XARELTO 20/MG FC TAB 28/FC TAB

Indications

Approved Uses

Approved indications (vary by jurisdiction): (1) Reduce risk of stroke/systemic embolism in non-valvular atrial fibrillation; (2) Treatment of DVT; (3) Treatment of PE; (4) Reduction in risk of recurrent DVT/PE; (5) VTE prophylaxis after elective hip or knee replacement surgery; (6) Reduction of risk of major cardiovascular events in chronic CAD or PAD (with aspirin, using 2.5 mg BID); (7) VTE prophylaxis in acutely ill medical patients at risk for thromboembolic complications (where approved).

Dosage & Administration

Dosing by Condition

NVAF stroke prevention: 20 mg PO once daily WITH evening meal (15 mg once daily with food if CrCl 15-50). DVT/PE treatment: 15 mg PO BID WITH food for 21 days, then 20 mg PO once daily WITH food. Extended prevention after ≥6 months: 20 mg once daily with food OR 10 mg once daily (per label/patient risk). Hip/knee replacement prophylaxis: 10 mg PO once daily (with or without food). CAD/PAD: 2.5 mg PO BID PLUS aspirin 75-100 mg daily (with or without food).

Initial Dose

20mg once daily with the evening meal (for non-valvular AF and DVT/PE maintenance)

Maintenance Dose

20mg once daily with food (AF, DVT/PE treatment); 2.5mg twice daily (ACS, CAD/PAD)

Maximum Dose

Maximum labeled daily dose is 30 mg/day during initial DVT/PE treatment (15 mg twice daily for 21 days); otherwise 20 mg once daily is the maximum for common adult indications (e.g., NVAF, extended VTE treatment).

Dose Adjustment Notes

Renal: For NVAF, 20 mg once daily with food if CrCl >50 mL/min; reduce to 15 mg once daily with food if CrCl 15-50 mL/min; avoid if CrCl <15 mL/min. For DVT/PE treatment and recurrence prevention, avoid if CrCl <30 mL/min (use with caution 30-49 mL/min depending on local label). Hepatic: avoid in hepatic disease associated with coagulopathy and clinically relevant bleeding risk; generally avoid Child-Pugh B or C. No routine age-based adjustment, but reassess renal function periodically. Switching to/from other anticoagulants requires label-specific timing to avoid gaps/overlap.

Side Effects

Common Side Effects

Bleeding-related events (e.g., epistaxis, bruising, GI bleeding, hematuria), anemia, nausea/dyspepsia/abdominal pain, dizziness/headache, and elevated liver enzymes (transaminases).

Safety & Warnings

Contraindications

Active pathological bleeding; hypersensitivity to rivaroxaban; hepatic disease associated with coagulopathy and clinically relevant bleeding risk.

Warnings & Precautions

Serious/fatal bleeding risk; thrombotic risk with premature discontinuation; spinal/epidural hematoma risk with neuraxial procedures; avoid/not recommended in mechanical/prosthetic heart valves; avoid in hepatic disease with coagulopathy and use caution/avoid in severe renal impairment; consider increased thrombosis risk in triple-positive antiphospholipid syndrome.

Age Restriction

Approved in pediatrics for specific indications (not for all uses); the 20 mg tablet strength is generally an adult dose and pediatric dosing is weight-based using pediatric formulations/strengths.

Drug Interactions

Food Interaction

15 mg and 20 mg tablets MUST be taken with food (a meal); 2.5 mg and 10 mg may be taken with or without food. No specific grapefruit avoidance is required in labeling, but caution is warranted with strong CYP3A4/P-gp inhibitors/inducers.

Special Populations

Elderly

No routine dose adjustment required; however, renal function should be assessed as rivaroxaban exposure increases with declining renal function; monitor closely for bleeding signs

Kidney Impairment

NVAF: 20 mg once daily with food if CrCl >50 mL/min; 15 mg once daily with food if CrCl 15-50 mL/min; avoid if CrCl <15 mL/min. DVT/PE treatment: standard dosing can be used if CrCl ≥15 mL/min but use caution in CrCl 15-29 mL/min; avoid if CrCl <15 mL/min.

Liver Impairment

Child-Pugh A: no dose adjustment; avoid use in Child-Pugh B and C or any hepatic disease associated with coagulopathy/clinically relevant bleeding risk.

Storage & Patient Advice

Missed Dose

Once-daily dosing (e.g., 20 mg): take the missed dose as soon as remembered on the same day; take the next dose the following day at the usual time (do not double the next day). 15 mg BID regimen (DVT/PE initial 21 days): take immediately to ensure 30 mg total that day; two 15 mg tablets may be taken at once if needed, then resume BID schedule the next day. 2.5 mg BID: take the next dose at the scheduled time; do not double to make up a missed dose.

Stopping the Medicine

Do not stop abruptly without medical advice; if discontinuation is necessary, transition to an alternative anticoagulant to reduce thrombotic risk.

Patient Counseling

Take Xarelto (rivaroxaban) 20 mg once daily WITH a meal (preferably the evening meal) and take it consistently each day; do not stop without prescriber advice. Watch for bleeding (unusual bruising, prolonged bleeding, red/black stools, blood in urine, coughing/vomiting blood, severe headache/weakness) and seek urgent care for severe symptoms. Tell all healthcare providers/dentists before procedures; avoid or consult before using NSAIDs/other blood thinners and discuss new prescriptions/OTCs/herbals. Carry an anticoagulant alert card/medical ID. Follow missed-dose instructions specific to your regimen (do not double the next day for once-daily dosing).

Monitoring Requirements

No routine coagulation monitoring (e.g., INR) required; monitor clinically for bleeding/thrombosis, check renal function at baseline and periodically (more often if elderly/CKD/acute illness), and assess hepatic function/hemoglobin/hematocrit as clinically indicated; review concomitant interacting drugs.

Pharmacology

Mechanism of Action

Selective, direct Factor Xa inhibitor that inhibits free and clot-bound Factor Xa and prothrombinase activity, reducing thrombin generation and thrombus development without requiring antithrombin.

Onset of Action

Rapid onset with peak effect about 2-4 hours after an oral dose.

Half-Life

5-9 hours in young, healthy subjects; 11-13 hours in the elderly.

Bioavailability

Dose-dependent: 10 mg has ~80-100% oral bioavailability and is not meaningfully affected by food; 20 mg has ~66% bioavailability when fasting and increases to near-complete (~100%) when taken with food (therefore 15-20 mg doses should be taken with food).

Excretion

Elimination is via both renal and fecal/biliary routes: ~1/3 of the administered dose is excreted unchanged in urine; the remaining ~2/3 is metabolized and eliminated as inactive metabolites via urine and feces (overall roughly half renal and half fecal/biliary).

Product Information

Composition per Dose

Each film-coated tablet contains: 20mg rivaroxaban

OTC Alternatives

No OTC alternative

Cv Drug Class

Anticoagulant

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 31-08-2026