Plavitol Tablets (Clopidogrel Hydrogen Sulfate)

Adult dose

○ Adults 1. In patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, administer clopidogrel 75 mg orally once daily. 2. In patients with acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), start treatment on the day this medicine is initiated 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 medicine once daily. 3. In patients with atrial fibrillation, administer this medicine 75 mg 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 hepatic impairment and a bleeding diathesis is limited. This medicine may be administered with or without food.

This drug helps prevent platelets from aggregating, allowing blood to flow smoothly. People with genetically reduced CYP2C19 enzyme activity may experience decreased effectiveness of this drug, and in such cases, treatment options should be reconsidered. Concomitant use of this drug with drugs that activate CYP2C19 may increase drug concentrations and heighten the risk of bleeding, so concomitant use should be avoided. This drug should not be used if there is an allergy to this drug or its components, if there is existing bleeding, if there is severe liver dysfunction, if the person is a nursing woman, or if there are certain genetic diseases. Patients at high risk of bleeding or those scheduled for surgery should use this drug with caution and should ideally discontinue it 5-7 days prior to surgery. The risk of bleeding may increase when this drug is used with other medications that increase bleeding risk, so caution is advised. If any bleeding symptoms or abnormal reactions occur during the course of this drug, immediate consultation with a physician is necessary. This drug has demonstrated similar safety to aspirin during long-term use; however, side effects such as bleeding, gastrointestinal disorders, skin rash, and headache may occur. Particularly, bleeding may occur in various areas such as the gastrointestinal tract, intracranial region, hematuria, and epistaxis, so caution is necessary. The risk to the fetus during pregnancy is not clearly established, but caution is needed due to the risk of bleeding during delivery. Nursing mothers should discuss whether to continue breastfeeding or to discontinue medication with their physician due to potential drug secretion into breast milk. It is not recommended to use this drug in children as safety and efficacy have not been established. Older adults may have increased bleeding risk due to diminished physical function, necessitating dosage adjustments and careful monitoring. In cases of overdose, bleeding can become severe and, as there is no specific antidote, immediate medical attention is necessary. This drug should be kept out of reach of children and should not be transferred to other containers. While taking this drug, always be mindful of bleeding symptoms and ensure to inform healthcare providers that you are taking this drug before starting new medications or undergoing surgery.

Hemorrhage, gastrointestinal bleeding, hemorrhage requiring hospitalization, purpura, contusion, hematoma, epistaxis, hematoma, hematuria, intraocular hemorrhage, intracranial hemorrhage, significant hemorrhage, mild hemorrhage, hemorrhagic stroke, thrombocytopenia, neutropenia, aplastic anemia, abdominal pain, dyspepsia, diarrhea, nausea, rash, pruritus, chest pain, accidental injury, influenza-like illness, pain, fatigue, edema, hypertension, headache, dizziness, depression, shortness of breath, rhinitis, bronchitis, cough, urinary tract infection, reduced motor function, tremor, speech disorders, abnormal gait, hyperkinesia, ataxia, sensory disturbances, constipation, vomiting, ulcer, abdominal pain, loss of appetite, hiccups, polydipsia, dysphagia, tongue disorders, insomnia, depression, amnesia, anxiety, agitation, accidents, abnormal behavior, rigidity, facial edema, syncope, purpura, bloody stools, thrombocytopenia, anemia, pneumonia, sinusitis, visual disturbances, vision impairment, dry eyes, temporary blindness, congestion, tinnitus, taste disturbances, urinary dysfunction, frequent urination, non-protein nitrogen increase, uremia, elevated 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, gastritis, hemorrhagic gastroenteritis, duodenal ulcer, gastric ulcer, perforated gastric ulcer, upper gastrointestinal tract ulcer bleeding, bloating, hyperbilirubinemia, infectious hepatitis, fatty liver, hemorrhagic arthropathy, hematuria, hemoptysis, intracranial hemorrhage, retroperitoneal hemorrhage, surgical wound bleeding, ocular hemorrhage, pulmonary hemorrhage, thrombocytopenia, aplastic anemia, hypochromic anemia, agranulocytosis, granulocytopenia, leukemia, leukopenia, neutropenia, eosinophilia, menorrhagia, hemothorax, giant hives, erythematous rash, maculopapular rash, urticaria, renal dysfunction, acute renal failure, cholecystitis, hematemesis, spinal hematoma

This drug may be sensitive to air and moisture, so it should be stored in a tightly closed container. Store at room temperature between 1°C and 30°C to help maintain the drug's effectiveness.

Appearance

This medicine is a round film-coated tablet that is pink to orange in color.

Package unit

30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle