Medication info
Newpid Tablet (Clopidogrel Bisulfate)

Newpid Tablet (Clopidogrel Bisulfate)

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

MFDS item code 201506676 · Approved 2015.09.22 · Insurance code 669906370

Summary

Main use
Improvement of atherosclerotic symptoms; prevention of atherothrombotic and thromboembolic events in patients with atrial fibrillation
Who uses it
Adults
Adult dosage
○ Adults 1. In patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, administer clopidogrel 75mg orally once daily. 2. In patients with acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), start treatment on the initiation day with a loading dose of 300mg of this medicine once daily, followed by an oral maintenance dose of 75mg once daily. Aspirin 75~325mg should be administered concomitantly with this medicine once daily. 3. In patients with atrial fibrillation, administer 75mg of this medicine orally once daily. Aspirin 75~100mg should be administered concomitantly with this medicine 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 medicine may be administered with or without food.

Ingredients

Manufacturer
Daehan New Pharm Co., Ltd.

Efficacy & effects

Improvement of atherosclerotic symptoms; prevention of atherothrombotic and thromboembolic events in patients with 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
  • atherothrombosis
  • thrombosis
View approved original text

This medicine is used to improve atherosclerotic symptoms in adult patients with ischemic stroke, myocardial infarction, and peripheral arterial disease. It also helps prevent complications due to cardiovascular abnormalities and improve symptoms after drug treatment, coronary intervention, or coronary artery bypass surgery in patients with acute coronary syndrome, particularly those with unstable angina or non-Q-wave myocardial infarction. Additionally, it improves health by reducing the risk of stroke and thrombosis in patients with atrial fibrillation who have one or more vascular risk factors where vitamin K antagonist therapy is inappropriate and who have a low risk of bleeding. Thus, it is used effectively in various situations related to cardiovascular disease to improve symptoms and reduce the risk of complications.

Dosage and Administration

Adult dosage

○ Adults 1. In patients with ischemic stroke, myocardial infarction, or peripheral arterial disease, administer clopidogrel 75mg orally once daily. 2. In patients with acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), start treatment on the initiation day with a loading dose of 300mg of this medicine once daily, followed by an oral maintenance dose of 75mg once daily. Aspirin 75~325mg should be administered concomitantly with this medicine once daily. 3. In patients with atrial fibrillation, administer 75mg of this medicine orally once daily. Aspirin 75~100mg should be administered concomitantly with this medicine 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 medicine may be administered with or without food.

Precautions

This drug prevents platelets from aggregating and prevents blood clotting. Before taking this medicine, you should consult your doctor if you have a genetic deficiency in the function of a specific enzyme (CYP2C19), as this may reduce its effectiveness. Additionally, using this drug with medications that enhance the activity of this enzyme may increase the risk of bleeding, so co-administration should be avoided. People allergic to this drug or its components, patients with bleeding, severely impaired liver function, nursing women, and patients with certain genetic lactose intolerance should not take this medication. Patients at high risk of bleeding or with bleeding disorders need to use this medicine cautiously and should inform their doctor immediately if bleeding symptoms occur. Particularly, patients scheduled for surgery should stop taking this medication 5-7 days before the surgery and resume once hemostasis is achieved. This medication may increase the risk of bleeding when taken with other medications that also pose a bleeding risk, so caution should be exercised. During treatment, patients should remain vigilant for bleeding symptoms, and if bleeding is suspected, it should be confirmed with blood tests, etc. Rarely, thrombocytopenia or serious blood abnormalities may occur; therefore, immediately consult a healthcare professional if symptoms of infection or fever arise. This medication may cause side effects such as indigestion, abdominal pain, diarrhea, headache, dizziness, and skin rash, and you should consult your doctor if symptoms are severe. During pregnancy, it is advisable to use this drug only when absolutely necessary, and it is better to discontinue use before childbirth due to the risk of bleeding. If you are breastfeeding, as this drug may be secreted in breast milk, you should consult your doctor about whether to continue or stop breastfeeding. Safety in children has not been established, so it is generally not used in pediatric patients. Elderly patients may have reduced kidney and liver function; thus, dosage adjustment and condition monitoring are necessary. Overdosing may increase the risk of bleeding, and there is no specific antidote, so treatment such as platelet transfusion may be necessary in case of bleeding. This medication should be kept out of the reach of children, and it is advisable to avoid transferring it to other containers. While on this medication, you must inform healthcare personnel if you are starting new medications or undergoing surgery.

