Brilinta Tablet 60mg (Ticagrelor)

Adult dose

Do not use this medicine in combination with other ADP receptor inhibitors (ticlopidine, clopidogrel, prasugrel). ㆍAcute coronary syndrome: Administer an initial dose of 180mg, followed by 90mg twice daily. Treatment for 12 months is recommended unless discontinuation is clinically necessary. Patients taking this medicine should also receive a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. In patients with acute coronary syndrome who are at increased risk of bleeding and have undergone percutaneous coronary intervention (PCI), monotherapy with this medicine (discontinuation of aspirin) may be considered after 3 months of combination treatment with this medicine and aspirin. (See 3. Patients Requiring Caution in Administration.) ㆍPatients 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. - Treatment with this medicine may also be initiated in patients within 2 years after myocardial infarction or within 1 year after discontinuing a previous ADP receptor inhibitor (ticlopidine, clopidogrel, prasugrel). - The safety and efficacy of this medicine were evaluated at 3 years of follow-up. ㆍPatients 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. - Refer to the dosage and administration for patients with acute coronary syndrome. - Data on the safety and efficacy of this medicine when administered for more than 3 years are limited. ㆍPatients 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. Method of administration This medicine is administered orally and may be taken with or without food. ㆍFor patients who have difficulty swallowing tablets, crush this medicine into a fine powder, disperse it in half a glass of water, and drink the mixture immediately. Rinse the glass used for the dose 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 tube with water after administration. ㆍWhen switching from another antiplatelet agent to this medicine, start this medicine 24 hours after the last dose of the previous medicine. ㆍIf a dose is missed, take only 1 tablet (the next scheduled dose) at the next scheduled dosing time. Patients with renal impairment No dose adjustment is necessary in patients with renal impairment. Patients with hepatic 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 with its use in patients with moderate hepatic impairment is limited.

Child dose

Pediatric patients under 18 years of age: Safety and efficacy have not been established (see 12. Information for Healthcare Professionals).

This medication prevents blood clotting to avoid thrombus formation. However, it may increase the risk of bleeding, thus it should not be used in patients with pathological bleeding or a history of intracranial hemorrhage. If surgery is planned, the medication should be discontinued at least 5 days prior, as the risk of bleeding may increase during the procedure. Any signs of bleeding should be reported to medical personnel immediately, and it is important to treat any bleeding without discontinuing the medication if possible. It should not be used in patients with hypersensitivity to this medication, severe liver impairment, or in conjunction with strong CYP3A4 inhibitors. Caution is advised when administering to patients at high risk of bleeding, those with recent surgeries or trauma, or those with blood coagulation disorders. Particularly be cautious when used with other medications that increase bleeding risk. Patients scheduled for surgery must inform their physician or dentist about using this medication, and care should be taken if symptoms of bradycardia or dyspnea are present. Patients with asthma or chronic obstructive pulmonary disease should be especially careful as this medication may worsen symptoms of dyspnea. Elderly patients, those with impaired renal function, and patients with a history of hyperuricemia or gout should also exercise caution while on this medication. As this medication may interact with many other drugs, patients taking other medications should consult their physician or pharmacist. Pregnant or breastfeeding women are advised to avoid this medication, and women of childbearing potential should ensure proper contraception to avoid pregnancy while on this medication. In case of overdose, the risk of bleeding may increase, and since there is no specific antidote, immediate medical attention is required. Dizziness or confusion may occur during treatment, warranting caution when driving or operating machinery. This medication has not been established for safety and efficacy in children under 18 years of age and is not recommended for them. Thus, during treatment, careful observation for symptoms of bleeding and dyspnea is necessary, and if any unusual symptoms arise, immediate medical consultation is advised.

Hemorrhage, intracranial hemorrhage, ocular hemorrhage, ear hemorrhage, hypotension, dyspnea, respiratory tract hemorrhage, gastrointestinal hemorrhage, diarrhea, nausea, dyspepsia, constipation, retroperitoneal hemorrhage, skin hemorrhage, rash, pruritus, muscle hemorrhage, urinary tract hemorrhage, genital hemorrhage, post-procedural hemorrhage, traumatic 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, asthenia, anaphylactic shock, epistaxis, hemoptysis, hematoma, cerebral hemorrhage, spinal stenosis, dementia, migraine, paralysis, gait abnormalities, rectal bleeding, anal bleeding, appendicitis, connective tissue disease, bursitis, diabetes mellitus, hyperkalemia, hyperglycemia, hepatitis, snoring, aneurysm, heart failure, palpitations, ventricular tachycardia, arrhythmia, ventricular fibrillation, cardiac arrest, ventricular fibrillation, urinary tract infection, renal calculi, cerebral ischemia, venous stenosis, cerebral infarction, arterial stenosis, angina, coronary artery thrombosis, myocardial ischemia, anemia, vestibular dysfunction, malignant neoplasm of male reproductive organs, chemical poisoning, post-procedural hematoma, laceration, road traffic accident, trauma, nausea, vomiting, atrial fibrillation, atrial arrhythmia, increased urination, dysuria, urinary tract infection, renal cyst, urinary retention, cerebral infarction, conjunctivitis, diabetic retinopathy, cataract, arterial stenosis, angina, cardiomyopathy, cardiac tamponade, pericardial effusion, decreased blood iron, tinnitus, ear pain, lymphadenopathy, eosinophilia, sexual dysfunction, benign prostatic hyperplasia, ovarian cyst, amenorrhea, vaginitis, loss of taste, olfactory dysfunction, increased TSH, hypothyroidism, injection site reaction, injection site pain, insomnia, anxiety, memory impairment, erectile dysfunction, restlessness, orthostatic hypotension, palpitations, bradycardia, atrial fibrillation, conjunctival injection, eye pain, visual disturbances, cyanosis, atrial fibrillation, ventricular tachycardia, cardiac arrest, ventricular fibrillation

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. A storage temperature between 1 degree and 30 degrees Celsius is recommended.

Appearance

Pink, round, film-coated tablet with double convex surfaces

Package unit

60 tablets (10 tablets × 6) / box