Medication info
Clothens Tablets (Clopidogrel Sulfate)

Clothens Tablets (Clopidogrel Sulfate)

Prescription medicationTablet
Ingredient · strength
Clopidogrel Bisulfate›97.875mg / 1 tablet
Manufacturer / importer
(주)씨티씨바이오
Appearance
Pink, round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201507899 · Approved 2015.11.25 · Insurance code 669501650

Summary

Main use
Improvement of symptoms of atherosclerosis such as ischemic stroke and myocardial infarction, and reduction of risks of stroke and thromboembolism.
Who uses it
Adults
Adult dosage
1. For patients with ischemic stroke, myocardial infarction, or peripheral artery disease, administer 75 mg of clopidogrel once daily orally. 2. For patients with acute coronary syndrome (unstable angina or non-ST elevation myocardial infarction), start with a loading dose of 300 mg once daily on the first day, followed by a maintenance dose of 75 mg once daily orally. At this time, aspirin 75–325 mg should be co-administered once daily.

Ingredients

Manufacturer
(주)씨티씨바이오

Efficacy & effects

Improvement of symptoms of atherosclerosis such as ischemic stroke and myocardial infarction, and reduction of risks of stroke and thromboembolism.

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

This medication is used to improve symptoms of atherosclerosis in adult patients suffering from ischemic stroke, myocardial infarction, or peripheral artery disease. Additionally, it helps reduce the risk of death, myocardial infarction, stroke, or severe ischemic symptoms due to cardiovascular events in patients with acute coronary syndrome (unstable angina or non-ST elevation myocardial infarction) who have received drug treatment, coronary intervention, or coronary artery bypass. Furthermore, it serves to decrease the risk of stroke and thromboembolism in patients with atrial fibrillation who have vascular risk factors but for whom vitamin K antagonists are not suitable. This drug is used to promote vascular health and prevent serious vascular complications.

Dosage and Administration

Adult dosage

1. For patients with ischemic stroke, myocardial infarction, or peripheral artery disease, administer 75 mg of clopidogrel once daily orally. 2. For patients with acute coronary syndrome (unstable angina or non-ST elevation myocardial infarction), start with a loading dose of 300 mg once daily on the first day, followed by a maintenance dose of 75 mg once daily orally. At this time, aspirin 75–325 mg should be co-administered once daily.

Precautions

This drug prevents the aggregation of platelets in the blood to prevent the formation of clots. It must be converted into its active form by a specific enzyme in the liver, CYP2C19, to be effective. Individuals who genetically have reduced function of this enzyme may experience diminished efficacy, so it is advisable to consult a physician. Taking this medication with drugs that activate the CYP2C19 enzyme can increase the concentration of the active metabolite and may elevate the risk of bleeding, so co-administration should be avoided. Patients with allergies to this medication, those with bleeding, individuals with severe liver disease, breastfeeding women, and those with lactose intolerance should not take this drug. Patients at risk of bleeding or with abnormalities in blood coagulation, those scheduled for surgery, elderly patients, and underweight individuals should use this medication cautiously, and report any signs of bleeding to a physician immediately. Since this drug can cause bleeding, it is crucial to undergo tests if symptoms of bleeding occur or if abnormalities are found in blood tests. Additionally, caution is necessary when combined with other medications that carry a bleeding risk. During the course of treatment, bleeding may take longer to stop, so it is crucial to inform medical personnel before any surgery or dental treatment. Rarely, thrombocytopenia or severe blood adverse reactions may occur, thus patients with fever or symptoms of infection should visit a hospital promptly. Side effects may include gastrointestinal disorders, diarrhea, rash, headache, dizziness, and abdominal pain. If pregnant, the effects of this medication on the fetus are minimal; however, due to the risk of bleeding during delivery, consultation with medical personnel is necessary. During breastfeeding, this medication may pass into breast milk, and it is essential to consult with a doctor regarding continuation or discontinuation of breastfeeding. This drug may increase the risk of bleeding in the event of an overdose, and since there is no antidote, treatments such as platelet transfusions may be necessary in cases of severe bleeding. Keep this medication out of reach of children and do not transfer it to other containers for safety. While taking this medication, it is important to routinely visit a physician to reduce the risk of bleeding and always consult with medical personnel regarding interactions with other medications being taken.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, abnormal breathing accompanied by coughing or fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, lightning-like headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Chest pain
  • accidental injury
  • influenza-like illness
  • pain
  • fatigue
  • swelling
  • hypertension
  • headache
  • dizziness
  • abdominal pain
Show 26 more
  • dyspepsia
  • diarrhea
  • nausea
  • hypercholesterolemia
  • arthralgia
  • back pain
  • purpura
  • epistaxis
  • depression
  • upper respiratory tract infections
  • shortness of breath
  • rhinitis
  • bronchitis
  • cough
  • rash
  • pruritus
  • urinary tract infection
  • reduced motor function
  • tremors
  • voice disorders
  • abnormal gait
  • hyperactivity
  • ataxia
  • sensory disturbances
  • constipation
  • nausea

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 sealed container. The recommended storage temperature is room temperature between 1 and 30 degrees Celsius. This helps to maintain the drug's effectiveness over a longer period.

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

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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.