BRILINTA™ (ticagrelor) tablets
| HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use BRILINTA safely and effectively. See full prescribing information for BRILINTA.
BRILINTA™ (ticagrelor) tablets, for oral use
BRILINTA contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor.
| Mechanism of Action
Ticagrelor and its major metabolite reversibly interact with the platelet P2Y12 ADP-receptor to prevent signal transduction and platelet activation. Ticagrelor and its active metabolite are approximately equipotent.
Indications and usage
| INDICATIONS AND USAGE
Acute Coronary Syndromes
BRILINTA has been studied in ACS in combination with aspirin. Maintenance doses of aspirin above 100 mg decreased the effectiveness of BRILINTA. Avoid maintenance doses of aspirin above 100 mg daily
| WARNINGS AND PRECAUTIONS:
| ADVERSE REACTIONS
Most common adverse reactions are bleeding 12% and dyspnea 14%.
To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Dosage and administration
| DOSAGE AND ADMINISTRATION
Initiate BRILINTA treatment with a 180 mg (two 90 mg tablets) loading dose and continue treatment with 90 mg twice daily.
After the initial loading dose of aspirin (usually 325 mg), use BRILINTA with a daily maintenance dose of aspirin of 75-100 mg.
ACS patients who have received a loading dose of clopidogrel may be started on BRILINTA.
BRILINTA can be administered with or without food.
A patient who misses a dose of BRILINTA should take one 90 mg tablet (their next dose) at its scheduled time.
| HOW SUPPLIED/STORAGE AND HANDLING
BRILINTA (ticagrelor) 90 mg is supplied as a round, biconvex, yellow, film-coated tablet marked with a “90” above “T” on one side.
Bottles of 60 – NDC 0186-0777-60
Bottles of 180 – NDC 0186-0777-18
100 count Hospital Unit Dose – NDC 0186-0777-39
Storage and Handling
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°- 86°F) [see USP controlled room temperature].
Keep BRILINTA in the container it comes in.
Keep BRILINTA tablets dry.
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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