Zuellig Pharma
Concise Prescribing Info
10-mg tab: Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement. 15- & 20-mg tab: 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. DVT & pulmonary embolism (PE). Prevention of recurrent DVT & PE in adults.
Dosage/Direction for Use
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. Severe (CrCl 15-29 mL/min) or moderate (30-49 mL/min) renal impairment 15 mg once daily. Initial treatment of acute DVT or PE 15 mg bd for 1st 3 wk followed by 20 mg once daily thereafter.
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 apple puree immediately prior to taking. Crushed tab may also be mixed w/ small amount of water & administered via gastric tube. The tube should be flushed w/ water after administration.
Hypersensitivity. Clinically significant active bleeding; lesion or condition at significant risk of major bleeding. Concomitant treatment w/ other anticoagulant agent except switching therapy or use of 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.
Special Precautions
Discontinue use if severe haemorrhage occurs. Serious skin reactions eg, Stevens-Johnson syndrome/toxic epidermal necrolysis Congenital or acquired bleeding disorders, uncontrolled severe arterial HTN; current or recent GI ulceration, other GI disease w/o active ulceration potentially leading to bleeding complications; recent intracranial or intracerebral hemorrhage; intraspinal or intracerebral vascular abnormalities; recent brain, spinal or ophth surgery; vascular retinopathy, bronchiectasis or history of pulmonary bleeding; epidural/spinal anesth or puncture. Patients w/ non-valvular atrial fibrillation who undergo percutaneous coronary intervention w/ stent placement; w/ prosthetic heart valves; w/ haemodynamically unstable PE or who require thrombolysis or pulmonary embolectomy; pre- & post-invasive procedures & surgical interventions. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended in concomitant use w/ potent azole-antimycotics, HIV PIs, other antiplatelets. May affect ability to drive & use machines. Renal impairment. Women of childbearing potential should avoid pregnancy during treatment. Elderly.
Adverse Reactions
Anemia; dizziness, headache; eye haemorrhage; hypotension, hematoma; epistaxis, haemoptysis; gingival bleeding, GIT haemorrhage; GI & abdominal pains, dyspepsia, nausea, constipation, diarrhea, 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 hemorrhage, contusion, wound secretion.
Drug Interactions
Increased AUC & bleeding risk w/ CYP3A4 & P-gp inhibitors (azole antimycotics eg, ketoconazole, itraconazole, voriconazole, posaconazole; HIV-PI eg, ritonavir). Reduced plasma conc w/ strong CYP3A4 inducers eg, phenytoin, carbamazepine, phenobarb or St. John's wort. Other anticoagulants; NSAIDs & platelet aggregation inhibitors.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AF01 - rivaroxaban ; Belongs to the class of direct factor Xa inhibitors. Used in the treatment of thrombosis.
Xarelto FC tab 10 mg
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Xarelto FC tab 20 mg
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