Brilinta Dosage & Drug Information

Concise Prescribing Info Bahasa Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Ticagrelor

Indications/Uses

60 mg: Prevention of thrombotic events (CV death, MI, stroke) in patients w/ history of MI (occurred at least 1 yr ago) & high risk of developing thrombotic event. 90 mg: Co-administered w/ ASA for prevention of thrombotic events (CV death, MI & stroke) in patients w/ acute coronary syndromes (ACS) [unstable angina, non-ST elevation MI (NSTEMI) or ST elevation MI (STEMI)] including patients managed w/ percutaneous coronary intervention (PCI) or CABG; reduce risk of stroke in patients w/ acute ischaemic stroke or high-risk transient ischaemic attack (TIA).

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Dosage/Direction for Use

ACS Initially, 180 mg as single loading dose, then continue at 90 mg twice daily w/ low maintenance dose of ASA 75-100 mg daily. History of MI (occurred at least 1 yr ago) 60 mg twice daily w/ low maintenance dose of ASA 75-100 mg daily. Acute ischaemic stroke or TIA Initially, 180 mg as single loading dose then continue w/ 90 mg twice daily for 30 days.

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Overdosage

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Administration

May be taken with or without food: FC tab: 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. Orodispersible tab: Place on tongue & allow to disperse then swallow w/ or w/o water. May be dispersed in water & administered via nasogastric tube.

Contraindications

Hypersensitivity. 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.

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Warnings

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Special Precautions

History of bleeding disorders; undergone percutaneous invasive procedures, hypotensive, recent coronary angiography, PCI, CABG & other surgical procedures. Not recommended in patients w/ uric acid nephropathy. Dyspnea; increased risk of bradycardic events. History of hyperuricaemia or gouty arthritis. Consider further clinical assessment if central sleep apnoea is suspected. Discontinue use 5 days prior to surgery. Not recommended for >1 yr in patients w/ history of MI w/ prior ischaemic stroke. Avoid interruption or premature discontinuation. May give false -ve result in platelet function test. Avoid use w/ strong CYP3A inhibitors & potent CYP3A inducers. Concomitant use of aspirin (>100 mg), chronic intake of NSAIDs, oral anticoagulants & fibrinolytics, high maintenance dose ASA (>300 mg), medicinal products inducing bradycardia, ARBs. May increase creatinine levels. Moderate hepatic impairment. Pregnancy & lactation. Childn <18 yr. Elderly ≥75 yr.

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Use In Pregnancy & Lactation

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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.

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Drug Interactions

Avoid use of 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/ maintenance dose aspirin >100 mg. Increased C_max & AUC w/ cyclosporine; potent P-gp inhibitors & moderate CYP3A4 inhibitors eg, verapamil, quinidine. Monitor digoxin levels. Delayed & decreased exposure w/ morphine. Concomitant use w/ medicinal products inducing bradycardia & altering haemostasis.

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Caution For Usage

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Storage

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Description

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Action

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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.

Regulatory Classification

Presentation/Packing

Form

Brilinta FC tab 60 mg

Packing/Price

4 × 14's

Form

Brilinta FC tab 90 mg

Packing/Price

4 × 14's (Rp1,302,737/boks)

Form

Brilinta orodispersible tab 90 mg

Packing/Price

7 × 8's

Brilinta

Manufacturer:

AstraZeneca