Brilinta

Brilinta

Manufacturer:

AstraZeneca

Distributor:

Zuellig
Concise Prescribing Info
Contents
Ticagrelor
Indications/Uses
60 mg FC tab: Prevention of thrombotic events (CV death, MI & stroke) in patients w/ history of MI (occurred at least 1 yr ago) & high risk of developing a thrombotic event. 90 mg FC tab: 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 those managed medically & w/ percutaneous coronary intervention (PCI) or CABG.
Dosage/Direction for Use
60 mg FC tab MI (occurred at least 1 yr ago) 60 mg bid, may be given in combination w/ ASA 75-150 mg daily (unless specifically contraindicated). 90 mg FC tab ACS Initially 180 mg as single loading dose (two 90-mg tab), then continue at 90 mg bid. Duration of treatment: At least 12 mth. Patient initiated on 90 mg bid may continue treatment w/ 60 mg bid w/o interruption after 1 yr. May be given in combination w/ ASA 75-150 mg daily (unless specifically contraindicated).
Administration
May be taken with or without food: For patients w/ swallowing difficulties, crush tab to a fine powd & mix in ½ glass of water. Drink immediately. Rinse glass w/ another ½ glass of water & drink. Mixt may be administered via a nasogastric tube (≥CH8). Flush tube w/ water after administration.
Contraindications
Hypersensitivity. Active pathological bleeding. History of intracranial hemorrhage. Severe hepatic impairment.
Special Precautions
Increased risk for bleeding in patients w/ a propensity to bleed (eg, due to recent trauma, recent surgery, active or recent GI bleeding, or moderate hepatic impairment) or who are at increased risk of trauma; concomitant use of drugs that may increase risk of bleeding (eg, NSAIDS, oral anticoagulants &/or fibrinolytics w/in 24 hr of ticagrelor). Patients who require surgery. Discontinue treatment 5 days prior surgery in patients to undergo elective surgery & if antiplatelet effect is not desired. 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). Dyspnoea. Thrombotic thrombocytopenic purpura. False -ve results in platelet function test for heparin induced thrombocytopenia. Not recommended w/ high maintenance dose of ASA (>300 mg). Avoid co-administration w/ strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, nefazodone, ritonavir, & atazanavir). Avoid premature discontinuation of treatment. May affect ability to drive or operate machinery. 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/ ketoconazole, other strong CYP3A4 inhibitors (eg, clarithromycin, nefazodone, ritonavir, atazanavir), diltiazem, other moderate CYP3A4 inhibitors (eg, amprenavir, aprepitant, erythromycin, fluconazole, verapamil) & cyclosporine. Decreased Cmax & AUC w/ rifampin & other CYP3A4 inducers (eg, phenytoin, carbamazepine, phenobarb). Delayed & decreased exposure w/ morphine. Increased Cmax & AUC of simvastatin, atorvastatin & digoxin.
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
60's
Form
Brilinta FC tab 90 mg
Packing/Price
60's
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