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GOCOVRI extended-release capsules: February 2026 label

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Local official-label summarySource retrieved 2026-09-07See the evidence for this drug3 sources available - open source summaries, references and comparisons

GOCOVRI extended-release capsules: February 2026 label / Gocovri

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Renal guidance at a glance

Cautions / source differences (2)

Use the renal measure and units named by this source. Confirm product, indication, age, stable versus changing kidney function, and exact dialysis modality. The selected summary is not a complete prescribing monograph. Renal method and dosing checklist

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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.

2 additional source qualifications - review before use
GOCOVRI: MDRD method despite a creatinine-clearance heading

The label expressly uses MDRD and indexed units. The immediate-release amantadine record has different product-specific schedules; a numerically similar renal value is not proof of equivalence.

Before applying: Verify renal method and formulation before selecting the nightly extended-release regimen. Do not transfer an immediate-release schedule or dialysis dose.

Gocovri - product and source limitations

The label uses an MDRD-derived value in mL/min/1.73 m2 although it calls it creatinine clearance. Do not substitute an unindexed Cockcroft-Gault value.

Before applying: Apply only to the stated formulation, indication and renal population.

Also check: GOCOVRI: MDRD method despite a creatinine-clearance heading; Gocovri - product and source limitations

Official source

GOCOVRI extended-release capsules: February 2026 label

Choose a product and source Product label GlobalRPh RX passage All evidence
Product / population
GOCOVRI extended-release amantadine capsules for adults with Parkinson-related indications; not immediate-release amantadine.
Renal measure
Table calls the measure creatinine clearance, but expressly specifies MDRD and mL/min/1.73 m2.
Source revision
February 2026
Retrieved
2026-09-07 (not the revision date)
Dose or interval guidance. Use only the product, indication, renal metric and population described in this source.

RX GOCOVRI retrieval failed; this separate official source does not make that RX attempt successful.

Renal dosing, restrictions and evidence limits

At the source's indexed renal estimate 60-89, start 137 mg nightly and increase after one week to 274 mg nightly. At 30-59, start 68.5 mg nightly; the maximum is 137 mg nightly, with increase if needed after one week. At 15-29, 68.5 mg nightly is both initial and maximum dose. Below 15, treatment is contraindicated. The renal table expressly uses MDRD despite its creatinine-clearance heading. Do not substitute an unindexed Cockcroft-Gault value or an immediate-release amantadine schedule without reconciliation. Do not stop abruptly; follow the label's withdrawal instructions.

Source revision: February 2026 | Retrieved: 2026-09-07. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2bee0631-0028-1314-e063-6394a90aaaed

Scope: Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph. GlobalRPh v7.4.

Full source card / provenance

Other formulations / related references (2)

Confirm the exact product. These links do not imply interchangeable doses or indications.

Amantadine (source heading: Amantidine)Related reference only; not an interchangeable dose or indication.Amantadine - OSMOLEX ER tabletsRelated reference only; not an interchangeable dose or indication.
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Source-first renal review

Evidence sources and renal implications

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Official product label

GOCOVRI extended-release capsules: February 2026 label

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

GOCOVRI extended-release amantadine capsules for adults with Parkinson-related indications; not immediate-release amantadine.

Renal method: Table calls the measure creatinine clearance, but expressly specifies MDRD and mL/min/1.73 m2.
Retrieved: 2026-09-07

Read local renal resultOpen this source quick answerOpen original reference
GlobalRPh RX List

Gocovri - selected RX renal passage

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

Amantadine (Gocovri), adult bedtime extended-release capsules

Renal method: Use the renal measure explicitly present in the RX passage.
Retrieved: 2026-11-07

Read local renal resultOpen this source quick answerOpen original reference

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

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Source-specific review points

Gocovri - product and source limitations

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

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Source differences and product cautions

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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.

renal measure and formulation

GOCOVRI: MDRD method despite a creatinine-clearance heading

The label expressly uses MDRD and indexed units. The immediate-release amantadine record has different product-specific schedules; a numerically similar renal value is not proof of equivalence.

How to use this: Verify renal method and formulation before selecting the nightly extended-release regimen. Do not transfer an immediate-release schedule or dialysis dose.

GOCOVRI extended-release capsules: February 2026 labelAmantadine (source heading: Amantidine)

Source-specific interpretation; independent clinician adjudication pending.

Source scope / renal recommendation differences

Gocovri - product and source limitations

The label uses an MDRD-derived value in mL/min/1.73 m2 although it calls it creatinine clearance. Do not substitute an unindexed Cockcroft-Gault value.

How to use this: Apply only to the stated formulation, indication and renal population.

Gocovri - labeled renal guidanceGocovri - selected RX renal passage

Selected renal passages reviewed; independent clinician adjudication pending.

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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.

Independent clinical review is pending. These selected summaries are not an approved institutional dosing protocol. Confirm the exact product, the complete current source and local policy before use.

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Original content / product scopeGOCOVRI extended-release capsules: February 2026 labelGocovri - labeled renal guidanceGocovri - selected RX renal passage
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.
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=2bee0631-0028-1314-e063-6394a90aaaed

Exact product and population

GOCOVRI extended-release amantadine capsules for adults with Parkinson-related indications; not immediate-release amantadine.

