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Pradaxa
dabigatran etexilate
Black Box Warnings .
Premature Tx Discontinuation
incr. thrombotic event risk when D/C dabigatran for reasons other than pathological bleeding or completion of therapy course; if must D/C dabigatran, consider administering another anticoagulant
Epidural/Spinal Hematoma Risk
epidural/spinal hematoma risk after neuraxial anesthesia or spinal puncture in anticoagulated pts; hematoma may result in long-term or permanent paralysis; incr. risk if indwelling epidural catheter use, concomitant use of drugs affecting hemostasis incl. NSAIDs, platelet inhibitors, or other anticoagulants, traumatic or repeated epidural or spinal puncture hx, spinal deformity or spinal surgery hx, unknown optimal timing between dabigatran admin. and neuraxial procedure; monitor s/sx neurologic impairment, treat urgently if needed; consider benefit vs. risk before neuraxial intervention in anticoagulated pts or planned anticoagulation
Adult Dosing .
Dosage forms: CAP: 75 mg, 110 mg, 150 mg
thromboembolism/stroke prophylaxis
- [150 mg PO bid]
- Info: for non-valvular atrial fibrillation w/o mod-severe mitral stenosis or mechanical heart valve; to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; consider holding tx 1-2 days before surgery or invasive procedure if CrCl >50 or 3-5 days if CrCl <50; do not open/dissolve cap
DVT/PE tx
- [150 mg PO bid]
- Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant x5-10 days; consider holding tx 1-2 days before surgery or invasive procedure if CrCl >50 or 3-5 days if CrCl <50; do not open/dissolve cap
DVT/PE prophylaxis, recurrent
- [150 mg PO bid]
- Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; consider holding tx 1-2 days before surgery or invasive procedure if CrCl >50 or 3-5 days if CrCl <50; do not open/dissolve cap
DVT/PE prophylaxis, hip replacement
- [220 mg PO qd x28-35 days]
- Start: 110 mg PO x1 dose 1-4h postop or 220 mg PO qd on day after surgery; Info: consider holding tx 1-2 days before surgery or invasive procedure if CrCl >50 or 3-5 days if CrCl <50; do not open/dissolve cap
VTE prophylaxis, cardioversion (off-label)
- [afib/flutter duration <48h]
- Dose: 150 mg PO bid; Start: ASAP before or immediately after cardioversion; Info: for pts w/ CHA2DS2-VASc score >2; continue tx for at least 4wk after procedure; refer to ACC/AHA/HRS guidelines; do not open/dissolve cap
- [afib/flutter duration >48h or unknown]
- Dose: 150 mg PO bid; Start: at least 3wk before cardioversion; Info: continue tx for at least 4wk after procedure; refer to ACC/AHA/HRS guidelines; do not open/dissolve cap
renal dosing
- [thromboembolism/stroke prophylaxis]
- CrCl 15-30: 75 mg bid; CrCl <15: avoid use
- HD/PD: avoid use
- [VTE prophylaxis, cardioversion]
- renal impairment: not defined
- HD/PD: not defined
- [all other indications]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: CAP: 75 mg, 110 mg, 150 mg; PELLET: 20 mg per packet, 30 mg per packet, 40 mg per packet, 50 mg per packet, 110 mg per packet, 150 mg per packet
Special Note
- [formulation clarification]
- Info: dabigatran etexilate cap not interchangeable w/ dabigatran etexilate pellet; do not substitute on a mg to mg basis
venous thromboembolism tx
- [pellet form, 3-3.9 kg, 3-5 mo]
- Dose: 30 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 4-4.9 kg, 3-9 mo]
- Dose: 40 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 5-6.9 kg, 3-4 mo]
- Dose: 40 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 5-6.9 kg, 5-23 mo]
- Dose: 50 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 7-8.9 kg, 3 mo]
- Dose: 50 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 7-8.9 kg, 4-8 mo]
- Dose: 60 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 7-8.9 kg, 9-23 mo]
- Dose: 70 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 9-10.9 kg, 5 mo]
- Dose: 60 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 9-10.9 kg, 6-10 mo]
- Dose: 80 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 9-10.9 kg, 11-23 mo]
- Dose: 90 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 11-12.9 kg, 8-17 mo]
- Dose: 100 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 11-12.9 kg, 18-23 mo]
- Dose: 110 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 13-15.9 kg, 10 mo]
- Dose: 100 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 13-15.9 kg, 11-23 mo]
- Dose: 140 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 16-20.9 kg, 12-23 mo]
- Dose: 140 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 21-25.9 kg, 18-23 mo]
- Dose: 180 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 7-8.9 kg, 2-11 yo]
- Dose: 70 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 9-10.9 kg, 2-11 yo]
- Dose: 90 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 11-12.9 kg, 2-11 yo]
- Dose: 110 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 13-15.9 kg, 2-11 yo]
- Dose: 140 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 16-20.9 kg, 2-11 yo]
