Medication info

Trilinta Tablets 60 mg (Ticagrelor)

Prescription medicationTabletOralExpired
Ingredient · strength
Ticagrelor›60mg / 1 tablet
Manufacturer / importer
Jeil Pharmaceutical Co., Ltd.
Appearance
Pink, round, biconvex film-coated tablet
Packaging
60 tablets/PTP [10 tablets/PTP X 6]
Approval status
Expired

MFDS item code 202001105 · Approved 2020.02.18

This product's status changed to Expired on 2025.02.18. 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 takes it
Adults · Children
Adult dose
This medicine should not be used concomitantly with other ADP receptor inhibitors (ticlopidine, clopidogrel, prasugrel). Acute 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 at increased risk of bleeding who have undergone percutaneous coronary intervention (PCI), monotherapy with this medicine (discontinuing aspirin) may be considered after 3 months of concomitant treatment with this medicine and aspirin. (See 3. Patients Requiring Caution.) 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 this medicine 90mg or another ADP receptor inhibitor (ticlopidine, clopidogrel, prasugrel) during the first year after myocardial infarction may continue treatment with this medicine 60mg. Treatment with 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 corresponding dosage and administration instructions. Data on the safety and efficacy of this medicine for treatment lasting longer 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 immediately; then rinse the glass 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 required in patients with renal impairment. No dose adjustment is required 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
The safety and efficacy of this medicine have not been established in pediatric patients under 18 years of age (see the 'Other' section).

Ingredients

Manufacturer
Jeil 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 helps to reduce the rate of thrombotic cardiovascular events, such as cardiovascular mortality, myocardial infarction, and stroke, when used in combination with aspirin. It is effective in patients with acute coronary syndrome and in those at high risk of thrombotic cardiovascular events who have a history of myocardial infarction for more than 1 year. It also reduces the occurrence of myocardial infarction or stroke in patients with type 2 diabetes who do not have a history of myocardial infarction or stroke and who have undergone coronary intervention. This medication, combined with aspirin, also reduces the occurrence of stroke in patients with acute ischemic stroke or high-risk transient ischemic attack. Thus, this drug is used to reduce the risk of various cardiovascular and cerebrovascular diseases.

How to take

Adult dose

This medicine should not be used concomitantly with other ADP receptor inhibitors (ticlopidine, clopidogrel, prasugrel). Acute 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 at increased risk of bleeding who have undergone percutaneous coronary intervention (PCI), monotherapy with this medicine (discontinuing aspirin) may be considered after 3 months of concomitant treatment with this medicine and aspirin. (See 3. Patients Requiring Caution.) 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 this medicine 90mg or another ADP receptor inhibitor (ticlopidine, clopidogrel, prasugrel) during the first year after myocardial infarction may continue treatment with this medicine 60mg. Treatment with 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 corresponding dosage and administration instructions. Data on the safety and efficacy of this medicine for treatment lasting longer 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 immediately; then rinse the glass 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 required in patients with renal impairment. No dose adjustment is required 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

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

Precautions

This medication works to inhibit platelets in the blood from aggregating to form clots. It may increase the risk of bleeding, therefore it should not be used in patients with bleeding or those at high risk of bleeding. It is advisable to discontinue this drug at least 5 days before surgery. During treatment with this medication, if symptoms of hypotension appear, bleeding should be suspected, and it is advisable to continue taking the medication while treating the bleeding if possible. Patients with a hypersensitivity to this medication, those with pathological bleeding or a history of intracranial bleeding, severe liver dysfunction, or those taking strong CYP3A4 inhibitors should not take this medication. Patients at high risk of bleeding, those scheduled for surgery, those with bradycardia symptoms, those with dyspnea, those at risk of central sleep apnea, and patients with ischemic stroke should use this medication with caution. In particular, patients with asthma or chronic obstructive pulmonary disease may experience more frequent dyspnea, so caution is needed. This medication may interact with several other drugs, so it is essential to inform the doctor or pharmacist if any other medications are being taken. Women who are pregnant or breastfeeding should avoid using this medication, and women of childbearing age should use appropriate contraception to avoid pregnancy. In case of overdose, the risk of bleeding may increase, and there is no specific antidote, so immediate medical attention is required. Dizziness or confusion may occur while taking this medication, so caution is advised during driving or operating machinery. This medication has not been established for safety and effectiveness in children. Older adults or patients with impaired kidney function require regular kidney function tests.

