amoxicillin: Highlights, Dosage and Administration and 2.5 give different instructions for one patient

Highlights, Dosage and Administration reads “severe renal impairment (GFR greater than 30 mL/min)”. 2.5 reads “less than 30 mL/min”. Example: A patient with GFR 45 mL/min is in the reduced-dose group by Highlights and not by 2.5 and 8.6; a patient with GFR 10 mL/min is the reverse. The same text is in 180 labels from 34 labelers in the DailyMed release of 29 October 2026.

Consequence

Potential effect on a prescribing decision: medium. Arxo does not say which instruction is correct and gives no dose.

Jurisdiction

United States — federal

Act

amoxicillin prescribing information (SPL set ID 06e5c07d-d95c-4955-8d35-a4703ca2359e)

Place

Highlights, Dosage and Administration and 2.5

Record

Discrepancy

Class

Text of the act

Where it arose

The text of the act

Arxo's conclusion

Confirmed

Official text

Unchanged at last check

Last checked

2026-10-31

Evidence

Reproduced by execution. Quotations are verbatim from the official material; translations are ours and marked.

severe renal impairment (GFR greater than 30 mL/min)

less than 30 mL/min

How to check it without Arxo's tools

1. Open Prescribing information, USAntibiotics, LLC, SPL set ID 06e5c07d-d95c-4955-8d35-a4703ca2359e, version 5 (DailyMed) and find Highlights, Dosage and Administration; 2.5. Compare the text with the quotation above. A copy is kept in this register: d9090eee66acd399-06e5c07d-d95c-4955-8d35-a4703ca2359e-v5.xml (SHA-256 d9090eee66acd399c5013fa6c3d26a7d9e8f8b633828db6da37970822264f2b3, copy of the official file).
2. The finding holds if the quoted passages read as shown and the comparison gives the result stated at the top of this page. If it does not, write to us with the record ID.

How this finding was made

AI agents read the labels, compared their parts and, where marked, ran the example patient through executable rules; an AI agent then read each place in full, with tables and footnotes, and confirmed it. No clinician has assessed these places. A person at Arxo approved publication (2026-10-31).

Responsible institutions

• USAntibiotics, LLC — holder of the labeling
• U.S. Food and Drug Administration, Center for Drug Evaluation and Research — regulator of prescription drug labeling

Reported to

Responses

No response recorded.

History

1. 2026-10-31Confirmed by Arxo
2. 2026-10-31Reported to USAntibiotics, LLC (e-mail)
3. 2026-10-31Reported to U.S. Food and Drug Administration, Center for Drug Evaluation and Research (e-mail)

Cite this record

Arxo Law, Arxo Findings Register, ARXO-2026-0303, https://arxo.io/findings/ARXO-2026-0303/ (status as of 2026-10-31). Data: ARXO-2026-0303.json.