Medication info

Btawon Tablet 60mg (Ticagrelor)

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

MFDS item code 201902016 · Approved 2019.04.03

This product's status changed to Expired on 2024.04.03. 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 takes it
Adults · Children
Adult dose
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 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. - 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 relevant dosage and administration instructions. - Data on the safety and efficacy of this medicine when administered for 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 it. Rinse the cup used with another half glass of water and drink that as well. 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 to this medicine from another antiplatelet agent, 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 in patients with moderate hepatic impairment is limited.
Child dose
Safety and efficacy have not been established in pediatric patients under 18 years of age (see the “Other” section).

Ingredients

Manufacturer
Medix Pharmaceutical Co., Ltd.

Efficacy & effects

Prevention of thrombotic cardiovascular events (e.g., myocardial infarction) and stroke

  • Acute coronary syndrome
  • thrombotic cardiovascular events
  • myocardial infarction
  • stroke
  • coronary artery disease
  • acute ischemic stroke
  • transient ischemic attack
View approved original text

This medication helps reduce the incidence of thrombotic cardiovascular events when used with aspirin in adult patients. It is particularly effective in patients with acute coronary syndrome or those with a history of myocardial infarction for more than a year who are at high risk for thrombotic events. It also contributes to the reduction of the risk of myocardial infarction and stroke in patients with type 2 diabetes who have undergone interventions for coronary artery disease. In cases of acute ischemic stroke or high-risk transient ischemic attacks, it can also reduce the incidence of stroke when used in conjunction with aspirin. Therefore, this drug is useful in preventing cardiovascular events in various high-risk patients associated with thrombotic cardiovascular events.

How to take

Adult dose

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 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. - 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 relevant dosage and administration instructions. - Data on the safety and efficacy of this medicine when administered for 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 it. Rinse the cup used with another half glass of water and drink that as well. 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 to this medicine from another antiplatelet agent, 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 in patients with moderate hepatic impairment is limited.

Child dose

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

Precautions

This medication is used to prevent platelets from aggregating in the blood to reduce the risk of cardiovascular diseases such as myocardial infarction or stroke. Since there is a risk of bleeding, this medication should not be administered to patients who already have bleeding or a history of intracranial hemorrhage. Particularly, if surgery is planned, this medication should be discontinued at least 5 days prior to the procedure. If symptoms of bleeding occur, immediately inform a doctor and, if possible, it is advisable to treat the bleed without discontinuing the medication. It should be avoided in patients who are hypersensitive to this drug, have severe liver dysfunction, or are taking certain strong medications. Patients at high risk of bleeding or who are taking medications that may cause bleeding should use this medication cautiously. Bradycardia or respiratory distress symptoms may occur, so caution is needed in those with these symptoms or at high risk. Elderly patients or those with reduced kidney function should receive regular kidney function tests, and patients with a history of hyperuricemia or gout should also use caution. This medication can interact with multiple drugs, so patients taking other medications must consult with a doctor or pharmacist. Pregnant or breastfeeding women may face risks when taking this medication, so professional consultation before use is necessary. In cases of overdose, the risk of bleeding may increase, and since there are no specific antidotes, immediate medical attention is required. This medication has not been established for safety and efficacy in children and is not recommended for them. If symptoms such as dizziness or confusion occur while taking this medication, it is advisable to avoid driving or operating machinery. Store the medication out of reach of children and keep it in its original container for safety.

Side effects

Hemorrhage, intracranial hemorrhage, ocular hemorrhage, auricular hemorrhage, hypotension, dyspnea, respiratory tract hemorrhage, gastrointestinal hemorrhage, diarrhea, nausea, dyspepsia, constipation, retroperitoneal hemorrhage, subcutaneous or cutaneous hemorrhage, rash, pruritus, muscular hemorrhage, urinary tract hemorrhage, reproductive tract hemorrhage, elevated serum creatinine, post-procedural hemorrhage, traumatic hemorrhage, thrombotic thrombocytopenic purpura, bradyarrhythmia, atrioventricular block, angioedema, Cheyne-Stokes respiration, central sleep apnea, confusion, dizziness, syncope, headache, vertigo, auricular hemorrhage, chest pain, pulmonary hemorrhage, pharyngitis, upper respiratory infection, asthma, pleural effusion, bronchitis, pneumothorax, pneumonia, pulmonary edema, asthenia, anaphylactic shock, nasal hemorrhage, hemoptysis, hematoma, cerebral hemorrhage, spinal canal stenosis, dementia, migraine, paralysis, gait abnormalities, rectal hemorrhage, anal hemorrhage, appendicitis, tendinopathy, bursitis, rhabdomyolysis, acute renal failure, aneurysm, heart failure, cardiac rhythm disorder, palpitations, ventricular tachycardia, arrhythmia, ventricular fibrillation, cardiac arrest, ventricular fibrillation, urinary tract infection, kidney stone, cerebral ischemia, venous stenosis, cerebral infarction, arterial stenosis, angina, coronary thrombosis, myocardial ischemia, fungal infection, anemia, vestibular dysfunction, malignant male reproductive system neoplasm, chemical poisoning, post-procedural hematoma, laceration, road traffic accident, trauma, oral edema, influenza-like syndrome, tuberculosis bacillus infection, hyperthermia, unspecified hernia, suffocation, generalized edema, thrombosis, deep vein thrombosis, cardiac thrombosis, coagulopathy, thrombocytosis, speech disorder, cerebral hypoxia, scalp tenderness, peripheral neuropathy, neck stiffness, speech impairment, seizure, neuropathy, neuralgia, movement disorders, tremor, lower limb paralysis, coma, sensory loss, oral pain, gastroenteritis, belching, irritable bowel syndrome, stomatitis, ulcerative stomatitis, benign gastrointestinal neoplasm, dental disease, tongue disease, tendonitis, osteoarthritis, chondrocalcinosis, spinal osteoarthritis, arthritis, contact dermatitis, fungal dermatitis, skin disease, erythematous rash, hyperkeratosis, acute urticaria, onychomycosis, hair loss, scleroderma, dermatofibroma, increased sweating, hyperlipidemia, hypertriglyceridemia, diabetes exacerbation, hypercholesterolemia, lipodystrophy, dehydration, hepatitis, cholelithiasis, gallbladder disease, alkaline phosphatase increase, fatty liver, drowsiness, neurosis, depression, snoring, hallucinations, orthostatic hypotension, hypertension exacerbation, cyanosis, palpitations, bradycardia, atrial fibrillation, frequent urination, acute renal failure, dysuria, urinary tract infection, ocular congestion, eye pain, visual disturbances, arterial stenosis, myocardial infarction, decreased blood iron, tinnitus, ear pain, vestibular dysfunction, lymphadenopathy, eosinophilia, sexual dysfunction, prostate hypertrophy, ovarian cyst, amenorrhea, vaginitis, loss of taste, olfactory dysfunction, increased TSH, hypothyroidism, injection site reaction, injection site pain, palpitations, bradycardia, atrial fibrillation

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 sealed container. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve the drug's effectiveness and safety for a long time.

Appearance and packaging

Appearance

Pink, biconvex, round film-coated tablet

Package unit

60 tablets/box [(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.