Indications, posology and method of administration
THERAPEUTIC INDICATIONS
Ticagrelor co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with:
- Acute coronary syndromes (ACS) or
- A history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Patients taking ticagrelor should also take a daily low maintenance dose of ASA 75 – 150 mg, unless specifically contraindicated.
Acute coronary syndromes:
Ticagrelor 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 ticagrelor 90 mg twice daily is recommended for 12 months in ACS patients unless discontinuation is clinically indicated History of myocardial infarction:
Ticagrelor 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. Treatment may be started without interruption as continuation therapy after the initial one-year treatment with ticagrelor 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.
If a switch is needed, the first dose of ticagrelor 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 ticagrelor should take only one tablet (their next dose) at its scheduled time.
Special populations
Elderly: No dose adjustment is required in elderly.
Renal impairment: No dose adjustment is necessary for patients with renal impairment.
Hepatic impairment: Ticagrelor has not been studied in patients with severe hepatic impairment and its use in these patients is therefore contraindicated. Only limited information is available in patients with moderate hepatic impairment. Dose adjustment is not recommended, but ticagrelor should be used with caution. No dose adjustment is necessary for patients with mild hepatic impairment.
Paediatric population: The safety and efficacy of ticagrelor in children below the age of 18 years have not been established. There is no relevant use of ticagrelor in children with sickle cell disease.
Method of administration:
For oral use.
Ticagrelor can be administered with or without food.
The orodispersible tablets may be used as an alternative to ticagrelor 90 mg film-coated tablets for patients who have difficulty swallowing the tablets whole or for whom there is a preference for orodispersible tablets. The tablet should be placed on the tongue, where it will rapidly disperse in saliva. It can then be swallowed with or without water. The tablet can also be dispersed in water and administered via a nasogastric tube (CH8 or greater). It is important to flush the nasogastric tube through with water after administration of the mixture. A 60 mg orodispersible tablet is not available.
CONTRAINDICATIONS
- Hypersensitivity to the active substance or to any of the excipients.
- Active pathological bleeding.
- History of intracranial haemorrhage.
- Severe hepatic impairment.
- Co-administration of ticagrelor with strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir), as co-administration may lead to a substantial increase in exposure to ticagrelor.
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