Brilinta倍林達

Brilinta

Manufacturer:

AstraZeneca

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Ticagrelor
Indications/Uses
Co-administered w/ ASA for prevention of atherothrombotic events in adults w/ acute coronary syndromes (ACS) or history of MI & a high risk of developing an atherothrombotic event.
Dosage/Direction for Use
Co-administer w/ ASA 75-150 mg daily, unless specifically contraindicated. ACS Initially 180 mg single loading dose (two 90-mg tab), then continue at 90 mg bd for 12 mth. History of MI 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. Co-administration w/ strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, nefazodone, ritonavir & atazanavir). Severe hepatic impairment.
Special Precautions
Avoid premature discontinuation of treatment. Discontinue treatment 5 days prior to elective surgery. Treatment beyond 1 yr is not recommended in patients w/ history of MI w/ prior ischaemic stroke. Creatinine levels may increase during treatment. Hyperuricaemia may occur during treatment. Use is discouraged in patients w/ uric acid nephropathy. Reports of dyspnoea. Post-marketing reports of central sleep apnoea including Cheyne-Stokes respiration. Very rare reports of TTP. Concomitant administration of medicinal products that may increase risk of bleeding (eg, NSAIDs, oral anticoagulants &/or fibrinolytics) w/in 24 hr of ticagrelor dosing; medicinal products known to induce bradycardia. Co-administration w/ high maintenance dose ASA (>300 mg) is not recommended. False -ve results in platelet function test for heparin-induced thrombocytopenia. May impair ability to drive or operate machinery. Caution in patients w/ propensity to bleed (eg, recent trauma, recent surgery, coagulation disorders, active or recent GI bleeding) or who are at increased risk of trauma; increased risk of bradycardic events (eg, w/o pacemaker who have sick sinus syndrome, 2nd or 3rd degree AV block or bradycardic-related syncope); history of asthma &/or COPD; history of hyperuricaemia or gouty arthritis; moderate hepatic impairment. Women of childbearing potential should use appropriate contraception during therapy. Not recommended during pregnancy. Discontinue breast-feeding or discontinue/abstain from therapy. Safety & efficacy in childn <18 yr have not been established. No relevant use in childn w/ sickle cell disease.
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 (P-gp & CYP3A inhibitor). Decreased Cmax & AUC w/ CYP3A inducers (eg, rifampicin, phenytoin, carbamazepine, phenobarb). Increased Cmax & AUC of simvastatin or lovastatin (CYP3A4 substrates); digoxin (P-gp substrate w/ narrow therapeutic index). May increase exposure of CYP3A4 substrates w/ narrow therapeutic indices (ie, cisapride or ergot alkaloids). Might affect renal excretion of rosuvastatin, increasing the risk of rosuvastatin accumulation. Increased risk of bleeding w/ SSRIs (eg, paroxetine, sertraline, citalopram). Potential for reduced efficacy w/ morphine. Potential interaction w/ medicinal products known to induce bradycardia eg, β-blockers, Ca channel blockers (diltiazem & verapamil), digoxin. Potential pharmacodynamic interactions w/ medicinal products known to alter haemostasis.
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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