Side effects

  • Hemorrhage
  • gastrointestinal bleeding
  • purpura
  • contusion
  • hematoma
  • epistaxis
  • hematoma
  • hematuria
  • intraocular hemorrhage
  • intracranial hemorrhage
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  • severe neutropenia
  • aplastic anemia
  • severe thrombocytopenia
  • thrombocytopenia
  • gastrointestinal symptoms
  • abdominal pain
  • dyspepsia
  • diarrhea
  • rash
  • pruritus
  • depression
  • dyspnea
  • rhinitis
  • bronchitis
  • cough
  • urinary tract infection
  • headache
  • dizziness
  • nausea
  • vomiting
  • constipation
  • thrombocytopenia
  • anemia
  • bloody stools
  • hematoma
  • hematuria
  • hemoptysis
  • muscle hemorrhage
  • gingival bleeding
  • anemia
  • pneumonia
  • sinusitis
  • eczema
  • skin ulcer
  • cystitis
  • cataract
  • conjunctivitis
  • decreased motor function
  • tremor
  • voice disorder
  • abnormal gait
  • hyperkinesia
  • ataxia
  • sensory disturbance
  • insomnia
  • forgetfulness
  • anxiety
  • confusion
  • thought disorder
  • abnormal behavior
  • arthralgia
  • myalgia
  • low back pain
  • gynecomastia
  • fever
  • weight loss
  • weight gain
  • facial flushing
  • weakness
  • rigidity
  • facial edema
  • syncope
  • cholecystitis
  • hematemesis
  • spinal hematoma
  • allergic symptoms
  • ischemic necrosis
  • generalized edema
  • gastritis
  • hemorrhagic gastritis
  • duodenal ulcer
  • gastric ulcer
  • perforated gastric ulcer
  • upper gastrointestinal ulcer bleeding
  • distention
  • hyperbilirubinemia
  • infectious hepatitis
  • fatty liver
  • hemorrhagic arthropathy
  • hemoptysis
  • pulmonary hemorrhage
  • thrombocytopenia
  • increased bleeding time
  • aplastic anemia
  • hypochromic anemia
  • agranulocytosis
  • granulocytopenia
  • leukemia
  • leukopenia
  • neutropenia
  • eosinophilia
  • menorrhagia
  • hemothorax
  • bullous pemphigoid
  • erythematous rash
  • maculopapular rash
  • urticaria
  • renal dysfunction
  • acute renal failure
  • confusion
  • hallucinations
  • taste disorder
  • taste loss
  • vasculitis
  • hypotension
  • bronchospasm
  • interstitial pneumonia
  • eosinophilic pneumonia
  • colitis
  • pancreatitis
  • gastritis
  • stomatitis
  • hepatitis
  • acute liver failure
  • maculopapular rash
  • urticaria
  • pruritus
  • angioedema
  • vesicular dermatitis
  • drug-induced hypersensitivity syndrome
  • eosinophilia
  • drug rash
  • eczema
  • lichen planus
  • arthritis
  • arthropathy
  • glomerulonephritis
  • gynecomastia
  • fever
  • abnormal liver function tests
  • increased blood creatinine
  • loss of appetite
  • weight loss
  • visual disturbances
  • confusion
  • weight gain
  • facial flushing
  • decreased motor function
  • polydipsia
  • forgetfulness
  • thought disorder
  • polyuria
  • arrhythmia
  • tremor
  • voice disorder
  • abnormal gait
  • hyperkinesia
  • ataxia
  • hiccups
  • dysphagia
  • tongue disorders
  • abnormal behavior
  • rigidity
  • visual disturbances
  • dry eye syndrome
  • transient blindness
  • congestion
  • voiding dysfunction
  • uremia
  • hypoglycemia
  • bradycardia
  • tinnitus
  • contact dermatitis
  • gynecomastia
  • elevated PSA

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a sealed container. It is best to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. This will help maintain the effectiveness and safety of the medication for a long time.

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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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.