Pravic Tablets (Clopidogrel Hydrogen Sulfate)

Adult dose

○ Adults 1. For patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, administer 75 mg of clopidogrel 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 medicine 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. 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 bleeding diathesis is limited. This medicine may be administered with or without food.

This drug is an anticoagulant that prevents blood clotting to avert thrombosis. This medication is converted to an active metabolite in the liver to inhibit platelet aggregation, and its efficacy can vary depending on genetic factors. In particular, individuals with reduced enzyme function of CYP2C19 may experience decreased efficacy of this drug, thus alternative treatment methods should be considered in such cases. Co-administration of this drug with agents that induce CYP2C19 can increase the concentration of this medication, thereby raising the risk of bleeding; therefore, combination should be avoided. Patients with hypersensitivity to this drug, existing bleeding, severe liver impairment, nursing mothers, and those with lactose intolerance should not use this medication. Patients with high bleeding risk or those scheduled for surgery should exercise caution when taking this drug and may need to discontinue use 5–7 days prior to the procedure. The concomitant use of this medication with other antiplatelet agents such as aspirin or anticoagulants may increase the risk of bleeding, so caution is advised under medical supervision. If any symptoms of bleeding appear during treatment, seek immediate medical attention for further examination. Rarely, this drug may cause blood dyscrasias such as thrombocytopenia or bone marrow suppression, so consult a physician immediately if any signs of infection occur. Gastrointestinal symptoms like abdominal pain, dyspepsia, and diarrhea may occur, along with reported skin adverse reactions such as rash or itching. The impact of this drug on the fetus during pregnancy is unclear, but emergency treatment should not be halted for situations like myocardial infarction or stroke. Nursing mothers should consult with their physician regarding the possible secretion of this drug into breast milk before deciding whether to stop breastfeeding. Elderly patients or those with impaired renal or liver function have an increased risk of bleeding and require careful dose adjustment and monitoring. Overdose may increase the risk of bleeding, and as no specific antidote exists, treatment such as platelet transfusion may be necessary in severe cases of bleeding. This medication must be kept out of reach of children and should not be transferred to another container as that can affect quality.

Hemorrhage, gastrointestinal bleeding, hemophilia requiring hospitalization, purpura, contusion, hematoma, epistaxis, hematoma, hematuria, intraocular hemorrhage, intracranial hemorrhage, major bleeding, life-threatening hemorrhage, fatal hemorrhage, hemorrhagic stroke, need for a hemostatic agent, need for blood transfusion, significant functional impairment, significant vision loss associated with intraocular hemorrhage, mild bleeding, neutropenia, agranulocytosis, aplastic anemia, thrombocytopenia, skin and skin appendage adverse reactions, rash, pruritus, diarrhea, abdominal pain, dyspepsia, nausea, headache, dizziness, depression, upper respiratory tract infection, shortness of breath, rhinitis, bronchitis, cough, urinary tract infection, chest pain, accidental injury, influenza-like illness, pain, fatigue, edema, hypertension, hypercholesterolemia, arthralgia, low back pain, depression, anxiety, insomnia, anemia, hematochezia, thrombocytopenia, pneumonia, sinusitis, eczema, skin ulcer, cystitis, cataract, conjunctivitis, allergic symptoms, ischemic necrosis, generalized edema, gastritis, hemorrhagic gastroenteritis, duodenal ulcer, gastric ulcer, perforated gastric ulcer, upper gastrointestinal ulcer bleeding, distension, hyperbilirubinemia, infectious hepatitis, fatty liver, hemorrhagic arthropathy, hematuria, hemoptysis, retroperitoneal hemorrhage, surgical site bleeding, pulmonary hemorrhage, vasculitis, hypotension, bronchospasm, interstitial pneumonia, eosinophilic pneumonia, colitis, pancreatitis, stomatitis, hepatitis, acute liver failure, maculopapular rash, erythematous skin rash, urticaria, itching, angioedema, vesicular dermatitis, drug-induced hypersensitivity syndrome, eosinophilia, drug rash, lichen planus, arthritis, myalgia, glomerulopathy, gynecomastia, fever, abnormal liver function tests, increased blood creatinine, cholecystitis, hematemesis, spinal hematoma

This drug should be stored in a tightly closed container to protect it from air and moisture. It is best maintained at room temperature between 1 degree and 30 degrees Celsius.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle