Medication info

Tigrelia Tablet 60 mg (Ticagrelor)

Prescription medicationApproval withdrawn
Ingredient · strength
Ticagrelor›Strength being verified
Manufacturer / importer
Ellison Pharmaceuticals Co., Ltd.
Appearance
Pink, double-convex, round film-coated tablet
Packaging
60 tablets (10 tablets/PTP x 6)
Approval status
Approval withdrawn

MFDS item code 202003563 · Approved 2020.05.15

This product's status changed to Approval withdrawn on 2023.07.18. 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 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 this medicine at 90mg 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 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. 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 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 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 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 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 (refer to “Other”).

Ingredients

Manufacturer
Ellison Pharmaceuticals 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
  • risk of thrombotic cardiovascular events
  • type 2 diabetes
  • coronary artery disease
  • acute ischemic stroke
  • transient ischemic attack
View approved original text

This medication is primarily used to reduce the risk of thrombotic cardiovascular events. It may be administered with aspirin to reduce the incidence of cardiovascular-related death, myocardial infarction, and stroke. It is particularly effective for patients with acute coronary syndrome or those with a history of myocardial infarction more than 1 year ago. Additionally, it is used in patients with type 2 diabetes who have no history of myocardial infarction or stroke and have undergone coronary intervention due to coronary artery disease. In patients with acute ischemic stroke or high-risk transient ischemic attacks, it may be combined with aspirin to reduce the incidence of stroke. This drug improves patients' health by preventing the occurrence of thrombotic cardiovascular events.

Dosage and Administration

Adult dosage

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 this medicine at 90mg 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 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. 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 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 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 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 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 (refer to “Other”).

Precautions

This medication prevents platelet aggregation in the blood, thus preventing clot formation. Therefore, it should not be used in patients with current bleeding or a history of bleeding disorders due to an increased risk of bleeding. If surgical procedures are planned, this medication should be discontinued at least 5 days prior. It is not indicated for patients with severe liver dysfunction or allergies to the medication. In addition, patients with compromised liver or kidney function, the elderly, and those on specific medications should use this drug cautiously. Extra care is needed when taking other medications that increase the risk of bleeding alongside this drug. Patients with asthma or chronic obstructive pulmonary disease should be cautious when taking this drug, as breathing difficulties may occur. Pregnant or nursing women should consult with a physician before taking this drug, and women of childbearing age should avoid pregnancy during the treatment period. Safety and efficacy have not been established for patients under 18 years of age. Overdose may increase the risk of bleeding, and there are no specific antidotes to manage it. If symptoms such as dizziness or confusion occur during treatment, caution should be exercised when driving or operating machinery. Since this drug is metabolized in the liver, care is needed in patients with reduced liver function or in combination with specific liver metabolic inhibitors. This drug may also interact with various other medications, so patients must inform their healthcare provider of any other medications they are taking.

