Medication info
Cerafix Tablets (Clopidogrel Hydrogen Sulfate)

Cerafix Tablets (Clopidogrel Hydrogen Sulfate)

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

MFDS item code 201900649 · Approved 2019.01.25 · Insurance code 654701840

Summary

Main use
Improvement of symptoms of atherosclerosis and 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 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 day this drug is initiated 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 coadministered with this drug once daily. 3. For patients with atrial fibrillation, administer this drug 75 mg orally once daily. Aspirin 75 ~ 100 mg should be coadministered with this drug once daily. ○ Patients with renal impairment : There is limited treatment experience in patients with renal impairment. ○ Patients with hepatic impairment : There is limited treatment experience in patients with moderate hepatic disease with a bleeding diathesis. This drug may be administered with or without food.

Ingredients

Manufacturer
KMS Pharmaceutical Co., Ltd.

Efficacy & effects

Improvement of symptoms of atherosclerosis and acute coronary syndrome; 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
  • myocardial infarction
  • stroke
  • refractory ischemia
  • vascular risk factors
  • atrial fibrillation
View approved original text

This medication effectively improves atherosclerotic symptoms in adult patients with ischemic stroke, myocardial infarction, and peripheral artery disease. It also helps reduce cardiovascular complications and alleviate symptoms in patients with acute coronary syndrome. Additionally, in patients with atrial fibrillation having multiple vascular risk factors where vitamin K antagonist therapy is not suitable, it is used to lower the risk of stroke and thromboembolism. Thus, it contributes to the management of various cardiovascular diseases and enhances patients' health.

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 day this drug is initiated 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 coadministered with this drug once daily. 3. For patients with atrial fibrillation, administer this drug 75 mg orally once daily. Aspirin 75 ~ 100 mg should be coadministered with this drug once daily. ○ Patients with renal impairment : There is limited treatment experience in patients with renal impairment. ○ Patients with hepatic impairment : There is limited treatment experience in patients with moderate hepatic disease with a bleeding diathesis. This drug may be administered with or without food.

Precautions

This medication prevents blood platelets from aggregating, thereby preventing thrombosis. Individuals with genetically reduced function of a specific enzyme (CYP2C19) may not respond effectively to this medication, and alternative treatment options should be considered in such cases. Additionally, taking this medication with drugs that activate certain enzymes can increase the risk of bleeding, so concomitant use should be avoided. Patients with allergies to this medication or its components, those with bleeding issues, severe liver damage, women who are breastfeeding, and individuals with genetic conditions such as lactose intolerance should not take this medication. Patients at high risk of bleeding or those suspected of having bleeding symptoms should have blood tests immediately, and caution is especially required when taking this medication with other drugs that increase bleeding risk (such as warfarin, aspirin, NSAIDs, etc.). Patients scheduled for surgery should discontinue this medication 5 to 7 days before the surgery and restart it after hemostasis is achieved postoperatively. While taking this medication, bleeding may take longer to stop, so if bleeding occurs, the doctor should be notified immediately. This medication can rarely cause Thrombotic Thrombocytopenic Purpura (TTP), a serious blood disorder, so if sudden bleeding, fever, or neurological symptoms occur, immediate treatment should be sought. During pregnancy, the risk to the fetus is low; however, the risk of bleeding during delivery may increase, so it is advisable to stop taking this medication before labor. In cases of breastfeeding, it is uncertain whether this medication is excreted in breast milk; thus, it's important to consult with a physician about whether to discontinue breastfeeding or the medication. Elderly patients and those with impaired renal or liver function have a higher risk of bleeding, and careful monitoring is required during treatment. Overdosage may increase the risk of bleeding, and since there is no antidote for this medication, platelet transfusion may be necessary in cases of severe bleeding. This medication should be kept out of reach of children and should not be transferred to another container. During treatment, it is essential to inform your doctor if you are starting any new medications or have plans for surgery.

Side effects

Hemorrhage, gastrointestinal bleeding, purpura, contusion, hematoma, epistaxis, hematoma, hematuria, intraocular hemorrhage, intracranial hemorrhage, neutropenia, agranulocytosis, aplastic anemia, thrombocytopenia, abdominal pain, dyspepsia, diarrhea, nausea, rash, pruritus, chest pain, traumatic injury, influenza-like illness, pain, fatigue, edema, hypertension, headache, dizziness, depression, dyspnea, rhinitis, bronchitis, cough, urinary tract infection, decreased motor function, tremor, voice disorder, abnormal gait, hyperkinesis, ataxia, sensory disturbance, constipation, vomiting, ulcer, abdominal pain, loss of appetite, hiccups, thirst, dysphagia, tongue disorders, insomnia, depression, forgetfulness, anxiety, delirium, abnormal behavior, rigidity, weight loss, weight gain, facial flushing, weakness, syncope, purpura, bloody stools, thrombocytopenia, anemia, hypochromic anemia, leukemia, leukopenia, eosinophilia, pneumonia, sinusitis, eczema, skin ulcer, cystitis, cataract, conjunctivitis, cholecystitis, hematemesis, spinal hematoma, confusion, hallucination, taste disturbance, loss of taste, vasculitis, hypotension, bronchospasm, interstitial pneumonia, eosinophilic pneumonia, colitis, pancreatitis, gastritis, stomatitis, hepatitis, acute liver failure, herpes zoster, erythematous rash, maculopapular rash, urticaria, angioedema, vesicular dermatitis, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms, lichen planus, arthralgia, arthritis, myalgia, glomerulonephritis, gynecomastia, fever, abnormal liver function tests, increased blood creatinine, decreased motor function, thirst, forgetfulness, delirium, pollakiuria, arrhythmia, tremor, voice disorder, abnormal gait, hyperkinesis, ataxia, hiccups, dysphagia, tongue disorders, abnormal behavior, rigidity, visual disturbance, dry eyes, temporary blindness, congestion, urination disorder, uremia, hypoglycemia, bradycardia, tinnitus, contact dermatitis, elevated PSA, gynecomastia

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

Storage

This medication is sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. It is important to maintain the storage temperature between 1 and 30 degrees Celsius to ensure the medication's effectiveness over time.

Appearance and packaging

Appearance

Pink round film-coated tablets

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.