raltegravir: wording question in 2.1

2.1 reads “Maximum daily dose is 300 mg taken by mouth twice daily”. Example: "Maximum daily dose" can be read as 300 mg per day or as 600 mg per day. The same text is in 7 labels from 6 labelers in the DailyMed release of 29 October 2026.

Consequence

Potential effect on a prescribing decision: low; careful reading of the whole label usually resolves it. Arxo does not say which instruction is correct and gives no dose.

Jurisdiction

United States — federal

Act

raltegravir prescribing information (SPL set ID 89a5ec53-d956-4329-8004-0f40f51c88a3)

Place

2.1

Record

Question of reading or data

Class

Question of reading or data

Where it arose

The text of the act

Arxo's conclusion

Confirmed

Official text

Unchanged at last check

Last checked

2026-10-31

Evidence

Contradiction within the text. Quotations are verbatim from the official material; translations are ours and marked.

Maximum daily dose is 300 mg taken by mouth twice daily

How to check it without Arxo's tools

1. Open Prescribing information, Merck Sharp & Dohme LLC, SPL set ID 89a5ec53-d956-4329-8004-0f40f51c88a3, version 71 (DailyMed) and find 2.1. Compare the text with the quotation above. A copy is kept in this register: e2469625d5e949fe-89a5ec53-d956-4329-8004-0f40f51c88a3-v71.xml (SHA-256 e2469625d5e949fe24389d4cd3aea3f58bc79b655a87d4464e6534295d0bb70a, 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

• Merck Sharp & Dohme 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 Merck Sharp & Dohme 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-2026-0331, https://arxo.io/findings/ARXO-2026-0331/ (status as of 2026-10-31). Data: ARXO-2026-0331.json.