Xarelto

Rivaroxaban

2.5 mg: Prevention of CV death, MI & stent thrombosis in patients after an acute coronary syndrome (ACS) (non-ST elevation or ST elevation MI or unstable angina) in combination w/ acetylsalicylic acid (ASA) alone or w/ ASA + clopidogrel or ticlopidine; prevention of stroke, MI & CV death & for the prevention of acute limb ischemia & mortality in patients w/ CAD or peripheral artery disease (PAD) in combination w/ ASA. 10 mg: Prevention of venous thromboembolism (VTE) in adult undergoing elective hip or knee replacement surgery. 10 mg, 15 mg & 20 mg: Treatment of & prevention of recurrent of deep vein thrombosis (DVT) & pulmonary embolism (PE). 15 mg & 20 mg: Prevention of stroke & systemic embolism in patients w/ non-valvular atrial fibrillation (SPAF).

2.5 mg ACS 2.5 mg bid w/ ASA 75-100 mg daily or ASA 75-100 mg daily in addition to clopidogrel 75 mg daily or a standard daily dose of ticlopidine. To be given for at least 24 mth. CAD/PAD 2.5 mg bid in combination w/ ASA 75-100 mg daily. 10 mg VTE prevention in major orthopedic surgery 10 mg once daily, initially w/in 6-10 hr after surgery. Duration of treatment: Major hip surgery: 5 wk; major knee surgery: 2 wk. Continued treatment & prevention of recurrent DVT & PE Initially 15 mg bid for the 1st 3 wk (day 1-21), followed by 20 mg once daily (day 22 onwards) for the continued treatment. Max: 30 mg during the 1st 3 wk of treatment & 20 mg daily for the following treatment phase. Prevention of recurrent DVT or PE 10 mg or 20 mg once daily (based on individual risk assessment) following completion of at least 6 mth treatment for DVT or PE. 15 mg & 20 mg SPAF 20 mg once daily. Max: 20 mg. Moderate renal impairment (CrCl <50-30 mL/min) 15 mg once daily. Patient who undergoes percutaneous coronary intervention (PCI) w/ stent placement 15 mg once daily (or 10 mg once daily in addition to P2Y12 inhibitor for patients w/ moderate renal impairment) for a max of 12 mth after PCI w/ stent placement. Treatment & prevention of recurrent DVT & PE Initially 15 mg bid for the 1st 3 wk (day 1-21), followed by 20 mg once daily (day 22 onwards). Max: 30 mg daily during the 1st 3 wk of treatment & 20 mg daily for the following treatment phase. Prevention of recurrent DVT or PE 10 mg or 20 mg once daily (based on individual risk assessment) following completion of at least 6 mth treatment for DVT or PE.

2.5-mg & 10-mg tab: May be taken with or without food. 15- & 20-mg tab: Should be taken with food. For patients unable to swallow, tab may be crushed & mixed w/ water or soft foods eg, applesauce immediately prior to taking. The crushed tab may also be administered in a small amount of water via gastric tube then flushed w/ water. After administration of crushed 15 mg or 20 mg tab, the dose should then be immediately followed by food/enteral feeding.

Hypersensitivity. Patients w/ clinically significant active bleeding (eg, intracranial & GI bleeding); hepatic disease associated w/ coagulopathy leading to clinically relevant bleeding risk. Pregnancy & lactation.

Not recommended for thromboprophylaxis in patients having recently undergone transcatheter aortic valve replacement (TAVR). Not recommended in patients receiving concomitant systemic treatment w/ azole-antimycotics (eg, ketoconazole) or HIV PIs (eg, ritonavir). Avoid in the treatment of ACS in patients w/ a prior stroke or TIA; avoid in combination w/ ASA in patients w/ previous haemorrhagic/ischemic or lacunar/non-lacunar stroke. Caution in patients w/ an increased bleeding risk eg, congenital or acquired bleeding disorders, uncontrolled severe arterial HTN, active ulcerative GI disease, recent GI ulcerations, vascular retinopathy, recent intracranial or intracerebral hemorrhage, intraspinal or intracerebral vascular abnormalities, recent brain, spinal or ophth surgery, bronchiectasis or history of pulmonary bleeding. Risk for development of an epidural or spinal hematoma when neuraxial (epidural/spinal) anesth or spinal puncture is performed patients treated w/ antithrombotics for prevention of thromboembolic complications. If an invasive procedure or surgical intervention is required, stop medication at least 12 hr (for 2.5 mg) & 24 hr (for 10 mg, 15 mg & 20 mg) before the intervention. Not recommended for patients w/ history of thrombosis who are diagnosed w/ antiphospholipid syndrome & are persistently triple +ve (for lupus anticoagulant, anticardiolipin antibodies & anti-β₂-glycoprotein I antibodies). Moderate to severe renal impairment. Lactose or galactose intolerance (eg, the Lapp lactase deficiency or glucose-galactose). May affect ability to drive or use machines. Use w/ effective contraception in women of childbearing potential. Childn & adolescent <18 yr. 10 mg: Patients undergoing hip fracture surgery. 10 mg, 15 mg & 20 mg: Not recommended as an alternative to unfractionated heparin in patients w/ pulmonary embolism who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy. 15 mg & 20 mg: Patients who undergo PCI w/ stent placement.

Anemia (including respective laboratory parameters); eye hemorrhage (including conjunctival hemorrhage); gingival bleeding, GIT hemorrhage (including rectal), GI & abdominal pains, dyspepsia, nausea, constipation, diarrhea, vomiting; fever, peripheral edema, decreased general strength & energy (including fatigue & asthenia); post-procedural hemorrhage (including post-op anemia & wound hemorrhage), contusion; increased transaminases; pain in extremity; dizziness, headache; urogenital tract hemorrhage (including hematuria & menorrhagia), renal impairment (including increased blood creatinine & urea); epistaxis, hemoptysis; pruritus, rash, ecchymosis, cutaneous & SC hemorrhage; hypotension, hematoma.

May lead to both reduced hepatic & renal clearance & thus significantly increased systemic exposure w/ strong CYP 3A4 & P-gp inhibitors. Increased mean steady state AUC & C_max w/ increased pharmacodynamic effects w/ azole-antimycotics (ketoconazole) & HIV PIs (ritonavir), clarithromycin, erythromycin & fluconazole. Decreased AUC w/ parallel decreased pharmacodynamic effects w/ strong CYP 3A4 & P-gp inducer rifampicin. Decreased plasma conc w/ other strong CYP 3A4 inducers (eg, phenytoin, carbamazepine, phenobarb or St. John's wort). Additive effect on anti-factor Xa activity was observed w/ enoxaparin w/o any additional effects on clotting tests (PT, aPTT). Relevant increase in bleeding times w/ clopidogrel. Increased prothrombin time/INR more than additively & additive effects on aPTT, inhibition of factor Xa activity & endogenous thrombin potential when converting patients from warfarin to rivaroxaban & vice versa. Increased risk of bleeding w/ SSRIs or serotonin norepinephrine reuptake inhibitors. May affect clotting parameter tests (eg, PT, aPTT, HepTest).

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

B01AF01 - rivaroxaban ; Belongs to the class of direct factor Xa inhibitors. Used in the treatment of thrombosis.

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