Medication info
Pravix Tablets (Clopidogrel Hydrogen Sulfate)

Pravix Tablets (Clopidogrel Hydrogen Sulfate)

Prescription medicationTablet
Ingredient · strength
Clopidogrel Bisulfate›97.875mg / 1 tablet
Manufacturer / importer
Aliko Pharma Co., Ltd.
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201504255 · Approved 2015.06.30 · Insurance code 656003880

Summary

Main use
Improvement of symptoms of atherosclerosis, treatment of acute coronary syndrome, and prevention of thromboembolism in atrial fibrillation
Who uses it
Adults
Adult dosage
○ 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 with a loading dose of 300 mg of this drug once daily on the day treatment is initiated, followed by an oral maintenance dose of 75 mg once daily. Aspirin 75 ∼ 325 mg must be coadministered with this drug once daily. 3. For patients with atrial fibrillation, administer 75 mg of this drug orally once daily. Aspirin 75 ∼ 100 mg must be coadministered with this drug 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 and bleeding diathesis is limited. This drug may be administered regardless of food intake.

Ingredients

Manufacturer
Aliko Pharma Co., Ltd.

Efficacy & effects

Improvement of symptoms of atherosclerosis, treatment of acute coronary syndrome, and prevention of thromboembolism in atrial fibrillation

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

This medication improves symptoms of atherosclerosis in adult patients with ischemic stroke, myocardial infarction, or peripheral artery disease. It is also used to reduce the risk of cardiovascular issues such as death, myocardial infarction, or stroke in patients with acute coronary syndrome, including unstable angina or non-ST elevation myocardial infarction who are undergoing medical treatment, coronary intervention (including stenting), or coronary artery bypass grafting. Additionally, it is effective in reducing the risk of stroke and thromboembolism in patients with atrial fibrillation carrying multiple vascular risk factors or for whom vitamin K antagonists are inappropriate. Overall, it helps improve vascular health and prevent recurrence of cardiovascular diseases.

Dosage and Administration

Adult dosage

○ 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 with a loading dose of 300 mg of this drug once daily on the day treatment is initiated, followed by an oral maintenance dose of 75 mg once daily. Aspirin 75 ∼ 325 mg must be coadministered with this drug once daily. 3. For patients with atrial fibrillation, administer 75 mg of this drug orally once daily. Aspirin 75 ∼ 100 mg must be coadministered with this drug 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 and bleeding diathesis is limited. This drug may be administered regardless of food intake.

Precautions

This medication helps prevent platelets from clumping together, allowing blood to flow more freely. Individuals with reduced function of the enzyme CYP2C19, responsible for metabolizing the drug in the liver, may experience diminished effectiveness of this medication, and a higher occurrence of cardiovascular issues such as myocardial infarction or stroke. Therefore, alternative treatment methods should be considered in such cases. Moreover, concurrent use with drugs that activate the CYP2C19 enzyme can increase the concentration of this medication, raising the risk of bleeding, so it is best to avoid taking them together. Patients allergic to this medication, those with severe bleeding, patients with severely impaired liver function, breastfeeding women, and patients with lactose intolerance should not take this medication. Those at high risk of bleeding should use this medication with caution, and bleeding symptoms should prompt immediate medical attention. If surgery is planned, discontinue this medication 5-7 days in advance. This medication may increase the risk of bleeding when taken with other drugs affecting blood coagulation, requiring careful monitoring. Various bleeding symptoms such as nosebleeds, bruising, and gastrointestinal bleeding have been reported. In rare cases, severe side effects such as a decrease in blood cell count may occur, so immediate consultation with a doctor is necessary if fever or infection symptoms arise. Other potential side effects include gastrointestinal disturbances, headache, dizziness, and rash. In pregnant women, the effects on the fetus are not clearly established, but there may be an increased risk of bleeding during delivery, so caution is advised. For breastfeeding mothers, this medication may be excreted in breast milk, warranting consideration of stopping breastfeeding or discontinuing the medication. Safety and efficacy have not been established in children. Older adults may have diminished bodily functions that increase the risk of side effects such as bleeding, necessitating dosage adjustments and monitoring. Patients with impaired kidney function should also use this medication cautiously, and overdose can increase bleeding risks, requiring immediate medical attention. Store this medication out of the reach of children and do not transfer to other containers. Caution is needed during use as bleeding may not stop easily, and patients should inform their healthcare providers about this medication before any surgery or new drug usage.

Side effects

Hemorrhage, gastrointestinal bleeding, hospitalization required for bleeding, purpura, contusion, hematoma, epistaxis, hematoma, hematuria, intraocular hemorrhage, intracranial hemorrhage, major bleeding, minor bleeding, severe bleeding, fatal bleeding, hemorrhagic stroke, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia, abdominal pain, dyspepsia, diarrhea, nausea, rash, pruritus, chest pain, accidental injury, influenza-like illness, pain, fatigue, edema, hypertension, headache, dizziness, depression, upper respiratory tract infection, shortness of breath, rhinitis, bronchitis, cough, urinary tract infection, syncope, palpitations, weakness, fever, hernia, heart failure, atrial fibrillation, leg cramps, hyposensitivity, neuralgia, dysesthesia, vertigo, constipation, vomiting, increased liver enzymes, gout, hyperuricemia, non-protein nitrogen increase, arthralgia, arthrosis, anxiety, insomnia, anemia, bloody stools, cerebral hemorrhage, gingival bleeding, pneumonia, sinusitis, eczema, skin ulcer, cystitis, cataract, conjunctivitis, decreased motor function, tremors, speech disorder, abnormal gait, hyperkinesia, ataxia, paresthesia, insomnia, depression, forgetfulness, convulsions, sensorium abnormality, abnormal behavior, weight loss, weight gain, facial flushing, rigidity, facial edema, purpura, thrombocytopenia, hypochromic anemia, leukemia, leukopenia, eosinophilia, vasculitis, hypotension, bronchospasm, interstitial pneumonia, eosinophilic pneumonia, colitis, pancreatitis, gastritis, stomatitis, hepatitis, acute liver failure, maculopapular rash, urticaria, itching, angioedema, vesicular dermatitis, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms, lichen planus, myalgia, glomerulopathy, gynecomastia, fever, abnormal liver function tests, increased blood creatinine, cholecystitis, hematemesis, spinal hematoma

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 best to keep the storage temperature between 1 and 30 degrees Celsius at room temperature. Doing so will help maintain the medication's effectiveness and safety.

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.

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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.