Brilinta

Brilinta

Manufacturer:

AstraZeneca

Distributor:

DKSH
Concise Prescribing Info
Contents
Ticagrelor
Indications/Uses
60 mg: Prevention of thrombotic events (CV death, MI & stroke) in patients w/ history of MI (occurred at least 1 yr ago) & high risk of developing thrombotic event. 90 mg: Reduces risk of stroke in patients w/ acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). Prevention of thrombotic events (CV death, MI & stroke) in patients w/ acute coronary syndromes (ACS) [unstable angina, non-ST elevation MI (NSTEMI) or ST elevation MI (STEMI)] including patients managed medically & w/ percutaneous coronary intervention (PCI) or CABG.
Dosage/Direction for Use
60 mg History of MI (occurred at least 1 yr ago) 60 mg bid. Co-administer w/ ASA 75-150 mg daily during treatment unless specifically contraindicated. 90 mg Acute ischemic stroke or TIA Initially 180 mg single loading dose (two 90-mg tab) then continue at 90 mg bid for 30 days. ACS Initially 180 mg single loading dose (two 90-mg tab) then continue at 90 mg bid for at least 12 mth. Patient initiated on 90 mg bid may continue treatment w/ 60 mg bid w/o interruption after 1 yr. Co-administer w/ ASA 75-150 mg daily during treatment unless specifically contraindicated.
Administration
May be taken with or without food: For patients w/ difficulty swallowing, may crush tab into fine powd, mix in ½ glass of water & drink immediately. Rinse further w/ another ½ glass of water & drink contents. Mixt may be administered via nasogastric tube then flush w/ water afterwards.
Contraindications
Hypersensitivity. Active pathological bleeding. History of intracranial haemorrhage. Severe hepatic impairment.
Special Precautions
Discontinue treatment at least 5 days prior to any surgery; if patient reports new, prolonged or worsened dyspnoea. Central sleep apnoea including Cheyne-Stokes respiration; TTP. Patients w/ propensity to bleed (eg, due to recent trauma or surgery, active or recent GI bleeding, moderate hepatic impairment), at increased risk of trauma; history of MI w/ prior ischemic stroke; increased risk of bradycardic events (eg, patients w/o pacemaker w/ sick sinus syndrome, 2nd or 3rd degree AV block, or bradycardic-related syncope). Assess patient's clinical condition & concomitant medication as potential causes of bradyarrhythmic events & AV blocks prior to adjusting treatment. Avoid premature discontinuation. Concomitant use w/ medicinal products that may increase bleeding risk (eg, NSAIDs, oral anticoagulants &/or fibrinolytics); antifibrinolytic therapy (aminocaproic acid or tranexamic acid) &/or recombinant clotting factor VIIa. Not recommended to be used concomitantly w/ high dose ASA (>300 mg). Avoid co-administration w/ strong CYP3A4 inhibitors eg, ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir. False -ve results w/ platelet function test for heparin induced thrombocytopenia. May affect ability to drive & use machines. Moderate hepatic impairment. Pregnancy. Not recommended during lactation. Childn <18 yr.
Adverse Reactions
Blood disorder bleedings; hyperuricaemia; dyspnoea. Gout; dizziness, syncope; vertigo; hypotension; resp system bleedings; GI haemorrhage, diarrhoea, nausea; SC or dermal bleeding, pruritus; urinary tract bleeding; increased blood creatinine; post-procedural haemorrhage, traumatic bleedings.
Drug Interactions
Increased Cmax & AUC w/ strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir); moderate CYP3A4 inhibitors (eg, diltiazem), & P-gp & CYP3A inhibitor eg, cyclosporine. Decreased Cmax & AUC w/ CYP3A4 inducers eg, rifampin. Decreased exposure w/ other CYP3A4 inducers eg, phenytoin, carbamazepine & phenobarb. Increased Cmax & AUC of simvastatin, atorvastatin & digoxin.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AC24 - ticagrelor ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Presentation/Packing
Form
Brilinta FC tab 60 mg
Packing/Price
6 × 10's
Form
Brilinta FC tab 90 mg
Packing/Price
6 × 10's
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