Dabigatran Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Deep Vein Thrombosis - Prophylaxis

Recommended doses: 150 mg orally twice a day

Comments: Generally, the extent of anticoagulation does not need to be assessed with this drug; however, when necessary, use aPTT or ECT, and not INR to assess anticoagulant activity.

Uses: Reduction of risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5 to 10 days; reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in patients who have been previously treated.

Usual Adult Dose for Prevention of Thromboembolism in Atrial Fibrillation

Recommended doses: 150 mg orally twice a day

Comments: Generally, the extent of anticoagulation does not need to be assessed with this drug; however, when necessary, use aPTT or ECT, and not INR to assess anticoagulant activity.

Uses: Reduction of risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5 to 10 days; reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in patients who have been previously treated.

Renal Dose Adjustments

To Reduce Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation:
-CrCl greater than 30 mL/min: 150 mg orally twice a day
-CrCl 15 to 30 mL/min: 75 mg orally twice a day
-CrCl less than 15 mL/min: Dosing recommendation cannot be provided

When coadministered with dronedarone or systemic ketoconazole:
-CrCl 30 to 50 mL/min: Dose may be reduced to 75 mg twice a day

Concomitant use with P-gp inhibitors:
-CrCl 30 to 50 mL/min: No adjustment recommended
-CrCl less than 30 mL/min: Avoid coadministration

For Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism:
-CrCl greater than 30 mL/min: 150 mg orally twice a day
-CrCl less than 30 mL/min: Dosing recommendation cannot be provided

Concomitant use with P-gp inhibitors:
-CrCl less than 50 mL/min: Avoid coadministration

Liver Dose Adjustments

Data not available

Dose Adjustments

When converting patients from warfarin therapy to dabigatran, discontinue warfarin and start dabigatran when the international normalized ratio (INR) is below 2.0.

When converting from dabigatran to warfarin, adjust the starting time of warfarin based on creatinine clearance as follows:
-CrCl greater than 50 mL/min, start warfarin 3 days before discontinuing dabigatran
-CrCl 30 to 50 mL/min, start warfarin 2 days before discontinuing dabigatran
-CrCl 15 to 30 mL/min, start warfarin 1 day before discontinuing dabigatran
-CrCl less than 15 mL/min, no recommendations can be made

When converting from a parenteral anticoagulant, start dabigatran 0 to 2 hours before the scheduled administration of the parenteral anticoagulant or at the time of discontinuation of a continuously administered parenteral anticoagulant.

When converting to a parenteral anticoagulant, start the parenteral anticoagulant 12 hours (CrCl 30 mL/min or greater) or 24 hours (CrCl less than 30 mL/min) after the last dose of dabigatran.

Precautions

BOXED WARNING:
Premature discontinuation of dabigatran increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if dabigatran is discontinued for a reason other than pathological bleeding or completion of a course of therapy.

Epidural or spinal hematomas may occur in patients treated with dabigatran who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term permanent paralysis. Consider these risks when scheduling patients for spinal procedures. 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 nonsteroidal 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 dabigatran and neuraxial procedures is not known

Monitor signs and symptoms of neurological impairment and if observed, treat urgently. Consider the benefits and risks before neuraxial intervention in patients who are or who need to be anticoagulated.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis: Dosing recommendation cannot be provided
Peritoneal dialysis: Data not available

Other Comments

Administration advice:
-Assess renal function prior to initiation of treatment with dabigatran.
-Breaking, chewing, or emptying capsules can increase exposure to dabigatran.
-Swallow the capsules whole with a full glass of water.
-Take a missed dose as soon as possible on the same day, but skip if it is less than 6 hours before the next scheduled dose.
-The dose of dabigatran should not be doubled to make up for a missed dose.

Monitoring:
-Cardiovascular: Hypotension.
-Hematologic: Signs of bleeding (hemoglobin, hematocrit)
-Nervous system: Signs and symptoms of neurological impairment
-Renal: Assess renal function periodically as clinically indicated and adjust therapy accordingly.

Patient advice:
-Report any experience of midline back pain, numbness, tingling, or weakness in lower limbs, bowel and/or bladder dysfunction.
-Patients should not stop taking dabigatran without medical advice.

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