Medication info

Brilique 60mg (Ticagrelor)

Prescription medicationApproval withdrawn
Ingredient · strength
Ticagrelor›Strength being verified
Manufacturer / importer
Daewoong Pharmaceutical Co., Ltd.
Appearance
Pink, biconvex, round film-coated tablets
Packaging
10 tablets/PTP
Approval status
Approval withdrawn

MFDS item code 201900087 · Approved 2019.01.09

This product's status changed to Approval withdrawn on 2023.03.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Prevention of thrombotic cardiovascular events (myocardial infarction, etc.) and stroke
Who uses it
Adults · Children
Adult dosage
Do not use this medicine concomitantly with other ADP receptor inhibitors (ticlopidine, clopidogrel, prasugrel). Acute coronary syndrome: Administer a loading dose of 180mg once, followed by 90mg per dose 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 per dose 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 this medicine at 60mg. - Treatment with this medicine may also be initiated in patients within 2 years of 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 per dose 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. - Data on the safety and efficacy of this medicine for treatment longer than 3 years are limited. Patients with acute ischemic stroke or high-risk transient ischemic attack: Administer a loading dose of 180mg once, followed by 90mg per dose 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 immediately. Rinse the glass used for administration with another half glass of water and drink it. This mixture may also be administered through a nasogastric tube (CH8 or larger); it is important to flush the nasogastric tube with water after administration. When switching from another antiplatelet agent to this medicine, 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 there is limited experience with its use in patients with moderate hepatic impairment.
Children's dosage
The safety and efficacy have not been established in pediatric patients under 18 years of age (see 'Other' section).

Ingredients

Manufacturer
Daewoong Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is beneficial for adult patients at high risk of cardiovascular disease. Firstly, it is used in conjunction with aspirin to reduce the occurrence of cardiovascular events such as heart attack or stroke in patients with acute coronary syndrome or those who have a history of myocardial infarction more than one year ago and have a high risk of thrombotic cardiovascular events. Additionally, it is effective in preventing myocardial infarction and stroke in patients with type 2 diabetes who have undergone percutaneous coronary intervention for coronary artery disease when used together with aspirin. Lastly, in patients with early mild acute ischemic stroke or high-risk transient ischemic attack, it is used together with aspirin to reduce the risk of recurrent stroke. Thus, this medication aids in lowering the incidence of complications in patients at risk for various cardiovascular and cerebrovascular diseases.

Dosage and Administration

Adult dosage

Do not use this medicine concomitantly with other ADP receptor inhibitors (ticlopidine, clopidogrel, prasugrel). Acute coronary syndrome: Administer a loading dose of 180mg once, followed by 90mg per dose 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 per dose 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 this medicine at 60mg. - Treatment with this medicine may also be initiated in patients within 2 years of 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 per dose 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. - Data on the safety and efficacy of this medicine for treatment longer than 3 years are limited. Patients with acute ischemic stroke or high-risk transient ischemic attack: Administer a loading dose of 180mg once, followed by 90mg per dose 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 immediately. Rinse the glass used for administration with another half glass of water and drink it. This mixture may also be administered through a nasogastric tube (CH8 or larger); it is important to flush the nasogastric tube with water after administration. When switching from another antiplatelet agent to this medicine, 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 there is limited experience with its use in patients with moderate hepatic impairment.

Children's dosage

The safety and efficacy have not been established in pediatric patients under 18 years of age (see 'Other' section).

Precautions

This drug inhibits platelet aggregation in the blood to reduce the risk of cardiovascular diseases such as myocardial infarction or stroke. However, this drug may increase the risk of bleeding, so it should not be used in patients with existing bleeding or a history of intracranial hemorrhage. If surgery is planned, this medication should be discontinued at least 5 days prior, and if any bleeding symptoms occur, immediate medical attention should be sought. This drug should not be administered to patients with severely impaired liver function or those taking certain antibiotics or antivirals that strongly inhibit CYP3A4 enzymes. Patients at high risk for bleeding, those who have recently sustained trauma or undergone surgery, and those with bleeding disorders should use this drug with caution and be careful when combined with other medications that may induce bleeding. In particular, patients at risk for bradycardia or those suffering from asthma or chronic obstructive pulmonary disease (COPD) should be cautious, as they may experience shortness of breath or heart rhythm abnormalities during treatment. This drug may increase uric acid levels in the blood, so patients with a history of hyperuricemia or gout should take precautions. Women who are pregnant or breastfeeding should consult a healthcare professional before taking this medication, and it is not to be administered to children under 18 years of age as safety and efficacy have not been established. This drug may interact with other medications, so patients should inform their healthcare provider of any other medications they are currently taking, particularly when used in conjunction with simvastatin, digoxin, cyclosporine, etc. In cases of overdose, the risk of bleeding may increase, and since there is currently no antidote available for this medication, appropriate medical treatment should be sought immediately. Caution is advised when driving or operating machinery, as this drug may cause dizziness or confusion. Finally, this drug should be stored out of reach of children and kept in its original packaging to maintain its quality.

