Sulopenem Etzadroxil | Uncomplicated Urinary Tract Infections | HongKong DengYue Medicine

Sulopenem Etzadroxil Application Scope

Approved by the U.S. FDA for the treatment of uncomplicated urinary tract infections (uUTIs) caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.

Sulopenem Etzadroxil Characteristics

• Ingredients: Each film-coated tablet contains 500 mg of sulopenem etzadroxil and 500 mg of probenecid.
• Properties: Sulopenem is a penem-class β-lactam antibiotic that inhibits bacterial cell wall synthesis. Probenecid is a renal tubular secretion inhibitor that increases sulopenem plasma concentrations by inhibiting organic anion transporters OAT1 and OAT3.
• Packaging Specification: Bottles containing 20 tablets.
• Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F).
• Expiry Date: 60 months from the date of manufacture.
• Executive Standard: Complies with FDA-approved standards.
• Approval Number: NDA 213972.
• Date of Revision: October 2024.
• Manufacturer: Iterum Therapeutics US Limited.

Guidelines for Use Sulopenem Etzadroxil

• Dosage and Administration: One tablet (500 mg sulopenem etzadroxil / 500 mg probenecid) orally every 12 hours with food for 5 days.
• Adverse Reactions: Common adverse reactions (≥2%) include diarrhea, nausea, vulvovaginal mycotic infection, headache, and vomiting.
• Contraindications:
  • Hypersensitivity to sulopenem, probenecid, or other β-lactam antibiotics.
  • Known blood dyscrasias.
  • Uric acid kidney stones.
  • Concomitant use with ketorolac.
• Precautions:
  • Serious allergic reactions, including anaphylaxis and angioedema, may occur.
  • Clostridioides difficile-associated diarrhea (CDAD) has been reported.
  • Use is not recommended for patients with creatinine clearance below 15 mL/min or those on hemodialysis due to lack of data.

Sulopenem Etzadroxil Drug Interactions

• Drug Interactions:
  • Probenecid may increase plasma concentrations of drugs eliminated via OAT1/3 transporters, such as methotrexate and naproxen.
  • Concomitant use with ketorolac is contraindicated.

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.