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1 local source card selected. Local card fingerprints checked where supplied. This is not an original-document hash, source-currency guarantee or clinical approval. Record-level cautions below are the current library's cautions, not a frozen prior version.
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Clinical context remains essential
Independent clinical review is pending. Confirm indication, exact formulation/route, population, renal measure and units, kidney-function stability, dialysis prescription, interacting drugs, monitoring and source revision. An RX mirror and its original label are not independent corroboration. Missing disagreement notes do not certify agreement.
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.
Check source scope before reading a dose
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 method
CrCl (mL/min)
Source revision
Official label updated 2025-06-25; full revision date not separately established
Retrieved
2026-09-10
Local review status
Selected source sections stored locally. Not a complete monograph or independent clinical approval.
Documented differences and cautions on this drug
All record notes are retained here, including notes about sources not selected in this review.
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.
What to reconcile: Choose exact formulation and indication before interpreting renal thresholds.
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
This reference does not select a regimen. Complete the indication, measured/estimated renal function and trend, dialysis setting, source rationale, monitoring and reassessment plan in your institution's approved documentation system. Confirm the complete current source before adopting its regimen.
GlobalRPh v6.6 | RDM66-DIRECT-PHP-20260911 | Local library date 2026-09-11. Selected-card identity does not imply clinical verification.