Restriction or avoidance
This summary uses the identified dated label. Verify the current label for this presentation before applying the regimen.
Renal measure Indexed GFR/eGFR, mL/min/1.73 m2 Renal action or finding Initiation is not recommended at eGFR 30-45. Reassess continuation below 45; discontinue below 30, where use is contraindicated. Limits and monitoring Use the dated FDA label for the specified ER product. Assess renal function and iodinated-contrast exposure.
Review 1 product or source caution
Verify the current prescribing information for this presentation.
Prescribing information revised 8/2026 | Selected sections checked 2026-11-07. Independent clinical review pending.
Restriction or avoidance
Renal measure Indexed GFR/eGFR, mL/min/1.73 m2 Renal action or finding Do not initiate at eGFR 30-45. For established treatment, reassess benefit and risk below 45 and discontinue below 30. Use below 30 is contraindicated. Limits and monitoring Check renal function before starting and periodically. Review the product's separate contrast-interruption instructions.
Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 32, effective 2026-09-02; posted Sep 21, 2026 | Selected sections checked 2026-11-07. Independent clinical review pending.
Restriction or avoidance
Renal measure Clinical renal category or population named in the cited section Renal action or finding The U.S. label contraindicates use in renal insufficiency. Limits and monitoring The contraindication supplies no numerical cutoff. Do not substitute a locally inferred eGFR threshold.
Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 1, effective 2022-02-02; posted Feb 03, 2022 | Selected sections checked 2026-11-07. Independent clinical review pending.
No adjustment within stated limits
This summary uses the identified dated label. Verify the current label for this presentation before applying the regimen.
Renal measure Clinical renal category or population named in the cited section Renal action or finding Use the indication-specific dose across renal impairment. A supplementary dose after hemodialysis is unnecessary. Limits and monitoring The appropriate daily dose depends on infection and treatment intent.
Review 1 product or source caution
Verify the current prescribing information for this presentation.
Prescribing information revised 8/2016 | Selected sections checked 2026-11-07. Independent clinical review pending.
Dose or interval change
Renal measure MDRD estimate, mL/min/1.73 m2 Renal action or finding At eGFR 30-89, start 25 mg once daily, maximum 50 mg daily. At 15-29, use 25 mg daily as both starting dose and maximum. Below 15 or on dialysis, use is not recommended. Limits and monitoring Use adult MDRD eGFR in mL/min/1.73 m2. Pediatric tablets and granules have different tables.
Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 17, effective 2024-08-01; posted Aug 20, 2024 | Selected sections checked 2026-11-07. Independent clinical review pending.
Dose or interval change
Renal measure Indexed GFR/eGFR, mL/min/1.73 m2 Renal action or finding For adults with GFR 15 to <30, use 15 mg once each morning. Below 15, use is not recommended. Limits and monitoring The units are mL/min/1.73 m2. Pediatric patients have separate recommendations; this adult amount must not be applied to them.
Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 38, effective 2026-04-30; posted May 06, 2026 | Selected sections checked 2026-11-07. Independent clinical review pending.
No adjustment within stated limits
This summary uses the identified dated label. Verify the current label for this presentation before applying the regimen.
Renal measure Clinical renal category or population named in the cited section Renal action or finding No renal reduction is required, including in hemodialysis and continuous ambulatory peritoneal dialysis (CAPD). Limits and monitoring This summary covers systemic oral therapy. Check the full fluoroquinolone warnings and the infection indication.
Review 1 product or source caution
Verify the current prescribing information for this presentation.
DailyMed SPL version 6, effective 2011-12-13; posted Dec 15, 2011 | Selected sections checked 2026-11-07. Independent clinical review pending.
Dose or interval change
This summary uses the identified dated label. Verify the current label for this presentation before applying the regimen.
Renal measure Creatinine clearance (CrCl), mL/min; use the product-specific calculation Renal action or finding In mild to moderate renal impairment start with 1 mg; do not exceed 2.5 mg in 24 hours. At CrCl <15 mL/min use is contraindicated. Limits and monitoring Verify the time and dose of prior triptan or ergot use before treating.
Review 2 product or source cautions
Verify the current prescribing information for this presentation.
Prescribing information revised 11/2016 | Selected sections checked 2026-11-07. Independent clinical review pending.
Dose or interval change
Renal measure Creatinine clearance (CrCl), mL/min; use the product-specific calculation Renal action or finding Start at 2.5 mg once daily when CrCl is below 30 mL/min. Titrate slowly as needed. Limits and monitoring Dialysis patients were not studied. Follow blood pressure and heart rate during titration.
Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 31, effective 2024-08-01; posted Dec 31, 2025 | Selected sections checked 2026-11-07. Independent clinical review pending.
Dose or interval change
Renal measure Cockcroft-Gault creatinine clearance, mL/min Renal action or finding At CrCl 31-50 mL/min, use 200 mg twice daily. At 51-80, no renal dose change is recommended. Limits and monitoring The selected label has no data for CrCl <=30 mL/min, including end-stage disease. Check interaction-related modifications separately.
Review 1 product or source caution
The U.S. label uses CrCl in mL/min. eviQ protocol 3737 uses indexed eGFR and leaves exactly 30 outside its printed bands. Use the renal estimate specified by the selected source.
DailyMed SPL version 38, effective 2025-07-10; posted Jul 25, 2025 | Selected sections checked 2026-11-07. Independent clinical review pending.
No adjustment within stated limits
Renal measure Creatinine clearance (CrCl), mL/min; use the product-specific calculation Renal action or finding No lower initial dose is recommended solely because CrCl is below 40 mL/min in adults with moderate to marked impairment. Limits and monitoring Monitor renal function and potassium. Do not infer a dialysis regimen from the initial-dose statement.
Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 1, effective 2025-09-23; posted Sep 25, 2025 | Selected sections checked 2026-11-07. Independent clinical review pending.
No adjustment within stated limits
Renal measure Creatinine clearance (CrCl), mL/min; use the product-specific calculation Renal action or finding No renal reduction is specified for CrCl greater than 15 mL/min. Limits and monitoring Hemodialysis pharmacokinetics were not studied. Verify capsule administration and the treatment cycle.
Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
Prescribing information revised 6/2026 | Selected sections checked 2026-11-07. Independent clinical review pending.
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