- Dose: 170 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 21-40.9 kg, 2-11 yo]
- Dose: 220 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, >41 kg, 2-11 yo]
- Dose: 260 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [capsule form, 11-15.9 kg, 8-17 yo]
- Dose: 75 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; do not open/dissolve cap
- [capsule form, 16-25.9 kg, 8-17 yo]
- Dose: 110 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; do not open/dissolve cap
- [capsule form, 26-40.9 kg, 8-17 yo]
- Dose: 150 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; do not open/dissolve cap
- [capsule form, 41-60.9 kg, 8-17 yo]
- Dose: 185 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; do not open/dissolve cap
- [capsule form, 61-80.9 kg, 8-17 yo]
- Dose: 220 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; do not open/dissolve cap
- [capsule form, >81 kg, 8-17 yo]
- Dose: 260 mg PO q12h; Start: ASAP after unfractionated heparin infusion D/C, or if transitioning from LMWH, give 0-2h before next LMWH dose would have been administered; Info: for use in pts initially treated w/ parenteral anticoagulant for at least 5 days; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; do not open/dissolve cap
venous thromboembolism prophylaxis, recurrent
- [pellet form, 3-3.9 kg, 3-5 mo]
- Dose: 30 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 4-4.9 kg, 3-9 mo]
- Dose: 40 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 5-6.9 kg, 3-4 mo]
- Dose: 40 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 5-6.9 kg, 5-23 mo]
- Dose: 50 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 7-8.9 kg, 3 mo]
- Dose: 50 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 7-8.9 kg, 4-8 mo]
- Dose: 60 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 7-8.9 kg, 9-23 mo]
- Dose: 70 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 9-10.9 kg, 5 mo]
- Dose: 60 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 9-10.9 kg, 6-10 mo]
- Dose: 80 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 9-10.9 kg, 11-23 mo]
- Dose: 90 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 11-12.9 kg, 8-17 mo]
- Dose: 100 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 11-12.9 kg, 18-23 mo]
- Dose: 110 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 13-15.9 kg, 10 mo]
- Dose: 100 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 13-15.9 kg, 11-23 mo]
- Dose: 140 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 16-20.9 kg, 12-23 mo]
- Dose: 140 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 21-25.9 kg, 18-23 mo]
- Dose: 180 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 7-8.9 kg, 2-11 yo]
- Dose: 70 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 9-10.9 kg, 2-11 yo]
- Dose: 90 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 11-12.9 kg, 2-11 yo]
- Dose: 110 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 13-15.9 kg, 2-11 yo]
- Dose: 140 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 16-20.9 kg, 2-11 yo]
- Dose: 170 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, 21-40.9 kg, 2-11 yo]
- Dose: 220 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [pellet form, >41 kg, 2-11 yo]
- Dose: 260 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; give before meals
- [capsule form, 11-15.9 kg, 8-17 yo]
- Dose: 75 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; do not open/dissolve cap
- [capsule form, 16-25.9 kg, 8-17 yo]
- Dose: 110 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; do not open/dissolve cap
- [capsule form, 26-40.9 kg, 8-17 yo]
- Dose: 150 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; do not open/dissolve cap
- [capsule form, 41-60.9 kg, 8-17 yo]
- Dose: 185 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; do not open/dissolve cap
- [capsule form, 61-80.9 kg, 8-17 yo]
- Dose: 220 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; do not open/dissolve cap
- [capsule form, >81 kg, 8-17 yo]
- Dose: 260 mg PO q12h; Info: to convert from warfarin, D/C warfarin, then start dabigatran when INR <2; to convert from other oral anticoagulants, D/C oral anticoagulant, then start dabigatran at next scheduled dose; to convert from parenteral anticoagulants, D/C parenteral anticoagulant, then start dabigatran 0-2h before next scheduled dose; hold tx 24h before surgery or invasive procedure if eGFR >80, or 2 days if eGFR 50-80; do not open/dissolve cap
renal dosing
- [see below]
- eGFR <50: avoid use
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy
- CrCl <15 (thromboembolism prevention or stroke prevention use)
- eGFR <50 (peds pts)
- bleeding, active major
- heart valve, mechanical
- antiphospholipid syndrome
- caution: pts 75 yo and older
- caution: female pts of reproductive potential
- caution: CrCl 15-30 (thromboembolism prevention or stroke prevention use)
- caution: bleeding risk
- caution: spinal puncture
- caution: epidural anesthesia use
- caution: spinal anesthesia use, concurrent
Drug Interactions .
