GlobalRPh Renal Dosing Masterv6.6
Evidence addition

Baclofen oral immediate-release tablets

READ THE SOURCE-SPECIFIC ANSWER

Renal guidance at a glance

Cautions / source differences (1)

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

Choose a source to read (4)

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.

1 additional source qualifications - review before use
Older-adult avoidance guidance is more conservative than a generic reduction instruction

AGS 2023 recommends avoidance in older adults below its eGFR threshold, whereas the product-label summary advises caution and possible reduction.

Before applying: Review the age-specific source before using a reduced-dose schedule. The geriatric warning is not an intrathecal dosing rule.

Also check: Older-adult avoidance guidance is more conservative than a generic reduction instruction

Official source

Baclofen oral immediate-release tablets - selected U.S. labeling

Product / population
Adults with spasticity; oral immediate-release baclofen only. Intrathecal doses and pump management are excluded. Severe kidney impairment is a high-risk toxicity setting.
Renal measure
Qualitative labeling only. The separate professional recommendation uses indexed eGFR.
Labeled basic dosing

The general label titration begins 5 mg orally three times daily for 3 days, then 10, 15 and 20 mg three times daily at successive 3-day steps. Maximum 80 mg/day. This is NOT a renal-adjusted schedule.

Renal information and dialysis

The label urges caution and possible dose reduction because renal excretion is substantial. It does not provide numeric CrCl-based doses or a safe dialysis dose.

Selected warnings and limits

Toxicity may include profound sedation, coma, respiratory depression and seizures. Avoid abrupt withdrawal except when serious adverse reactions require a different immediate plan.

Source revision: Label revision date not separately recorded; retrieval date is not the revision date. | Retrieved: 2026-09-05. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=346af8fe-3816-49de-bfd3-5a7425e728f9

Scope: Selected dosing/renal sections read; concise local summary, not full prescribing information. 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.

Read 1 source difference / applicability notes

Official product label

Baclofen oral immediate-release tablets - selected U.S. labeling

Adults with spasticity; oral immediate-release baclofen only. Intrathecal doses and pump management are excluded. Severe kidney impairment is a high-risk toxicity setting.

Renal method: Qualitative labeling only. The separate professional recommendation uses indexed eGFR.
Retrieved: 2026-09-05

Professional guidance

Baclofen toxicity in kidney disease - author recommendations

Adults with spasticity; oral immediate-release baclofen only. Intrathecal doses and pump management are excluded. Severe kidney impairment is a high-risk toxicity setting.

Renal method: eGFR, mL/min/1.73 m2
Retrieved: 2026-09-05

Professional guidance

AGS Beers 2023 - baclofen renal risk

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

Adults aged 65 years and older receiving oral baclofen; not intrathecal therapy.

Renal method: eGFR below 60 mL/min as printed; indexing is not specified in the selected row. Do not silently replace with CrCl.
Retrieved: 2026-09-07

Handbook

Renal Drug Handbook, fifth edition - Baclofen oral immediate-release tablets

Historical renal/RRT cross-check for the named ingredient; not a current U.S. prescribing instruction.

Renal method: Book table headings say GFR (mL/min); the preface states adjustment information is based on Cockcroft-Gault CrCl, not indexed eGFR. Do not substitute methods.
Retrieved: 2026-09-05

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

Product / population check

Confirm the exact formulation before using a renal source

These links compare product identities, not interchangeable doses. A selected summary is not a complete prescribing monograph.

Source-quality holds
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:

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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

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.

Read before choosing a regimen

Source differences and product cautions

Search differences across all drugs

These are specific issues found during source review, not an automated judgment that one source is universally correct. A label mirror and its original label are not independent evidence.

population specific risk

Older-adult avoidance guidance is more conservative than a generic reduction instruction

AGS 2023 recommends avoidance in older adults below its eGFR threshold, whereas the product-label summary advises caution and possible reduction.

How to use this: Review the age-specific source before using a reduced-dose schedule. The geriatric warning is not an intrathecal dosing rule.

Source-specific interpretation; independent clinician adjudication pending.

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.

Official source

Baclofen oral immediate-release tablets - selected U.S. labeling

Adults with spasticity; oral immediate-release baclofen only. Intrathecal doses and pump management are excluded. Severe kidney impairment is a high-risk toxicity setting.

