Medication info
Hurofix Tablets (Clopidogrel Hydrogen Sulfate)

Hurofix Tablets (Clopidogrel Hydrogen Sulfate)

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

MFDS item code 200701040 · Notified 2007.01.11 · Insurance code 649101260

Summary

Main use
Improvement of atherosclerotic symptoms (including acute coronary syndrome), prevention of thromboembolism 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 once daily in combination with this medicine. 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 once daily in combination with this medicine. ○ 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 with a bleeding diathesis is limited. This medicine may be administered with or without food.

Ingredients

Manufacturer
Korea Hutech Pharmaceutical Co., Ltd.

Efficacy & effects

Improvement of atherosclerotic symptoms (including acute coronary syndrome), prevention of thromboembolism in 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
  • atherothrombosis
  • thromboembolism
View approved original text

This medication is used to improve atherosclerotic symptoms in adult patients with ischemic stroke, myocardial infarction, or peripheral arterial disease. It also alleviates atherosclerotic symptoms associated with cardiovascular complications in patients with acute coronary syndrome, such as unstable angina or non-Q wave myocardial infarction, who have received medical treatment or coronary intervention procedures, or coronary artery bypass surgery. This drug is also effective in reducing the risk of stroke and thromboembolism in atrial fibrillation patients when vitamin K antagonists are not suitable. In summary, this medication is used for the improvement of atherosclerosis and thrombosis related to various cardiovascular and cerebrovascular 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 once daily in combination with this medicine. 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 once daily in combination with this medicine. ○ 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 with a bleeding diathesis is limited. This medicine may be administered with or without food.

Precautions

This medication helps prevent platelets from aggregating and allows blood to flow smoothly. This medication may be less effective in individuals with genetically reduced function of a specific enzyme, CYP2C19, so alternative treatments should be considered in such cases. Moreover, co-administration of this drug with medications that activate CYP2C19 may increase drug concentration and raise the risk of bleeding, so concurrent use should be avoided. This medication should not be used in patients with bleeding issues, severely damaged liver, nursing women, or individuals with specific genetic disorders. Patients at high risk of bleeding or those scheduled for surgery should either discontinue this medication or use it cautiously under medical supervision. This medication can prolong bleeding time, making even minor wounds bleed longer; thus, if bleeding does not stop or if there are unusual symptoms, it is essential to notify a doctor immediately. When taking this medication, caution should be exercised as the risk of bleeding may increase if used with aspirin or other drugs that affect blood coagulation. It is important to regularly check for bleeding or blood-related adverse reactions through blood tests or other examinations. This drug can rarely cause a serious blood disorder known as Thrombotic Thrombocytopenic Purpura (TTP), so if sudden bleeding, symptoms of anemia, or neurological abnormalities occur, visit a hospital immediately. Side effects such as headache, dizziness, dyspepsia, diarrhea, and rash may occur during treatment; however, most are mild, and serious symptoms should be discussed with a doctor. During pregnancy, the effects on the fetus are not clear; however, in emergency situations like myocardial infarction or stroke, treatment should not be delayed, and to reduce bleeding risk, administration should be stopped before delivery. In the case of nursing mothers, it is uncertain whether this medication is excreted in breast milk, so a discussion with a doctor is essential regarding whether to continue breastfeeding or discontinue medication. Elderly patients or those with reduced kidney function may have a higher risk of bleeding; thus, dosage adjustment and monitoring of conditions are necessary. Overdosage may increase the risk of bleeding, so the prescribed dosage must be strictly followed, and if bleeding is severe, measures such as platelet transfusion may be necessary. This medication should be kept out of reach of children, and care must be taken not to transfer it to another container as this may alter its quality.

Side effects

  • Hemorrhage
  • gastrointestinal bleeding
  • purpura
  • contusion
  • hematoma
  • epistaxis
  • hematoma
  • hematuria
  • intraocular hemorrhage
  • intracranial hemorrhage
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  • neutropenia
  • agranulocytosis
  • aplastic anemia
  • thrombocytopenia
  • 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 disturbance
  • constipation
  • nausea
  • ulcer
  • abdominal pain
  • anorexia
  • vomiting
  • hiccup
  • thirst
  • dysphagia
  • tongue disorders
  • insomnia
  • depression
  • amnesia
  • anxiety
  • confusion
  • abnormal behavior
  • rigidity
  • facial edema
  • syncope
  • purpura
  • hematochezia
  • thrombocytopenia
  • anemia
  • cerebral hemorrhage
  • hematoma
  • hematuria
  • hemoptysis
  • muscle hemorrhage
  • gingival bleeding
  • cough
  • dyspnea
  • rhinitis
  • visual disturbances
  • visual field defects
  • dry eye syndrome
  • transient blindness
  • congestion
  • tinnitus
  • dysuria
  • polyuria
  • nonprotein nitrogen increase
  • uremia
  • increased blood urea nitrogen
  • hypoglycemia
  • hyperuricemia
  • elevated liver enzymes
  • ALT increase
  • liver dysfunction
  • leg edema
  • arrhythmia
  • bradycardia
  • palpitations
  • rash
  • itching
  • contact dermatitis
  • gynecomastia
  • elevated prostate-specific antigen
  • allergy symptoms
  • ischemic necrosis
  • generalized edema
  • gastritis
  • hemorrhagic gastroenteritis
  • duodenal ulcer
  • gastric ulcer
  • perforated gastric ulcer
  • upper gastrointestinal bleeding
  • bloating
  • hyperbilirubinemia
  • infectious hepatitis
  • fatty liver
  • hemorrhagic arthropathy
  • hematuria
  • hemoptysis
  • retroperitoneal hemorrhage
  • ocular hemorrhage
  • pulmonary hemorrhage
  • purpura
  • thrombocytopenia
  • prolonged bleeding time
  • aplastic anemia
  • hypochromic anemia
  • agranulocytosis
  • granulocytopenia
  • leukemia
  • leukopenia
  • neutropenia
  • eosinophilia
  • excessive menstruation
  • hemothorax
  • herpes zoster
  • erythematous rash
  • maculopapular rash
  • urticaria
  • renal dysfunction
  • acute renal failure
  • fever
  • abnormal liver function tests
  • increased serum creatinine
  • cholecystitis
  • hematemesis
  • spinal hematoma

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be between 1 to 30 degrees Celsius (room temperature) to safely maintain the efficacy of the medication.

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.

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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.