TICAGRELOR tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

TICAGRELOR (UNII: GLH0314RVC) (TICAGRELOR - UNII:GLH0314RVC)

Boleh didapati daripada:

Amneal Pharmaceuticals NY LLC

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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

Ringkasan produk:

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].

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

TICAGRELOR- TICAGRELOR TABLET
Amneal Pharmaceuticals NY LLC
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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

Ciri produk

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