Briclot

Briclot

Manufacturer:

Dexa Medica
Concise Prescribing Info
Contents
Ticagrelor
Indications/Uses
Co-administered w/ acetylsalicylic acid 75-100 mg 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 coronary artery bypass grafting (CABG).
Dosage/Direction for Use
Acute coronary syndromes Initially, 180 mg single loading dose followed by 90 mg twice daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity eg, angioedema. History of intracranial hemorrhage. Active pathological bleeding eg, peptic ulcer or intracranial hemorrhage. Co-administration w/ strong CYP3A4 inhibitors eg, ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir. Severe hepatic impairment.
Special Precautions
Increased risk of bleeding. Not to be initiated in patients planned to undergo urgent CABG. Not to be used in patients w/ uric acid nephropathy. Not recommended to treat patients w/ history of MI w/ prior ischemic stroke for >1 yr. Hypotensive & has recently undergone coronary angiography, PCI, CABG or other surgical procedures. Dyspnea; at risk of bradycardia; history of hyperuricemia or gouty arthritis. Discontinue use at least 5 days prior to any surgery. Avoid premature discontinuation of treatment; discontinuation of treatment increases risk of CV events including MI, stent thrombosis & death. Assess pulmonary function after 1 mth or at least 6 mth of chronic treatment. Regularly check renal function & monitor 1 mth after initiating treatment in patients w/ ACS. Avoid use w/ potent CYP3A inducers eg, rifampin, phenytoin, carbamazepine & phenobarb. Avoid co-administration w/ high maintenance dose of acetylsalicylic acid (>100 mg); not recommended in co-administration w/ high-dose acetylsalicylic acid (>300 mg). Concomitant use w/ medications increasing risk of bleeding & inducing bradycardia. Not recommended in patients on renal dialysis. Moderate hepatic impairment. Pregnancy & lactation. Childn <18 yr. Elderly.
Adverse Reactions
Blood disorder bleedings; hyperuricemia; dyspnea. Gout/gouty arthritis; dizziness, syncope, headache; vertigo; hypotension; resp system bleedings; GI hemorrhage, diarrhea, nausea, dyspepsia, constipation; SC or dermal bleeding, rash, pruritus; urinary tract bleeding; increased blood creatinine; post-procedural hemorrhage, traumatic bleedings.
Drug Interactions
Increased exposure w/ strong CYP3A inhibitors eg, ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, telithromycin. Reduced blood levels w/ potent CYP3A inducers eg, rifampin, phenytoin, carbamazepine, phenobarb. Higher serum conc of simvastatin, lovastatin. Reduced effectiveness w/ aspirin maintenance doses >100 mg. Increased Cmax & AUC w/ ciclosporin. Monitor digoxin levels. Increased ethinyl estradiol exposure. Medicinal products inducing bradycadia; altering hemostasis.
ATC Classification
B01AC24 - ticagrelor ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Presentation/Packing
Form
Briclot FC tab 90 mg
Packing/Price
3 × 10's
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