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These highlights do not include all the information needed to use ORLYNVAH TM safely and effectively. See full prescribing information for ORLYNVAH TM . ORLYNVAH TM (sulopenem etzadroxil and probenecid) tablets, for oral use Initial U.S. Approval: 2024
Medication labelWhy this: Advisory · dailymed-prescription
ORLYNVAH is indicated for the treatment of uncomplicated urinary tract infections (uUTI) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. Limitations of Use ORLYNVAH is not indicated for the treatment of: Complicated urinary tract infections (cUTI) or as step-down treatment after intravenous antibacterial treatment of cUTI [see Clinical Studies ( 14.2 )]. Complicated intra-abdominal infections (cIAI)) or as step-down treatment after intravenous antibacterial treatment of cIAI [see Clinical Studies ( 14.3 )]. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ORLYNVAH and other antibacterial drugs, ORLYNVAH should be used only to treat uUTI that are proven or strongly suspected to be caused by susceptible bacteria. Culture and susceptibility information should be utilized in selecting or modifying antibacterial therapy [see Warnings and Precautions ( 5.5 )].
- generic_name
- sulopenem etzadroxil and probenecid
- product_names
- sulopenem etzadroxil and probenecid
- ndc
- 81153-100, 81153-100-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en