Medication info
Hanbix Tablet 75 mg (Clopidogrel Hydrogen Sulfate)

Hanbix Tablet 75 mg (Clopidogrel Hydrogen Sulfate)

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

MFDS item code 201804600 · Approved 2018.11.20

Summary

Main use
Improvement of acute coronary syndrome and atherosclerotic symptoms; prevention of thromboembolism in atrial fibrillation
Who uses it
Adults
Adult dosage
○ Adults 1. In patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, administer clopidogrel 75 mg orally once daily. 2. In patients with acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), start treatment on the day of initiation with a loading dose of 300 mg 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. In patients with atrial fibrillation, administer this medicine 75 mg 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 hepatic disease and a bleeding diathesis is limited. This medicine may be administered with or without food.

Ingredients

Manufacturer
Daehan Pharmaceutical Co., Ltd.

Efficacy & effects

Improvement of acute coronary syndrome and atherosclerotic symptoms; prevention of thromboembolism in atrial fibrillation

  • Ischemic stroke
  • myocardial infarction
  • peripheral artery disease
  • acute coronary syndrome
  • unstable angina
  • non-Q-wave myocardial infarction
  • cardiovascular abnormalities
  • stroke
  • refractory ischemia
  • vascular risk factors
  • atrial fibrillation
  • atherothrombosis
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 helps improve mortality, myocardial infarction, stroke, or refractory ischemia symptoms due to cardiovascular abnormalities in patients with acute coronary syndrome (including unstable angina or non-Q-wave myocardial infarction). Furthermore, it is used to reduce the risk of stroke and atherothrombosis and thromboembolism in patients with atrial fibrillation who have vascular risk factors and when vitamin K antagonist therapy is inappropriate, provided the risk of bleeding is low. This medication is effective for the prevention and treatment of cardiovascular complications.

Dosage and Administration

Adult dosage

○ Adults 1. In patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, administer clopidogrel 75 mg orally once daily. 2. In patients with acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), start treatment on the day of initiation with a loading dose of 300 mg 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. In patients with atrial fibrillation, administer this medicine 75 mg 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 hepatic disease and a bleeding diathesis is limited. This medicine may be administered with or without food.

Precautions

This medication prevents blood from clotting to prevent thrombosis. When taking this medication, caution is needed for individuals with genetically reduced activity of a specific enzyme (CYP2C19) as the effectiveness may not be sufficient. Also, taking medications that activate certain enzymes in conjunction can increase the risk of bleeding; thus, co-administration should be avoided. Patients with an allergy to this medication or those with bleeding, severe liver damage, nursing mothers, lactose intolerance, etc., should not take this medication. Patients at high risk of bleeding or those scheduled for surgery must consult with a doctor prior to taking this medication and may need to discontinue use 5 to 7 days before surgery. During the use of this medication, if any bleeding symptoms or abnormalities occur, notify healthcare providers immediately, and it may be necessary to check the condition through blood tests, etc. This medication may increase bleeding risk when taken with other medications that also raise bleeding risk; therefore, caution is advised. Pregnant women have a low risk to the fetus when taking this medication, but the risk of bleeding may increase during delivery, so discontinuation 5 to 7 days before delivery is recommended. It is unknown whether this medication is excreted in breast milk; therefore, nursing mothers should consult their doctor regarding whether to continue breastfeeding or to discontinue the medication. Safety and efficacy in children have not yet been established. Older adults may have increased risk of bleeding due to decreased bodily functions; therefore, dose adjustments and careful monitoring are necessary. In case of overdose, bleeding time may be prolonged, and bleeding complications may occur; there is no specific antidote, but platelet transfusions can reverse the drug's effects. This medication should be kept out of the reach of children, and transferring to another container should be avoided.

Side effects

  • Hemorrhage
  • gastrointestinal bleeding
  • hospitalization required for bleeding
  • purpura
  • contusion
  • hematoma
  • epistaxis
  • hematoma
  • hematuria
  • ocular hemorrhage
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  • intracranial hemorrhage
  • major bleeding
  • life-threatening bleeding
  • fatal bleeding
  • hemorrhagic stroke
  • blood transfusion required
  • thrombocytopenia
  • neutropenia
  • agranulocytosis
  • aplastic anemia
  • abdominal pain
  • dyspepsia
  • diarrhea
  • nausea
  • rash
  • pruritus
  • headache
  • dizziness
  • chest pain
  • accidental injury
  • influenza-like illness
  • pain
  • fatigue
  • edema
  • hypertension
  • depression
  • upper respiratory tract infection
  • dyspnea
  • rhinitis
  • bronchitis
  • cough
  • urinary tract infection
  • decreased motor function
  • tremor
  • voice disorder
  • abnormal gait
  • hyperkinesia
  • ataxia
  • sensory disturbance
  • insomnia
  • depression
  • amnesia
  • anxiety
  • confusion
  • thought disorder
  • abnormal behavior
  • arthralgia
  • myalgia
  • low back pain
  • weight loss
  • weight gain
  • facial flushing
  • weakness
  • rigidity
  • facial swelling
  • syncope
  • purpura
  • hematochezia
  • hematoma
  • hemoptysis
  • muscle hemorrhage
  • gingival bleeding
  • pneumonia
  • sinusitis
  • visual disturbances
  • visual field defects
  • dry eyes
  • temporary blindness
  • congestion
  • tinnitus
  • taste disturbances
  • urinary difficulties
  • frequent urination
  • non-protein nitrogen increase
  • uremia
  • increased blood urea nitrogen
  • hypoglycemia
  • hyperuricemia
  • increased liver enzymes
  • ALT elevation
  • abnormal liver function
  • leg edema
  • arrhythmia
  • bradycardia
  • palpitations
  • contact dermatitis
  • gynecomastia
  • elevated prostate-specific antigen
  • anorexia
  • cholecystitis
  • hematemesis
  • spinal hematoma
  • allergic symptoms
  • ischemic necrosis
  • hemorrhagic arthropathy
  • hematuria
  • hemoptysis
  • retroperitoneal hemorrhage
  • surgical wound bleeding
  • pulmonary hemorrhage
  • vasculitis
  • hypotension
  • bronchospasm
  • interstitial pneumonia
  • eosinophilic pneumonia
  • colitis
  • pancreatitis
  • gastritis
  • stomatitis
  • hepatitis
  • acute liver failure
  • petechial rash
  • erythematous rash
  • urticaria
  • renal dysfunction
  • acute kidney failure
  • confusion
  • hallucinations
  • taste alteration
  • taste loss
  • angioedema
  • vesicular dermatitis
  • drug-induced hypersensitivity syndrome
  • eosinophilia
  • drug rash
  • eczema
  • lichen planus
  • glomerulonephritis
  • gynecomastia
  • fever
  • abnormal liver function tests
  • increased blood creatinine

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

Storage

This medication must be stored in a tightly sealed container to protect it from air and moisture. Additionally, the medication should be kept in a cool place, away from extreme heat or cold, and it is best stored at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablets

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.