Medication info
Nucleophine Tablets (Clopidogrel Hydrogen Sulfate)

Nucleophine Tablets (Clopidogrel Hydrogen Sulfate)

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

MFDS item code 201801536 · Approved 2018.04.09 · Insurance code 053600700

Summary

Main use
Improvement of atherosclerotic symptoms such as ischemic stroke and myocardial infarction, and reduction of the risk of stroke and thromboembolic events.
Who takes it
Adults
Adult dose
1. For patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, administer clopidogrel at 75 mg 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 orally on the first day of treatment, followed by a maintenance dose of 75 mg orally once daily. During this period, aspirin 75 - 325 mg should be co-administered once daily.

Ingredients

Manufacturer
안국뉴팜(주)

Efficacy & effects

Improvement of atherosclerotic symptoms such as ischemic stroke and myocardial infarction, and reduction of the risk of stroke and thromboembolic events.

  • Ischemic stroke
  • myocardial infarction
  • peripheral arterial disease
  • acute coronary syndrome
  • unstable angina
  • non-Q wave myocardial infarction
  • cardiovascular events
  • stroke
  • refractory ischemia
  • vascular risk factors
  • bleeding risk
  • atrial fibrillation.
View approved original text

This medication helps improve symptoms caused by atherosclerosis in adult patients with ischemic stroke, myocardial infarction, or peripheral arterial disease. It is also used to reduce the risk of cardiovascular events, such as death, myocardial infarction, and stroke in patients with acute coronary syndrome (unstable angina, non-Q wave myocardial infarction) following pharmacological treatment or procedures. Additionally, it has an effect in reducing the risk of stroke and thromboembolism in adult patients with atrial fibrillation who have vascular risk factors and are unsuitable for vitamin K antagonist use and have a low risk of bleeding. In summary, this medication is used to improve symptoms and reduce risks of various cardiovascular and cerebrovascular diseases caused by atherosclerosis.

How to take

Adult dose

1. For patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, administer clopidogrel at 75 mg 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 orally on the first day of treatment, followed by a maintenance dose of 75 mg orally once daily. During this period, aspirin 75 - 325 mg should be co-administered once daily.

Precautions

This medication prevents platelet aggregation and thereby plays a role in preventing the formation of blood clots. The effectiveness of this medication may be reduced in individuals who genetically have impaired function of a specific enzyme (CYP2C19); in such cases, it may be necessary to alter the treatment approach or substitute with another medication. Furthermore, concurrent use of this medication with drugs that activate the CYP2C19 enzyme may increase drug concentration, elevating the risk of bleeding, thus should be avoided. This medication should not be administered to individuals with allergic reactions or bleeding, severe liver impairment, breastfeeding women, or those with specific genetic issues such as lactose intolerance. Patients at high risk of bleeding or those with bleeding disorders should use this medication cautiously, and if symptoms of bleeding occur during treatment, they must immediately consult a physician. Particularly, patients undergoing surgery should discontinue this medication 5 to 7 days prior to surgery and resume once hemostasis is confirmed. There is an increased risk of bleeding when this medication is used in conjunction with other anticoagulants, so caution is advised. During treatment, it may take longer than usual for bleeding to stop; if bleeding persists or becomes severe, healthcare personnel should be informed immediately. Rarely, this medication may cause thrombocytopenia or serious blood disorders; thus, patients should undergo blood tests if symptoms of infection or bleeding appear. The risks to the fetus during pregnancy are unknown, but there may be an increased risk of bleeding during childbirth; therefore, it is advisable to cease this medication 5 to 7 days prior to delivery or neuraxial blocks. In the case of breastfeeding, as it is uncertain whether this medication is secreted in breast milk, it is recommended to consult with a physician regarding whether to continue breastfeeding or discontinue the medication. Elderly patients or those with reduced renal function may have a higher risk of bleeding, requiring careful monitoring and dose adjustments. In cases of overdose, the risk of bleeding may increase, but there is no specific antidote; if necessary, bleeding can be managed with platelet transfusion. This medication should be kept out of reach of children and should not be transferred to other containers to ensure safety.

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 high fever, blisters, mucosal pain in mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory issues with coughing and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination.

Mild side effects

  • Chest pain
  • accidental injury
  • influenza-like illness
  • pain
  • fatigue
  • hypertension
  • edema
  • headache
  • dizziness
  • abdominal pain
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  • dyspepsia
  • diarrhea
  • nausea
  • hypercholesterolemia
  • arthralgia
  • low back pain
  • petechiae
  • nasal bleeding
  • depression
  • upper respiratory tract infections
  • dyspnea
  • rhinitis
  • bronchitis
  • cough
  • rash
  • pruritus
  • urinary tract infection
  • reduced motor function
  • tremor
  • voice disorder
  • abnormal gait
  • hyperactivity
  • ataxia
  • sensory disturbance
  • constipation
  • nausea

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

Storage

This medication must be stored in a tightly sealed container to protect it from air or moisture. The appropriate storage temperature is recommended to be between 1°C and 30°C at room temperature.

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.

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.