Side effects

  • Hemorrhage
  • intracranial hemorrhage
  • ocular hemorrhage
  • ear hemorrhage
  • hypotension
  • dyspnea
  • respiratory tract hemorrhage
  • gastrointestinal hemorrhage
  • diarrhea
  • nausea
Show 126 more
  • dyspepsia
  • constipation
  • retroperitoneal hemorrhage
  • skin hemorrhage
  • rash
  • pruritus
  • muscle hemorrhage
  • urinary tract hemorrhage
  • reproductive tract hemorrhage
  • postoperative hemorrhage
  • thrombotic thrombocytopenic purpura
  • bradyarrhythmia
  • heart block
  • thrombosis
  • deep vein thrombosis
  • cardiac thrombus
  • thrombocytosis
  • thrombocytopenia
  • hematoma
  • cerebral hemorrhage
  • confusion
  • dizziness
  • syncope
  • headache
  • vertigo
  • ear hemorrhage
  • chest pain
  • pulmonary hemorrhage
  • pneumonia
  • pulmonary edema
  • pharyngitis
  • upper respiratory infection
  • asthma
  • pleural effusion
  • bronchitis
  • pneumothorax
  • weakness
  • anaphylactic shock
  • vomiting
  • melena
  • nausea
  • acute renal failure
  • heart failure
  • cardiac rhythm disorder
  • palpitations
  • ventricular tachycardia
  • arrhythmia
  • ventricular fibrillation
  • cardiac arrest
  • atrial fibrillation
  • complete heart block
  • urinary tract infection
  • kidney stones
  • cerebral ischemia
  • cerebral infarction
  • arterial stenosis
  • angina pectoris
  • coronary thrombosis
  • myocardial ischemia
  • aneurysm
  • cardiac compression syndrome
  • anemia
  • vestibular disorder
  • malignant male reproductive neoplasm
  • chemical toxicity
  • postoperative hematoma
  • laceration
  • road traffic accident
  • trauma
  • speech disorder
  • spinal canal stenosis
  • dementia
  • migraine
  • paralysis
  • gait abnormality
  • appendicitis
  • tendon disease
  • bursitis
  • rhabdomyolysis
  • diabetes
  • hyperkalemia
  • hyperglycemia
  • thirst
  • worsening of diabetes
  • hepatitis
  • snoring
  • palpitations
  • bradycardia
  • atrial fibrillation
  • frequent urination
  • dysuria
  • conjunctival congestion
  • ocular pain
  • visual disturbance
  • memory disturbance
  • erectile dysfunction
  • anxiety
  • insomnia
  • restlessness
  • tinnitus
  • ear pain
  • lymphadenopathy
  • eosinophilia
  • sexual dysfunction
  • benign prostatic hyperplasia
  • ovarian cyst
  • amenorrhea
  • vaginitis
  • loss of taste
  • olfactory disturbance
  • increased TSH
  • hypothyroidism
  • injection site reaction
  • injection site pain
  • urticaria
  • increased sweating
  • orthostatic hypotension
  • worsening of hypertension
  • cyanosis
  • hypertriglyceridemia
  • hypokalemia
  • hypocalcemia
  • hypomagnesemia
  • hypoglycemia
  • elevated AST
  • elevated ALT

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

Storage

This medication should be stored in a tightly closed container to protect from air and moisture. The recommended storage temperature is between 1 and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Pink, biconvex, round film-coated tablets

Package unit

10 tablets/PTP

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.