Medication info

Tibrintan Tablets 90 mg (Ticagrelor)

Prescription medicationTabletOralExpired
Ingredient · strength
Ticagrelor›90mg / 1 tablet
Manufacturer / importer
Withus Pharmaceutical Co., Ltd.
Appearance
Yellow, convex on both sides, circular film-coated tablet
Packaging
56 tablets/box [14 tablets/PTP×4], 30 tablets/box [10 tablets/PTP×3]
Approval status
Expired

MFDS item code 201902019 · Approved 2019.04.03

This product's status changed to Expired on 2024.04.03. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Prevention of thrombotic cardiovascular events (e.g., myocardial infarction and stroke)
Who takes it
Adults · Children
Adult dose
This medicine should not be used in combination with other ADP receptor inhibitors (ticlopidine, clopidogrel, prasugrel). Acute coronary syndrome: Administer an initial dose of 180mg, followed by 90mg twice daily. Treatment is recommended for 12 months unless discontinuation of this medicine is clinically necessary. Patients taking this medicine should also receive a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. Patients with a history of myocardial infarction (occurring at least 1 year previously) who are at high risk of thrombotic cardiovascular events: Administer 60mg twice daily. Patients taking this medicine should also receive a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. - Patients who took 90mg of this medicine or another ADP receptor inhibitor (ticlopidine, clopidogrel, prasugrel) during the first year after myocardial infarction may continue treatment with 60mg of this medicine. - This medicine may also be initiated in patients within 2 years after myocardial infarction or within 1 year of discontinuing a previous ADP receptor inhibitor (ticlopidine, clopidogrel, prasugrel). - The safety and efficacy of this medicine were evaluated at 3 years of follow-up. Patients with type 2 diabetes who have undergone percutaneous coronary intervention (PCI) for coronary artery disease: Administer 60mg twice daily. Patients taking this medicine should also receive a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. - For patients with acute coronary syndrome, refer to the relevant dosage and administration instructions. - Data on the safety and efficacy of this medicine when administered for more than 3 years are limited. Patients with acute ischemic stroke or high-risk transient ischemic attack: Administer an initial dose of 180mg, followed by 90mg twice daily for 30 days. Patients taking this medicine should also receive a maintenance dose of aspirin (75 - 100mg), unless specifically contraindicated. An initial loading dose of aspirin (300-325mg) is recommended for patients with acute ischemic stroke or high-risk transient ischemic attack. This medicine is administered orally and may be taken with or without food. For patients who have difficulty swallowing tablets, crush this medicine into a fine powder, disperse it in half a glass of water, and drink it. Rinse the cup used with another half glass of water and drink that as well. This mixture may also be administered through a nasogastric tube (CH8 or larger); it is important to flush the tube with water after administration. If switching to this medicine from another antiplatelet agent, start this medicine 24 hours after the last dose of the previous medicine. If a dose is missed, take only 1 tablet (the next scheduled dose) at the next scheduled dosing time. No dose adjustment is necessary in patients with renal impairment. No dose adjustment is necessary in patients with mild hepatic impairment. This medicine has not been studied in patients with severe hepatic impairment, and experience in patients with moderate hepatic impairment is limited.
Child dose
Safety and efficacy have not been established in pediatric patients under 18 years of age (see the “Other” section).

Ingredients

Manufacturer
Withus Pharmaceutical Co., Ltd.

Efficacy & effects

Prevention of thrombotic cardiovascular events (e.g., myocardial infarction and stroke)

  • Thrombotic cardiovascular events
  • cardiovascular abnormalities
  • myocardial infarction
  • stroke
  • acute coronary syndrome
  • elevated risk of thrombotic cardiovascular events
  • type 2 diabetes
  • coronary artery disease
  • acute ischemic stroke
  • transient ischemic attacks
View approved original text

This medication helps reduce various risks associated with cardiovascular diseases when used in combination with aspirin. It is effective for adult patients experiencing acute coronary syndrome or those at high risk of thrombotic cardiovascular events who have experienced a myocardial infarction over a year ago. Additionally, it lowers the risk of myocardial infarction or stroke in patients with type 2 diabetes who have undergone PCI due to coronary artery disease. It is also used in conjunction with aspirin to reduce the occurrence of stroke in patients with acute ischemic stroke or high-risk transient ischemic attacks. This efficacy improves cardiovascular health.

