XOPENEX nebulized solution: renal caution without a numeric adjustment algorithm
What matters first
Product: XOPENEX 0.31, 0.63 or 1.25 mg per 3 mL nebulized solution; adult renal summary. Not the HFA metered-dose inhaler.
- Renal action / finding
- Use caution and careful dose selection; no numeric renal algorithm is supplied.
- Evidence or dialysis limit
- Supporting renal study used racemic albuterol, not this exact levalbuterol product.
- Monitoring / application
- Nebulized solution only. The mixed-formulation RX mirror is excluded.
- Product / population
- XOPENEX 0.31, 0.63 or 1.25 mg per 3 mL nebulized solution; adult renal summary. Not the HFA metered-dose inhaler.
- Renal measure
- Renal caution; supporting racemic-albuterol study used CrCl 7-53 mL/min
- Source revision
- 12/2018
- Retrieved
- 2026-11-07 (not the revision date)
Supporting renal study used racemic albuterol, not this exact levalbuterol product.
Sections 8.6 and 12.3, renal impairment
Renal excretion supports careful dose selection and renal monitoring, particularly in older patients. The supporting study used racemic albuterol in five participants with CrCl 7-53 mL/min and found reduced clearance. High doses of levalbuterol warrant caution in renal impairment. The selected label does not give a numeric renal adjustment or dialysis schedule. This is not an affirmative no-adjustment recommendation and does not authorize HFA inhaler dosing for nebulized solution.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7e2644e6-36c5-4988-8e52-bec90e2cd2f0
