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INTRODUCTION

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dabigatran (da-bye-gat-ran)

Pradaxa

Classification

Therapeutic: anticoagulants

Pharmacologic: thrombin inhibitors

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Indications
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To ↓ risk of stroke/systemic embolization associated with nonvalvular atrial fibrillation

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Action
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Acts as a direct inhibitor of thrombin. Therapeutic Effects: Lowered risk of thrombotic sequelae (stroke and systemic embolization) of nonvalvular atrial fibrillation.

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Adverse Reactions/Side Effects
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GI: abdominal pain, diarrhea, dyspepsia, gastritis, nausea. Hemat: BLEEDING. Misc: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS.

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PHYSICAL THERAPY IMPLICATIONS

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Examination and Evaluation
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  • Watch for signs of bleeding and hemorrhage, including bleeding gums, nosebleeds, unusual bruising, black/tarry stools, hematuria, and a fall in hematocrit or blood pressure. Notify physician or nursing staff immediately of these signs.

  • Monitor signs of hypersensitivity reactions and anaphylaxis, including pulmonary symptoms (tightness in the throat and chest, wheezing, cough, dyspnea) or skin reactions (rash, pruritus, urticaria). Notify physician or nursing staff immediately if these reactions occur.

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Interventions
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  • Use caution with any physical interventions that could increase bleeding, including wound débridement, chest percussion, joint mobilization, and application of local heat.

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Patient/Client-Related Instruction
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  • Instruct patient to report immediately signs of Gi bleeding, including abdominal pain, vomiting blood, blood in stools, or black, tarry stools.

  • Instruct patient to report other Gi problems such as severe or prolonged nausea, diarrhea, indigestion, and stomach pain.

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Pharmacokinetics
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Absorption: 3–7% absorbed following oral administration.

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Distribution: Unknown.

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Metabolism and Excretion: Of the amount absorbed, mostly excreted by kidneys (80%); 86% of ingested dose is eliminated in feces due to poor bioavailability.

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Half-life: 12–17 hr.

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TIME/ACTION PROFILE (effects on coagulation)

ROUTE ONSET PEAK DURATION
PO within hrs unknown 2 days*

*Following discontinuation, 3–5 days in renal impairment.

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Contraindications/Precautions
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Contraindicated in: Hypersensitivity; Active pathologic bleeding; Concurrent use of Pg-P inducers.

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Use Cautiously in: Concurrent medications/preexisting conditions that ↑ bleeding risk (other anticoagulants, antiplatelet agents, antifibrinolytics, heparins, chronic NSAiD use, labor and delivery); Surgical procedures (discontinue 1–2 days prior if CCr ≥50 mL/min or 3–4 days prior if CCr <50mL/min); Geri: ↑ risk of bleeding; Lactation: Use cautiously during breastfeeding; Pedi: Safety and effectiveness not established.

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Interactions
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Drug-Drug: Concurrent use of other anticoagulants, antiplatelet agents, antifibrinolytics, heparins, prasugrel, clopidogrel, or chronic use of NSAIDs ↑ risk of bleeding; Concurrent use of P-gp inducers, including rifampin, ↓ blood levels and effectiveness and should be avoided.

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Route/Dosage
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PO (Adults): 150 mg twice daily; CCr 15–30 mL/min—75 mg twice daily.

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Availability
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