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dabigatran

dabigatran

Brand names: Pradaxa

Form	Strength
CAPSULE, ORAL	75 mg; 150 mg

Display Direct Thrombin Inhibitors Class: 20120412

High Alert Drug : Policy

Medication comments:

Note: Clinical trial evaluating safety and efficacy utilized the Cockcroft-Gault formula with the use of actual body weight (data on file; Boehringer Ingelheim Pharmaceuticals Inc 2012).

High Alert Drug: direct thrombin inhibitors
• Nurses and pharmacists verify dose and that patient is not on another anticoagulant prior to administration. • Two RNs independently verify dose prior to administration if the dosing requires manipulation (i.e. drawing up a portion of a vial, or giving a portion of a syringe}. • Anticoagulation comparison chart available on nursing units for reference. • Pharmacists/nurses provide patient education for oral anticoagulants. • Pharmacists monitor for appropriate dosing, labs, and prevention of adverse events. • Reversal agents and order sets for oral anticoagulants

High Alert Drug: direct thrombin inhibitors

• Nurses and pharmacists verify dose and that patient is not on another anticoagulant prior to administration.
• Two RNs independently verify dose prior to administration if the dosing requires manipulation (i.e. drawing up a portion of a vial, or giving a portion of a syringe}.
• Anticoagulation comparison chart available on nursing units for reference.
• Pharmacists/nurses provide patient education for oral anticoagulants.
• Pharmacists monitor for appropriate dosing, labs, and prevention of adverse events.
• Reversal agents and order sets for oral anticoagulants

Anticoagulant / Antiplatelet Stoppage For Procedures
generic (Brand)	Dept.	Procedure Type (hover over entry for examples)	Stop Medication Prior To Procedure Restart after:
dabigatran (Pradaxa)	Anesthesia	High-risk	4 days (5-6 days impaired renal function) Restart after 24 hours
		Intermediate-risk	4 days (5-6 days impaired renal function) Restart after 24 hours
		Low-risk	Requires shared assessment and risk stratification Restart after 24 hours
		Patients with high risk of bleeding (eg, old age, history of bleeding tendency, concurrent uses of other anticoagulants/antiplatelets, liver cirrhosis or advanced liver disease, and advanced renal disease) undergoing low- or intermediate-risk procedures should be treated as intermediate or high risk, respectively.

	Radiology	Invasive Procedures	3 days (Hold time may need to by extended with impaired renal function)
	Radiology	Paracentesis/Thoracentesis	24 hours (Hold time may need to be extended with impaired renal function)
	Surgery	High-risk	CrCl > 50 mL/min - 3 days CrCl 30-50 mL/min - 5 days Restart after 2-3 days
	Surgery	Low-risk	CrCl > 50 mL/min - 3 days CrCl 30-50 mL/min - 5 days Restart after 2-3 days

Enteral Drug Administration notes.
Generic (Brand)	Comments and Considerations	Recommendations for Administration with Enteral Nutrition
dabigatran (Pradaxa)	Capsules should not be broken or opened.	Suggest using another form of anticoagulation until patient is able to take capsule whole.

2023 American Geriatrics Society Beers Criteria^® for potentially inappropriate medication use in older adults.
Medication:	dabigatran (Pradaxa)
Criteria 3: Potentially inappropriate medications: drugs to be used with caution in older adults. (Table 4)
Comments	for long-term treatment of nonvalvular atrial fibrillation or venous thromboembolism (VTE) When selecting among DOACs and choosing a dosage, pay special consideration to kidney function (see Table 6), indication, and body weight.
Drug(s)	dabigatran
Rationale	Increased risk of GI bleeding compared with warfarin (based on head-to-head clinical trials) and of GI bleeding and major bleeding compared with apixaban (based on observational studies and meta-analyses) in older adults when used for long-term treatment of nonvalvular atrial fibrillation or VTE.
Recommendation	Use caution in selecting dabigatran over other DOACs (e.g., apixaban) for long-term treatment of nonvalvular atrial fibrillation or VTE. See also criteria on warfarin and rivaroxaban (Table 2) and comment above regarding choice among DOACs.
Quality of evidence: Moderate, Strength of Recommendation: Strong

Criteria 5: medications that should be avoided or have their dosage reduced with varying levels of kidney function in older adults. (Table 6)
CrCl (mL/min) at which action is required	<30
Rationale	Lack of evidence for efficacy and safety in individuals with a CrCl <30 mL/min. Label dose for patients with CrCl 15-30 mL/min based on pharmacokinetic data.
Recommendation	Avoid when CrCl <30 mL/min; dose adjustment is advised when CrCl >30 mL/min in the presence of drug-drug interactions.
Quality of evidence: Moderate, Strength of Recommendation: Strong

Last updated: Sep. 18, 2025

Black Box Warnings Discontinuation without anticoagulation
Look-Alike/Sound-Alike dabigatran confused with vigabatrin

UpToDate Lexidrug

Pharmacy Contact Info:

Main Inpatient Pharmacy: ext 4599, 3503
Fax: 704-878-7283

Director of Pharmacy - Randi Raynor, PharmD: ext 4501
Clinical Coordinator - Laura Rollings, PharmD: ext 4597
Pharmacy Informaticist - Stephen Pringle, PharmD: ext 7645
Pharmacy Technician Supervisor - Amy Wingler, CPhT: ext 7385
Pharmacy Automation Coordinator (Omnicell) - Melissa Fulford, CPhT: ext 3556

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