Posology : מינונים

4.2   Posology and method of administration

Posology
Patients taking BRILINTA should also take ASA daily, unless specifically contraindicated.
Following an initial dose of ASA, BRILINTA should be used with a maintenance dose of ASA of 75-150 mg (see section 5.1).
Acute coronary syndromes
BRILINTA treatment should be initiated with a single 180 mg loading dose (two tablets of 90 mg) and then continued at 90 mg twice daily.

Treatment with Brilinta 90mg twice daily is recommended for up to 12 months in ACS patinets unless discontinuation is clinically indicated (see section 5.1).

History of myocardial infarction
Brilinta 60 mg twice daily is the recommended dose when an extended treatment is required for patients with a history of MI of at least one year and a high risk of an atherothrombotic event (see section 5.1). Treatment may be started without interruption as continuation therapy after the initial one-year treatment with Brilinta 90 mg or other adenosine diphosphate (ADP) receptor inhibitor therapy in ACS patients with a high risk of an atherothrombotic event. Treatment can also be initiated up to 2 years from the MI, or within one year after stopping previous ADP receptor inhibitor treatment. There are limited data on the efficacy and safety of ticagrelor beyond 3 years of extended treatment. Therefore, Brilinta should not be used for more than 36 months.


If a switch is needed, the first dose of Brilinta should be administered 24 hours following the last dose of the other antiplatelet medication.

Missed dose
Lapses in therapy should also be avoided. A patient who misses a dose of BRILINTA should take only one tablet (their next dose) at its scheduled time.

Special populations

Elderly
No dose adjustment is required in elderly (see section 5.2).
Renal impairment
No dose adjustment is necessary for patients with renal impairment (see section 5.2).

Hepatic impairment
BRILINTA has not been studied in patients with severe hepatic impairment and its use in patients is therefore contraindicated (see section 4.3, 4.4 and 5.2). Only limited information is available in patients with moderate hepatic impairment. Dose adjustment is not recommended, but ticagrelor should be used with caution (see sections 4.4 and 5.2). No dose adjustment is necessary for patients with mild hepatic impairment (see section 5.2).

Paediatric population
The safety and efficacy of BRILINTA in children below the age of 18 years have not been established. No data are available.

Method of administration
For oral use.
BRILINTA can be administered with or without food.
For patients who are unable to swallow the tablet(s) whole, the tablets can be crushed to a fine powder and mixed in half a glass of water and drunk immediately. The glass should be rinsed with a further half glass of water and the contents drunk. The mixture can also be administered via a nasogastric tube (CH8 or greater). It is important to flush the nasogastric tube through with water after administration of the mixture.