Ticagrelor 90 mg Tablets

Adult dose

Do not use this medicine 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. In patients with acute coronary syndrome who have an increased risk of bleeding and have undergone percutaneous coronary intervention (PCI), monotherapy with this medicine (discontinuation of aspirin) may be considered after 3 months of concomitant treatment with this medicine and aspirin. (See section 3, Patients Requiring Caution, in Precautions for Use.) 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 were taking 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 this medicine when administered 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 in patients with acute ischemic stroke or high-risk transient ischemic attack. Method of administration This medicine is administered orally and may be taken with or without food. ㆍPatients who have difficulty swallowing tablets may crush this medicine into a fine powder, disperse it in half a glass of water, and drink the mixture 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. ㆍIf 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 there is limited experience with its use in patients with moderate hepatic impairment.

Child dose

The safety and efficacy of this medicine in pediatric patients younger than 18 years have not been established (see section Other).

This medication prevents the aggregation of platelets in the blood to prevent thrombus formation. However, it may increase the risk of bleeding, and thus should not be used in patients with active bleeding or a history of bleeding disorders. It is recommended to stop taking this medication at least 5 days prior to a scheduled surgery for safety. Additionally, if symptoms of hypotension occur while on this medication, the possibility of bleeding should be suspected, and it is advisable to continue treatment while managing bleeding if necessary. Stopping this medication suddenly may increase the risk of cardiovascular problems, so caution is warranted. Patients with severely impaired liver function or those taking strong CYP3A4 inhibitors such as certain antibiotics and antivirals should not use this medication. Patients at high risk of bleeding or those taking medications that may induce bleeding should use this medication with caution. In particular, the risk of bleeding may increase when used in combination with non-steroidal anti-inflammatory drugs, anticoagulants, or high doses of aspirin. Special caution is needed for patients scheduled for surgery, those with bradycardia, asthma, or chronic obstructive pulmonary disease. Dyspnea may occur, so if such symptoms arise, immediate consultation with medical personnel is advised. It is best for women who are pregnant or breastfeeding to avoid this medication, and fertile women should try to avoid pregnancy during the treatment. The safety and efficacy of this medication have not been established in children and adolescents under 18 years of age, so it is not recommended for them. Overdosing on this medication increases the risk of bleeding, so immediate medical assistance should be sought, and currently, there are no known antidotes for this medication. This medication can interact with various other drugs, so any other medications being taken should be disclosed to medical personnel. Caution is needed while driving or operating machinery as dizziness or confusion may occur. Patients should vigilantly monitor for symptoms of bleeding, dyspnea, abnormal heart rhythms, and other unusual symptoms during treatment.

• Hemorrhage
• intracranial hemorrhage
• ocular hemorrhage
• ear hemorrhage
• hypotension
• dyspnea
• respiratory tract hemorrhage
• gastrointestinal hemorrhage
• diarrhea
• nausea

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to maintain storage temperature between 1 and 30 degrees Celsius.

Appearance

Yellow, round, biconvex film-coated tablet

Package unit

60 tablets/box [10 tablets/PTP*6]