Medication info

Clopidogrel Hydrogen Sulfate 75 mg Tablet

Prescription medicationTabletOralExpired
Ingredient · strength
Clopidogrel Bisulfate›97.875mg / 1 tablet
Manufacturer / importer
CL Pharm Co., Ltd.
Appearance
Pink, round, film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 201907440 · Approved 2019.10.24

This product's status changed to Expired on 2024.10.24. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Acute coronary syndrome, improvement of symptoms of atherosclerosis, and reduction of the risk of thrombosis in atrial fibrillation
Who takes it
Adults
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 with a loading dose of 300 mg of this medicine once daily on the day treatment is initiated, followed by a maintenance dose of 75 mg orally once daily. In this case, aspirin 75 ~ 325 mg should be administered in combination with this medicine once daily. 3. For patients with atrial fibrillation, administer 75 mg of this medicine orally once daily. In this case, aspirin 75 ~ 100 mg should be administered in combination 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.

Ingredients

Manufacturer
CL Pharm Co., Ltd.

Efficacy & effects

Acute coronary syndrome, improvement of symptoms of atherosclerosis, and reduction of the risk of thrombosis in atrial fibrillation

  • Ischemic stroke
  • myocardial infarction
  • peripheral artery disease
  • acute coronary syndrome
  • unstable angina
  • non-ST-elevation myocardial infarction
  • cardiovascular abnormalities
  • stroke
  • refractory ischemia
  • vascular risk factors
  • bleeding risks
  • atrial fibrillation
View approved original text

This medication is used to improve symptoms caused by atherosclerosis in adult patients with ischemic stroke, myocardial infarction, or peripheral artery disease. It also reduces the risks of mortality, myocardial infarction, and stroke due to cardiovascular abnormalities in adults with acute coronary syndrome, such as unstable angina or non-ST-elevation myocardial infarction, and helps improve symptoms after drug therapy, coronary interventions, or coronary artery bypass surgery. Additionally, it is used to lower the risks of stroke and thromboembolism in patients with atrial fibrillation who have one or more vascular risk factors and who are not suitable for vitamin K antagonists, provided they have a low bleeding risk. This medication effectively improves atherothrombotic symptoms and thrombotic risks associated with various cardiovascular diseases.

How to take

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 with a loading dose of 300 mg of this medicine once daily on the day treatment is initiated, followed by a maintenance dose of 75 mg orally once daily. In this case, aspirin 75 ~ 325 mg should be administered in combination with this medicine once daily. 3. For patients with atrial fibrillation, administer 75 mg of this medicine orally once daily. In this case, aspirin 75 ~ 100 mg should be administered in combination 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.

Precautions

This medication prevents platelet aggregation and blood clotting. It needs to be converted to its active form in the liver to be effective, and the effectiveness may be reduced in individuals with impaired function of the enzymes involved in this process. There is an increased risk of bleeding while taking this medication, so it should not be used by patients with bleeding issues or tendencies. Particularly, patients with gastrointestinal bleeding, intracranial hemorrhage, hemophilia, severe liver impairment, nursing mothers, and those with lactose intolerance should not take this medication. Patients with a bleeding risk or those scheduled for surgery should use caution when taking this medication and are advised to discontinue it 5-7 days prior to surgery. Caution is also warranted if this medication is taken with other bleeding risk medications (e.g., warfarin, aspirin, nonsteroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors) as this may increase the risk of bleeding. If symptoms such as rash, skin abnormalities, or hematological symptoms (e.g., thrombocytopenia, neutropenia) occur during treatment, consult a physician immediately. During pregnancy, its effects on the fetus are not clearly defined, so it should be used cautiously unless in an emergency. For nursing women, a careful decision regarding its use is recommended due to the possibility of excretion into breast milk. In cases of overdose, the risk of bleeding may significantly increase, and no specific antidote exists; hence, treatments such as platelet transfusion may be necessary for severe bleeding. The safety of this medication has not been established in children, and elderly patients should take caution as they may have an increased bleeding risk due to diminished bodily functions. If a patient starts any new medications or is planning surgery while taking this medication, they must inform their healthcare provider of this fact. Proper storage of this medication is essential, and it should be kept out of reach of children.

Side effects

Hemorrhage, gastrointestinal bleeding, hospitalization required for bleeding, purpura, contusion, hematoma, epistaxis, hematoma, hematuria, ocular hemorrhage, intracranial hemorrhage, hemorrhagic stroke, thrombocytopenia, neutropenia, aplastic anemia, abdominal pain, dyspepsia, diarrhea, rash, pruritus, urinary tract infection, chest pain, accidental injury, influenza-like illness, pain, fatigue, edema, hypertension, headache, dizziness, nausea, depression, upper respiratory tract infection, dyspnea, rhinitis, bronchitis, cough, urinary tract infection, decreased motor function, tremor, voice disorder, abnormal gait, hyperkinesia, ataxia, sensory disturbances, constipation, nausea, ulcer, abdominal pain, loss of appetite, vomiting, hiccups, thirst, dysphagia, tongue disorders, insomnia, depression, amnesia, anxiety, stupor, abnormal behavior, rigidity, facial edema, syncope, purpura, hematochezia, hematoma, hematuria, hemoptysis, muscle hemorrhage, gingival bleeding, anemia, cough, dyspnea, rhinitis, visual disturbances, visual field defects, dry eye syndrome, transient blindness, congestion, tinnitus, taste disturbances, taste loss, vasculitis, hypotension, bronchospasm, interstitial pneumonia, eosinophilic pneumonia, colitis, pancreatitis, gastritis, stomatitis, hepatitis, acute liver failure, maculopapular rash, erythematous skin rash, urticaria, pruritus, angioedema, vesicular dermatitis, drug-induced hypersensitivity syndrome, eosinophilia, arthralgia, arthritis, myalgia, glomerular disease, gynecomastia, fever, abnormal liver function tests, increased blood creatinine, cholecystitis, hematemesis, spinal hematoma, allergic symptoms, ischemic necrosis, hemorrhagic arthropathy, hematuria, hemoptysis, intracranial hemorrhage, retroperitoneal hemorrhage, surgical wound bleeding, pulmonary hemorrhage, purpura, thrombocytopenia, anemia, aplastic anemia, hypochromic anemia, agranulocytosis, granular leukopenia, leukemia, leukopenia, neutropenia, eosinophilia, menorrhagia, hemothorax, herpes zoster, erythematous rash, maculopapular rash, urticaria, pruritus, angioedema, vesicular dermatitis, drug-induced hypersensitivity syndrome, drug rash accompanied by eosinophilia and systemic symptoms, eczema, lichen planus, arthralgia, arthritis, myalgia, glomerular disease, gynecomastia, fever, abnormal liver function tests, increased blood creatinine

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from exposure to air or moisture and should be kept at room temperature, between 1 to 30 degrees Celsius. This storage will help maintain its effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Pink, round, film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.