How to take

Adult dose

This medicine should not be used in combination with other ADP receptor inhibitors (ticlopidine, clopidogrel, prasugrel). Acute coronary syndrome: Administer an initial dose of 180mg, followed by 90mg twice daily. Treatment is recommended for 12 months unless discontinuation of this medicine is clinically necessary. Patients taking this medicine should also receive a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. Patients with a history of myocardial infarction (occurring at least 1 year previously) who are at high risk of thrombotic cardiovascular events: Administer 60mg twice daily. Patients taking this medicine should also receive a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. - Patients who took 90mg of this medicine or another ADP receptor inhibitor (ticlopidine, clopidogrel, prasugrel) during the first year after myocardial infarction may continue treatment with 60mg of this medicine. - This medicine may also be initiated in patients within 2 years after myocardial infarction or within 1 year of discontinuing a previous ADP receptor inhibitor (ticlopidine, clopidogrel, prasugrel). - The safety and efficacy of this medicine were evaluated at 3 years of follow-up. Patients with type 2 diabetes who have undergone percutaneous coronary intervention (PCI) for coronary artery disease: Administer 60mg twice daily. Patients taking this medicine should also receive a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. - For patients with acute coronary syndrome, refer to the relevant dosage and administration instructions. - Data on the safety and efficacy of this medicine when administered for more than 3 years are limited. Patients with acute ischemic stroke or high-risk transient ischemic attack: Administer an initial dose of 180mg, followed by 90mg twice daily for 30 days. Patients taking this medicine should also receive a maintenance dose of aspirin (75 - 100mg), unless specifically contraindicated. An initial loading dose of aspirin (300-325mg) is recommended for patients with acute ischemic stroke or high-risk transient ischemic attack. This medicine is administered orally and may be taken with or without food. For patients who have difficulty swallowing tablets, crush this medicine into a fine powder, disperse it in half a glass of water, and drink it. Rinse the cup used with another half glass of water and drink that as well. This mixture may also be administered through a nasogastric tube (CH8 or larger); it is important to flush the tube with water after administration. If switching to this medicine from another antiplatelet agent, start this medicine 24 hours after the last dose of the previous medicine. If a dose is missed, take only 1 tablet (the next scheduled dose) at the next scheduled dosing time. No dose adjustment is necessary in patients with renal impairment. No dose adjustment is necessary in patients with mild hepatic impairment. This medicine has not been studied in patients with severe hepatic impairment, and experience in patients with moderate hepatic impairment is limited.

Child dose

Safety and efficacy have not been established in pediatric patients under 18 years of age (see the “Other” section).

Precautions

This medication helps to reduce the risk of cardiovascular events such as myocardial infarction or stroke by preventing platelets in the blood from clumping together to form clots. However, this medication may increase the risk of bleeding and should not be administered to patients with active pathological bleeding or a history of intracranial hemorrhage. Patients scheduled for surgery should discontinue this medication at least 5 days prior to the procedure and consult their healthcare provider to reduce post-surgical bleeding risk. During treatment with this medication, patients should be closely monitored for sudden symptoms of hypotension or signs of bleeding, and should immediately notify a healthcare provider if bleeding is suspected. Particularly high-risk patients or those with severe liver impairment, as well as patients taking certain medications (strong CYP3A4 inhibitors) should not use this medication, and potential interactions with other drugs need to be confirmed. This medication can cause various adverse reactions including dyspnea, bradycardia, and bleeding, so if these symptoms occur, immediate consultation with a healthcare provider is necessary. Women who are pregnant or breastfeeding should consult a physician before taking this medication, as it may pose risks to the fetus or newborn. This medication is not recommended for children and adolescents under 18 years of age, as safety and efficacy have not been established. In cases of overdose, the risk of bleeding may increase, and since there is no specific antidote, appropriate medical treatment should be sought immediately. While taking this medication, patients should be aware that symptoms such as dizziness or confusion may occur during driving or operating machinery.

