Medication info
Innoen Clopidogrel Tablets (Clopidogrel Hydrogen Sulfate)

Innoen Clopidogrel Tablets (Clopidogrel Hydrogen Sulfate)

Prescription medicationTablet
Ingredient · strength
Clopidogrel Bisulfate›97.875mg / 1 tablet
Manufacturer / importer
HK Inno.N Co., Ltd.
Appearance
Pink round film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201703070 · Approved 2017.06.05 · Insurance code 640007140

Summary

Main use
Management of acute coronary syndrome; improvement of atherosclerotic symptoms; prevention of thromboembolism in atrial fibrillation
Who uses it
Adults
Adult dosage
○ Adults 1. In patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, administer clopidogrel 75 mg orally once daily. 2. In patients with acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), initiate treatment on the first day with a loading dose of 300 mg of this drug once daily, followed by a maintenance dose of 75 mg orally once daily. Aspirin 75 ~ 325 mg should be coadministered with this drug once daily. 3. In patients with atrial fibrillation, administer 75 mg of this drug orally once daily. Aspirin 75 ~ 100 mg should be coadministered with this drug once daily. ○ Patients with renal impairment: There is limited treatment experience in patients with renal impairment. ○ Patients with hepatic impairment: There is limited treatment experience in patients with moderate liver disease with a bleeding diathesis. This drug may be administered with or without food.

Ingredients

Manufacturer
HK Inno.N Co., Ltd.

Efficacy & effects

Management of acute coronary syndrome; improvement of atherosclerotic symptoms; prevention of thromboembolism in atrial fibrillation

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

This medicine is used to improve symptoms in adult patients with atherosclerotic symptoms such as ischemic stroke, myocardial infarction, and peripheral artery disease. It is also effective in patients suffering from acute coronary syndrome or those who have undergone coronary intervention or coronary artery bypass grafting in improving mortality from cardiovascular abnormalities, myocardial infarction, stroke, and symptoms of ischemia. Additionally, it helps to reduce the risk of stroke and thromboembolism in patients with atrial fibrillation who are at high risk for vascular diseases and have difficulties using Vitamin K antagonists. It is used to reduce the risk factors and improve symptoms of various cardiovascular diseases.

Dosage and Administration

Adult dosage

○ Adults 1. In patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, administer clopidogrel 75 mg orally once daily. 2. In patients with acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), initiate treatment on the first day with a loading dose of 300 mg of this drug once daily, followed by a maintenance dose of 75 mg orally once daily. Aspirin 75 ~ 325 mg should be coadministered with this drug once daily. 3. In patients with atrial fibrillation, administer 75 mg of this drug orally once daily. Aspirin 75 ~ 100 mg should be coadministered with this drug once daily. ○ Patients with renal impairment: There is limited treatment experience in patients with renal impairment. ○ Patients with hepatic impairment: There is limited treatment experience in patients with moderate liver disease with a bleeding diathesis. This drug may be administered with or without food.

Precautions

This drug helps to prevent platelets from sticking together, facilitating better blood flow. However, individuals with a genetic predisposition that hinders the activation of this drug's enzymes may experience reduced effectiveness, leading to a higher likelihood of cardiovascular issues such as heart attacks or strokes. It is advisable to avoid concurrent use of this medication with specific enzyme-activating drugs, as this can elevate the concentration of the active ingredient, increasing the risk of bleeding. Patients allergic to this drug or its components, those with bleeding disorders, severely impaired liver function, nursing mothers, and those with lactose intolerance should not take this medication. Patients at high risk for bleeding or those scheduled for surgery should carefully consider the decision to take this drug, and it is generally safe to discontinue it 5 to 7 days before surgery. Since this drug can prolong bleeding time, leading to an increased risk of bleeding, any bleeding symptoms should prompt immediate consultation with a physician. Particularly, caution is advised when taking this drug in conjunction with aspirin, warfarin, non-steroidal anti-inflammatory drugs, thrombolytics, and selective serotonin reuptake inhibitors (SSRIs), as it may increase the risk of bleeding. This drug can rarely cause a decrease in blood cell counts; therefore, patients should have blood tests if they experience symptoms of infection or signs of bleeding during treatment. Additionally, gastrointestinal disturbances, diarrhea, headache, and rashes may occur, so any unusual symptoms should be reported to a doctor. During pregnancy, the risk to the fetus is considered low; however, the risk of bleeding during delivery may increase, so discontinuation before 5 to 7 days prior to delivery is advisable. In nursing mothers, it is uncertain whether this drug is excreted in breast milk, so consultation with a physician regarding the continuation of breastfeeding is necessary. Elderly patients or those with reduced kidney or liver function are at higher risk of bleeding, thus dosage adjustments and careful monitoring of conditions are required. In case of overdose, prolonged bleeding time may occur, and since there is no specific antidote, platelet transfusions or other treatments may be necessary if bleeding is severe. This drug should be kept out of the reach of children, and caution should be exercised not to transfer it to other containers, as this may affect its quality.

Side effects

  • Hemorrhage
  • gastrointestinal bleeding
  • purpura
  • contusion
  • hematoma
  • epistaxis
  • hematoma
  • hematuria
  • intraocular hemorrhage
  • intracranial hemorrhage
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  • severe neutropenia
  • agranulocytosis
  • aplastic anemia
  • thrombocytopenia
  • abdominal pain
  • dyspepsia
  • diarrhea
  • rash
  • pruritus
  • depression
  • upper respiratory tract infection
  • dyspnea
  • rhinitis
  • bronchitis
  • cough
  • urinary tract infection
  • chest pain
  • accidental injury
  • influenza-like illness
  • pain
  • fatigue
  • edema
  • hypertension
  • headache
  • dizziness
  • nausea
  • hypercholesterolemia
  • arthralgia
  • low back pain
  • depression
  • pneumonia
  • sinusitis
  • eczema
  • skin ulcer
  • cystitis
  • cataract
  • conjunctivitis
  • allergic symptoms
  • ischemic necrosis
  • vasculitis
  • hypotension
  • bronchospasm
  • interstitial pneumonia
  • eosinophilic pneumonia
  • colitis
  • pancreatitis
  • gastritis
  • stomatitis
  • hepatitis
  • acute liver failure
  • maculopapular rash
  • erythematous skin rash
  • urticaria
  • itching
  • angioedema
  • vesiculobullous dermatitis
  • drug-induced hypersensitivity syndrome
  • eosinophilia
  • arthritis
  • 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

Store this medication in a tightly sealed container to protect it from air and moisture. It is best to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets/bottle, 300 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.