Probix Tablet (Clopidogrel Hydrogen Sulfate)

Adult dose

○ Adults 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 with a loading dose of 300 mg of this medicine orally 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. 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. ○ 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 administered with or without food.

This medicine is used to prevent blood clots by inhibiting platelets from aggregating. The effectiveness of this medication may be reduced in individuals with reduced function of the CYP2C19 enzyme, which metabolizes the drug in the liver. In such cases, alternative treatments or medications may need to be considered. Additionally, taking this drug with medications that activate the CYP2C19 enzyme may increase the concentration of the active ingredient, raising the risk of bleeding; therefore, co-administration should be avoided. Patients who are allergic to this medication, patients who are currently bleeding, patients with severe liver damage, breastfeeding women, and those with specific genetic conditions such as lactase deficiency should not use this medication. Patients at high risk of bleeding or with suspected bleeding should have their condition monitored with blood tests, and if undergoing surgery, should stop taking this medication 5 to 7 days prior to the procedure. Furthermore, caution is required when this drug is taken with other medications that increase bleeding risk, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), anticoagulants, and selective serotonin reuptake inhibitors (SSRIs). While on this medication, patients should always monitor for symptoms of bleeding, as it may take longer than usual for bleeding to stop. Patients taking this medication must inform their healthcare providers before undergoing surgery or starting any new medications. This medication can rarely cause thrombocytopenia or serious blood disorders, so if symptoms of fever or infection appear, immediate consultation with a healthcare professional is necessary. Pregnant or breastfeeding women should carefully consider the effects of this medication on their fetus or newborn and should consult with their healthcare provider, especially as the risk of bleeding may increase before and after delivery. In older adults or patients with impaired kidney and liver function, the risk of bleeding is heightened, so they should be closely monitored and treated with caution. Overdosing may increase the risk of bleeding, and as there is no specific antidote, treatments such as platelet transfusion may be necessary in cases of severe bleeding. This medication has not been sufficiently validated for safety and efficacy in children, so it is advisable not to use it in this population. Store this medication out of reach of children, and transferring it to other containers may adversely affect its quality.

Hemorrhage, gastrointestinal hemorrhage, hemorrhage requiring hospitalization, purpura, contusion, hematoma, epistaxis, hematoma, hematuria, intraocular hemorrhage, intracranial hemorrhage, significant hemorrhage, life-threatening hemorrhage, fatal hemorrhage, hemorrhagic stroke, requirement for anticoagulant use, requirement for blood transfusion, substantial degree of functional impairment, intraocular hemorrhage with significant vision loss, mild hemorrhage, severe neutropenia, aplastic anemia, severe thrombocytopenia, thrombocytopenia, thrombocytopenia, gastrointestinal symptoms, abdominal pain, indigestion, gastritis, constipation, diarrhea, rash, pruritus, depression, headache, dizziness, nausea, chest pain, accidental injury, influenza-like illness, pain, fatigue, edema, hypertension, purpura, bloody stool, thrombocytopenia, pneumonia, sinusitis, cough, urinary tract infection, allergic symptoms, ischemic necrosis, generalized edema, gastritis, hemorrhagic gastroenteritis, duodenal ulcer, gastric ulcer, perforated gastric ulcer, upper gastrointestinal ulcer hemorrhage, distension, hyperbilirubinemia, infectious hepatitis, fatty liver, hemorrhagic arthropathy, hematuria, hemoptysis, retroperitoneal hemorrhage, surgical wound bleeding, ocular hemorrhage, pulmonary hemorrhage, thrombocytopenia, anemia, aplastic anemia, hypochromic anemia, agranulocytosis, granulocytopenia, leukemia, leukopenia, neutropenia, eosinophilia, menorrhagia, hemothorax, herpes zoster, erythematous rash, maculopapular rash, urticaria, renal dysfunction, acute renal failure, gynecomastia, fever, abnormal liver function tests, increased serum creatinine, cholecystitis, hematemesis, spinal hematoma

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, and it is best kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's efficacy over time.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle