Medication info
Plavix Tablet (Clopidogrel Hydrogen Sulfate)

Plavix Tablet (Clopidogrel Hydrogen Sulfate)

Prescription medicationTabletOral
Ingredient · strength
Clopidogrel Bisulfate›97.875mg / 1 tablet
Manufacturer / importer
Sungwon Adcock Pharmaceutical Co., Ltd.
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201208077 · Approved 2012.11.09 · Insurance code 664900930

Summary

Main use
Improvement of atherosclerotic symptoms; prevention of thrombosis in patients with 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 medication orally once daily on the first day of treatment, followed by a maintenance dose of 75 mg orally once daily. Aspirin 75 ~ 325 mg should be administered concomitantly with this medication once daily. 3. For patients with atrial fibrillation, administer 75 mg of this medication orally once daily. Aspirin 75 ~ 100 mg should be administered concomitantly with this medication once daily. ○ Patients with renal impairment: Experience with treatment in patients with renal impairment is limited. ○ Patients with hepatic impairment: Experience with treatment in patients with moderate hepatic disease and a bleeding diathesis is limited. This medication may be administered with or without food.

Ingredients

Manufacturer
Sungwon Adcock Pharmaceutical Co., Ltd.

Efficacy & effects

Improvement of atherosclerotic symptoms; prevention of thrombosis in patients with atrial fibrillation

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

This medication helps improve symptoms in adult patients with atherosclerotic conditions such as ischemic stroke, myocardial infarction, and peripheral arterial disease. It is also used to reduce the risk of death, myocardial infarction, and stroke due to cardiovascular complications in patients with acute coronary syndrome, such as unstable angina or non-ST elevation myocardial infarction, following drug therapy, coronary interventions, or coronary artery bypass surgery. Additionally, it is effective in reducing the risk of stroke and thromboembolism in patients with atrial fibrillation who have vascular risk factors and cannot use vitamin K antagonists. This medication is used to improve symptoms and reduce risks associated with various cardiovascular-related 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 medication orally once daily on the first day of treatment, followed by a maintenance dose of 75 mg orally once daily. Aspirin 75 ~ 325 mg should be administered concomitantly with this medication once daily. 3. For patients with atrial fibrillation, administer 75 mg of this medication orally once daily. Aspirin 75 ~ 100 mg should be administered concomitantly with this medication once daily. ○ Patients with renal impairment: Experience with treatment in patients with renal impairment is limited. ○ Patients with hepatic impairment: Experience with treatment in patients with moderate hepatic disease and a bleeding diathesis is limited. This medication may be administered with or without food.

Precautions

This medication prevents blood platelets from clumping together to prevent the formation of blood clots. The drug is activated in the liver by a specific enzyme, CYP2C19. Caution is needed as the effectiveness may be reduced in individuals with diminished enzyme function. Additionally, taking medications that activate this enzyme alongside this drug can enhance its effect and increase the risk of bleeding, so co-administration should be avoided. Patients with allergies to this medication or its components, those with bleeding disorders, severe liver damage, breastfeeding women, and individuals with lactose intolerance should not use it. Patients with a high risk of bleeding, reduced liver or kidney function, those who have recently experienced a stroke, hypertensive patients, and the elderly should use this medication cautiously and should consult a healthcare provider immediately if bleeding symptoms appear. This drug may increase the risk of bleeding when taken with other antiplatelet medications or drugs affecting blood coagulation, so caution is necessary when co-administered. During pregnancy, the risk to the fetus is minimal; however, caution should be exercised due to potential bleeding at delivery, and breastfeeding women should determine usage in consultation with their physician. Due to insufficient safety and efficacy data, it is not recommended for use in children. In case of overdose, the risk of bleeding may increase significantly, so the dosage must be adhered to precisely. If severe bleeding occurs, treatment such as platelet transfusion may be required. While taking this medication, bleeding may occur more easily, so patients should promptly inform their healthcare provider if they experience injuries or prolonged bleeding. When undergoing surgery or dental procedures, it is important to inform the healthcare provider that this medication is being taken, and it may be necessary to discontinue use 5-7 days prior to surgery if required. This medication should be kept out of reach of children and it is advisable not to transfer it to other containers.

Side effects

  • Hemorrhage
  • gastrointestinal bleeding
  • purpura
  • contusion
  • hematoma
  • epistaxis
  • hematoma
  • hematuria
  • intraocular hemorrhage
  • intracranial hemorrhage
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  • severe neutropenia
  • aplastic anemia
  • thrombocytopenia
  • gastrointestinal symptoms
  • abdominal pain
  • dyspepsia
  • diarrhea
  • nausea
  • rash
  • pruritus
  • chest pain
  • accidental injury
  • influenza-like illness
  • pain
  • fatigue
  • edema
  • hypertension
  • headache
  • dizziness
  • depression
  • upper respiratory tract infection
  • shortness of breath
  • rhinitis
  • bronchitis
  • cough
  • urinary tract infection
  • reduced motor function
  • tremor
  • speech disorder
  • abnormal gait
  • hyperkinesia
  • ataxia
  • sensory disturbances
  • constipation
  • vomiting
  • ulcer
  • abdominal pain
  • loss of appetite
  • hiccup
  • dry mouth
  • dysphagia
  • tongue disorders
  • insomnia
  • depression
  • forgetfulness
  • anxiety
  • delirium
  • abnormal perceptions
  • abnormal behavior
  • rigidity
  • weight loss
  • weight gain
  • facial flushing
  • weakness
  • syncope
  • purpura
  • melena
  • thrombocytopenia
  • anemia
  • pneumonia
  • sinusitis
  • visual disturbances
  • visual field defects
  • dry eye syndrome
  • transient blindness
  • congestion
  • tinnitus
  • urinary disorders
  • polyuria
  • non-protein nitrogen increase
  • uremia
  • elevated blood urea nitrogen
  • hypoglycemia
  • hyperuricemia
  • elevated liver enzymes
  • ALT elevation
  • 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 ulcer bleeding
  • distension
  • hyperbilirubinemia
  • infectious hepatitis
  • fatty liver
  • hemorrhagic arthropathy
  • hematuria
  • hemoptysis
  • retroperitoneal hemorrhage
  • surgical wound bleeding
  • pulmonary hemorrhage
  • vasculitis
  • hypotension
  • bronchospasm
  • interstitial pneumonia
  • eosinophilic pneumonia
  • colitis
  • pancreatitis
  • stomatitis
  • hepatitis
  • acute liver failure
  • purpuric rash
  • erythematous skin rash
  • urticaria
  • angioedema
  • vesicular dermatitis
  • drug-induced hypersensitivity syndrome
  • eosinophilia
  • drug rash
  • eczema
  • lichen planus
  • arthralgia
  • arthritis
  • myalgia
  • glomerulopathy
  • gynecomastia
  • fever
  • abnormal liver function tests
  • elevated serum creatinine
  • cholecystitis
  • hematemesis
  • spinal hematoma

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a sealed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius to preserve its efficacy and safety for an extended period.

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.