GlobalRPh Renal Dosing Masterv6.6
Evidence addition

Ursodiol tablets for PBC

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

Ursodeoxycholic acid

READ THE SOURCE-SPECIFIC ANSWER

Renal guidance at a glance

Confirm the product, indication and renal measure. The selected summary is not a complete prescribing monograph.

Choose a source to read (2)

Display order is not a clinical ranking. Date of retrieval is not the label revision date. Sources are never merged into one regimen. Other sources and conflicts remain below.

Official source

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 measure
No renal-function dose bands specified for this summary.

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.

Source revision: DailyMed updated 2025-08-10. | Retrieved: 2026-09-05. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d666bbc-98c4-445f-a5a2-cad1bcccde4e

Scope: Locally included source-specific summary. Regimen differences are not automatically resolved. GlobalRPh v6.6.

Full source card / provenance

All sources, comparison tools and evidence navigation
Source-first renal review

Evidence sources and renal implications

Choose a source to jump directly to its locally stored result. Qualitative precautions and evidence gaps remain visible even when no numerical clearance schedule is supplied.

Official product label

Ursodiol tablets for PBC - label dose; renal protocol not specified

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.
Retrieved: 2026-09-05

Read local renal resultOpen original reference
Handbook

Renal Drug Handbook, 5th edition - Ursodeoxycholic acid

Historical adult renal/RRT summary. U.S. product identity anchored to the separate locally included DailyMed label. This is not a current U.S. product label.

Renal method: Book table headed GFR (mL/min); its preface states renal adjustments generally derive from Cockcroft-Gault CrCl. Do not silently relabel as indexed eGFR.
Retrieved: 2026-09-05

Read local renal result

Source presence is not independent validation. A label mirror is not a second independent source; review the original reference and exact formulation.

Find text within this drug
Find a term without leaving this drug

Search the stored clinical text

Locate a word or phrase within this drug's source summaries. Choose all sources or one source to focus the search. The selection never hides warnings or source text, changes a dose, or proves that a renal finding is absent.

Find:

Enter at least two characters. Searches stay on this page and are not saved or sent.

All source summaries, original wording and provenance
Before applying a renal protocol

Check the setting. Compare whole sources.

No patient-specific dose is calculated. Context choices only display reminders; they do not validate, hide or change any regimen.

Share a reproducible source review

Choose sources below, then open a print-ready comparison with product scope, renal method, dates and cautions. Links can pin the exact local cards; they never contain patient values or choose a dose.

Open / share selected sources
Jump to renal guidanceClinician guide

Select two distinct source versions. The complete stored summaries will appear below.

Build a source-review outline for documentation

This creates a blank decision outline with the source identities you select, not a dose recommendation or completed clinical assessment. No patient fields are collected, saved or sent. Complete the clinical decisions in your approved documentation system.

Choose one or two sources above or use the source checkboxes below.

Renal-context checklist: population, kidney trend and dialysis

These prompts are a reading aid, not a prescription checklist or proof that all requirements have been met. No selections are stored or sent to a server.

Read the exact source scope, renal metric and date before selecting a row. No applicability assessment has been performed.

See source-specific renal methods and the clinical interpretation guide for the supporting context.

Go directly to the relevant source section

Renal dosing and precautions

Choose a source, then jump to its renal or dialysis section. These links locate stored text; they do not merge regimens or certify that sources agree.

Handbook source

Renal Drug Handbook, 5th edition - Ursodeoxycholic acid

Historical adult renal/RRT summary. U.S. product identity anchored to the separate locally included DailyMed label. This is not a current U.S. product label.

Method: Book table headed GFR (mL/min); its preface states renal adjustments generally derive from Cockcroft-Gault CrCl. Do not silently relabel as indexed eGFR.

Historical renal / replacement-therapy guidanceRead this complete source summary

No dialysis or renal heading shown? Read the complete source summary. Absence of a heading is not evidence that dose adjustment is unnecessary.

Compare or copy source versions

All content below is stored locally. Read a whole source version; do not combine its dose with another source's interval, renal metric or dialysis assumptions.