Side effects

  • Hemorrhage
  • intracranial hemorrhage
  • ocular hemorrhage
  • ear hemorrhage
  • hypotension
  • dyspnea
  • respiratory tract hemorrhage
  • gastrointestinal hemorrhage
  • diarrhea
  • nausea
Show 183 more
  • dyspepsia
  • constipation
  • retroperitoneal hemorrhage
  • skin hemorrhage
  • rash
  • pruritus
  • muscle hemorrhage
  • urinary tract hemorrhage
  • genital tract hemorrhage
  • post-procedural hemorrhage
  • traumatic hemorrhage
  • thrombotic thrombocytopenic purpura
  • bradyarrhythmia
  • atrioventricular block
  • angioedema
  • confusion
  • dizziness
  • syncope
  • headache
  • vertigo
  • ear hemorrhage
  • elevated serum creatinine
  • chest pain
  • pulmonary hemorrhage
  • pharyngitis
  • upper respiratory infection
  • asthma
  • pleural effusion
  • bronchitis
  • pneumothorax
  • pneumonia
  • pulmonary edema
  • myasthenia
  • anaphylactic shock
  • epistaxis
  • hemoptysis
  • hematoma
  • cerebral hemorrhage
  • spinal stenosis
  • dementia
  • migraine
  • paralysis
  • gait abnormalities
  • rectal hemorrhage
  • anal hemorrhage
  • appendicitis
  • tendinitis
  • bursitis
  • diabetes
  • hyperkalemia
  • hyperglycemia
  • hepatitis
  • snoring
  • aneurysm
  • heart failure
  • palpitations
  • ventricular tachycardia
  • arrhythmia
  • ventricular fibrillation
  • cardiac arrest
  • myocardial infarction
  • urinary tract infection
  • kidney stones
  • cerebral ischemia
  • venous stenosis
  • cerebral infarction
  • anemia
  • vestibular disorder
  • malignant male genital neoplasm
  • chemical poisoning
  • post-procedural hematoma
  • laceration
  • road traffic accident
  • trauma
  • nausea
  • vomiting
  • acute renal failure
  • hyperuricemia
  • gout
  • coma
  • speech impairment
  • brain hypoxia
  • scalp tenderness
  • peripheral neuropathy
  • cervical stiffness
  • vocal disorders
  • seizures
  • neuropathy
  • neuralgia
  • movement disorders
  • tremors
  • lower limb paralysis
  • oral pain
  • gastroenteritis
  • belching
  • irritable bowel syndrome
  • stomatitis
  • ulcerative stomatitis
  • benign gastrointestinal neoplasm
  • dental disease
  • tongue disease
  • tendinopathy
  • arthropathy
  • chondrocalcinosis
  • spondyloarthritis
  • arthritis
  • contact dermatitis
  • fungal dermatitis
  • skin diseases
  • erythematous rash
  • hyperkeratosis
  • acute urticaria
  • onychomycosis
  • hair loss
  • scleroderma
  • dermatofibroma
  • increased sweating
  • hyperlipidemia
  • hypertriglyceridemia
  • hypercholesterolemia
  • lipodystrophy
  • dehydration
  • hepatitis
  • cholelithiasis
  • gallbladder disease
  • increased alkaline phosphatase
  • fatty liver
  • drowsiness
  • neurosis
  • depression
  • hallucinations
  • memory impairment
  • erectile dysfunction
  • anxiety
  • orthostatic hypotension
  • worsening hypertension
  • cyanosis
  • atrial fibrillation
  • atrial arrhythmia
  • complete atrioventricular block
  • urinary incontinence
  • nocturia
  • worsening chronic renal failure
  • cystitis
  • urinary abnormalities
  • renal cyst
  • benign renal neoplasm
  • urinary retention
  • azotemia
  • intermittent claudication
  • conjunctivitis
  • diabetic retinopathy
  • cataract
  • cardiomyopathy
  • cardiac compression syndrome
  • pericardial effusion
  • abscess
  • oral candidiasis
  • herpes zoster
  • bacterial infection
  • esophageal candidiasis
  • decreased blood iron
  • tinnitus
  • ear pain
  • lymphadenopathy
  • eosinophilia
  • leukocytosis
  • sexual dysfunction
  • benign prostatic hyperplasia
  • ovarian cyst
  • amenorrhea
  • vaginitis
  • loss of taste
  • olfactory dysfunction
  • increased TSH
  • hypothyroidism
  • injection site reaction
  • injection site pain
  • concussion
  • intervertebral disc disease
  • non-drug allergy
  • septal deviation
  • surgical site reaction

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and it is important to maintain the storage temperature between 1 and 30 degrees Celsius. Therefore, it should be kept in a cool, dry place until use, and exposure to direct sunlight or high temperatures should be avoided.

Appearance and packaging

Appearance

Pink, double-convex, round film-coated tablet

Package unit

60 tablets (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.

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.