Medication info

Trilinta Tablet 90 mg (Ticagrelor)

Prescription medicationExpired
Ingredient · strength
Ticagrelor›Strength being verified
Manufacturer / importer
Jeil Pharmaceutical Co., Ltd.
Appearance
Yellow, bilaterally convex, round, film-coated tablet
Packaging
56 tablets (14 tablets/PTP x 4)
Approval status
Expired

MFDS item code 201801354 · Approved 2018.03.28

This product's status changed to Expired on 2023.03.28. 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 uses it
Adults · Children
Adult dosage
This medicine should not be used concomitantly 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 of this medicine is clinically necessary. Patients taking this medicine should also receive a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. 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. - For patients with acute coronary syndrome, refer to the corresponding dosage and administration instructions. - Data on the safety and efficacy of treatment with this medicine 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. 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. 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 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.
Children's dosage
Safety and efficacy have not been established in pediatric patients under 18 years of age (see ‘Other’ section).

Ingredients

Manufacturer
Jeil 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 syndromes
  • risk of thrombotic cardiovascular event occurrence
  • type 2 diabetes
  • coronary artery disease
  • acute ischemic stroke
  • transient ischemic attacks
View approved original text

This medicine helps reduce the occurrence of thrombotic cardiovascular events, such as death from cardiovascular causes, myocardial infarction, and stroke, in adult patients when used with aspirin. It is particularly beneficial for patients with acute coronary syndromes and those at high risk for thrombotic cardiovascular events who experienced a myocardial infarction more than a year ago. Additionally, it may lower the risk of myocardial infarction or stroke in patients with diabetes who have received treatment for coronary artery disease. It has also been shown to reduce the incidence of stroke in patients with acute ischemic stroke or high-risk transient ischemic attacks when used in conjunction with aspirin. This medication is used for the prevention of thrombotic cardiovascular events and strokes.

Dosage and Administration

Adult dosage

This medicine should not be used concomitantly 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 of this medicine is clinically necessary. Patients taking this medicine should also receive a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. 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. - For patients with acute coronary syndrome, refer to the corresponding dosage and administration instructions. - Data on the safety and efficacy of treatment with this medicine 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. 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. 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 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.

Children's dosage

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

Precautions

This medication inhibits platelet function, preventing blood from clotting. Therefore, the risk of bleeding may increase, and it should not be used in patients with active pathological bleeding or a history of intracranial hemorrhage. If surgery is planned, this medication should be discontinued at least 5 days before the procedure to reduce the risk of bleeding. During treatment, patients should consult a doctor immediately if symptoms of hypotension or bleeding occur, and it is preferable not to stop this medication during bleeding treatment. Patients who are allergic to this medication, have severe hepatic impairment, or are taking strong CYP3A4 inhibitors should not use this medication. Special caution is warranted for patients at high risk of bleeding, recent trauma or surgery, or with coagulation disorders. Particular attention should be paid when taking this medication together with drugs that increase the risk of bleeding, such as non-steroidal anti-inflammatory drugs, oral anticoagulants, and high doses of aspirin. Caution is also required for patients with bradycardia or atrioventricular block or those taking such medications, as this drug may affect heart rhythm. Patients with asthma or chronic obstructive pulmonary disease may experience shortness of breath, and special caution is needed for patients with central sleep apnea, the elderly, and those with impaired renal function. The most common side effects of this medication are bleeding and shortness of breath, with bleeding potentially occurring in various areas, including the gastrointestinal tract, skin, muscles, and urinary system. In case of severe bleeding, notify healthcare professionals immediately, as discontinuation of the medication may be necessary due to bleeding. This medication may interact with various other drugs, so patients taking other medications should notify their physician or pharmacist and seek advice. Special attention is needed when combined with drugs that inhibit or induce the CYP3A4 enzyme and P-glycoprotein (P-gp) related medications. Women who are pregnant or breastfeeding should avoid this medication, and women of childbearing age should use appropriate contraception to avoid pregnancy while taking this medication. Its safety and efficacy have not been established in children or adolescents under the age of 18. In cases of overdose, the risk of bleeding may increase, and since there is no specific antidote, appropriate symptomatic treatment is required. This medication should be stored out of reach of children and kept in its original container for safety. Dizziness or confusion may occur while taking this medication, so caution is advised when driving or operating machinery.

Side effects

  • Hemorrhage
  • intracranial hemorrhage
  • ocular hemorrhage
  • ear hemorrhage
  • hypotension
  • dyspnea
  • respiratory tract hemorrhage
  • gastrointestinal hemorrhage
  • diarrhea
  • nausea
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  • dyspepsia
  • constipation
  • retroperitoneal hemorrhage
  • skin hemorrhage
  • rash
  • pruritus
  • muscle hemorrhage
  • urinary tract hemorrhage
  • reproductive system hemorrhage
  • elevated serum creatinine
  • post-procedural hemorrhage
  • traumatic hemorrhage
  • thrombocytopenic purpura
  • bradyarrhythmia
  • atrioventricular block
  • angioedema
  • Cheyne-Stokes respiration
  • central sleep apnea
  • confusion
  • dizziness
  • syncope
  • headache
  • vertigo
  • ear hemorrhage
  • chest pain
  • pulmonary hemorrhage
  • pharyngitis
  • upper respiratory infection
  • asthma
  • pleural effusion
  • bronchitis
  • pneumothorax
  • pneumonia
  • pulmonary edema
  • fatigue
  • anaphylactic shock
  • epistaxis
  • hemoptysis
  • hematoma
  • cerebral hemorrhage
  • spinal canal stenosis
  • dementia
  • migraine
  • paralysis
  • gait abnormalities
  • rectal hemorrhage
  • anal hemorrhage
  • appendicitis
  • tendinopathy
  • bursitis
  • rhabdomyolysis
  • diabetes mellitus
  • hyperkalemia
  • hyperglycemia
  • thirst
  • hepatitis
  • snoring
  • aneurysm
  • heart failure
  • cardiac rhythm disorders
  • 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 male genital neoplasm
  • chemical poisoning
  • post-procedural hematoma
  • laceration
  • road traffic accident
  • trauma
  • nausea
  • vomiting
  • acute renal failure
  • chest pain
  • insomnia
  • anxiety
  • memory disorders
  • erectile dysfunction
  • restlessness
  • orthostatic hypotension
  • cyanosis
  • atrial fibrillation
  • atrial arrhythmia
  • complete heart block
  • urinary incontinence
  • nocturia
  • exacerbation of chronic renal failure
  • cystitis
  • abnormal urination
  • frequent urination
  • dysuria
  • conjunctival hyperemia
  • ocular pain
  • visual disturbances
  • abscess
  • oral candidiasis
  • shingles
  • bacterial infection
  • esophageal candidiasis
  • decreased blood iron
  • tinnitus
  • ear pain
  • lymphadenopathy
  • eosinophilia
  • sexual dysfunction
  • benign prostatic hyperplasia
  • ovarian cyst
  • amenorrhea
  • vaginitis
  • loss of taste
  • altered sense of smell
  • increased TSH
  • hypothyroidism
  • injection site reaction
  • injection site pain
  • increased sweating
  • urticaria

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve the medication's efficacy.

Appearance and packaging

Appearance

Yellow, bilaterally convex, round, film-coated tablet

Package unit

56 tablets (14 tablets/PTP x 4)

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.