Medication info
Antiplatelet Tablet (Clopidogrel Hydrogen Sulfate)

Antiplatelet Tablet (Clopidogrel Hydrogen Sulfate)

Prescription medicationTablet
Ingredient · strength
Clopidogrel Bisulfate›97.875mg / 1 tablet
Manufacturer / importer
Jungheon Pharmaceuticals Co., Ltd.
Appearance
Pink, round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201707646 · Approved 2017.10.30 · Insurance code 053300190

Summary

Main use
Improvement of atherosclerotic symptoms and prevention of atherothrombotic and thromboembolic events in patients with atrial fibrillation
Who uses it
Adults
Adult dosage
○ 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 with a loading dose of 300 mg of this medicine once on the day treatment is started, followed by a maintenance dose of 75 mg orally once daily. Aspirin 75 ~ 325 mg should be coadministered 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 coadministered 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
Jungheon Pharmaceuticals Co., Ltd.

Efficacy & effects

Improvement of atherosclerotic symptoms and prevention of atherothrombotic and thromboembolic events in patients with atrial fibrillation

  • Ischemic stroke
  • myocardial infarction
  • peripheral arterial disease
  • acute coronary syndrome
  • unstable angina
  • non-Q wave myocardial infarction
  • cardiovascular abnormalities
  • stroke
  • refractory ischemia
  • vascular risk factors
  • 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 arterial disease. Additionally, it improves symptoms while reducing the risk of death, myocardial infarction, and stroke related to cardiovascular abnormalities in patients with acute coronary syndrome, including unstable angina or non-Q wave myocardial infarction, as well as those who have undergone drug therapy, percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG). Moreover, for patients with atrial fibrillation who have vascular risk factors and are unsuitable for vitamin K antagonist therapy with a low risk of bleeding, it is effective in reducing the risks of stroke and thromboembolism. In summary, this drug is used to improve vascular-related symptoms related to cardiovascular diseases and to reduce the risk of stroke and thrombosis.

Dosage and Administration

Adult dosage

○ 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 with a loading dose of 300 mg of this medicine once on the day treatment is started, followed by a maintenance dose of 75 mg orally once daily. Aspirin 75 ~ 325 mg should be coadministered 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 coadministered 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 helps to prevent platelets from clumping together, facilitating better blood flow. However, individuals who genetically have reduced function of the enzyme CYP2C19, which activates this medication, may not experience its full effectiveness. In such cases, it is advisable to consult a physician to change the treatment method or use another medication. Furthermore, taking other medications that enhance the effect of this drug may increase the risk of bleeding, so it is best not to use them together. Patients who are allergic to this medication or have severe bleeding, patients with significant liver damage, nursing women, lactose intolerant patients, or individuals with allergies to soybean oil, peanuts, or beans should not take this medication. Patients at high risk of bleeding or those scheduled for surgery must consult a doctor before taking this drug, and they may be advised to stop taking it 5-7 days before surgery. This medication may increase the risk of bleeding when taken with other bleeding risk medications, so caution is necessary. If bleeding symptoms are suspected during the course of treatment, notify healthcare professionals immediately, and it is important to regularly check blood tests to assess the risk of bleeding. Possible side effects of this medication include bleeding, reduction in blood cell counts, gastrointestinal disturbances, skin rashes, and, rarely, serious blood disorders; hence, consult a physician immediately if any unusual symptoms occur. If pregnant or nursing, it is essential to discuss the use of this medication with a doctor. Overdosage may increase the risk of bleeding, so it is crucial to adhere to the prescribed dosage, particularly for children, the elderly, and patients with compromised kidney or liver function. This medication has not been confirmed to be safe and effective for use in children, so it is advisable to avoid using it. While taking this medication, inform healthcare providers of interactions with other medications or supplements that may increase the risk of bleeding. Finally, this medication should be stored out of the reach of children, and it is advisable not to transfer it to other containers.

Side effects

  • Hemorrhage
  • gastrointestinal bleeding
  • hospitalization required hemorrhage
  • purpura
  • contusion
  • hematoma
  • epistaxis
  • hematoma
  • hematuria
  • intraocular hemorrhage
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  • intracranial hemorrhage
  • major hemorrhage
  • minor hemorrhage
  • thrombocytopenia
  • neutropenia
  • agranulocytosis
  • aplastic anemia
  • abdominal pain
  • dyspepsia
  • diarrhea
  • rash
  • pruritus
  • depression
  • dyspnea
  • rhinitis
  • bronchitis
  • cough
  • urinary tract infection
  • chest pain
  • accidental injury
  • influenza-like illness
  • pain
  • fatigue
  • edema
  • hypertension
  • headache
  • dizziness
  • nausea
  • hypercholesterolemia
  • arthralgia
  • low back pain
  • purpura
  • hematochezia
  • thrombocytopenia
  • anemia
  • visual disturbance
  • field of vision disturbance
  • dry eye syndrome
  • transient vision loss
  • congestion
  • tinnitus
  • urination disorder
  • hypoglycemia
  • elevated liver enzymes
  • ALT elevation
  • abnormal liver function
  • leg edema
  • arrhythmia
  • bradycardia
  • palpitations
  • rash
  • itching
  • contact dermatitis
  • gynecomastia
  • elevated prostate-specific antigen
  • decreased motor function
  • tremor
  • voice disorder
  • abnormal gait
  • hyperactivity
  • ataxia
  • sensory disturbance
  • insomnia
  • forgetfulness
  • anxiety
  • hypoactivity
  • abnormal thoughts
  • abnormal behavior
  • rigidity
  • appetite loss
  • weight loss
  • weight gain
  • facial flushing
  • weakness
  • syncope
  • hemothorax
  • colitis
  • pancreatitis
  • gastritis
  • 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
  • myalgia
  • glomerular disease
  • fever
  • abnormal liver function tests
  • increased blood creatinine
  • spinal hematoma
  • Kounis syndrome
  • anaphylaxis-like reaction
  • serum sickness
  • confusion
  • hallucination
  • taste disturbance
  • loss of taste
  • vasculitis
  • bronchospasm
  • interstitial pneumonia
  • eosinophilic pneumonia
  • cholecystitis
  • hematemesis
  • thrombocytopenia
  • thrombocytopenic purpura
  • thrombocytopenic purpura
  • thrombocytopenia
  • thrombocytopenia
  • thrombocytopenia
  • thrombocytopenia

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

Storage

This medication should be stored in a closed container to prevent air or moisture ingress and maintained at a temperature between 1 to 30 degrees Celsius (34 to 86 degrees Fahrenheit). This helps maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Pink, round film-coated tablet

Package unit

30 tablets/bottle, 100 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.

Questions about this medicine

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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.