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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.
The selected label provides actual PBC dosing but no renal algorithm. The historical handbook renal statement is additional professional guidance, not an inferred FDA no-adjustment recommendation.
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Ursodiol tablets for PBC - label dose; renal protocol not specified
Product / population
Adults; named product and route only. Selected dosing and renal summary, not the full prescribing information.
Renal method
No renal-function dose bands specified for this summary.
Source revision
DailyMed updated 2025-08-10.
Retrieved
2026-09-05
Local review status
Locally included source-specific summary. Regimen differences are not automatically resolved.
Official
Ursodiol tablets for PBC - label dose; renal protocol not specified
NIH/NLM DailyMed - U.S. product labeling · Adults; named product and route only. Selected dosing and renal summary, not the full prescribing information.
Renal method: No renal-function dose bands specified for this summary. Source date: DailyMed updated 2025-08-10. Retrieved: 2026-09-05
Locally included source-specific summary. Regimen differences are not automatically resolved.
Dosing / renal protocol and limits
For adult primary biliary cholangitis, the selected 250/500-mg tablet label uses 13-15 mg/kg/day orally in 2-4 divided doses with food. Monitor liver tests and bilirubin monthly for the first 3 months, then every 6 months.
The reviewed label does not provide a renal-impairment adjustment or dialysis regimen. Absence of that instruction is not proof of no adjustment. Any handbook renal recommendation is displayed separately, and should not be called FDA-confirmed. Gallstone-dissolution capsule regimens are not covered by this tablet/PBC card.
RDM30-089-ursodiol-pbc-1 · Source locator: Ursodiol tablets for PBC - label dose; renal protocol not specified; renal/dosing sections and stated qualifiers
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.