Brilinta

Brilinta

Manufacturer:

AstraZeneca
Concise Prescribing Info
Contents
Ticagrelor
Indications/Uses
60 mg: Prevention of thrombotic events (CV death, MI, stroke) in patients w/ history of MI (MI occurred at least 1 yr ago) & a high risk of developing a thrombotic event. 90 mg: Co-administered w/ acetylsalicylic acid (ASA) for prevention of thrombotic events (CV death, MI & stroke) in patients w/ acute coronary syndromes (ACS) [unstable angina, non-ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI)] including patients managed w/ percutaneous coronary intervention (PCI) or CABG.
Dosage/Direction for Use
Acute coronary syndromes Initially, 180 mg loading dose (2 tab of 90 mg) followed by 90 mg twice daily w/ low maintenance dose of acetylsalicylic acid 75-100 mg daily unless specifically contraindicated. History of MI (occurred at least 1 yr ago) 60 mg twice daily when an extended treatment is required w/ low maintenance dose of acetylsalicylic acid 75-100 mg unless specifically contraindicated.
Administration
May be taken with or without food: For patients w/ swallowing difficulties, crush tab to a fine powd & mix in a ½ glass of water then drink immediately. Rinse the glass w/ another ½ glass of water & drink. Mixt may also be administered via nasogastric tube.
Contraindications
Hypersensitivity (eg, angioedema). History of intracranial haemorrhage. Active pathological bleeding eg, peptic ulcer or intracranial hemorrhage. Co-administration w/ strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir). Severe hepatic impairment.
Special Precautions
History of bleeding disorders, undergone percutaneous invasive procedures, recent coronary angiography, PCI, CABG & other surgical procedures. Patients at risk for bradycardic events, dyspnea. Discontinue therapy 5 days pre-op when possible. Treatment >1 yr is not recommended in patients w/ history of MI w/ prior ischaemic stroke. Concomitant administration of aspirin (>100 mg), chronic intake of NSAIDs, oral anticoagulants & fibrinolytics, high maintenance dose of acetylsalicylic acid (>300 mg) is not recommended. Avoid use w/ strong CYP3A inhibitors & potent CYP3A inducers. May increase creatinine levels. History of hyperuricaemia or gouty arthritis. Avoid abrupt discontinuation. Moderate hepatic impairment. Pregnancy & lactation. Childn. Elderly.
Adverse Reactions
Blood disorder, bleedings; hyperuricaemia; dyspnea. Gout/gouty arthritis; dizziness, syncope, headache; vertigo; hypotension; resp system bleedings; GI haemorrhage, diarrhoea, nausea, dyspepsia, constipation; SC or dermal bleeding, rash, pruritus; urinary tract bleeding; increased blood creatinine; post-procedural haemorrhage, traumatic bleedings.
Drug Interactions
Strong CYP3A inhibitors (eg, ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir & telithromycin). Potent CYP3A inducers (eg, rifampin, phenytoin, carbamazepine & phenobarb). Higher serum conc of simvastatin, lovastatin. Reduced effectiveness w/ >100 mg aspirin maintenance dose. Increased ticagrelor Cmax and AUC w/ cyclosporine. Monitor digoxin levels w/ initiation or any change in Brilinta therapy.
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
4 × 14's
Form
Brilinta FC tab 90 mg
Packing/Price
4 × 14's (Rp1,291,001/boks)
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