GlobalRPh Renal Dosing Masterv6.6
GlobalRPh source record

Dabigatran (Pradaxa) - source atrial fibrillation protocol

Local official-label summaryBase record retrieved 2026-09-05See the evidence for this drug2 sources available - open source summaries, references and comparisons
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Renal guidance at a glance

Cautions / source differences (1)
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Capsule NVAF guidance is not the pellet or VTE regimen

The current capsule label supplies the adult NVAF renal regimen; the retrieved generic-title RX page describes pediatric pellets. VTE and interaction restrictions differ.

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Evidence for this qualification

Source-specific interpretation; independent clinician adjudication pending.

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Official source

PRADAXA capsules - official adult NVAF renal guidance

Product / population
PRADAXA oral capsules: adult nonvalvular AF only. Separate from pediatric oral pellets and VTE regimens.
Renal measure
CrCl (mL/min)
Before using this finding

Confirm capsule formulation, adult NVAF indication, interactions and stable renal assessment before choosing a regimen.

Renal guidance and important limits

Adult nonvalvular atrial fibrillation only: CrCl above 30 mL/min, 150 mg twice daily; 15-30, 75 mg twice daily. No dose recommendation is provided below 15 or on dialysis. With CrCl 30-50 and dronedarone or systemic ketoconazole, reduce to 75 mg twice daily; avoid concomitant P-gp inhibitors at CrCl 15-30. Reassess renal function during therapy; acute renal failure requires discontinuation and consideration of an alternative. This 75 mg NVAF regimen is not a VTE renal dose: the adult VTE sections provide no dose at CrCl 30 or below. Capsules are not substitutable milligram-for-milligram with other dabigatran formulations. Major bleeding and premature-discontinuation/neuraxial boxed warnings remain applicable.

Source revision: Official label updated 2025-06-25; full revision date not separately established | Retrieved: 2026-09-10. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9

Scope: Selected source sections stored locally. Not a complete monograph or independent clinical approval. GlobalRPh v6.6.

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What the dialysis evidence actually supports

Removal information alone does not define a maintenance dose, supplemental dose or dialysis schedule. A reported regimen still requires its product, indication, renal measure and dialysis assumptions to match the patient.

PRADAXA capsules - official adult NVAF renal guidance

Authored v6.1; retrieved 2026-09-10 - retained source, not freshly reviewed in this release

No dialysis regimen established in selected content

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These manual classifications apply only to the identified selected sections, not every retained source or the entire prescribing information. They are not dosing clearance.

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Evidence sources and renal implications

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Preserved GlobalRPh source

Preserved original GlobalRPh source

Preserved historical content; not revalidated as current prescribing guidance.

Renal method: Read the measure and population stated in the original source sections.
Retrieved: 2026-09-05

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Official product label

PRADAXA capsules - official adult NVAF renal guidance

Dose or interval guidance. Use only the product, indication, renal metric and population described in this source.
Before using this finding

Confirm capsule formulation, adult NVAF indication, interactions and stable renal assessment before choosing a regimen.

Dialysis evidence: No dialysis regimen established in selected content

PRADAXA oral capsules: adult nonvalvular AF only. Separate from pediatric oral pellets and VTE regimens.

Renal method: CrCl (mL/min)
Retrieved: 2026-09-10

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Source differences and product cautions

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source scope and renal guidance

Capsule NVAF guidance is not the pellet or VTE regimen

The current capsule label supplies the adult NVAF renal regimen; the retrieved generic-title RX page describes pediatric pellets. VTE and interaction restrictions differ.

How to use this: Choose exact formulation and indication before interpreting renal thresholds.

PRADAXA capsules - official adult NVAF renal guidanceDabigatran - PRADAXA oral pellets (pediatric product)

Source-specific interpretation; independent clinician adjudication pending.

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Renal dosing and precautions

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Original content / product scopePRADAXA capsules - official adult NVAF renal guidance
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Historical source content is not a current prescription. Original GlobalRPh recommendations are preserved, not automatically certified as current. Product-label and professional additions below are separately attributed. Confirm indication, population, kidney-function method, monitoring and the full prescribing information before applying a regimen.

Important source distinctions

This preserved protocol is for the source non-valvular atrial-fibrillation indication, not all dabigatran indications or formulations. Current interacting-drug restrictions require exact-label review.

Locally stored source content

Original GlobalRPh protocol

Clinical facts and comments transcribed into a structured reading format. This is not a byte-for-byte HTML archive. Original source: https://globalrph.com/renal/dabigatran/

Mechanism and indication

Dabigatran and its acyl glucuronides competitively inhibit free and clot-bound thrombin and thrombin-induced platelet aggregation, preventing conversion of fibrinogen to fibrin and thrombus formation.

PRADAXA is indicated in this source for stroke/systemic embolism risk reduction in non-valvular atrial fibrillation.

GRPH-dabigatran-01 · Source section: Mechanism and indicationRenal section finder

Usual Dosing (Adults)

CrCl >30 mL/min: 150 mg orally twice daily, with or without food. CrCl 15 to 30: 75 mg twice daily. No dosing recommendation can be provided for CrCl <15 or dialysis. Swallow capsules whole; breaking, chewing or emptying increases exposure.