Method: Qualitative labeling only. The separate professional recommendation uses indexed eGFR.

Professional source

Baclofen toxicity in kidney disease - author recommendations

Adults with spasticity; oral immediate-release baclofen only. Intrathecal doses and pump management are excluded. Severe kidney impairment is a high-risk toxicity setting.

Method: eGFR, mL/min/1.73 m2

Handbook source

Renal Drug Handbook, fifth edition - Baclofen oral immediate-release tablets

Historical renal/RRT cross-check for the named ingredient; not a current U.S. prescribing instruction.

Method: Book table headings say GFR (mL/min); the preface states adjustment information is based on Cockcroft-Gault CrCl, not indexed eGFR. Do not substitute methods.

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.

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

High-priority source disagreement: the old handbook supplies small doses in severe renal disease, while the later toxicity recommendation advises avoidance. No patient-specific safe dose is calculated.

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=346af8fe-3816-49de-bfd3-5a7425e728f9

Product and population scope

Adults with spasticity; oral immediate-release baclofen only. Intrathecal doses and pump management are excluded. Severe kidney impairment is a high-risk toxicity setting.

RDM31-baclofen-oral-scope · Source section: Editorial scope tied to selected U.S. labelRenal section finder
Separate U.S. product-label layer

FDA / DailyMed dosing and renal information

Official

Baclofen oral immediate-release tablets - selected U.S. labeling

Open original reference

Open / share this exact local source

U.S. product labeling / DailyMed · Adults with spasticity; oral immediate-release baclofen only. Intrathecal doses and pump management are excluded. Severe kidney impairment is a high-risk toxicity setting.

Renal method: Qualitative labeling only. The separate professional recommendation uses indexed eGFR.
Source date: Label revision date not separately recorded; retrieval date is not the revision date.
Retrieved: 2026-09-05

Selected dosing/renal sections read; concise local summary, not full prescribing information.

Labeled basic dosing

The general label titration begins 5 mg orally three times daily for 3 days, then 10, 15 and 20 mg three times daily at successive 3-day steps. Maximum 80 mg/day. This is NOT a renal-adjusted schedule.

RDM31-baclofen-oral-label-dose · Source locator: Dosage and Administration

Renal information and dialysis

The label urges caution and possible dose reduction because renal excretion is substantial. It does not provide numeric CrCl-based doses or a safe dialysis dose.

RDM31-baclofen-oral-label-renal · Source locator: Warnings: Impaired Renal Function

Selected warnings and limits

Toxicity may include profound sedation, coma, respiratory depression and seizures. Avoid abrupt withdrawal except when serious adverse reactions require a different immediate plan.

RDM31-baclofen-oral-label-limits · Source locator: Warnings; Overdosage: signs and symptoms

Source identity and provenance
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=346af8fe-3816-49de-bfd3-5a7425e728f9
Retrieved
2026-09-05
DailyMed Set ID
346af8fe-3816-49de-bfd3-5a7425e728f9
Renal-function method
Qualitative labeling only. The separate professional recommendation uses indexed eGFR.
Source date/version
Label revision date not separately recorded; retrieval date is not the revision date.
Hash meaning
SHA-256 identifies this local summary, not original SPL XML or label PDF.
Local summary SHA-256
d4cbbf27a6d283a0e5380560f3327b24be759b20b3e8b1230a43d9307495524e
Separate handbook layer

Renal Drug Handbook cross-check

Handbook

Renal Drug Handbook, fifth edition - Baclofen oral immediate-release tablets

Open / share this exact local source

UK Renal Pharmacy Group / CRC Press · Historical renal/RRT cross-check for the named ingredient; not a current U.S. prescribing instruction.

Renal method: Book table headings say GFR (mL/min); the preface states adjustment information is based on Cockcroft-Gault CrCl, not indexed eGFR. Do not substitute methods.
Source date: Fifth edition, 2019
Retrieved: 2026-09-05

Historical source, separately displayed. Renal tables were read with page-image inspection.

Historical renal and dialysis observations

The historical table proposes 5 mg three times daily at 20-50 mL/min, twice daily at 10-20 and daily below 10. The following page documents encephalopathy and major toxicity in dialysis patients after small doses.

