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1 additional source qualifications - review before use
No adjustment is required at CrCl >=15 mL/min. Use at CrCl <15 or on hemodialysis is not recommended. Despite increased exposure with mild, moderate and severe impairment, available safety information does not indicate a reduction in those supported groups. Known uric acid kidney stones and concomitant ketorolac are contraindications. The uncomplicated-UTI indication and limited-alternative population still apply; renal eligibility alone does not establish suitability.
Source revision: Prescribing information revised December 2025. | Retrieved: 2026-09-09. Retrieval date is not the revision date.
All sources, comparison tools and evidence navigation
Source-first renal review
Evidence sources and renal implications
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Renal-context checklist: population, kidney trend and dialysis
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population scope
ORLYNVAH: no adjustment is not sufficient prescribing eligibility
The renal range does not expand the limited-alternative uncomplicated-UTI indication or remove uric-acid-stone and interaction contraindications.
How to use this: Confirm indication, population, dialysis status, kidney-stone history and interacting drugs.
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New source summary - independent clinical review pending. Summaries of the identified label sections are included locally. Source import and numeric transcription checks are not independent two-reference validation. Do not treat this card as an approved institutional dosing protocol.
Official source
ORLYNVAH - official renal prescribing summary
ORLYNVAH - official renal prescribing summary; selected source sections only, not a complete prescribing monograph.
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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.
DailyMed / Iterum Therapeutics · ORLYNVAH - official renal prescribing summary; selected source sections only, not a complete prescribing monograph.
Renal method: Cockcroft-Gault creatinine clearance (CrCl), mL/min. Source date: Prescribing information revised December 2025. Retrieved: 2026-09-09
No adjustment within stated limits. This does not establish dosing outside the studied renal range or population.
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Renal dosing, restrictions and evidence limits
No adjustment is required at CrCl >=15 mL/min. Use at CrCl <15 or on hemodialysis is not recommended. Despite increased exposure with mild, moderate and severe impairment, available safety information does not indicate a reduction in those supported groups. Known uric acid kidney stones and concomitant ketorolac are contraindications. The uncomplicated-UTI indication and limited-alternative population still apply; renal eligibility alone does not establish suitability.
RDM49-official-sulopenem-probenecid-orlynvah-6af64b77ef-C1 · Source locator: Sections 2.2, 4 and 8.6, lines 338-356 and 538-540.
GlobalRPh-hosted RX List · Sulopenem etzadroxil / probenecid - ORLYNVAH tablets; selected source sections only, not a complete prescribing monograph.
Renal method: Cockcroft-Gault creatinine clearance (CrCl), mL/min. Source date: RX page prints March 2025. Retrieved: 2026-09-09
Label mirror, not independent corroboration. This is selected locally stored RX List content. Full monograph import and current official-label review are not implied.
No adjustment within stated limits. This does not establish dosing outside the studied renal range or population.
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Renal dosing, restrictions and evidence limits
For the labeled uncomplicated UTI population, give one 500 mg/500 mg tablet twice daily for 5 days, preferably with food. No adjustment is required at CrCl >=15 mL/min; use below 15 or during hemodialysis is not recommended. Eligibility is limited to adult women with limited or no alternative oral antibacterial options; this is not a complicated-UTI or post-IV complicated-UTI step-down regimen. Increased exposure alone is not an instruction to invent a dose reduction.
RDM49-rxlist-sulopenem-probenecid-orlynvah-45c16385ca-C1 · Source locator: Indications and limitations, lines 34-45; dosage and renal subsection, lines 48-53; PK renal strata use Cockcroft-Gault.
Additional summaries stored on this page: 1 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.
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.