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. Severe renal impairment. Females of reproductive potential. Abnormal uterine bleeding. Nursing mothers: not recommended. Antagonized by P-gp inducers eg, rifampin ; avoid. Increased dabigatran levels in renal impairment with concomitant P-gp inhibitors eg, [dronedarone, systemic ketoconazole; reduce dabigatran dose], verapamil, amiodarone, quinidine, clarithromycin, ticagrelor.
Switching to or from warfarin: monitor closely. Gastritis-like symptoms eg, GERD, esophagitis, erosive gastritis, gastric hemorrhage, ulcer , bleeding may be fatal. Adult Dosage: Swallow whole.
Children Dosage: Not established. Mechanical prosthetic heart valve. Boxed Warning: Premature discontinuation of Pradaxa increases the risk of thrombotic events. You are now leaving a Boehringer Ingelheim Pharmaceuticals, Inc. BIPI site.
BIPI is not responsible for the way information is processed by sites linked to this one. Please review those sites' privacy policies and terms of use to understand how your information will be processed. Linking to any other site is at your own risk. Skip to main content. For treatment only: Initial treatment with parenteral anticoagulant for days. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs NSAIDs , platelet inhibitors, other anticoagulants a history of traumatic or repeated epidural or spinal punctures a history of spinal deformity or spinal surgery optimal timing between the administration of PRADAXA and neuraxial procedures is not known Monitor patients frequently for signs and symptoms of neurological impairment.
Promptly evaluate any signs or symptoms of blood loss e. Risk factors for bleeding include concomitant use of medications that increase the risk of bleeding e. Prothrombin complex concentrates or recombinant Factor VIIa may be considered but their use has not been evaluated. Protamine sulfate and vitamin K are not expected to affect dabigatran anticoagulant activity. Consider administration of platelet concentrates where thrombocytopenia is present or long-acting antiplatelet drugs have been used.
Increased Risk of Thrombosis in Patients with Triple-Positive Antiphospholipid Syndrome There is an increased risk of thrombosis in patients with triple-positive antiphospholipid syndrome. Lactation: Breastfeeding is not recommended. Females and Males of Reproductive Potential: Discuss pregnancy planning with females of reproductive potential requiring anticoagulation.
Assess the risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, in females of reproductive potential and those with abnormal uterine bleeding. Pediatric Use: The safety and effectiveness of PRADAXA Capsules for the treatment and the reduction in risk of recurrence of venous thromboembolism have been established in pediatric patients 8 to less than 18 years of age. Other age-appropriate pediatric dosage forms of dabigatran etexilate are available for pediatric patients less than 8 years of age for these indications.
Safety and effectiveness of PRADAXA Capsules have not been established in pediatric patients with non-valvular atrial fibrillation or those who have undergone hip replacement surgery.
0コメント