Brilinta倍林達

Brilinta

Manufacturer:

AstraZeneca

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Ticagrelor
Indications/Uses
Co-administered w/ acetylsalicylic acid (ASA) for prevention of atherothrombotic events in adult patients w/ acute coronary syndromes (ACS) or history of MI & a high risk of developing an atherothrombotic event.
Dosage/Direction for Use
90 mg Take in combination w/ ASA 75-150 mg, unless specifically contraindicated. ACS Initially 180 mg single loading dose then continue at 90 mg bd for 12 mth. Elderly, renal impairment, mild hepatic impairment No dose adjustment necessary. 60 mg History of MI Co-administered w/ ASA (75-150 mg), 60 mg bd when an extended treatment is required.
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, severe hepatic impairment, co-administration w/ strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, nefazodone, ritonavir & atazanavir).
Special Precautions
Patients w/ propensity to bleed (eg, recent trauma, recent surgery, coagulation disorders, active or recent GI bleeding); concomitant w/ medicines that may increase risk of bleeding (eg, NSAIDs, oral anticoagulant &/or fibrinolytics) w/in 24 hr of dosing. Discontinue at least 7 days prior to any surgery. Patients w/ an increased risk for bradycardic events (eg, patients w/o pacemaker who have sick sinus syndrome, 2nd or 3rd degree AV block or bradycardic-related syncope); concomitant w/ medicines known to induce bradycardia. Prolonged or worsened dyspnoea; patients w/ history of asthma &/or COPD. Check renal function 1 mth after therapy & thereafter according to routine medical practice especially to patients ≥75 yr, w/ moderate/severe renal impairment & those receiving concomitant w/ an ARB. Moderate hepatic impairment. History of hyperuricaemia or gouty arthritis. Use is discouraged in patients w/ uric acid nephropathy. Concomitant high dose ASA (>300 mg). Avoid premature discontinuation. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Blood disorder bleedings (bruise, spontaneous haematoma, haemorrhagic diathesis), hyperuricaemia, dyspnoea, gout/gouty arthritis, dizziness, syncope, headache, vertigo, hypotension, resp system bleedings (epistaxis, haemoptysis), GI haemorrhage (gingival bleeding, rectal bleeding, gastric ulcer haemorrhage), diarrhoea, nausea, dyspepsia, constipation, SC or dermal bleeding (ecchymosis, skin haemorrhage, petechiae), rash, pruritus; urinary tract bleeding (haematuria, cystitis haemorrhage), blood creatinine increased; post procedural haemorrahge, traumatic bleedings (contusion, traumatic haematoma, traumatic haemorrhage).
Drug Interactions
Increased Cmax & AUC w/ strong CYP3A4 inhibitors (ketoconazole, clarithromycin, nefazodone, ritonavir & atazanavir), moderate CYP3A4 inhibitors (diltiazem, amprenavir, aprepitant, erythromycin & fluconazole), as well as cyclosporine. Decreased exposure & efficacy w/ CYP3A inducers (rifampicin, phenytoin, carbamazepine & phenobarb). Increased Cmax & AUC of simvastatin or lovastatin, atorvastatin; digoxin. Concomitant w/ simvastatin or lovastatin >40 mg is not recommended. Increased exposure of CYP3A4 substrates w/ narrow therapeutic indices (ie, cisapride or ergot alkaloids). Use w/ caution when co-administered w/ ≥1 medicinal products known to induce bradycardia (eg, β-blockers, Ca channel blockers diltiazem & verapamil, digoxin). Potential pharmacodynamic interactions w/ medicines known to alter haemostasis. Increased risk of bleeding w/ SSRIs (eg, paroxetine, sertraline & citalopram).
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
56's
Form
Brilinta FC tab 90 mg
Packing/Price
56's
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