Original content / product scopeUrsodiol tablets for PBC - label dose; renal protocol not specifiedRenal Drug Handbook, 5th edition - Ursodeoxycholic acid
Choose two source checkboxes below.
Exact product and population matter. This added page contains locally stored, source-specific clinical summaries. Historical handbook information, when present, is identified separately and may conflict with U.S. labeling. Confirm indication, population, kidney-function method, monitoring and the full prescribing information before applying a regimen.

Important source distinctions

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.

Locally stored source content

Exact product and population

Product identity selected for the separately displayed source protocols below. Reference: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d666bbc-98c4-445f-a5a2-cad1bcccde4e

Product and population scope

Adult Ursodiol tablets for PBC. Use only the product, route, indication and renal-replacement setting explicitly stated in the source protocol selected below. Sources are alternatives to compare, not ingredients of a blended regimen.

SCOPE-ursodiol-pbc · Source section: Editorial scope; each clinical recommendation is separately attributed belowRenal section finder
Separate U.S. product-label layer

FDA / DailyMed dosing and renal information

Official

Ursodiol tablets for PBC - label dose; renal protocol not specified

Open original reference

Open / share this exact local source

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

Source identity and provenance
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d666bbc-98c4-445f-a5a2-cad1bcccde4e
Retrieved
2026-09-05
DailyMed Set ID
9d666bbc-98c4-445f-a5a2-cad1bcccde4e
Renal-function method
No renal-function dose bands specified for this summary.
Source date/version
DailyMed updated 2025-08-10.
Hash meaning
Locally authored summary text; not original SPL, HTML or PDF bytes
Local summary SHA-256
92f902dc55be9425e418003e93bfd4a4743095ebb8aaef75217d48379398d367
Separate handbook layer

Renal Drug Handbook cross-check

Handbook

Renal Drug Handbook, 5th edition - Ursodeoxycholic acid

Open / share this exact local source

UK Renal Pharmacy Group / CRC Press · Historical adult renal/RRT summary. U.S. product identity anchored to the separate locally included DailyMed label. This is not a current U.S. product label.

Renal method: Book table headed GFR (mL/min); its preface states renal adjustments generally derive from Cockcroft-Gault CrCl. Do not silently relabel as indexed eGFR.
Source date: 5th edition; 2019 copyright; historical reference
Retrieved: 2026-09-05

Historical handbook cross-check; not a current U.S. protocol

Historical renal / replacement-therapy guidance

The 20-50, 10-20 and <10 mL/min bands retain the usual indication-specific dose. All four listed RRT modalities retain the usual dose, but dialyzability is explicitly unknown. The historical PBC range is 12-16 mg/kg/day in three doses, whereas the selected U.S. tablet label uses 13-15 mg/kg/day in 2-4 doses. Keep these source-specific ranges separate; the label itself supplies no renal adjustment table.

HB30-ursodiol-pbc-1 · Source locator: Printed page 1040: renal impairment, RRT and other information

Source-specific limits

Separate source recommendation, not proof of agreement or contemporary clinical validation. Dialysis predictions are retained with their original certainty.

Source identity and provenance
Retrieved
2026-09-05
Handbook page
5th edition, printed p. 1040; uploaded PDF p. 1059
Renal-function method
Book table headed GFR (mL/min); its preface states renal adjustments generally derive from Cockcroft-Gault CrCl. Do not silently relabel as indexed eGFR.
Source date/version
5th edition; 2019 copyright; historical reference
U.S. product identity basis
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d666bbc-98c4-445f-a5a2-cad1bcccde4e
Hash meaning
Local paraphrase; original book not redistributed
Local summary SHA-256
2fb6090a797712a822e6d7dbb739dbb0c081f1f3c7e3495cda1c2e79dee3e41b

Provenance and preservation

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

Original source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d666bbc-98c4-445f-a5a2-cad1bcccde4e
Source retrieval
2026-09-05. This is not the source publication or label revision date.
Original source type
multisource addition
Local text SHA-256
2f4e638299bb76e0b9df5a617f0282bf20348ed780ddc90708b3e8bbaaaf61e4
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.

This page is an additional exact-product entry, not a recovered GlobalRPh monograph. Its primary scope text and separately attributed clinical summaries are locally included.

Read the full coverage report