Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
TICAGRELOR (UNII: GLH0314RVC) (TICAGRELOR - UNII:GLH0314RVC)
Amneal Pharmaceuticals NY LLC
ORAL
PRESCRIPTION DRUG
Ticagrelor tablets are indicated to reduce the risk of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor tablets also reduce the risk of stent thrombosis in patients who have been stented for treatment of ACS [see Clinical Studies (14.1)] . Ticagrelor tablets are indicated to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events [see Clinical Studies (14.2)]. While use is not limited to this setting, the efficacy of ticagrelor tablets were established in a population with type 2 diabetes mellitus (T2DM). Ticagrelor tablets are contraindicated in patients with a history of intracranial hemorrhage (ICH) because of a high risk of recurrent ICH in this population [see Clinical Studies (14.1), (14.2)] . Ticagrelor tablets are contraindicated in patients with active pathological bleeding
Ticagrelor Tablets, 90 mg are supplied as yellow colored, round, biconvex film-coated tablets marked with “A” above “11” on one side and plain on the other side. They are available as follows: Bottles of 60: NDC 69238-1134-6 Bottles of 100: NDC 69238-1134-1 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
TICAGRELOR- TICAGRELOR TABLET Amneal Pharmaceuticals NY LLC ---------- MEDICATION GUIDE Ticagrelor (tye ka' grel or) Tablets What is the most important information I should know about ticagrelor tablets? Ticagrelor tablets are used to lower your chance of having a heart attack or dying from a heart attack or stroke but ticagrelor tablets (and similar drugs) can cause bleeding that can be serious and sometimes lead to death. In cases of serious bleeding, such as internal bleeding, the bleeding may result in the need for blood transfusions or surgery. While you take ticagrelor tablets: • you may bruise and bleed more easily • you are more likely to have nose bleeds • it will take longer than usual for any bleeding to stop Call your doctor right away, if you have any of these signs or symptoms of bleeding while taking ticagrelor tablets: • bleeding that is severe or that you cannot control • pink, red or brown urine • vomiting blood or your vomit looks like “coffee grounds” • red or black stools (looks like tar) • coughing up blood or blood clots Do not stop taking ticagrelor tablets without talking to the doctor who prescribes it for you. People who are treated with a stent, and stop taking ticagrelor tablets too soon, have a higher risk of getting a blood clot in the stent, having a heart attack, or dying. If you stop ticagrelor tablets because of bleeding, or for other reasons, your risk of a heart attack or stroke may increase. Your doctor may instruct you to stop taking ticagrelor tablets 5 days before surgery. This will help to decrease your risk of bleeding with your surgery or procedure. Your doctor should tell you when to start taking ticagrelor tablets again, as soon as possible after surgery. Taking ticagrelor tablets with aspirin Ticagrelor tablets are taken with aspirin. Talk to your doctor about the dose of aspirin that you should take with ticagrelor tablets. You should not take a dose of aspirin higher than 100 mg daily because it can affect how well ticagrelor tablets works. Do n Đọc toàn bộ tài liệu
TICAGRELOR- TICAGRELOR TABLET AMNEAL PHARMACEUTICALS NY LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TICAGRELOR TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TICAGRELOR TABLETS. TICAGRELOR TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2011 WARNING: (A) BLEEDING RISK, AND (B) ASPIRIN DOSE AND TICAGRELOR EFFECTIVENESS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. _ BLEEDING RISK TICAGRELOR, LIKE OTHER ANTIPLATELET AGENTS, CAN CAUSE SIGNIFICANT, SOMETIMES FATAL BLEEDING. (5.1, 6.1) DO NOT USE TICAGRELOR IN PATIENTS WITH ACTIVE PATHOLOGICAL BLEEDING OR A HISTORY OF INTRACRANIAL HEMORRHAGE. (4.1, 4.2) DO NOT START TICAGRELOR IN PATIENTS UNDERGOING URGENT CORONARY ARTERY BYPASS GRAFT SURGERY (CABG). (5.1, 6.1) IF POSSIBLE, MANAGE BLEEDING WITHOUT DISCONTINUING TICAGRELOR. STOPPING TICAGRELOR INCREASES THE RISK OF SUBSEQUENT CARDIOVASCULAR EVENTS. (5.4) ASPIRIN DOSE AND TICAGRELOR EFFECTIVENESS MAINTENANCE DOSES OF ASPIRIN ABOVE 100 MG DAILY REDUCE THE EFFECTIVENESS OF TICAGRELOR AND SHOULD BE AVOIDED. (2.3, 5.2, 14.1) RECENT MAJOR CHANGES Indications and Usage (1.2) 05/2020 Dosage and Administration (2.2) 05/2020 Warnings and Precautions (5.7) 10/2019 INDICATIONS AND USAGE Ticagrelor tablets are a P2Y platelet inhibitor indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor tablets also reduce the risk of stent thrombosis in patients who have been stented for treatment of ACS. (1.1) to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor tablets were established in a population with type 2 diabetes mellitus (T2DM). (1.2) DOSAGE AND ADMINISTRATION ACS or History of MI In the manageme Đọc toàn bộ tài liệu