Medication info
Aicleo Tablets (Clopidogrel Bisulfate)

Aicleo Tablets (Clopidogrel Bisulfate)

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

MFDS item code 201603030 · Approved 2016.05.30 · Insurance code 669604590

Summary

Main use
Improvement of atherosclerosis symptoms and acute coronary syndrome; prevention of thrombi in atrial fibrillation
Who uses it
Adults
Adult dosage
○ Adults 1. For patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, administer 75 mg of clopidogrel orally once daily. 2. For patients with acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), start treatment with a loading dose of 300 mg of this drug once daily on the day treatment is initiated, followed by a maintenance dose of 75 mg once daily orally. In this case, aspirin 75 ~ 325 mg should be administered concomitantly with this drug once daily. 3. For patients with atrial fibrillation, administer 75 mg of this drug orally once daily. In this case, aspirin 75 ~ 100 mg should be administered concomitantly 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 hepatic disease with a bleeding diathesis is limited. This drug may be administered regardless of food intake.

Ingredients

Manufacturer
I-World Pharmaceutical Co., Ltd.

Efficacy & effects

Improvement of atherosclerosis symptoms and acute coronary syndrome; prevention of thrombi in atrial fibrillation

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

This medication is used to improve symptoms in adult patients with atherosclerotic conditions such as ischemic stroke, myocardial infarction, and peripheral arterial disease. It also helps reduce the risk of death, myocardial infarction, and stroke due to cardiovascular anomalies in patients with acute coronary syndrome or those who have undergone coronary intervention or coronary artery bypass surgery. This drug reduces the risk of stroke and thromboembolism in atrial fibrillation patients with one or more vascular risk factors where vitamin K antagonists are inappropriate. In other words, it plays a role in enhancing vascular health in various cardiovascular diseases and preventing severe complications, thereby improving patients' conditions.

Dosage and Administration

Adult dosage

○ Adults 1. For patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, administer 75 mg of clopidogrel orally once daily. 2. For patients with acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), start treatment with a loading dose of 300 mg of this drug once daily on the day treatment is initiated, followed by a maintenance dose of 75 mg once daily orally. In this case, aspirin 75 ~ 325 mg should be administered concomitantly with this drug once daily. 3. For patients with atrial fibrillation, administer 75 mg of this drug orally once daily. In this case, aspirin 75 ~ 100 mg should be administered concomitantly 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 hepatic disease with a bleeding diathesis is limited. This drug may be administered regardless of food intake.

Precautions

This drug inhibits platelet aggregation to prevent blood clot formation. It must be activated in the liver to be effective, so caution is needed for patients with genetic impairment of certain enzymes as this may reduce the drug's effectiveness. Patients at risk of bleeding, patients with severely impaired liver function, nursing women, and patients with specific lactose metabolism disorders should not use this medication. Patients at high risk of bleeding, those with liver or kidney disorders, and elderly patients should use this drug cautiously; it is necessary to discontinue use 5 to 7 days before a scheduled surgery. This medication can cause bleeding; hence, if any bleeding symptoms occur, one should immediately inform a physician and undergo examination. Moreover, this drug may increase the risk of bleeding when used in conjunction with other medications that pose a bleeding risk, so caution is warranted during combined therapy. During pregnancy, the risk to the fetus is low, but the risk of bleeding during delivery suggests a recommendation to discontinue medication before childbirth. If nursing, consider stopping breastfeeding or discontinuing the medication due to the potential for the drug to be excreted in breast milk. The safety and efficacy of this drug in children have not been established, and elderly patients may have a higher risk of bleeding due to decreased physiological functions, necessitating dosage adjustments and careful monitoring. In cases of overdose, bleeding time may be prolonged, and platelet transfusion may reverse the drug's effect if needed. This drug must be kept out of reach of children and should not be transferred to another container.

Side effects

Hemorrhage, gastrointestinal bleeding, purpura, contusion, hematoma, epistaxis, hematuria, intraocular hemorrhage, intracranial hemorrhage, neutropenia, agranulocytosis, aplastic anemia, thrombocytopenia, abdominal pain, dyspepsia, diarrhea, nausea, rash, pruritus, chest pain, accidental injury, influenza-like illness, pain, fatigue, edema, hypertension, headache, dizziness, depression, dyspnea, rhinitis, bronchitis, cough, urinary tract infection, decreased motor function, tremor, vocal dysfunction, abnormal gait, hyperactivity, ataxia, sensory disturbances, constipation, vomiting, ulcer, stomach pain, loss of appetite, hiccups, thirst, dysphagia, tongue disorders, insomnia, depression, forgetfulness, anxiety, confusion, abnormal thoughts, abnormal behavior, rigidity, weight loss, weight gain, facial flushing, weakness, fainting, purpura, melena, hematoma, hemoptysis, muscle hemorrhage, gingival bleeding, anemia, pneumonia, sinusitis, visual disturbance, visual field defect, dry eye syndrome, transient blindness, congestion, tinnitus, taste disorder, urinary dysfunction, polyuria, non-protein nitrogen increase, uremia, increased blood urea nitrogen, hypoglycemia, hyperuricemia, increased liver enzymes, ALT elevation, abnormal liver function, leg edema, arrhythmia, bradycardia, palpitations, contact dermatitis, gynecomastia, elevated prostate-specific antigen, cholecystitis, hematemesis, spinal hematoma, allergic symptoms, ischemic necrosis, gastritis, hemorrhagic gastroenteritis, duodenal ulcer, gastric ulcer, perforated gastric ulcer, upper gastrointestinal tract ulcer bleeding, bloating, hyperbilirubinemia, infectious hepatitis, fatty liver, hemorrhagic arthropathy, hematuria, hemoptysis, retroperitoneal hemorrhage, surgical wound bleeding, pulmonary hemorrhage, serum sickness, confusion, hallucination, taste loss, vasculitis, hypotension, bronchospasm, interstitial pneumonia, eosinophilic pneumonia, colitis, pancreatitis, stomatitis, hepatitis, acute liver failure, petechial eruptions, erythematous skin rash, urticaria, itching, angioedema, vesicular dermatitis, drug rash, eczema, lichen planus, arthralgia, arthritis, myalgia, glomerulonephritis, gynecomastia, fever

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

Storage

Store this medication in a tightly sealed container to avoid exposure to air or moisture. Additionally, it is best to store it at room temperature between 1°C to 30°C.

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.

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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.