Home Drug Guide Dabigatran Etexilate Mesylate

Drug Guide

Generic Name

Dabigatran Etexilate Mesylate

Brand Names Pradaxa

Classification

Therapeutic: Anticoagulant

Pharmacological: Direct Thrombin Inhibitor

FDA Approved Indications

Prevention of stroke and systemic embolism in non-valvular atrial fibrillation
Treatment of deep vein thrombosis (DVT)
Treatment of pulmonary embolism (PE)
Secondary prevention of DVT and PE

Mechanism of Action

Dabigatran is a direct thrombin inhibitor that prevents the conversion of fibrinogen to fibrin, thereby inhibiting clot formation.

Dosage and Administration

Adult: 150 mg twice daily after an initial 5-10 day parenteral anticoagulant

Pediatric: Not approved for pediatric use

Geriatric: Use with caution; dose adjustment based on renal function

Renal Impairment: Adjust dose based on renal function, using creatinine clearance (CrCl) guidelines

Hepatic Impairment: Use caution; contraindicated in severe hepatic impairment

Pharmacokinetics

Absorption: Rapid absorption with peak plasma levels within 2 hours

Distribution: Approximately 35% plasma protein binding

Metabolism: Minimal hepatic metabolism; primarily excreted unchanged by kidneys

Excretion: Mainly renal (about 80%)

Half Life: 12-17 hours in healthy individuals, prolonged in renal impairment

Contraindications

Active pathological bleeding
Significant kidney impairment (CrCl <30 mL/min)
Hypersensitivity to dabigatran or excipients

Precautions

Use caution in elderly, renal impairment, or liver disease; assess bleeding risk

Adverse Reactions - Common

Gastrointestinal upset (e.g., dyspepsia) (Common)
Bleeding (Common)

Adverse Reactions - Serious

Major hemorrhage (Serious)
Thrombotic events upon discontinuation (Serious)

Drug-Drug Interactions

NSAIDs, antiplatelet agents, other anticoagulants, certain P-gp inhibitors (e.g., dronedarone, ketoconazole)

Drug-Food Interactions

Avoid foods that increase bleeding risk
Alcohol—avoid excessive intake

Drug-Herb Interactions

Ginkgo biloba, garlic—may increase bleeding risk

Nursing Implications

Assessment: Monitor for signs of bleeding, renal function, and adherence to medication

Diagnoses:

Risk for bleeding
Risk for falls

Implementation: Administer with water, assess renal function before initiation and periodically during therapy, educate on bleeding precautions

Evaluation: Assess for any signs of bleeding, and evaluate renal function regularly

Patient/Family Teaching

Take medication exactly as prescribed
Report signs of bleeding (e.g., bleeding gums, dark stools, unusual bruising)
Inform healthcare providers of anticoagulant use before procedures or surgeries
Maintain consistent ingestion of medication without missed doses

Special Considerations

Black Box Warnings:

Risk of serious bleeding; use with caution in high bleeding risk patients

Genetic Factors: Consideration of genetic variations affecting P-glycoprotein and CYP3A4 may influence drug levels

Lab Test Interference: Does not significantly affect routine coagulation tests; specific assays needed for certain assessments

Overdose Management

Signs/Symptoms: Excessive bleeding, hypotension, tachycardia, anemia symptoms

Treatment: Discontinue dabigatran, supportive care, consider administration of idarucizumab (Praxbind) for reversal of anticoagulant effects

Storage and Handling

Storage: Store at room temperature (20-25°C), in original container to protect from moisture

Stability: Stable under recommended storage conditions for the duration of the product’s shelf life