Pramipexole - immediate-release tablets | GlobalRPh Renal Dosing Master

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Pramipexole IR: 14-day titration interval is not dosing every 14 days

Parkinson disease and RLS have separate instructions. The RLS renal interval concerns titration steps, while administration remains daily.

Before applying: Do not transfer the Parkinson maximum or ER frequency to RLS; verify the indication-specific schedule.

Also check: Pramipexole IR: 14-day titration interval is not dosing every 14 days

Official source

Pramipexole - immediate-release tablets

Product / population: Pramipexole dihydrochloride immediate-release oral tablets; adult Parkinson disease and separate RLS titration instructions. Not MIRAPEX ER. Selected sections, not a complete prescribing monograph.
Renal measure: Creatinine clearance (CrCl), mL/min; equation not specified in the selected passage.

Identity check: DailyMed labeler American Health Packaging. Current archive version 5 published 2026-03-05. This archive date is separate from the prescribing-information revision and does not itself prove that renal instructions changed. Raw SPL XML was not independently downloaded or hashed.

Renal dosing, restrictions and evidence limits

Adult Parkinson disease renal table (CrCl, mL/min):

>50: start 0.125 mg three times daily; maximum 1.5 mg three times daily.

30-50: start 0.125 mg twice daily; maximum 0.75 mg three times daily.

15 to <30: start 0.125 mg daily; maximum 1.5 mg daily.

<15 or hemodialysis: inadequately studied; no regimen established.

For restless legs syndrome, the separate renal instruction is to extend the interval between titration steps to 14 days at CrCl 20-60. This does not mean administer a dose every 14 days. The RLS schedule starts at 0.125 mg once daily 2-3 hours before bedtime; increases to 0.25 or 0.5 mg are based on need. These IR instructions must not be transferred to MIRAPEX ER.

Source revision: Prescribing information revised October 2022. | Retrieved: 2026-09-09. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f4d97c2e-f447-4cfe-b9d4-852323f0cfb5

Scope: Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph. GlobalRPh v6.6.

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Official product label

Pramipexole - immediate-release tablets

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

Pramipexole dihydrochloride immediate-release oral tablets; adult Parkinson disease and separate RLS titration instructions. Not MIRAPEX ER. Selected sections, not a complete prescribing monograph.

Renal method: Creatinine clearance (CrCl), mL/min; equation not specified in the selected passage.
Retrieved: 2026-09-09

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Pramipexole IR: 14-day titration interval is not dosing every 14 days

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Pramipexole IR: 14-day titration interval is not dosing every 14 days

Parkinson disease and RLS have separate instructions. The RLS renal interval concerns titration steps, while administration remains daily.

How to use this: Do not transfer the Parkinson maximum or ER frequency to RLS; verify the indication-specific schedule.

Pramipexole - immediate-release tablets Pramipexole extended-release (MIRAPEX ER)

Source-specific interpretation; independent clinician adjudication pending.

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Renal dosing and precautions

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Official source

Pramipexole - immediate-release tablets

Pramipexole dihydrochloride immediate-release oral tablets; adult Parkinson disease and separate RLS titration instructions. Not MIRAPEX ER. Selected sections, not a complete prescribing monograph.

Method: Creatinine clearance (CrCl), mL/min; equation not specified in the selected passage.

Renal dosing, restrictions and evidence limits Read this complete source summary

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Original content / product scope Pramipexole - immediate-release tablets

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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/lookup.cfm?setid=f4d97c2e-f447-4cfe-b9d4-852323f0cfb5

Exact product and population

Pramipexole dihydrochloride immediate-release oral tablets; adult Parkinson disease and separate RLS titration instructions. Not MIRAPEX ER. Selected sections, not a complete prescribing monograph.

RDM50-SCOPE-pramipexole-immediate-release · Source section: Selected source product scopeRenal section finder

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FDA / DailyMed dosing and renal information

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Pramipexole - immediate-release tablets

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DailyMed / American Health Packaging · Pramipexole dihydrochloride immediate-release oral tablets; adult Parkinson disease and separate RLS titration instructions. Not MIRAPEX ER. Selected sections, not a complete prescribing monograph.

Renal method: Creatinine clearance (CrCl), mL/min; equation not specified in the selected passage.
Source date: Prescribing information revised October 2022.
Retrieved: 2026-09-09

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

Adult Parkinson disease renal table (CrCl, mL/min):

>50: start 0.125 mg three times daily; maximum 1.5 mg three times daily.

30-50: start 0.125 mg twice daily; maximum 0.75 mg three times daily.

15 to <30: start 0.125 mg daily; maximum 1.5 mg daily.

<15 or hemodialysis: inadequately studied; no regimen established.

RDM50-official-pramipexole-immediate-release-177a142ac2-C1 · Source locator: Section 2.2 renal table, lines 385-392; section 2.3 and RLS titration, lines 397-407 and 209-215.

Source-specific limits

Source identity and provenance

Source family: product_label
Source: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f4d97c2e-f447-4cfe-b9d4-852323f0cfb5
Retrieved: 2026-09-09
Exact label title: PRAMIPEXOLE DIHYDROCHLORIDE tablet
DailyMed Set ID: f4d97c2e-f447-4cfe-b9d4-852323f0cfb5
Labeler: American Health Packaging
Label revision: Prescribing information revised October 2022.
Archive publication date: 2026-03-05
SPL version: 5
FDA application: ANDA090865
Renal-function method: Creatinine clearance (CrCl), mL/min; equation not specified in the selected passage.
Source date/version: Prescribing information revised October 2022.
Hash meaning: SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256: 12e4edecb3b4d847c9f27358019f8513d36e8957b0711364a80b89ff8a7d078a

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://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f4d97c2e-f447-4cfe-b9d4-852323f0cfb5
Source retrieval: 2026-09-09. This is not the source publication or label revision date.
Original source type: source summary
Local text SHA-256: eff16d9e9136967bf1383ae629edda961c8fc9158a761cd62f022f2493667bf8
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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