RDM31-baclofen-oral-book · Source locator: Dose in renal impairment; renal replacement therapies; Other information

Source-specific limits

SAFETY DISAGREEMENT: these historical doses must not be read as established safe regimens. The separate Wolf et al. recommendation advises avoidance below eGFR 30 mL/min/1.73 m2 or during renal replacement therapy.

Source identity and provenance
Retrieved
2026-09-05
Handbook page
Printed page(s) 107-108; PDF page(s) 126,127
Renal-function method
Book table headings say GFR (mL/min); the preface states adjustment information is based on Cockcroft-Gault CrCl, not indexed eGFR. Do not substitute methods.
Source date/version
Fifth edition, 2019
U.S. product identity basis
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=346af8fe-3816-49de-bfd3-5a7425e728f9
Hash meaning
SHA-256 identifies the local paraphrase; the source PDF is not redistributed.
Local summary SHA-256
326b43b77fb6aa9e19b5235e8aa337f371fbde4309da941bfd92087bc4645b66
Separate professional-source layer

University and professional protocols

Professional

Baclofen toxicity in kidney disease - author recommendations

Open original reference

Open / share this exact local source

Wolf et al. / American Journal of Kidney Diseases · Adults with spasticity; oral immediate-release baclofen only. Intrathecal doses and pump management are excluded. Severe kidney impairment is a high-risk toxicity setting.

Renal method: eGFR, mL/min/1.73 m2
Source date: 2018; published online 2017
Retrieved: 2026-09-05

Separate professional-source protocol; not automatically equivalent to product labeling.

Source-specific renal protocol

The authors recommend reducing baclofen exposure when eGFR is 30-60 mL/min/1.73 m2 and avoiding baclofen when eGFR is below 30 or the patient receives renal replacement therapy. This case-based recommendation does not supply a validated numeric reduced-dose schedule.

RDM31-baclofen-oral-prof-1 · Source locator: Abstract: recommendations; PMID 28899601

Source-specific limits

Do not convert this qualitative reduction into an invented dose. It conflicts with permissive older handbook dialysis dosing.

Source identity and provenance
Source
https://pubmed.ncbi.nlm.nih.gov/28899601/
Retrieved
2026-09-05
Renal-function method
eGFR, mL/min/1.73 m2
Source date/version
2018; published online 2017
Hash meaning
SHA-256 identifies the local paraphrase, not original source bytes.
Local summary SHA-256
aec6318877cf78c08587f572653736b786c3d058e55dfa66272794b7036124e8
Professional

AGS Beers 2023 - baclofen renal risk

Open original reference

Open / share this exact local source

American Geriatrics Society expert panel · Adults aged 65 years and older receiving oral baclofen; not intrathecal therapy.

Renal method: eGFR below 60 mL/min as printed; indexing is not specified in the selected row. Do not silently replace with CrCl.
Source date: 2023 AGS Beers Criteria, published May 4, 2023
Retrieved: 2026-09-07

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

Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.

Renal dosing, restrictions and evidence limits

In older adults, avoid baclofen when eGFR is below 60 because of encephalopathy risk. When unavoidable, use the lowest effective dose and monitor for CNS toxicity, including altered mental status. The source also identifies risk in chronic dialysis. This is not a numeric dose-reduction schedule.

RDM34-professional-baclofen-oral-ags2023-C1 · Source locator: Table 6, baclofen row.

Source identity and provenance
Source family
professional_guidance
Source
https://pmc.ncbi.nlm.nih.gov/articles/PMC12478568/
Retrieved
2026-09-07
Renal-function method
eGFR below 60 mL/min as printed; indexing is not specified in the selected row. Do not silently replace with CrCl.
Source date/version
2023 AGS Beers Criteria, published May 4, 2023
Hash meaning
SHA-256 of local authored summary only, not original HTML, PDF or SPL bytes.
Local summary SHA-256
af12fd4c422c7dd2213a3f37f64198fe1ade87ea270f49aff75051761dac8117

Provenance and preservation

Additional summaries stored on this page: 1 official-label, 0 RX List, 2 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=346af8fe-3816-49de-bfd3-5a7425e728f9
Source retrieval
2026-09-05. This is not the source publication or label revision date.
Original source type
multisource addition
Local text SHA-256
439b4d4406e141e7db0b6d3407504456f43aa046b9d5675ef8e06482e059cd28
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.

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