Newbix Tablet (Clopidogrel Hydrogen Sulfate)

Adult dose

1. For patients with ischemic stroke, myocardial infarction, or peripheral artery disease, administer 75 mg of clopidogrel orally once daily. 2. For patients with acute coronary syndrome (unstable angina or non-Q wave myocardial infarction), initiate treatment with a loading dose of 300 mg of this medication orally once daily on the same day, followed by a maintenance dose of 75 mg orally once daily. Concurrent use of aspirin 75 mg to 325 mg is recommended. 3. For patients with atrial fibrillation, administer 75 mg of this medication orally once daily. Concurrent use of aspirin 75 mg to 100 mg with this medication is recommended. ○ In patients with renal impairment: Experience is limited in treating patients with renal impairment. ○ In patients with liver impairment: Experience is limited in treating moderate liver disease patients with bleeding diathesis. This medication can be administered regardless of food intake.

This medication may be less effective in individuals genetically deficient in CYP2C19 enzyme activity; therefore, alternative treatment should be considered in such cases. Avoid concomitant use with drugs that induce CYP2C19 as this can increase the active ingredient concentration, heightening the risk of bleeding. This medication should not be used in patients with known allergies to this drug or its components, those with severe bleeding, severe liver impairment, breastfeeding women, and patients with genetic issues such as lactose intolerance. Patients with bleeding risks, those with blood coagulation disorders, scheduled for surgery, elderly patients, and those with hypertension or decreased kidney and liver function should use this medication cautiously. When taken with aspirin, the risk of bleeding may increase; thus, follow your doctor's guidance and report any bleeding symptoms immediately. During treatment, if bleeding or abnormalities in blood conditions are suspected, immediate blood tests are crucial. This medication may cause side effects such as gastrointestinal disturbances, skin rash, headache, and dizziness; consult healthcare professionals if symptoms appear. If pregnant or breastfeeding, the decision to use this medication should be made after consulting a physician, especially if considering stopping before delivery due to bleeding risk. Safety and effectiveness in children have not been established; therefore, it is advisable not to use this medication in children. In case of overdose, the risk of bleeding may increase, and since no specific antidote is available, appropriate treatment should be sought immediately at a medical facility. While this medication is known not to significantly affect driving or machinery operation, individual variations may occur, so caution is advised. Store out of reach of children and do not transfer to other containers for safety.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction, high fever with severe rash, blisters, skin peeling, pain in oral/ocular mucosa, severe skin abnormalities, breathlessness or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), severe lethargy, liver abnormalities (jaundice), sudden and severe

Mild side effects

• Chest pain
• accidental injury
• influenza-like illness
• pain
• fatigue
• swelling
• hypertension
• headache
• dizziness
• abdominal pain

This medication should be stored in a tightly closed container to prevent air or moisture from entering, and it is safe to store at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for an extended period.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle