![]() ![]() This test is a better marker of the anticoagulant activity of dabigatran than activated partial thromboplastin time (aPTT), prothrombin time (PT)/INR, or thrombin time (TT). ![]() ![]() Bleeding risk can be assessed by the ecarin clotting time (ECT). ![]() This risk of bleeding should be weighed against the urgency of intervention. If surgery cannot be delayed, there is an increased risk of bleeding. Consider longer times for patients undergoing major surgery, spinal puncture, or placement of a spinal or epidural catheter or port, in whom complete hemostasis may be required. If possible, discontinue PRADAXA 1 to 2 days (CrCl ≥50 mL/min) or 3 to 5 days (CrCl <50 mL/min) before invasive or surgical procedures because of the increased risk of bleeding. FULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dose 2.2 Converting from or to Warfarin 2.3 Converting from or to Parenteral Anticoagulants 2.4 Surgery and Interventions 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Risk of Bleeding 5.2 Temporary Discontinuation of PRADAXA 5.3 Effect of P-gp Inducers and Inhibitors on Dabigatran Exposure 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Labor and Delivery 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION 17.1 Instructions for Patients 17.2 Bleeding 17.3 Gastrointestinal Adverse Reactions 17.4 Invasive or Surgical Procedures 17.5 Concomitant Medications * Sections or subsections omitted from the full prescribing information are not listed. ![]()
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