Medication info
Plaris 300 mg Tablets (Clopidogrel Sulfate)

Plaris 300 mg Tablets (Clopidogrel Sulfate)

Prescription medicationTablet경구
Ingredient · strength
Clopidogrel Bisulfate›391.5mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
Pink oval film-coated tablet
Packaging
2 tablets/box [(1 tablet/PTP*2)]
Approval status
Active

MFDS item code 202105592 · Approved 2021.07.28 · Insurance code 647805230

Summary

Main use
Improvement of atherosclerotic symptoms such as ischemic stroke, myocardial infarction, and reduction of stroke risk
Who takes it
Adults
Adult dose
Clopidogrel 300 mg is used only as a loading dose. 1. For patients with ischemic stroke, myocardial infarction, or peripheral artery disease, 75 mg should be taken 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 on the day of initiation, then maintain with 75 mg orally once daily.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Improvement of atherosclerotic symptoms such as ischemic stroke, myocardial infarction, and reduction of stroke risk

  • Ischemic stroke
  • myocardial infarction
  • peripheral artery disease
  • acute coronary syndrome
  • unstable angina
  • non-Q-wave myocardial infarction
  • cardiovascular abnormalities
  • stroke
  • resistant ischemia
  • vascular risk factors
  • atherothrombosis
  • thromboembolism
View approved original text

This medication is used to improve the symptoms of adult patients with atherosclerotic conditions such as ischemic stroke, myocardial infarction, or peripheral artery disease. It also helps prevent complications due to cardiovascular abnormalities after medical treatment or procedures in patients with acute coronary syndrome, such as unstable angina or non-Q-wave myocardial infarction. Additionally, it is effective in reducing the risk of stroke and other thrombotic risks in patients with atrial fibrillation who have a low risk of bleeding and for whom vitamin K antagonists are not suitable. In summary, this medication is used for improving vascular health, preventing cardiovascular abnormalities, and reducing the risk of stroke.

How to take

Adult dose

Clopidogrel 300 mg is used only as a loading dose. 1. For patients with ischemic stroke, myocardial infarction, or peripheral artery disease, 75 mg should be taken 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 on the day of initiation, then maintain with 75 mg orally once daily.

Precautions

This medication may be less effective in individuals with genetically reduced CYP2C19 enzyme function; alternative treatment options should be considered in these cases. Co-administration of this drug and medications that increase CYP2C19 enzyme activity may increase drug concentration, leading to an increased risk of bleeding; thus, concurrent use should be avoided. This drug should not be administered to patients with a known allergy to this medication or its components, as well as patients with bleeding disorders, severe liver damage, nursing women, and certain genetically lactose intolerant patients. Caution is required for patients at high risk of bleeding or those planning surgery; if any bleeding symptoms occur, immediate consultation with medical staff is necessary. Especially when taken with anticoagulants like warfarin, the risk of bleeding may increase, so careful use is required. This medication inhibits platelet function and extends bleeding time, thus usage should be adjusted in situations where bleeding is a concern. While taking this medication, gastrointestinal bleeding, skin rash, and hematologic abnormalities may occur; any abnormal symptoms should be reported to medical personnel immediately. During pregnancy or breastfeeding, it is important to consult a physician regarding the use of this medication, particularly to consider the timing of discontinuation to mitigate bleeding risks around delivery. Elderly patients or those with impaired kidney and liver function require careful observation when taking this medication. In cases of overdose, the risk of bleeding may increase, so it is essential to adhere to prescribed doses and regimens; severe bleeding may require platelet transfusion or other treatment. This medication has not been sufficiently confirmed for safety and efficacy in children, so it is advisable not to use it in pediatric patients. This medication may interact with other drugs, so inform medical professionals of any other medications being taken.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Chest pain
  • accidental injury
  • influenza-like illness
  • pain
  • fatigue
  • edema
  • hypertension
  • headache
  • dizziness
  • abdominal pain
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  • dyspepsia
  • diarrhea
  • nausea
  • hypercholesterolemia
  • arthralgia
  • low back pain
  • purpura
  • epistaxis
  • depression
  • upper respiratory tract infection
  • dyspnea
  • rhinitis
  • bronchitis
  • cough
  • rash
  • pruritus
  • urinary tract infection
  • decreased motor function
  • tremor
  • voice disturbance
  • abnormal gait
  • hyperkinesia
  • ataxia
  • sensory abnormalities
  • 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. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius to ensure the drug's effectiveness and safety.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

2 tablets/box [(1 tablet/PTP*2)]

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.