Overview
dabigatran
thrombin inhibitor
- P-gp substrate
- anticoagulant
- gastric pH sensitive
Contraindicated
- defibrotide
- mifepristone
Avoid/Use Alternative
- abrocitinib
- adagrasib
- amiodarone
- anagrelide
- apalutamide
- asciminib
- azithromycin
- berotralstat
- bisoprolol
- brigatinib
- canagliflozin
- cannabidiol
- caplacizumab
- capmatinib
- captopril
- carbamazepine
- carvedilol
- cimetidine
- clarithromycin
- cobicistat
- conivaptan
- cyclosporine
- danicopan
- danshen
- daridorexant
- darunavir
- dasabuvir
- diltiazem
- diosmin
- dronedarone
- edoxaban
- efavirenz
- elacestrant
- elagolix
- elexacaftor/tezacaftor/ivacaftor
- eliglustat
- enasidenib
- enoxaparin
- entrectinib
- enzalutamide
- erdafitinib
- erythromycin
- felodipine
- flibanserin
- fluvoxamine
- fondaparinux
- fosphenytoin
- fostamatinib
- futibatinib
- gilteritinib
- ginkgo
- glecaprevir
- ibritumomab tiuxetan
- ibrutinib
- indomethacin
- isavuconazonium
- istradefylline
- itraconazole
- ivacaftor
- ketoconazole
- lapatinib
- lasmiditan
- ledipasvir
- lenacapavir
- levoketoconazole
- lifileucel
- lomitapide
- lonafarnib
- lopinavir/ritonavir
- lorlatinib
- lumacaftor/ivacaftor
- maribavir
- meropenem
- milk thistle
- mirabegron
- mitapivat
- naproxen
- nefazodone
- nelfinavir
- neratinib
- nifedipine
- nilotinib
- omacetaxine mepesuccinate
- osimertinib
- oxcarbazepine
- pacritinib
- paritaprevir
- paroxetine
- phenobarbital
- phenytoin
- pibrentasvir
- pirtobrutinib
- ponatinib
- posaconazole
- pretomanid
- primidone
- propafenone
- quercetin
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- ranolazine
- rifabutin
- rifampin
- rifapentine
- ritonavir
- rivaroxaban
- rolapitant
- rucaparib
- saquinavir
- sarecycline
- selpercatinib
- sodium phenylbutyrate/taurursodiol
- sorafenib
- sotagliflozin
- sotorasib
- sparsentan
- St. John's wort
- stiripentol
- suvorexant
- tacrolimus
- telmisartan
- temsirolimus
- tepotinib
- tezacaftor/ivacaftor
- ticagrelor
- tipranavir
- tolvaptan
- trazodone
- trimethoprim
- tucatinib
- turmeric
- uridine triacetate
- vaborbactam
- valbenazine
- vandetanib
- velpatasvir
- vemurafenib
- venetoclax
- verapamil
- voclosporin
- vorapaxar
- voxilaprevir
- zonisamide
Monitor/Modify Tx
- acalabrutinib
- ado-trastuzumab emtansine
- aducanumab
- afatinib
- alteplase
- anacaulase
- antithrombin
- apixaban
- argatroban
- asparaginase
- aspirin
- avapritinib
- axitinib
- bevacizumab
- binimetinib
- bivalirudin
- bromelain
- bromfenac ophthalmic
- cabazitaxel
- cabozantinib
- calaspargase
- cangrelor
- carfilzomib
- cefaclor
- cefadroxil
- cefazolin
- cefdinir
- cefepime
- cefixime
- cefotetan
- cefoxitin
- cefpodoxime proxetil
- cefprozil
- ceftazidime
- ceftriaxone
- cefuroxime axetil
- cefuroxime sodium
- celecoxib
- cephalexin
- cilostazol
- citalopram
- clopidogrel
- collagenase clostridium histolyticum
- dalteparin
- daprodustat
- dasatinib
- deferasirox
- desvenlafaxine
- diclofenac
- diclofenac ophthalmic
- diclofenac topical
- diflunisal
- dimethyl fumarate
- dipyridamole
- diroximel fumarate
- duloxetine
- encorafenib
- epoprostenol