Side effects

Bleeding, intracranial hemorrhage, ocular hemorrhage, ear bleeding, hypotension, respiratory distress, respiratory tract bleeding, gastrointestinal bleeding, diarrhea, nausea, dyspepsia, constipation, retroperitoneal bleeding, skin bleeding, rash, pruritus, muscle bleeding, urinary tract bleeding, reproductive tract bleeding, post-procedural bleeding, traumatic bleeding, thrombotic thrombocytopenic purpura, bradycardia arrhythmia, atrioventricular block, angioedema, confusion, dizziness, syncope, headache, vertigo, ear bleeding, elevated blood creatinine, chest pain, cough, pulmonary bleeding, pharyngitis, upper respiratory infection, asthma, pleural effusion, bronchitis, pneumothorax, pneumonia, pulmonary edema, weakness, anaphylactic shock, nasal bleeding, hemoptysis, hematoma, cerebral hemorrhage, spinal canal stenosis, dementia, migraine, paralysis, gait abnormalities, rectal bleeding, anal bleeding, appendicitis, tendon disease, bursitis, rhabdomyolysis, diabetes, hyperkalemia, hyperglycemia, thirst, worsening of diabetes, hepatitis, snoring, aneurysm, heart failure, cardiac rhythm disturbance, palpitations, ventricular tachycardia, arrhythmia, ventricular fibrillation, cardiac arrest, ventricular fibrillation, urinary tract infection, kidney stones, cerebral ischemia, venous stenosis, cerebral infarction, arterial stenosis, angina, coronary thrombosis, myocardial ischemia, anemia, vestibular disorders, malignant neoplasm of the male reproductive system, chemical poisoning, post-procedural hematoma, laceration, traffic accident, trauma, nausea, vomiting, acute renal failure, worsening hypertension, atrial fibrillation, atrial arrhythmia, frequent urination, dysuria, urinary tract infection, urinary retention, azotemia, intermittent claudication, conjunctivitis, diabetic retinopathy, cataract, arterial stenosis, cardiomyopathy, cardiac tamponade, pericardial effusion, abscess, fungal infection, oral candidiasis, herpes zoster, bacterial infection, esophageal candidiasis, reduced blood iron, tinnitus, ear pain, lymphadenopathy, eosinophilia, sexual dysfunction, benign prostatic hyperplasia, ovarian cysts, amenorrhea, vaginitis, loss of taste, abnormal sense of smell, increased TSH, hypothyroidism, injection site reaction, injection site pain, insomnia, anxiety, memory impairment, erectile dysfunction, restlessness, orthostatic hypotension, palpitations, bradycardia, conjunctival congestion, ocular pain, visual disturbances, photophobia, atrial fibrillation, ventricular tachycardia, ventricular fibrillation, frequent urination, acute renal failure, dysuria, urinary tract infection, pharyngitis, sputum disease, rhinitis, upper respiratory infection, throat irritation, back pain, myalgia, skeletal pain, joint pain, urticaria, hypokalemia, hypocalcemia, hyperkalemia, hypomagnesemia, elevated AST, elevated ALT, insomnia, anxiety, palpitations, bradycardia, atrial fibrillation, palpitations

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. It is best to maintain the storage temperature between 1 degree and 30 degrees Celsius at room temperature. This helps to preserve the effectiveness and safety of the medication.

Appearance and packaging

Appearance

Pink, round, biconvex film-coated tablet

Package unit

60 tablets/PTP [10 tablets/PTP X 6]

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.