Therapeutic Classification: anticoagulants
Pharmacologic Classification: thrombin inhibitors
Absorption: 3–7% absorbed following oral administration. Bioavailability of oral pellets higher than that of capsules in adults.
Distribution: Unknown.
Metabolism/Excretion: Of the amount absorbed, mostly excreted by kidneys (80%); 86% of ingested dose is eliminated in feces due to poor bioavailability.
Half-Life: 12–17 hr.
- Do not interchange capsules and oral pellets on a milligram-to-milligram basis and do not combine these dose forms to achieve the total dose.
Reduction in Risk of Stroke/Systemic Embolism in Nonvalvular Atrial Fibrillation
- PO (Adults ): Capsules: 150 mg twice daily.
Renal Impairment
- PO (Adults ): CCr 30–50 mL/min and taking dronedarone or systemic ketoconazole: Capsules: 75 mg twice daily; CCr <30 mL/min and taking P-gp inhibitor: Avoid concomitant use; CCr 15–30 mL/min: Capsules: 75 mg twice daily; CCr <15 mL/min or on dialysis: Not recommended.
Treatment of and Reduction in Risk of Recurrence of Deep Vein Thrombosis or Pulmonary Embolism
- Capsules
- PO (Adults ): 150 mg twice daily.
- PO (Children 8–<18 yr and ≥81 kg actual body weight): 260 mg (one 150-mg capsule + one 110-mg capsule or one 110-mg capsule + two 75-mg capsules) twice daily.
- PO (Children 8–<18 yr and 61–<81 kg actual body weight): 220 mg (two 110-mg capsules) twice daily.
- PO (Children 8–<18 yr and 41–<61 kg actual body weight): 185 mg (one 110-mg capsule + one 75-mg capsule) twice daily.
- PO (Children 8–<18 yr and 26–<41 kg actual body weight): 150 mg (one 150-mg capsule or two 75-mg capsules) twice daily.
- PO (Children 8–<18 yr and 16–<26 kg actual body weight): 110 mg (one 110-mg capsule) twice daily.
- PO (Children 8–<18 yr and 11–<16 kg actual body weight): 75 mg (one 75-mg capsule) twice daily.
- Oral Pellets
- PO (Children 2–<12 yr and ≥41 kg actual body weight): 260 mg (one 110-mg pkt + one 150-mg pkt) twice daily.
- PO (Children 2–<12 yr and 21–<41 kg actual body weight): 220 mg (two 110-mg pkts) twice daily.
- PO (Children 2–<12 yr and 16–<21 kg actual body weight): 170 mg (one 20-mg pkt + one 150-mg pkt) twice daily.
- PO (Children 2–<12 yr and 13–<16 kg actual body weight): 140 mg (one 30-mg pkt + one 110-mg pkt) twice daily.
- PO (Children 2–<12 yr and 11–<13 kg actual body weight): 110 mg (one 110-mg pkt) twice daily.
- PO (Children 2–<12 yr and 9–<11 kg actual body weight): 90 mg (one 40-mg pkt + one 50-mg pkt) twice daily.
- PO (Children 2–<12 yr and 7–<9 kg actual body weight): 70 mg (one 30-mg pkt + one 40-mg pkt) twice daily.
- PO (Children 18 mo-<2 yr and 21–<26 kg actual body weight): 180 mg (one 30-mg pkt + one 150-mg pkt) twice daily.
- PO (Children 12 mo-<2 yr and 16–<21 kg actual body weight): 140 mg (one 30-mg pkt + one 110-mg pkt) twice daily.
- PO (Children 11 mo-<2 yr and 13–<16 kg actual body weight): 140 mg (one 30-mg pkt + one 110-mg pkt) twice daily.
- PO (Children 10 mo-<11 mo and 13–<16 kg actual body weight): 100 mg (two 50-mg pkts) twice daily.
- PO (Children 18 mo-<2 yr and 11–<13 kg actual body weight): 110 mg (one 110-mg pkt) twice daily.
- PO (Children 8 mo-<18 mo and 11–<13 kg actual body weight): 100 mg (two 50-mg pkts) twice daily.
- PO (Children 11 mo–<2 yr and 9–<11 kg actual body weight): 90 mg (one 40-mg pkt + one 50-mg pkt) twice daily.
- PO (Children 6–<11 mo and 9–<11 kg actual body weight): 80 mg (two 40-mg pkts) twice daily.
- PO (Children 5–<6 mo and 9–<11 kg actual body weight): 60 mg (two 30-mg pkts) twice daily.
- PO (Children 9 mo-<2 yr and 7–<9 kg actual body weight): 70 mg (one 30-mg pkt + one 40-mg pkt) twice daily.
- PO (Children 4–<9 mo and 7–<9 kg actual body weight): 60 mg (two 30-mg pkts) twice daily.
- PO (Children 3–<4 mo and 7–<9 kg actual body weight): 50 mg (one 50-mg pkt) twice daily.
- PO (Children 5 mo–<2 yr and 5–<7 kg actual body weight): 50 mg (one 50-mg pkt) twice daily.
- PO (Children 3–<5 mo and 5–<7 kg actual body weight): 40 mg (one 40-mg pkt) twice daily.
- PO (Children 3–<10 mo and 4–<5 kg actual body weight): 40 mg (one 40-mg pkt) twice daily.
- PO (Children 3–<6 mo and 3–<4 kg actual body weight): 30 mg (one 30-mg pkt) twice daily.
Renal Impairment
- PO (Adults ): CCr <50 mL/min and taking P-gp inhibitor: Avoid concomitant use; CCr <30 mL/min or on dialysis: Not recommended.
Renal Impairment
- (Children 8–<18 yr and ≥11 kg): eGFR <50 mL/min/1.73 m2: Not recommended.
Prevention of Deep Vein Thrombosis and Pulmonary Embolism Following Hip Replacement Surgery
- PO (Adults ): Capsules: 110 mg taken 1–4 hr after surgery and once hemostasis achieved, then 220 mg once daily for 28–35 days; if unable to start on day of surgery, once hemostasis achieved, start with 220 mg once daily.
Renal Impairment
- PO (Adults ): CCr <50 mL/min and taking P-gp inhibitor: Avoid concomitant use; CCr ≤30 mL/min or on dialysis: Not recommended.
