Pradaxa

Capsules and oral pellets are not substitutable on a mg-to-mg basis; do not combine dosage forms. Premature discontinuation increases risk of thrombotic events; if discontinued for reason other than bleeding or therapy completion, consider coverage with another anticoagulant and restart dabigatran as soon as appropriate. Increased risk of spinal/epidural hematoma in anticoagulated patients receiving neuraxial anesthesia or undergoing spinal puncture; monitor for signs/symptoms of neurological impairment. Increased risk of serious bleeding. Promptly evaluate signs/symptoms of blood loss (eg, a drop in hemoglobin and/or hematocrit or hypotension). Use specific reversal agent (idarucizumab) to reverse anticoagulant effect of dabigatran as needed (eg, emergency surgery/urgent procedures, life-threatening/uncontrolled bleeding); efficacy and safety of idarucizumab in pediatric patients have not been established. Suspend treatment before invasive therapy or surgery, including dental procedures (see full labeling); restart promptly. Bioprosthetic heart valve or triple-positive antiphospholipid syndrome: not recommended. Monitor renal function prior to initiation, then periodically as clinically indicated; discontinue if acute renal failure develops and consider alternate therapy. Avoid lapses in therapy. Renal impairment (see Adult dosage & Children dosage). Bleeding risk can be assessed by ecarin clotting time (ECT), or if not available, aPTT. Elderly (>75yrs). Labor & delivery. Neonates. Pregnancy. Females of reproductive potential. Abnormal uterine bleeding. Nursing mothers: not recommended.