RDM39-SCOPE-amantadine-gocovri-er · Source section: Selected source product scopeRenal section finder
Separate U.S. product-label layer

FDA / DailyMed dosing and renal information

Official

GOCOVRI extended-release capsules: February 2026 label

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DailyMed / Supernus Pharmaceuticals · GOCOVRI extended-release amantadine capsules for adults with Parkinson-related indications; not immediate-release amantadine.

Renal method: Table calls the measure creatinine clearance, but expressly specifies MDRD and mL/min/1.73 m2.
Source date: February 2026
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

At the source's indexed renal estimate 60-89, start 137 mg nightly and increase after one week to 274 mg nightly. At 30-59, start 68.5 mg nightly; the maximum is 137 mg nightly, with increase if needed after one week. At 15-29, 68.5 mg nightly is both initial and maximum dose. Below 15, treatment is contraindicated. The renal table expressly uses MDRD despite its creatinine-clearance heading. Do not substitute an unindexed Cockcroft-Gault value or an immediate-release amantadine schedule without reconciliation. Do not stop abruptly; follow the label's withdrawal instructions.

RDM39-official-amantadine-gocovri-er-01b72804c0-C1 · Source locator: Sections 2.3, 2.4, 4 and 8.6

Source-specific limits

RX GOCOVRI retrieval failed; this separate official source does not make that RX attempt successful.

Source identity and provenance
Source family
product_label
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2bee0631-0028-1314-e063-6394a90aaaed
Retrieved
2026-09-07
Exact label title
GOCOVRI extended-release capsules: February 2026 label
DailyMed Set ID
2bee0631-0028-1314-e063-6394a90aaaed
Labeler
Supernus Pharmaceuticals
Label revision
February 2026
Renal-function method
Table calls the measure creatinine clearance, but expressly specifies MDRD and mL/min/1.73 m2.
Source date/version
February 2026
Hash meaning
SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256
073ddef32e6fccb3334c87e56b522eb8c2059b44ba79d5d12ac378551325aa3e
Official

Gocovri - labeled renal guidance

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DailyMed / product prescribing information · Amantadine (Gocovri), adult bedtime extended-release capsules

Renal method: MDRD estimate, mL/min/1.73 m2
Source date: DailyMed SPL version 8, effective 2026-10-05; posted Oct 06, 2026
Retrieved: 2026-11-07

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

Selected renal passages reviewed; independent clinician adjudication pending.

Renal guidance: 2.3, 4 and 8.6

At 60-89, start 137 mg at bedtime and increase after one week to 274 mg. At 30-59, start 68.5 mg at bedtime and, if needed after one week, increase to 137 mg. At 15-29, use 68.5 mg at bedtime. Below 15, use is contraindicated. The label uses an MDRD-derived value in mL/min/1.73 m2 although it calls it creatinine clearance. Do not substitute an unindexed Cockcroft-Gault value.

RDM73-gocovri-official-1 · Source locator: Renal guidance: 2.3, 4 and 8.6

Source identity and provenance
Source family
product_label
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2bee0631-0028-1314-e063-6394a90aaaed
Retrieved
2026-11-07
Renal-function method
MDRD estimate, mL/min/1.73 m2
Source date/version
DailyMed SPL version 8, effective 2026-10-05; posted Oct 06, 2026
Hash meaning
SHA-256 of the local selected-source summary
Local summary SHA-256
1ff2813b6e2fc7e68d427caf87900896d55e8db558c3e5c69851397f373edf34
Locally imported selected renal sections

GlobalRPh RX List renal information

Rxlist

Gocovri - selected RX renal passage

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GlobalRPh RX List / product-label mirror · Amantadine (Gocovri), adult bedtime extended-release capsules

Renal method: Use the renal measure explicitly present in the RX passage.
Source date: Mirror revision not established in the reviewed passage.
Retrieved: 2026-11-07

Label mirror, not independent corroboration. This is selected locally stored RX List content. Full monograph import and current official-label review are not implied.
Dose or interval guidance. Use only the product, indication, renal metric and population described in this source.

Selected renal passages reviewed; independent clinician adjudication pending.

RX List: selected renal passage

The mirror identifies increased exposure in severe impairment and a contraindication below 15 mL/min/1.73 m2.

RDM73-gocovri-rxlist-1 · Source locator: RX List: selected renal passage

Source-specific limits

This mirror and the underlying product label share a source family.

Source identity and provenance
Source family
product_label_mirror
Source
https://globalrph.com/rx-list/gocovri-drug/
Retrieved
2026-11-07
Renal-function method
Use the renal measure explicitly present in the RX passage.
Source date/version
Mirror revision not established in the reviewed passage.
Hash meaning
SHA-256 of the local selected-source summary
Local summary SHA-256
3e002ca49987e658b09f9a67cfcc768ef6af0c2f3a1c7a42b3ae5d44e4abfdca

Provenance and preservation

Additional summaries stored on this page: 2 official-label, 1 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/drugInfo.cfm?setid=2bee0631-0028-1314-e063-6394a90aaaed
Source retrieval
2026-09-07. This is not the source publication or label revision date.
Original source type
source summary
Local text SHA-256
3cf2d6f5354f9f17814ec4c8993524c6a5b7d45f00a11f09a16539739a3530e1
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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