Xarelto

DVT & pulmonary embolism (PE) & prevention of recurrent DVT & PE in adults. 10 mg: Prevention of VTE in adult patients undergoing elective hip or knee replacement. 15 mg: VTE & prevention of recurrent VTE in childn & adolescents <18 yr & 30-50 kg. 20 mg: VTE & prevention of recurrent VTE in childn & adolescents <18 yr & >50 kg. 15 & 20 mg: Prevention of stroke & systemic embolism in adult patients w/ non-valvular atrial fibrillation w/ ≥1 risk factors eg, CHF, HTN, age ≥75 yr, DM, prior stroke or transient ischaemic attack.

Adult VTE prevention in hip or knee replacement surgery 10 mg once daily. Duration of treatment: Depends on the type of major orthopaedic surgery. Initial dose to be taken 6-10 hr after surgery when hemostasis is established. Prevention of stroke & systemic embolism 20 mg once daily. Initial treatment of acute DVT or PE 15 mg bd for 1st 3 wk followed by 20 mg once daily thereafter. Extended prevention of recurrent DVT & PE 10 or 20 mg once daily following completion of at least 6 mth therapy. VTE & prevention of recurrent VTE Childn & adolescent <18 yr, 30-50 kg 15 mg once daily, ≥50 kg 20 mg once daily, initiated following at least 5 days of initial parenteral anticoagulation treatment. Duration: At least 3 mth, may be extended up to 12 mth when clinically necessary. Severe (CrCl 15-29 mL/min) or moderate (30-49 mL/min) renal impairment Prevention of stroke & systemic embolism w/ non-valvular atrial fibrillation 15 mg once daily. DVT & PE & prevention of recurrent DVT & PE 15 mg bd for 1st 3 wk.

10 mg: May be taken with or without food.. 15 & 20 mg: Should be taken with food.. For patients unable to swallow, may be crushed & mixed w/ water/apple puree immediately prior to taking. Crushed tab may also be mixed w/ small amount of water & administered via gastric tube. Flush tube w/ water after administration then immediately followed by enteral feeding.

Hypersensitivity. Clinically significant active bleeding; lesion or condition at significant risk for major bleeding. Concomitant treatment w/ other anticoagulants except switching therapy or use of unfractioned heparin (UFH) to maintain open central venous or arterial catheter. Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk including cirrhotic patients w/ Child-Pugh B & C. Pregnancy & lactation.

Discontinue use if severe haemorrhage occurs; at 1st appearance of severe skin rash or any other sign of hypersensitivity. Not recommended in patients w/ prosthetic heart valves, other valve procedures, high-risk triple +ve antiphospholipid syndrome. Not an alternative to UFH in haemodynamically unstable PE patients or patients requiring thrombolysis or pulmonary embolectomy. Serious skin reactions eg, SJS/TEN. Congenital or acquired bleeding disorders, uncontrolled severe arterial HTN; other GI disease w/o active ulceration potentially leading to bleeding complications; vascular retinopathy, bronchiectasis or history of pulmonary bleeding; active cancer; epidural/spinal anesth or puncture. Patients w/ non-valvular atrial fibrillation undergoing percutaneous coronary intervention w/ stent placement. Discontinue use at least 24 hr prior to surgery & other interventions. Patients undergoing cardioversion. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended in concomitant use w/ azole-antimycotics, HIV PIs. Concomitant use w/ haemostasis-affecting drugs. May affect ability to drive & use machines. Not recommended in CrCl <15 mL/min. Severe renal impairment. Women of childbearing potential should avoid pregnancy during treatment. Not recommended in childn & adolescents <18 yr, w/ moderate or severe renal impairment (GFR <50 mL/min/1.73 m²). Advanced age.

Anaemia; dizziness, headache; eye haemorrhage; hypotension, haematoma; epistaxis, haemoptysis; gingival bleeding, GIT haemorrhage; GI & abdominal pains, dyspepsia, nausea, constipation, diarrhoea, vomiting; pruritus, rash, ecchymosis, cutaneous & SC haemorrhage; pain in extremity; urogenital tract haemorrhage, renal impairment; fever, peripheral oedema, decreased general strength & energy; increased transaminases; post-procedural haemorrhage, contusion, wound secretion.

Increased AUC & bleeding risk w/ CYP3A4 & P-gp inhibitors (azole antimycotics eg, ketoconazole, itraconazole, voriconazole, posaconazole; HIV-PIs eg, ritonavir). Increased bleeding risk w/ SSRIs/SNRIs; other anticoagulants; NSAIDs & platelet aggregation inhibitors. Reduced plasma conc w/ strong CYP3A4 inducers eg, phenytoin, carbamazepine, phenobarb or St. John's wort. Avoid co-administration w/ dronedarone. Affected clotting parameters (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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