Brilinta

Brilinta

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Ticagrelor
Indications/Uses
60 mg: Co-administered w/ acetylsalicylic acid (ASA) for prevention of atherothrombotic events in adult patients w/ history of MI (occurred at least 1 yr ago) & high risk of developing atherothrombotic event. 90 mg: Co-administered w/ ASA for prevention of atherothrombotic events in adult patients w/ acute coronary syndromes (unstable angina, non-ST or ST elevation MI) including patients managed medically w/ percutaneous coronary intervention or CABG.
Dosage/Direction for Use
60 mg 60 mg bd w/ ASA 75-150 mg daily during treatment. 90 mg Initially, 180 mg as single loading dose, then continue at 90 mg bd followed by maintenance: ASA 75-150 mg daily. Duration of therapy: Up to 12 mth.
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. The mixt may be administered via a nasogastric tube (CH8 or greater). Flush tube w/ water after administration.
Contraindications
Hypersensitivity. Active pathological bleeding. History of intracranial haemorrhage. Co-administration w/ strong CYP3A4 inhibitors eg, ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir. Severe hepatic impairment.
Special Precautions
Not recommended in patients w/ history of MI w/ prior ischaemic stroke. Increased risk of bleeding eg, recent trauma or surgery, coagulation disorders, active or recent GI bleeding; active pathological bleeding, history of intracranial haemorrhage; sick sinus syndrome (w/o pacemaker), 2nd or 3rd degree AV block or bradycardic-related syncope; asthma &/or COPD; hyperuricaemia or gouty arthritis, uric acid neuropathy; thrombotic thrombocytopenia purpura. Interference w/ platelet function tests to diagnose heparin-induced thrombocytopenia. Routinely check renal function 1 mth after initiation of therapy. Discontinue use 5 days prior to elective surgery. Not recommended in co-administration w/ high maintenance dose ASA >300 mg. Concomitant use w/ NSAIDs, oral anticoagulants &/or fibrinolytics; antifibrinolytic therapy &/or recombinant factor VIIa; drugs inducing bradycardia; ARBs. Avoid premature discontinuation of treatment. May affect ability to drive & use machines. Moderate to severe renal & hepatic impairment. Women of childbearing potential should use effective contraception. Not recommended during pregnancy. Lactation. Childn <18 yr. Elderly ≥75 yr.
Adverse Reactions
Blood disorder bleedings; hyperuricaemia; dyspnoea. 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
Increased Cmax & AUC w/ strong CYP3A4 inhibitors eg, ketoconazole; moderate CYP3A4 inhibitors eg, diltiazem, amprenavir, aprepitant, erythromycin, fluconazole; cyclosporine. Decreased Cmax & AUC w/ CYP3A4 inducers eg, rifampicin. Decreased exposure w/ other CYP3A4 inducers eg, phenytoin, carbamazepine, phenobarb. Delayed & decreased exposure w/ morphine. Increased Cmax & AUC of simvastatin, atorvastatin, digoxin. Increased exposure to CYP3A4 substrates w/ narrow therapeutic index eg, cisapride, ergot alkaloids. Increased risk of bleeding w/ SSRIs eg, paroxetine, sertraline, citalopram. Heparin, enoxaparin, desmopressin; P-gp inhibitors.
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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