Haemorrhagic risk. Discontinue if severe haemorrhage occurs. Not recommended in patients w/ congenital or acquired bleeding disorders; uncontrolled severe arterial HTN; other GI disease w/o active ulceration that can potentially lead to bleeding complications; vascular retinopathy; bronchiectasis or history of pulmonary bleeding. Not recommended in patients w/ prosthetic heart valves. Not recommended in patients w/ history of thrombosis who are diagnosed w/ antiphospholipid syndrome. Risk of developing epidural or spinal hematoma w/ spinal or epidural anaesth or puncture. Reports of serious skin reactions. Discontinue at the 1st appearance of a severe skin rash, or any other sign of hypersensitivity in conjunction w/ mucosal lesions. Affected clotting parameters (eg, PT, aPTT, HepTest). Not recommended in patients receiving concomitant treatment w/ strong CYP3A4 & P-gp inhibitors (eg, azole-antimycotics or HIV PIs). Use w/ caution in patients treated concomitantly w/ medicinal products affecting haemostasis eg, NSAIDs, ASA, platelet aggregation inhibitors, SSRIs, & SNRIs. In patients at risk of ulcerative GI disease, prophylactic treatment may be considered. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Minor influence on the ability to drive or operate machinery. Not recommended in patients w/ CrCl <15 mL/min. Use w/ caution in patients w/ severe renal impairment (CrCl 15-29 mL/min) or moderate renal impairment (CrCl 30-49 mL/min) concomitantly receiving other medicinal products which increase rivaroxaban plasma conc. Elderly. Not recommended in childn <18 yr. 2.5-mg tab:
Not indicated in combination w/ dual antiplatelet therapy. Use w/ caution in CAD/PAD patients ≥75 yr; lower body wt (<60 kg); severe symptomatic heart failure. Previous haemorrhagic or lacunar stroke, or ischaemic, non-lacunar stroke w/in the previous mth. Discontinue at least 12 hr before an invasive procedure or surgical intervention; restart as soon as possible after. 10-mg tab:
Hip fracture surgery. 15- & 20-mg tab:
Patients w/ non-valvular atrial fibrillation who undergo percutaneous coronary intervention (PCI) w/ stent placement. 10-, 15-, 20-mg tab:
Not recommended as an alternative to UFH in patients w/ PE who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy. Discontinue at least 24 hr before an invasive procedure or surgical intervention (10-mg tab: invasive procedure or surgical intervention other than elective hip or knee replacement therapy); restart as soon as possible after.