CV: syncope.
Derm: blister, pruritus.
Hemat: BLEEDING.
Local: wound secretion.
MS: extremity pain, muscle spasm.
Prevention of Deep Vein Thrombosis Following Knee or Hip Replacement Surgery
- PO (Adults): 10 mg once daily, initiated 6–10 hr postoperatively (when hemostasis is achieved) continued for 35 days after hip replacement or 12 days after knee replacement.
Prevention of Venous Thromboembolism in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding
- PO (Adults): 10 mg once daily while in the hospital and after hospital discharge for a total of 31–39 days.
Treatment of Deep Vein Thrombosis or Pulmonary Embolism
- PO (Adults): 15 mg twice daily with food for 21 days, then 20 mg once daily with food for remainder of treatment period.
Reduction in Risk of Recurrent Deep Vein Thrombosis and/or Pulmonary Embolism in Patients at Continued Risk for Recurrent Deep Vein Thrombosis and/or Pulmonary Embolism
- PO (Adults): 10 mg once daily to be initiated after ≥6 mo of standard anticoagulant treatment.
Reduction in Risk of Stroke/Systemic Embolism in Nonvalvular Atrial Fibrillation
- PO (Adults): 20 mg once daily with evening meal.
Renal Impairment
- PO (Adults): CCr ≤50 mL/min: 15 mg once daily with evening meal.
Reduction in Risk of Major Cardiovascular Events in Patients With Chronic Coronary Artery Disease or Reduction in Risk of Major Thrombotic Vascular Events in Peripheral Arterial Disease, Including Patients After Lower Extremity Revascularization Due to Symptomatic Peripheral Arterial Disease
- PO (Adults): 2.5 mg twice daily.
Treatment of Venous Thromboembolism and Reduction in Risk of Recurrent Venous Thromboembolism in Pediatric Patients
- PO (Children Birth–<18 yr and ≥50 kg): Oral suspension or tablets: 20 mg once daily with food to be initiated after ≥5 days of initial parenteral anticoagulation therapy. Continue therapy for ≥3 mo (unless <2 yr with catheter-related thrombosis).
- PO (Children Birth–<18 yr and 30–49.9 kg): Oral suspension or tablets: 15 mg once daily with food to be initiated after ≥5 days of initial parenteral anticoagulation therapy. Continue therapy for ≥3 mo (unless <2 yr with catheter-related thrombosis).
- PO (Children Birth–<18 yr and 12–29.9 kg): Oral suspension: 5 mg twice daily with feeding or food to be initiated after ≥5 days of initial parenteral anticoagulation therapy. Continue therapy for ≥3 mo (unless <2 yr with catheter-related thrombosis).
- PO (Children Birth–<18 yr and 10–11.9 kg): Oral suspension: 3 mg three times daily with feeding or food to be initiated after ≥5 days of initial parenteral anticoagulation therapy. Continue therapy for ≥3 mo (unless <2 yr with catheter-related thrombosis).
- PO (Children Birth–<18 yr and 9–9.9 kg): Oral suspension: 2.8 mg three times daily with feeding or food to be initiated after ≥5 days of initial parenteral anticoagulation therapy. Continue therapy for ≥3 mo (unless <2 yr with catheter-related thrombosis).
- PO (Children Birth–<18 yr and 8–8.9 kg): Oral suspension: 2.4 mg three times daily with feeding or food to be initiated after ≥5 days of initial parenteral anticoagulation therapy. Continue therapy for ≥3 mo (up to 12 mo) unless <2 yr with catheter-related VTE in which duration should be 1 mo (up to 3 mo).
- PO (Children Birth-<18 yr and 7–7.9 kg): Oral suspension: 1.8 mg three times daily with feeding or food to be initiated after ≥5 days of initial parenteral anticoagulation therapy. Continue therapy for ≥3 mo (up to 12 mo) unless <2 yr with catheter-related VTE in which duration should be 1 mo (up to 3 mo).
- PO (Children Birth-<18 yr and 5–6.9 kg): Oral suspension: 1.6 mg three times daily with feeding or food to be initiated after ≥5 days of initial parenteral anticoagulation therapy. Continue therapy for ≥3 mo (up to 12 mo) unless <2 yr with catheter-related VTE in which duration should be 1 mo (up to 3 mo).
- PO (Children Birth-<18 yr and 4–4.9 kg): Oral suspension: 1.4 mg three times daily with feeding or food to be initiated after ≥5 days of initial parenteral anticoagulation therapy. Continue therapy for ≥3 mo (up to 12 mo) unless <2 yr with catheter-related VTE in which duration should be 1 mo (up to 3 mo).
- PO (Children Birth-<18 yr and 3–3.9 kg): Oral suspension: 0.9 mg three times daily with feeding or food to be initiated after ≥5 days of initial parenteral anticoagulation therapy. Continue therapy for ≥3 mo (up to 12 mo) unless <2 yr with catheter-related VTE in which duration should be 1 mo (up to 3 mo).
- PO (Children Birth-<18 yr and 2.6–2.9 kg): Oral suspension: 0.8 mg three times daily with feeding or food to be initiated after ≥5 days of initial parenteral anticoagulation therapy. Continue therapy for ≥3 mo (up to 12 mo) unless <2 yr with catheter-related VTE in which duration should be 1 mo (up to 3 mo).
Thromboprophylaxis in Pediatric Patients with Congenital Heart Disease after Fontan Procedure
- PO (Children ≥2 yr and ≥50 kg): Oral suspension or tablets: 10 mg once daily.
- PO (Children ≥2 yr and 30–49.9 kg): Oral suspension: 7.5 mg once daily.
- PO (Children ≥2 yr and 20–29.9 kg): Oral suspension: 2.5 mg twice daily.
- PO (Children ≥2 yr and 12–19.9 kg): Oral suspension: 2 mg twice daily.
- PO (Children ≥2 yr and 10–11.9 kg): Oral suspension: 1.7 mg twice daily.
- PO (Children ≥2 yr and 8–9.9 kg): Oral suspension: 1.6 mg twice daily.
- PO (Children ≥2 yr and 7–7.9 kg): Oral suspension: 1.1 mg twice daily.
Therapeutic Classification: anticoagulants
Pharmacologic Classification: antithrombotics
Absorption: Well absorbed (80%) following oral administration; absorption occurs in the stomach and ↓ as it enters the small intestine.
Distribution: Unknown.
Metabolism/Excretion: 51% metabolized by the liver; 36% excreted unchanged in urine. Metabolites do not have anticoagulant activity.
Half-life: 5–9 hr.