleeding, patients with severe liver impairment, nursing mothers, and individuals with specific genetic disorders such as lactose intolerance should not take this medication. Patients with a high risk of bleeding or bleeding disorders should use this medication with caution, and it is important to undergo blood tests immediately if bleeding symptoms are suspected. Particularly, caution is necessary when taking this medication with anticoagulants like warfarin, as this increases the risk of bleeding. Patients scheduled for surgery should stop taking this medication 5 to 7 days prior to the surgery and resume only after bleeding has ceased. This medication should be used carefully with other antiplatelet agents or medications that carry a bleeding risk such as non-steroidal anti-inflammatory drugs, thrombolytics, and selective serotonin reuptake inhibitors (SSRIs). During the course of treatment, watch for bleeding symptoms (such as skin bruising, nosebleeds, or hematuria) and immediately inform healthcare professionals of any unusual symptoms. The most common side effect of this medication is bleeding, which may include gastrointestinal bleeding, intracranial bleeding, and skin bruising. Rarely, side effects may include a decrease in blood cell count, so it is important to visit a hospital immediately if symptoms of infection or fever occur. Various side effects such as dyspepsia, diarrhea, headache, and rash have been reported, so if symptoms persist, consulting with a healthcare professional is necessary. Women who are pregnant or nursing should consult a physician before taking this medication, as caution is needed particularly during breastfeeding due to the potential transfer of the drug in breast milk. Elderly patients or those with impaired kidney or liver function may be at higher risk of bleeding, so careful monitoring is required while taking this medication. In cases of overdose, bleeding time may be prolonged, and bleeding complications may occur, so it is important to adhere to the prescribed dosage and administration. This medication should be kept out of the reach of children and should not be transferred to other containers for safety.

Hemorrhage, gastrointestinal hemorrhage, hospitalization required for hemorrhage, purpura, contusion, hematoma, epistaxis, hematoma, hematuria, intraocular hemorrhage, intracranial hemorrhage, significant hemorrhage, mild hemorrhage, severe hemorrhage, fatal hemorrhage, hemorrhagic stroke, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia, abdominal pain, dyspepsia, diarrhea, nausea, rash, pruritus, depression, shortness of breath, rhinitis, bronchitis, cough, urinary tract infection, headache, dizziness, chest pain, accidental injury, influenza-like illness, pain, fatigue, edema, hypertension, depression, upper respiratory tract infection, gynecomastia, insomnia, anxiety, somnolence, abnormal behavior, joint pain, myalgia, low back pain, anemia, hematochezia, thrombocytopenia, pneumonia, sinusitis, eczema, skin ulcer, cystitis, cataract, conjunctivitis, allergic symptoms, ischemic necrosis, systemic edema, gastritis, hemorrhagic gastroenteritis, duodenal ulcer, gastric ulcer, perforated gastric ulcer, upper gastrointestinal tract ulcer hemorrhage, abdominal distension, hyperbilirubinemia, 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, petechial rash, erythematous skin rash, urticaria, angioedema, vesicular dermatitis, drug-induced hypersensitivity syndrome, eosinophilia, drug rash, lichen planus, glomerulopathy, gynecomastia, fever, abnormal liver function tests, increased serum creatinine, cholecystitis, hematemesis, spinal hematoma

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the efficacy of the drug for a longer period.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle