Medication info
Eravix Tablets (Clopidogrel Hydrogen Sulfate)

Eravix Tablets (Clopidogrel Hydrogen Sulfate)

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

MFDS item code 201207403 · Approved 2012.10.23 · Insurance code 644003250

Summary

Main use
Improvement of atherosclerotic symptoms and acute coronary syndrome; prevention of thrombi in atrial fibrillation
Who takes it
Adults
Adult dose
○ 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), start treatment on the first day with a loading dose of 300 mg of this medicine 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. For patients with atrial fibrillation, administer 75 mg of this medicine 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 liver disease with a bleeding diathesis is limited. This medicine may be administered with or without food.

Ingredients

Manufacturer
Samik Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication improves symptoms caused by atherosclerosis in adults with ischemic stroke, myocardial infarction, or peripheral arterial disease. It is also used to improve atherosclerotic symptoms, such as cardiovascular-related death, myocardial infarction, stroke, or refractory ischemia, in patients with acute coronary syndrome, unstable angina, or non-ST elevation myocardial infarction, who have undergone medical treatment or coronary interventions (PCI) or coronary artery bypass grafting (CABG). Moreover, it is effective in reducing the risk of stroke and thromboembolic disorders in adult patients with atrial fibrillation who have vascular risk factors and for whom vitamin K antagonists are not suitable. Through these effects, this medication helps improve various cardiovascular disease symptoms and reduces the risk of complications.

How to take

Adult dose

○ 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), start treatment on the first day with a loading dose of 300 mg of this medicine 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. For patients with atrial fibrillation, administer 75 mg of this medicine 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 liver disease with a bleeding diathesis is limited. This medicine may be administered with or without food.

Precautions

This medication helps prevent platelets from clumping together, ensuring smooth blood flow. The efficacy of this medication may be reduced in individuals with genetically lower function of a specific enzyme (CYP2C19), and in such cases, alternative treatments should be considered. Additionally, using this medication with drugs that activate certain enzymes may increase drug concentration and elevate bleeding risks, therefore, it is advisable not to combine them. Patients with allergies to this medication or its components, patients with severe bleeding, patients with significantly impaired liver function, nursing mothers, and those with lactose intolerance should not take this medication. Patients with bleeding risks or bleeding disorders, or those planned for surgery should use this medication with caution and may need to discontinue it 5 to 7 days before surgery if necessary. This medication may increase bleeding risks when combined with other antiplatelet agents, anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs), selective serotonin reuptake inhibitors (SSRIs), and similar medications. During the use of this medication, it may take longer for bleeding to stop, so if there is heavy or prolonged bleeding, report immediately to a doctor. Rarely, this medication may cause blood disorders such as thrombocytopenia, agranulocytosis, and aplastic anemia, so consult medical personnel if there are symptoms of infection or unusual symptoms. Gastrointestinal symptoms such as abdominal pain, dyspepsia, diarrhea may occur, as well as allergic reactions like skin rashes or itching. The impact on the fetus during pregnancy is unclear; however, it may be used as needed for treating severe cardiovascular diseases, and discontinuation 5 to 7 days before delivery is recommended due to the risk of bleeding during labor. For nursing mothers, it is uncertain if this medication is secreted in breast milk, so consultation with a doctor is necessary to decide whether to continue nursing or stop the medication. The safety and efficacy in children have not been established yet. Elderly patients may have decreased physiological function and a higher risk of bleeding, thus, dose adjustment and careful monitoring are required. Patients with impaired kidney function should also use this medication cautiously, although dose adjustments are not necessary. In cases of overdose, there may be a risk of bleeding, so adherence to the prescribed dosage is essential, and if heavy bleeding occurs, appropriate treatment like platelet transfusion may be necessary. This medication should be kept out of reach of children and should not be transferred to another container for safety.

Side effects

  • Hemorrhage
  • gastrointestinal hemorrhage
  • hospitalization necessary for hemorrhage
  • purpura
  • contusion
  • hematoma
  • epistaxis
  • hematoma
  • hematuria
  • intraocular hemorrhage
Show 166 more
  • intracranial hemorrhage
  • significant hemorrhage
  • minor hemorrhage
  • severe hemorrhage
  • fatal hemorrhage
  • hemorrhagic stroke
  • thrombocytopenia
  • neutropenia
  • agranulocytosis
  • 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
  • purpura
  • hematochezia
  • thrombocytopenia
  • anemia
  • pneumonia
  • sinusitis
  • eczema
  • skin ulcer
  • cystitis
  • cataract
  • conjunctivitis
  • syncope
  • palpitations
  • asthenia
  • fever
  • hernia
  • heart failure
  • atrial fibrillation
  • leg cramps
  • sensory impairment
  • neuralgia
  • paresthesia
  • vertigo
  • constipation
  • vomiting
  • increased liver enzymes
  • gout
  • hyperuricemia
  • increased non-protein nitrogen
  • arthritis
  • arthrosis
  • anxiety
  • insomnia
  • anemia
  • hemothorax
  • herpes zoster
  • erythema multiforme
  • maculopapular rash
  • urticaria
  • kidney dysfunction
  • acute renal failure
  • gynecomastia
  • fever
  • abnormal liver function tests
  • increased blood creatinine
  • cholecystitis
  • hematemesis
  • spinal hematoma
  • allergy
  • ischemic necrosis
  • gastritis
  • hemorrhagic gastroenteritis
  • duodenal ulcer
  • gastric ulcer
  • perforated gastric ulcer
  • upper gastrointestinal ulcer hemorrhage
  • distension
  • hyperbilirubinemia
  • infectious hepatitis
  • fatty liver
  • hemorrhagic arthropathy
  • hemoptysis
  • postoperative wound hemorrhage
  • pulmonary hemorrhage
  • vasculitis
  • hypotension
  • bronchospasm
  • interstitial pneumonia
  • eosinophilic pneumonia
  • colitis
  • pancreatitis
  • stomatitis
  • hepatitis
  • acute liver failure
  • maculopapular rash
  • angioedema
  • vesicular dermatitis
  • drug-induced hypersensitivity syndrome
  • eosinophilia
  • drug rash
  • lichen planus
  • arthralgia
  • myalgia
  • glomerulopathy
  • gynecomastia
  • elevated prostate-specific antigen
  • reduced motor function
  • tremor
  • voice disorder
  • abnormal gait
  • hyperactivity
  • ataxia
  • sensory abnormality
  • insomnia
  • depression
  • forgetfulness
  • rigidity
  • abnormal behavior
  • rigidity
  • facial edema
  • hematochezia
  • hematoma
  • hematuria
  • hemoptysis
  • muscle hemorrhage
  • intracranial hemorrhage
  • ocular hemorrhage
  • gingival bleeding
  • thrombocytopenia
  • visual disturbance
  • visual field defect
  • dry eye syndrome
  • transient blindness
  • congestion
  • tinnitus
  • dysuria
  • pollakiuria
  • increased non-protein nitrogen
  • uremia
  • increased blood urea nitrogen
  • hypoglycemia
  • hyperuricemia
  • increased liver enzymes
  • elevated ALT
  • liver dysfunction
  • leg edema
  • arrhythmia
  • bradycardia
  • palpitations
  • rash
  • itching
  • contact dermatitis
  • gynecomastia
  • fever

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. Additionally, it is best to store the medication at room temperature between 1 degree and 30 degrees Celsius, avoiding extremely hot or cold locations. Proper storage can help maintain the effectiveness of the medication for a longer 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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.