Carglumic acid - CARBAGLU tablets for suspension

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Renal guidance at a glance

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Total daily doses, indexed eGFR and metabolic indication must stay together

CARBAGLU has separate renal tables for NAGS deficiency and acute PA/MMA-associated hyperammonemia. The numbers are total daily doses, not doses per administration.

Before applying: Confirm the indication, indexed eGFR, actual weight/BSA, dose splitting and rounding before prescribing; no ESRD dose is inferred.

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Official source

Carglumic acid - CARBAGLU tablets for suspension

Product / population: CARBAGLU 200 mg tablets for suspension. Match NAGS deficiency versus PA/MMA and acute versus chronic hyperammonemia.
Renal measure: Indexed eGFR, mL/min/1.73 m2

Selected sections only; not a complete prescribing monograph or independent clinician approval.

Exact DailyMed HTML identity and named sections checked. Raw SPL XML, original document hash and complete revision history were not obtained.

Renal dosing, restrictions and evidence limits

Use indexed eGFR (mL/min/1.73 m2). At 60-89 no renal adjustment is needed. The following are total DAILY doses, not per-dose amounts:

NAGS deficiency, acute: eGFR 30-59, 50-125 mg/kg/day; eGFR 15-29, 15-60 mg/kg/day. Chronic: 30-59, 5-50 mg/kg/day; 15-29, 2-25 mg/kg/day. Use actual body weight, divide into 2-4 doses, and round to the nearest 50 mg.

PA/MMA, acute: at 30-59, 75 mg/kg/day if weight <=15 kg or 1.7 g/m2/day if >15 kg. At 15-29, 25 mg/kg/day if <=15 kg or 0.55 g/m2/day if >15 kg. Divide into two equal doses 12 hours apart and round UP to the nearest 50 mg. Continue until ammonia is below 50 micromol/L, for a maximum of seven days.

Monitor ammonia and use concurrent ammonia-lowering treatment as indicated. ESRD PK is unevaluated; dialysis for hyperammonemia is not a replacement-dose instruction. Disperse tablets in water; do not swallow whole or crush.

Source revision: 1/2024 | Retrieved: 2026-09-10. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=10175e73-5172-4dde-a508-8a88b7afc0a1

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

Carglumic acid - CARBAGLU tablets for suspension

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

CARBAGLU 200 mg tablets for suspension. Match NAGS deficiency versus PA/MMA and acute versus chronic hyperammonemia.

Renal method: Indexed eGFR, mL/min/1.73 m2
Retrieved: 2026-09-10

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Total daily doses, indexed eGFR and metabolic indication must stay together

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indication measure and daily dose

Total daily doses, indexed eGFR and metabolic indication must stay together

CARBAGLU has separate renal tables for NAGS deficiency and acute PA/MMA-associated hyperammonemia. The numbers are total daily doses, not doses per administration.

How to use this: Confirm the indication, indexed eGFR, actual weight/BSA, dose splitting and rounding before prescribing; no ESRD dose is inferred.

Carglumic acid - CARBAGLU tablets for suspension

Source-specific interpretation; independent clinician adjudication pending.

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Renal dosing and precautions

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Official source

Carglumic acid - CARBAGLU tablets for suspension

CARBAGLU 200 mg tablets for suspension. Match NAGS deficiency versus PA/MMA and acute versus chronic hyperammonemia.

Method: Indexed eGFR, mL/min/1.73 m2

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

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Original content / product scope Carglumic acid - CARBAGLU tablets for suspension

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=10175e73-5172-4dde-a508-8a88b7afc0a1

Exact product and population

CARBAGLU 200 mg tablets for suspension. Match NAGS deficiency versus PA/MMA and acute versus chronic hyperammonemia.

RDM57-SCOPE-carglumic-acid-carbaglu · Source section: Selected source product scopeRenal section finder

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Carglumic acid - CARBAGLU tablets for suspension

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DailyMed / Recordati Rare Diseases Inc. · CARBAGLU 200 mg tablets for suspension. Match NAGS deficiency versus PA/MMA and acute versus chronic hyperammonemia.

Renal method: Indexed eGFR, mL/min/1.73 m2
Source date: 1/2024
Retrieved: 2026-09-10

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

Use indexed eGFR (mL/min/1.73 m2). At 60-89 no renal adjustment is needed. The following are total DAILY doses, not per-dose amounts:

RDM57-official-carglumic-acid-carbaglu-bfa0c652bf-C1 · Source locator: Sections 2.2-2.5 and 8.6, renal dose table

Source-specific limits

Selected sections only; not a complete prescribing monograph or independent clinician approval.

Exact DailyMed HTML identity and named sections checked. Raw SPL XML, original document hash and complete revision history were not obtained.

Source identity and provenance

Source family: product_label
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=10175e73-5172-4dde-a508-8a88b7afc0a1
Retrieved: 2026-09-10
Exact label title: Carglumic acid - CARBAGLU tablets for suspension
DailyMed Set ID: 10175e73-5172-4dde-a508-8a88b7afc0a1
Labeler: Recordati Rare Diseases Inc.
Label revision: 1/2024
Renal-function method: Indexed eGFR, mL/min/1.73 m2
Source date/version: 1/2024
Hash meaning: SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256: cde65aee6f598bad7cd97cfbe4b99b0e4a4270b06c902543afcb58cba31085df

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/drugInfo.cfm?setid=10175e73-5172-4dde-a508-8a88b7afc0a1
Source retrieval: 2026-09-10. This is not the source publication or label revision date.
Original source type: source summary
Local text SHA-256: 67abae661b8c969a3e91761e4c18bd7ab864d22cc6392871d6aab980990088ad
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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