Plarem 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), initiate treatment on the first day with a loading dose of 300 mg of this drug once daily, followed by a maintenance dose of 75 mg once daily orally. In this case, aspirin 75 ～ 325 mg should be administered once daily in combination with this drug. 3. For patients with atrial fibrillation, administer 75 mg of this drug orally once daily. In this case, aspirin 75 ～ 100 mg should be administered once daily in combination with this drug. ○ 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 drug may be administered with or without food.

This medication prevents blood clotting to prevent thrombosis. It may be less effective in individuals with genetically reduced function of the enzyme CYP2C19, and in such cases, alternative treatment options should be considered. Co-administration of this drug with medications that activate the CYP2C19 enzyme may excessively enhance its effects, increasing bleeding risk, so concurrent use should be avoided. This medication should not be used in the following cases: if there is an allergy to this drug or its components, in patients with bleeding, severe liver dysfunction, nursing women, and those with genetic conditions such as lactose intolerance. Caution should be exercised when administering this drug to patients with a high risk of bleeding. Symptoms of bleeding should be reported to medical personnel immediately, especially for patients scheduled for surgery, who should discontinue this medication 5 to 7 days prior to surgery. The concurrent use of this medication with other antiplatelet agents or drugs affecting blood coagulation may increase the risk of bleeding, so caution is needed. The major side effect of this drug is bleeding, which may manifest as gastrointestinal bleeding, nosebleeds, bruising, and hematuria. Rarely, a drop in blood cell count has also been reported. The impact on the fetus during pregnancy is unclear; however, its use may be considered in cases requiring treatment for serious cardiovascular diseases. Nursing mothers should consult a physician on whether to discontinue breastfeeding or the medication as it may be secreted in breast milk. The safety and efficacy in children have not yet been established, so its use is not recommended. Elderly patients or those with impaired kidney or liver function may have an increased bleeding risk, thus dosage adjustment and careful monitoring are necessary. In cases of overdose, the risk of bleeding may increase, and while there is no specific antidote, platelet transfusions may reverse the effects if necessary. This medication should be kept out of reach of children and should not be transferred to another container.

Hemorrhage, gastrointestinal hemorrhage, hemorrhage requiring hospitalization, purpura, contusion, hematoma, epistaxis, hematuria, intraocular hemorrhage, intracranial hemorrhage, major hemorrhage, life-threatening hemorrhage, fatal hemorrhage, hemorrhagic stroke, transfusion requirement, thrombocytopenia, neutropenia, aplastic anemia, abdominal pain, dyspepsia, diarrhea, rash, pruritus, urinary tract infection, chest pain, traumatic injury, influenza-like illness, pain, fatigue, edema, hypertension, headache, dizziness, nausea, depression, upper respiratory tract infection, dyspnea, rhinitis, bronchitis, cough, urinary tract infection, reduced motor function, tremor, voice disorder, abnormal gait, hyperkinesia, ataxia, sensory disturbances, insomnia, depression, forgetfulness, anxiety, somnolence, thought disturbances, abnormal behavior, arthralgia, myalgia, back pain, weight loss, weight gain, facial flushing, weakness, rigidity, facial edema, syncope, purpura, melena, hematoma, thrombocytopenia, anemia, pneumonia, sinusitis, visual disturbances, visual field defects, dry eyes, transient blindness, congestion, tinnitus, gustatory disturbances, urinary disturbances, frequent urination, non-protein nitrogen increase, uremia, elevated blood urea nitrogen, hypoglycemia, hyperuricemia, elevated liver enzymes, increased ALT, abnormal liver function, leg edema, arrhythmia, bradycardia, palpitations, rash, itching, 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 hemorrhage, bloating, hyperbilirubinemia, infectious hepatitis, fatty liver, hemorrhagic arthropathy, hemoptysis, retroperitoneal hemorrhage, surgical wound hemorrhage, pulmonary hemorrhage, serum sickness, confusion, hallucinations, gustatory abnormalities, vasculitis, hypotension, bronchospasm, interstitial pneumonia, eosinophilic pneumonia, colitis, pancreatitis, stomatitis, hepatitis, acute liver failure, maculopapular rash, erythematous skin rash, urticaria, angioedema, vesicular dermatitis, drug-induced hypersensitivity syndrome, eosinophilia, drug rash, eczema, lichen planus, arthritis, glomerulonephritis, gynecomastia, fever, abnormal liver function tests, increased blood 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 important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Pink, round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle