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Ticalor

Ticalor

Manufacturer:

Micro Labs

Distributor:

DKSH

Marketer:

Viva Healthcare
Concise Prescribing Info
Contents
Ticagrelor
Indications/Uses
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 medically & w/ percutaneous coronary intervention (PCI) or CABG. Reduce risk of stroke in patients w/ acute ischemic stroke (NIH stroke scale score ≤5) or high-risk transient ischemic attack (TIA).
Dosage/Direction for Use
ACS Initially 180 mg single loading dose (two 90-mg tab) then continue at 90 mg bid for at least 12 mth. Acute ischemic stroke or TIA Initially 180 mg single loading dose (two 90-mg tab) then continue w/ 90 mg bid for 30 days. Co-administer w/ ASA 75-150 mg daily, unless specifically contraindicated.
Administration
May be taken with or without food: For patients unable to swallow whole tab, may crush tab into a fine powd & mix in ½ glass of water & drink immediately. Rinse further w/ ½ glass of water & drink. Mixt may also be administered via nasogastric tube (≥CH8); flush w/ water after administration of mixt.
Contraindications
Hypersensitivity. Active pathological bleeding (eg, peptic ulcer, intracranial hemorrhage). History of intracranial hemorrhage. Severe hepatic impairment.
Special Precautions
Do not start therapy in patients undergoing urgent CABG. Discontinue at least 5 days prior to any surgery; if patient reports new, prolonged or worsened dyspnoea. Not to be used in patients w/ active pathological bleeding or history of intracranial hemorrhage. Avoid premature discontinuation of treatment; if treatment must be temporarily stopped due to adverse event(s), re-initiate as soon as possible. Reduced efficacy w/ higher aspirin dosage (avoid maintenance doses >100 mg). Increased risk of bleeding; can cause significant, sometimes fatal bleeding. Platelet transfusions. Suspect bleeding in hypotensive patients that has recently undergone coronary angiography, PCI, CABG, or other invasive procedure, even if no overt manifestations of bleeding are present. Patients w/ increased risk of bradycardic events (eg, w/o pacemaker w/ sick sinus syndrome, 2nd or 3rd degree AV block or bradycardic-related syncope); using medicinal products that may increase risk of bleeding eg, NSAIDs, oral anticoagulants &/or fibrinolytics; antifibrinolytic therapy (aminocaproic acid or tranexamic acid) &/or recombinant factor VIIa therapy. Stopping therapy increases risk of subsequent CV events; manage bleeding w/o discontinuation if possible. Concomitant use w/ strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, nefazodone, ritonavir & atazanavir). Moderate hepatic impairment. Not to be used in patients w/ severe hepatic impairment. Pregnancy. Not recommended during breastfeeding. Childn <18 yr.
Adverse Reactions
Blood disorder bleedings; hyperuricaemia; dyspnoea. Gout/gouty arthritis; headache, dizziness; eye haemorrhage (intraocular, conjunctival, retinal); vertigo; hypotension; epistaxis, haemoptysis; constipation, diarrhoea, dyspepsia, GI haemorrhage, nausea; SC or dermal bleeding, rash, pruritus; urinary tract bleeding; increased blood creatinine; post-procedural haemorrhage, traumatic bleedings.
Drug Interactions
Increased Cmax & AUC w/ ketoconazole & other strong CYP3A4 inhibitors (clarithromycin, nefazadone, ritonavir & atazanavir); moderate CYP3A4 inhibitors (diltiazem); cyclosporine (PgP & CYP3A inhibitor). Decreased Cmax & AUC w/ rifampin & other CYP3A inducers (phenytoin, carbamazepine & phenobarb). Increased Cmax & AUC of simvastatin, atorvastatin; digoxin (PgP substrate).
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
Ticalor FC tab 90 mg
Packing/Price
6 × 10's
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