Brilinta

Brilinta

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Ticagrelor
Indications/Uses
60 mg: Co-administered w/ ASA for prevention of atherothrombotic events in adults w/ history of MI (occurred at least 1 yr ago) & high risk of developing atherothrombotic event; reduction of risk of 1st MI or stroke in patients w/ CAD, type 2 DM & history of percutaneous coronary intervention (PCI). 90 mg: Co-administered w/ ASA for prevention of atherothrombotic events in adults w/ acute coronary syndromes (unstable angina, non-ST or ST elevation MI) including patients managed medically & w/ PCI or CABG. Reduce risk of stroke in patients w/ acute ischemic stroke or high-risk transient ischemic attack (TIA).
Dosage/Direction for Use
60 mg History of MI (at least 1 yr ago) 60 mg bd w/ low maintenance dose ASA 75-150 mg daily during treatment. CAD & type 2 DM w/ history of PCI w/ no prior MI 60 mg bd. 90 mg Acute coronary syndrome or history of MI Initially 180 mg as single loading dose, then continue at 90 mg bd w/ initial maintenance dose ASA 75-150 mg daily. Duration of therapy: Up to 12 mth. Acute ischemic stroke or TIA Initially 180 mg loading dose, then continue at 90 mg bd w/ loading dose ASA 300-325 mg & maintenance dose ASA 75-150 mg daily. Duration of therapy: 30 days.
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 ≥1 yr, CAD, type 2 DM & prior ischaemic stroke. Patients w/ propensity to bleed (eg, due to recent trauma or surgery, coagulation disorders, active or recent GI bleeding) or at increased risk of trauma; w/o pacemaker w/ sick sinus syndrome, 2nd or 3rd degree AV block or bradycardic-related syncope; asthma &/or COPD; hyperuricaemia or gouty arthritis, uric acid neuropathy. Central sleep apnoea including Cheyne-Stokes respiration; TTP. Interference w/ platelet function tests to diagnose heparin-induced thrombocytopenia. Routinely check renal function 1 mth after initiation of treatment. Discontinue use 5 days prior to elective surgery if antiplatelet effect is not desired. Avoid premature discontinuation of treatment. Not recommended in co-administration w/ high maintenance dose ASA >300 mg. Concomitant administration w/ NSAIDs, oral anticoagulants &/or fibrinolytics w/in 24 hr; antifibrinolytic therapy &/or recombinant factor VIIa; medicinal products inducing bradycardia; ARBs. May affect ability to drive & use machines. Moderate hepatic impairment. Moderate & severe renal impairment. Women of childbearing potential should use effective contraception during therapy. Not recommended during pregnancy. Lactation. Childn <18 yr. Elderly ≥75 yr. 90 mg: Not recommended in patients at NIHSS >5 & receiving thrombolysis.
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, clarithromycin, nefazodone, ritonavir, atazanavir; moderate CYP3A4 inhibitors eg, diltiazem, amprenavir, aprepitant, erythromycin, fluconazole; cyclosporine. Increased exposure w/ grapefruit juice; potent P-gp & moderate CYP3A4 inhibitors eg, verapamil, quinidine. Decreased Cmax & AUC w/ CYP3A inducers eg, rifampicin. Decreased exposure w/ other CYP3A 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. Medicinal products altering haemostatis (eg, heparin, enoxaparin, desmopressin) & inducing bradycardia.
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
60's
Form
Brilinta FC tab 90 mg
Packing/Price
60's
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