Side effects

  • Hemorrhage
  • intracranial hemorrhage
  • ocular hemorrhage
  • ear hemorrhage
  • hypotension
  • dyspnea
  • respiratory tract hemorrhage
  • gastrointestinal tract hemorrhage
  • diarrhea
  • nausea
Show 188 more
  • dyspepsia
  • constipation
  • retroperitoneal hemorrhage
  • skin hemorrhage
  • rash
  • pruritus
  • muscle hemorrhage
  • urinary tract hemorrhage
  • reproductive tract hemorrhage
  • post-procedural hemorrhage
  • trauma hemorrhage
  • thrombotic thrombocytopenic purpura
  • bradyarrhythmia
  • atrioventricular block
  • angioedema
  • Cheyne-Stokes respiration
  • central sleep apnea
  • confusion
  • dizziness
  • syncope
  • headache
  • vertigo
  • ear hemorrhage
  • hyperuricemia
  • gout
  • chest pain
  • cough
  • pulmonary hemorrhage
  • pharyngitis
  • upper respiratory infection
  • asthma
  • pleural effusion
  • bronchitis
  • pneumothorax
  • pneumonia
  • pulmonary edema
  • weakness
  • anaphylactic shock
  • increased tendency to bruise
  • spontaneous hematoma
  • bleeding diathesis
  • coma
  • spinal canal stenosis
  • dementia
  • migraine
  • paralysis
  • gait abnormalities
  • abdominal pain
  • rectal bleeding
  • anal bleeding
  • appendicitis
  • tendinopathy
  • bursitis
  • rhabdomyolysis
  • urinary tract infection
  • nephrolithiasis
  • thrombosis
  • deep vein thrombosis
  • cardiac thrombus
  • coagulation disorders
  • thrombocytosis
  • speech disorders
  • cerebral hypoxia
  • scalp tenderness
  • peripheral neuropathy
  • cervical dystonia
  • vocal disorders
  • seizures
  • neuropathy
  • neuralgia
  • movement disorders
  • tremors
  • lower limb paralysis
  • sensory impairment
  • oral pain
  • gastroenteritis
  • belching
  • irritable bowel syndrome
  • stomatitis
  • ulcerative stomatitis
  • benign gastrointestinal neoplasm
  • dental disease
  • tongue disease
  • tendinitis
  • arthropathy
  • chondrocalcinosis
  • spinal osteoarthritis
  • arthritis
  • contact dermatitis
  • fungal dermatitis
  • skin disease
  • erythematous rash
  • hyperkeratosis
  • acute urticaria
  • onychomycosis
  • hair loss
  • scleroderma
  • dermatofibroma
  • increased sweating
  • hyperlipidemia
  • hypertriglyceridemia
  • worsening of diabetes
  • hypercholesterolemia
  • lipodystrophy
  • dehydration
  • hepatitis
  • drowsiness
  • neurosis
  • depression
  • snoring
  • memory impairment
  • erectile dysfunction
  • anxiety
  • aneurysm
  • heart failure
  • palpitations
  • ventricular tachycardia
  • arrhythmia
  • ventricular fibrillation
  • cardiac arrest
  • complete atrioventricular block
  • atrial fibrillation
  • increased urination
  • dysuria
  • urinary tract infection
  • urinary incontinence
  • nocturia
  • worsening of chronic kidney failure
  • cystitis
  • renal cysts
  • urinary retention
  • azotemia
  • cerebral ischemia
  • venous stenosis
  • cerebral infarction
  • conjunctivitis
  • diabetic retinopathy
  • cataracts
  • tinnitus
  • ear pain
  • vestibular disorders
  • lymphadenopathy
  • eosinophilia
  • sexual dysfunction
  • benign prostatic hyperplasia
  • ovarian cysts
  • amenorrhea
  • vaginitis
  • loss of taste
  • altered smell
  • increased TSH
  • hypothyroidism
  • injection site reactions
  • injection site pain
  • chemical poisoning
  • concussion
  • disc disease
  • non-drug allergies
  • septal deviation
  • surgical site reactions
  • road traffic accidents
  • trauma
  • pharyngitis
  • sputum disorders
  • rhinitis
  • throat irritation
  • fever
  • leg pain
  • edema
  • fatigue
  • limb pain
  • pain
  • facial edema
  • chills
  • altered body temperature sensation
  • orthostatic hypotension
  • worsening of hypertension
  • cyanosis
  • cough
  • pneumonia
  • pulmonary edema
  • asthma
  • pleural effusion
  • pharyngitis
  • increased sputum
  • bronchiectasis
  • sleep apnea
  • pulmonary congestion

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

Storage

This medication should be kept in a tightly closed container to prevent exposure to air, and it is advisable to store it at room temperature between 1 and 30 degrees Celsius. Proper storage can help maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

Yellow, convex on both sides, circular film-coated tablet

Package unit

56 tablets/box [14 tablets/PTP×4], 30 tablets/box [10 tablets/PTP×3]

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.