Sulopenem Etzadroxil (1 brand name, 1 dosage form, 1 route)
Available dosage forms: TABLET.
Routes of administration: ORAL.
Brand Names
- ORLYNVAH
Contraindications
ORLYNVAH is contraindicated in patients with: • A history of hypersensitivity to the components of ORLYNVAH (sulopenem etzadroxil and probenecid) or other beta-lactam antibacterial drugs [see Warnings and Precautions ( 5.1 )] • Known uric acid kidney stones [see Warnings and Precautions ( 5.3 )] Concomitant use of ORLYNVAH and ketorolac tromethamine is contraindicated [see Drug Interactions ( 7.1 )]
Adverse Reactions
The following adverse reactions are described in greater detail in the Warnings and Precautions section. Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Clostridioides difficile-Associated Diarrhea [see Warnings and Precautions ( 5.2 )] Risk of Uric Acid Kidney Stone Development [see Warnings and Precautions ( 5.3 )] Exacerbation of Gout [see Warnings and Precautions ( 5.4 )]
Mechanism of Action
ORLYNVAH is a combination of sulopenem etzadroxil, a penem antibacterial drug [see Microbiology 12.4 ] and probenecid, a renal tubular transport inhibitor. Probenecid inhibits OAT3-mediated renal clearance of sulopenem, resulting in increased plasma concentrations of sulopenem.
Overdosage
There is no information on clinical signs and symptoms associated with an overdose of ORLYNVAH. No clinical information is available on the use of hemodialysis to treat ORLYNVAH overdosage.