- eptifibatide
- erlotinib
- escitalopram
- ethanol
- etodolac
- evening primrose oil
- fenoprofen
- fenugreek
- fluoxetine
- flurbiprofen
- flurbiprofen ophthalmic
- fruquintinib
- garlic
- gefitinib
- gemtuzumab ozogamicin
- heparin
- hydrocortisone
- ibuprofen
- ibuprofen lysine
- icosapent ethyl
- iloprost inhaled
- imatinib
- inotersen
- ketoprofen
- ketorolac
- ketorolac ophthalmic
- krill oil
- lecanemab
- lenvatinib
- levomilnacipran
- magnesium salicylate
- meclofenamate
- mefenamic acid
- meloxicam
- methotrexate
- methyl salicylate topical
- milnacipran
- mitotane
- monomethyl fumarate
- nabumetone
- nattokinase
- nepafenac ophthalmic
- niacin (vitamin B3)
- nintedanib
- nusinersen
- omega-3-acid
- oxaprozin
- pazopanib
- pegaspargase
- penicillin G
- pentosan polysulfate sodium
- pentoxifylline
- piperacillin
- piroxicam
- plasminogen, human
- porfimer
- pralsetinib
- prasugrel
- ramucirumab
- ranibizumab
- regorafenib
- reteplase
- salsalate
- saw palmetto
- selumetinib
- sertraline
- sirolimus albumin-bound
- sodium zirconium cyclosilicate
- sotatercept
- sugammadex
- sulindac
- sunitinib
- tenecteplase
- tirofiban
- tisotumab vedotin
- tivozanib
- tolmetin
- trametinib
- treprostinil
- upadacitinib
- valproic acid
- venlafaxine
- vilazodone
- vinpocetine
- vortioxetine
- warfarin
- willow bark
- zanubrutinib
- ziv-aflibercept
Adverse Reactions .
Serious Reactions
- epidural hematoma
- spinal hematoma
- bleeding, severe
- esophageal ulcer
- thrombocytopenia
- neutropenia
- agranulocytosis
- thrombosis if premature D/C
- hypersensitivity rxn
- angioedema
- anaphylaxis
- nephropathy
Common Reactions
- bleeding
- dyspepsia
- gastritis
- vomiting (peds pts)
- nausea (peds pts)
- diarrhea (peds pts)
- abdominal pain (peds pts)
Safety/Monitoring .
Monitoring Parameters
Cr at baseline, then as clinically indicated (peds), or q6-12mo if CrCl >50 and q3mo if CrCl <50 (adults)
Look/Sound-Alike Drug Names
Pradaxa confused with: Plavix; Ranexa
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; no human data available; risk of embryo-fetal toxicity and death and excess maternal bleeding near delivery based on animal data at 2.6-3x MRHD; risk of maternal hemorrhage during delivery and fetal bleeding based on drug's mechanism of action
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available, though low risk of infant harm based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: liver; CYP450: none; Info: prodrug converted to dabigatran
Excretion: urine primarily; Half-life: 12-17h, 9-11h (pellet form)
Subclass: Anticoagulants
Mechanism of Action
directly, reversibly inhibits thrombin
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: Boehringer Ingelheim Pharmaceuticals, Inc.
DEA/FDA: Rx
Approximate Retail Price
from http://www.goodrx.com/pradaxa
oral capsule:
- 75 mg (60 ea): $496.00
- 110 mg (60 ea): $496.00
- 150 mg (60 ea): $496.00
oral capsule:
- 75 mg (1 dose pack, 60 capsules): $496.00
- 110 mg (1 dose pack, 60 capsules): $496.00
- 150 mg (1 dose pack, 60 capsules): $496.00
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