Medication info

Tigrelia Tablets 90mg (Ticagrelor)

Prescription medicationApproval withdrawn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Approval withdrawn

MFDS item code 202003770 · Approved 2020.05.22

This product's status changed to Approval withdrawn on 2023.07.18.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 (such as myocardial infarction and stroke)
Who uses it
Adults · Children
Adult dosage
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. 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 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 discontinuation of 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 dosage and administration for that condition. Data on the safety and efficacy of this medicine for use beyond 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 tube with water after administration. If switching from another antiplatelet agent to this medicine, start this medicine 24 hours after the last dose of the previous medication. 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
Pediatric patients under 18 years of age: Safety and efficacy have not been established (see the ‘Other’ section).

Ingredients

Manufacturer
Erisun Pharmaceutical Co., Ltd.

Efficacy & effects

Prevention of thrombotic cardiovascular events (such as myocardial infarction and stroke)

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

This medication is used to reduce the incidence of thrombotic cardiovascular events, such as death due to cardiovascular issues, myocardial infarction, and stroke. It is particularly effective when combined with aspirin in patients with acute coronary syndrome and high-risk patients with a history of myocardial infarction. Additionally, it is effective in reducing the incidence of myocardial infarction or stroke in patients with type 2 diabetes who have undergone PCI for coronary artery disease. It also reduces the incidence of stroke when used in conjunction with aspirin in patients with acute ischemic stroke or high-risk transient ischemic attack. This medication is utilized for the prevention of thrombotic cardiovascular events in various high-risk patient groups.

Dosage and Administration

Adult dosage

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. 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 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 discontinuation of 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 dosage and administration for that condition. Data on the safety and efficacy of this medicine for use beyond 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 tube with water after administration. If switching from another antiplatelet agent to this medicine, start this medicine 24 hours after the last dose of the previous medication. 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

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

Precautions

This medication is an antiplatelet agent that prevents the formation of blood clots by inhibiting platelet aggregation. However, it may increase the risk of bleeding; hence, it should not be used in patients with a pathological active bleeding condition or a history of intracranial hemorrhage. Patients scheduled for surgery must discontinue this medication at least 5 days prior to the procedure, and any signs of bleeding should be immediately reported to healthcare professionals. It should not be administered to patients with hypersensitivity to this drug, severe liver dysfunction, or in combination with certain strong medications. Patients at high risk of bleeding or those scheduled for surgery, as well as those with arrhythmias or symptoms of dyspnea should use this medication with caution. Specifically, patients with asthma or chronic obstructive pulmonary disease may experience worsening of dyspnea and thus require careful monitoring. While taking this medication, be alert for signs of bleeding such as easy bruising, nosebleeds, or gum bleeding. Furthermore, this drug may affect liver and kidney function, necessitating regular monitoring. Women who are pregnant or nursing should avoid this medication, and those planning to become pregnant should employ appropriate contraception methods. Elderly patients or those with impaired kidney function require special attention; while dosage adjustment is usually not necessary, consulting with healthcare providers is advisable. There may be interactions with other medications; therefore, inform your healthcare provider of any concurrent drug use, especially in cases of certain antibiotics, antifungals, and antivirals, which should be avoided. Overdose may increase the risk of bleeding, so seek immediate medical attention, as this drug is not removed through dialysis, necessitating prompt treatment. Lastly, while on this medication, dizziness or confusion may occur; exercise caution when driving or operating machinery.

Side effects

Bleeding, intracranial hemorrhage, ocular hemorrhage, ear bleeding, hypotension, dyspnea, respiratory tract bleeding, gastrointestinal bleeding, diarrhea, nausea, dyspepsia, constipation, retroperitoneal hemorrhage, skin bleeding, rash, pruritus, muscle bleeding, urinary tract bleeding, reproductive bleeding, post-procedure bleeding, traumatic bleeding, thrombotic thrombocytopenic purpura, bradyarrhythmia, atrioventricular block, angioedema, Cheyne-Stokes respiration, central sleep apnea, confusion, dizziness, syncope, headache, vertigo, elevated serum creatinine, hyperuricemia, gout, chest pain, cough, pulmonary hemorrhage, pharyngitis, upper respiratory infection, asthma, pleural effusion, bronchitis, pneumothorax, pneumonia, pulmonary edema, weakness, anaphylactic shock, epistaxis, hemoptysis, hematoma, cerebral hemorrhage, spinal canal stenosis, dementia, migraine, paralysis, gait disturbance, rectal bleeding, anal bleeding, appendicitis, tendon diseases, bursitis, rhabdomyolysis, diabetes mellitus, hyperkalemia, hyperglycemia, thirst, worsening of diabetes mellitus, hepatitis, snoring, aneurysm, heart failure, palpitations, ventricular tachycardia, arrhythmia, ventricular fibrillation, cardiac arrest, ventricular fibrillation, urinary tract infection, kidney stones, cerebral ischemia, venous stenosis, cerebral infarction, arterial stenosis, angina pectoris, coronary thromboembolism, myocardial ischemia, anemia, vestibular dysfunction, malignant neoplasm of the male reproductive system, chemical toxicity, post-procedure hematoma, laceration, traffic accident, trauma, oral edema, flu-like syndrome, tuberculosis infection, hyperthermia, unspecified hernia, shortness of breath, generalized edema, thrombosis, deep vein thrombosis, cardiac thrombosis, coagulation disorders, thrombocytosis, speech disorders, cerebral hypoxia, scalp tenderness, peripheral neuropathy, neck stiffness, voice disorders, seizures, neuropathy, neuralgia, movement disorders, tremors, lower limb paralysis, coma, sensory loss, oral pain, gastritis, belching, irritable bowel syndrome, stomatitis, ulcerative stomatitis, benign gastrointestinal neoplasm, dental diseases, tongue diseases, tendinitis, arthropathy, chondrocalcinosis, spinal osteoarthritis, 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, memory disorders, erectile dysfunction, anxiety, orthostatic hypotension, worsening hypertension, cyanosis, atrial fibrillation, cardiac arrest, complete atrioventricular block, polyuria, dysuria, urinary tract infection, urinary retention, azotemia, intermittent claudication, ocular congestion, eye pain, visual disturbances, cardiomyopathy, cardiac compression, pericardial effusion, abscess, oral candidiasis, herpes zoster, bacterial infection, esophageal candidiasis, anemia of blood iron deficiency, tinnitus, ear pain, lymphadenopathy, eosinophilia, leukocytosis, sexual dysfunction, benign prostatic hyperplasia, ovarian cyst, amenorrhea, vaginitis, anosmia, hyposmia, increased TSH, hypothyroidism, injection site reaction, injection site pain

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

Storage

Store this medication in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1°C and 30°C. Proper storage helps to preserve the medication's efficacy and safety.

Appearance and packaging

Appearance

Yellow, double-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

No questions yet.

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

Related searches

Search tags

Suggested searches

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.