Rivaxored

Rivaroxaban

Deep vein thrombosis (DVT) & pulmonary embolism (PE) in adults. Prevention of recurrent DVT & PE in adults. 10 mg: Prevention of VTE in adults undergoing elective hip or knee replacement surgery. 15 mg & 20 mg: Prevention of stroke & systemic embolism in adults w/ non-valvular atrial fibrillation w/ ≥1 risk factors eg, CHF, HTN, age ≥75 yr, DM, prior stroke or transient ischaemic attack. Treatment & prevention of VTE in childn & adolescents <18 yr weighing 30-50 kg (for 15 mg) or >50 kg (for 20 mg) after at least 5 days of initial parenteral anticoagulation treatment.

Adult DVT & PE & prevention of recurrent DVT & PE 15 mg bid for the 1st 3 wk, then 20 mg once daily for continued treatment & prevention. Extended prevention of recurrent DVT & PE 10 mg once daily following completion of at least 6 mth therapy. Patient w/ high risk of recurrent DVT or PE 20 mg once daily. 10 mg Prevention of VTE in patient undergoing elective hip or knee replacement surgery Initially 10 mg once daily 6-10 hr after surgery. Patient undergoing major hip surgery Treatment duration: 5 wk, major knee surgery Treatment duration: 2 wk. 15 mg & 20 mg Prevention of stroke & systemic embolism Max recommended dose: 20 mg once daily. Treatment & prevention of VTE in childn & adolescent <18 yr weighing ≥50 kg Max dose: 20 mg once daily, 30-50 kg Max dose: 15 mg once daily. Both are initiated following at least 5 days of initial parenteral anticoagulation treatment & continue for at least 3 mth & may be extended up to 12 mth. Moderate (CrCl 30-49 mL/min) or severe (CrCl 15-29 mL/min) renal impairment; DVT & PE & prevention of recurrent DVT & PE 15 mg bid for the 1st 3 wk. Reduce dose to 15 mg once daily when recommended dose is 20 mg once daily, Prevention of stroke & systemic embolism in patient w/ non-valvular atrial fibrillation Recommended dose: 15 mg once daily.

10-mg tab: May be taken with or without food., 15-mg & 20-mg tab: Should be taken with food. Swallow w/ water. For patients w/ difficulty swallowing, tab may be crushed & mixed w/ water/apple puree immediately prior to administration. Crushed tab may be given via gastric tubes.

Hypersensitivity. Active clinically significant bleeding. Current or recent GI ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophth surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities. Concomitant treatment w/ any other anticoagulants eg, unfractionated heparin, LMWH (enoxaparin, dalteparin), heparin derivatives (fondaparinux), oral anticoagulants (warfarin, dabigatran etexilate, apixaban). Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk including cirrhotic patients w/ Child-Pugh B & C. Pregnancy & lactation.

Discontinue if severe haemorrhage occurs; at 1st appearance of severe skin rash eg, spreading, intense &/or blistering, or any other sign of hypersensitivity in conjunction w/ mucosal lesions. Stop treatment at least 24 hr before invasive procedure or surgical intervention. Not to be used for thromboprophylaxis in patients having recently undergone transcatheter aortic valve replacement. Not recommended in patients w/ increased bleeding risk eg, congenital or acquired bleeding disorders, uncontrolled severe arterial HTN, other GI disease w/o active ulceration that can potentially lead to bleeding complications (inflammatory bowel disease, oesophagitis, gastritis & GERD), vascular retinopathy, bronchiectasis or history of pulmonary bleeding; in patients w/ history of thrombosis who are diagnosed w/ antiphospholipid syndrome; as alternative to unfractionated heparin in patients w/ PE who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy. Increased risk of haemorrhage; unexplained fall in Hb or BP. Risk of developing epidural or spinal haematoma resulting in long-term or permanent paralysis. Patients w/ malignant neoplasms; who are triple +ve for lupus anticoagulant, anticardiolipin Abs, & anti-β2 glycoprotein I Abs. Observe signs of bleeding. Detect occult bleeding through lab testing of Hb/haematocrit. Monitor for signs & symptoms of bleeding complications & anaemia after treatment initiation; neurological impairment eg, leg numbness or weakness, bowel or bladder dysfunction. Delay for 24 hr if traumatic puncture occurs. Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ azole-antimycotics or HIV PIs; medicinal products affecting haemostasis eg, NSAIDs, ASA & platelet aggregation inhibitors or SSRIs & SNRIs. Minor influence on ability to drive & use machines. Renal impairment. Avoid becoming pregnant during treatment. Not recommended in childn <18 yr. Elderly. 10 mg: Patients undergoing hip fracture surgery. 15 mg & 20 mg: Patients w/ non-valvular atrial fibrillation who undergo PCI w/ stent placement. Not recommended in childn & adolescents w/ moderate or severe renal impairment (GFR <50 mL/min/1.73 m²). Carefully evaluate risk of bleeding before & during therapy in childn w/ cerebral vein & sinus thrombosis who have CNS infection.

Anaemia including respective lab parameters; dizziness, headache; eye haemorrhage including conjunctival haemorrhage; hypotension, haematoma; epistaxis, haemoptysis; gingival bleeding, GIT haemorrhage including rectal haemorrhage, GI & abdominal pains, dyspepsia, nausea, constipation, diarrhoea, vomiting; increased transaminases; pruritus including uncommon cases of generalised pruritus, rash, ecchymosis, cutaneous & SC haemorrhage; pain in extremity; urogenital tract haemorrhage including haematuria & menorrhagia, renal impairment including increased blood creatinine & urea; fever, peripheral oedema, decreased general strength & energy including fatigue & asthenia; post-procedural haemorrhage including post-op anaemia & wound haemorrhage, contusion, wound secretion. SJS/TEN, DRESS syndrome.

Increased mean AUC & C_max w/ ketoconazole or ritonavir, erythromycin, fluconazole. Concomitant use w/ azole-antimycotics eg, ketoconazole, itraconazole, voriconazole & posaconazole or HIV PIs; dronedarone; other anticoagulants. Additive effect on anti-factor Xa activity w/ enoxaparin. Relevant increase in bleeding time w/ clopidogrel. Increased risk of bleeding w/ NSAIDs & platelet aggregation inhibitors, SSRIs or SNRIs. Increased prothrombin time/INR w/ warfarin. Decreased mean AUC w/ strong CYP3A4 inducer eg, rifampicin. Reduced plasma conc w/ other strong CYP3A4 inducers eg, phenytoin, carbamazepine, phenobarb or St. John's Wort (Hypericum perforatum).

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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