Missed dose: take as soon as possible on the same day only if at least 6 hours remain before the next scheduled dose; otherwise skip. Do not double doses.

Warfarin to PRADAXA: stop warfarin and start PRADAXA when INR <2.0.

PRADAXA to warfarin: start warfarin before stopping PRADAXA, 3 days before for CrCl >50, 2 days before for 31 to 50, 1 day before for 15 to 30. No recommendation at <15. PRADAXA may raise INR; INR better reflects warfarin after PRADAXA has been stopped at least 2 days.

Parenteral anticoagulant to PRADAXA: start 0 to 2 hours before the next parenteral dose would be due, or when a continuous parenteral infusion is stopped. PRADAXA to parenteral anticoagulant: wait 12 hours after last dose for CrCl >=30 or 24 hours for CrCl <30.

Before invasive/surgical procedures, discontinue 1 to 2 days beforehand for CrCl >=50 or 3 to 5 days for CrCl <50 if possible. Consider longer for major surgery, spinal puncture, or spinal/epidural catheter/port where complete hemostasis is required. If surgery cannot wait, weigh increased bleeding risk against urgency. The source describes ecarin clotting time as a better activity marker than aPTT, PT/INR or thrombin time; if unavailable, aPTT gives an approximation.

GRPH-dabigatran-02 · Source section: Usual Dosing (Adults)Renal section finder

Renal Dosing

No adjustment for mild or moderate impairment. Reduce dose for severe impairment (CrCl 15 to 30), as above. No dosing recommendation for CrCl <15 or dialysis.

GRPH-dabigatran-03 · Source section: Renal DosingRenal section finder

Hemodialysis

Dosing recommendations for CrCl <15 mL/min or dialysis cannot be provided.

GRPH-dabigatran-04 · Source section: HemodialysisRenal section finder
Separate U.S. product-label layer

FDA / DailyMed dosing and renal information

Official

PRADAXA capsules - official adult NVAF renal guidance

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National Library of Medicine / manufacturer labeling · PRADAXA oral capsules: adult nonvalvular AF only. Separate from pediatric oral pellets and VTE regimens.

Renal method: CrCl (mL/min)
Source date: Official label updated 2025-06-25; full revision date not separately established
Retrieved: 2026-09-10

Dose or interval guidance. Use only the product, indication, renal metric and population described in this source.
Before using this finding

Confirm capsule formulation, adult NVAF indication, interactions and stable renal assessment before choosing a regimen.

Dialysis evidence: No dialysis regimen established in selected content

Selected source sections stored locally. Not a complete monograph or independent clinical approval.

Renal guidance and important limits

Adult nonvalvular atrial fibrillation only: CrCl above 30 mL/min, 150 mg twice daily; 15-30, 75 mg twice daily. No dose recommendation is provided below 15 or on dialysis. With CrCl 30-50 and dronedarone or systemic ketoconazole, reduce to 75 mg twice daily; avoid concomitant P-gp inhibitors at CrCl 15-30. Reassess renal function during therapy; acute renal failure requires discontinuation and consideration of an alternative. This 75 mg NVAF regimen is not a VTE renal dose: the adult VTE sections provide no dose at CrCl 30 or below. Capsules are not substitutable milligram-for-milligram with other dabigatran formulations. Major bleeding and premature-discontinuation/neuraxial boxed warnings remain applicable.

RDM61-official-dabigatran-b383f7d56c-C1 · Source locator: 2.2, 2.4, 5.5 and 7.1

Source identity and provenance
Source family
product_label
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9
Retrieved
2026-09-10
Exact label title
PRADAXA capsules - official adult NVAF renal guidance
DailyMed Set ID
ba74e3cd-b06f-4145-b284-5fd6b84ff3c9
Label revision
Official label updated 2025-06-25; full revision date not separately established
Renal-function method
CrCl (mL/min)
Source date/version
Official label updated 2025-06-25; full revision date not separately established
Hash meaning
Local authored summary, not source HTML/XML/PDF bytes
Local summary SHA-256
4040e6c51e6a2931697b72ba2c3dbeccb6bd7f894ed8649f9430d46ac8c571a8

Provenance and preservation

Additional summaries stored on this page: 1 official-label, 0 RX List, 0 professional, 0 handbook. Empty additional-source groups are not shown. A missing layer is not a no-adjustment recommendation.

Original source
https://globalrph.com/renal/dabigatran/
Source retrieval
2026-09-05. This is not the source publication or label revision date.
Original source type
globalrph individual
Local text SHA-256
d12f0e5915f27712ed379fbe0f6b710111c0b42b4045107fc2e6e92b3989690b
Import versus clinical validation
Source-section locators identify where retained content came from. A source-section identifier does not assert that every numeric statement has been independently corroborated. The local text hash is not a hash of original HTML, an FDA PDF or SPL XML.

The original individual GlobalRPh pages commonly cite NIH/NLM DailyMed and instruct readers to review the applicable package insert for updates. That historical reference is preserved as context; it is not counted as an independently retrieved current label.

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