Sulopenem-Etzadroxil-Probenecid

Sulopenem Etzadroxil-Probenecid is a prescription medication indicated for the treatment of uncomplicated urinary tract infections (uUTI) caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in women who have limited or no alternative oral antibacterial treatment options.

• Sulopenem Etzadroxil-Probenecid is available under the following different brand names: Orlynvah.

Common side effects of Sulopenem Etzadroxil-Probenecid include:

• diarrhea
• nausea
• vulvovaginal mycotic infection 
• headache
• vomiting

Serious side effects of Sulopenem Etzadroxil-Probenecid include:

• not available

Rare side effects of Sulopenem Etzadroxil-Probenecid include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 500 mg/500 mg

Urinary tract infection

Adult dosage

• 1 tablet (sulopenem etzadroxil 500 mg/probenecid 500 mg) orally two times a day for 5 days with food

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Sulopenem Etzadroxil-Probenecid has severe interactions with the following drug:
  • ketorolac
• Sulopenem Etzadroxil-Probenecid has serious interactions with the following drugs:
  • ketoprofen
  • methotrexate
  • microbiota oral
• Sulopenem Etzadroxil-Probenecid has moderate interactions with the following drugs:
  • fexinidazole
  • gemfibrozil
  • glimepiride
  • glipizide
  • glyburide
  • ibuprofen
  • ibuprofen IV
  • indomethacin
  • leflunomide
  • lorazepam
  • meropenem
  • meropenem/vaborbactam
  • naproxen
  • nitisinone
  • pretomanid
  • rifampin
  • teriflunomide
  • vadadustat
• Sulopenem Etzadroxil-Probenecid has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• A history of hypersensitivity to Sulopenem Etzadroxil-Probenecid or other beta-lactam antibiotics
• Known blood dyscrasias
• Known uric acid kidney stones
• Coadministration with ketorolac

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Sulopenem Etzadroxil-Probenecid?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Sulopenem Etzadroxil-Probenecid?”

Cautions

• Hypersensitivity reactions
  • Hypersensitivity reactions, specifically cases of angioedema, reported
  • Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, and serious skin reactions reported in patients receiving beta-lactam antibacterial drugs
  • Before initiating, carefully inquire about previous hypersensitivity reactions to other carbapenems, cephalosporins, penicillins, or other beta-lactams owing to cross-hypersensitivity among beta-lactam antibacterials
  • Severe allergic reactions and anaphylaxis reported with probenecid
  • Discontinue if allergic reaction occurs and institute appropriate supportive measures
• Clostridioides difficile-associated diarrhea
  • Clostridioides difficile-associated diarrhea (CDAD) reported in users of nearly all systemic antibiotics with severity ranging from mild diarrhea to fatal colitis
  • Antibacterial agents can alter the colon’s normal flora and may permit overgrowth of C difficile
  • C difficile produces toxins A and B which contribute to the development of CDAD
  • Hypertoxin-producing C difficile strains cause increased morbidity and mortality, owing to antibiotic resistance and may require colectomy
  • Consider CDAD in all patients who present with diarrhea following antibacterial use
  • Careful medical history is necessary because CDAD has been reported to occur more than 2 months after antibiotic administration
  • If suspected or confirmed, ongoing antibacterial use not directed against C difficile should be discontinued, if possible
  • Institute appropriate measures (e.g., fluid and electrolyte management, protein supplementation, antibacterial treatment of C difficile, and surgical evaluation) as clinically indicated
• Risk of uric acid kidney stones
  • Institute appropriate measures (e.g., increased fluid intake, urine alkalinization) to reduce the risk of uric kidney stones in patients with a history of gout
  • Contraindicated in patients with known uric acid kidney stones
• Gout exacerbation
  • May exacerbate gout
  • Ensure appropriate therapy for gout is instituted when prescribing to patients with a known history of gout
• Development of drug-resistant bacteria
  • Prescribing Sulopenem Etzadroxil-Probenecid in the absence of proven or strongly suspected susceptible uUTI is unlikely to provide benefit and increases the risk of developing drug-resistant bacteria
• Drug interaction overview
  • Potential for probenecid to affect OAT1/3 substrates
    • Probenecid is an OAT1/3 inhibitor
    • Coadministration may increase the plasma concentration of drugs dependent on OAT1/3 for elimination
    • Refer to the drug-specific prescribing information for dosage adjustment instructions of substrates
  • Contraindicated with ketorolac
  • Not recommended with ketoprofen
  • Potential for drugs to affect Sulopenem etzadroxil
    • Monitor for adverse effects (e.g., diarrhea, nausea)
    • Sulopenem is an OAT3 substrate; monitor for adverse effects if coadministered with drugs that inhibit OAT3

Pregnancy and Lactation

• Sulopenem etzadroxil
  • Data are not available on sulopenem etzadroxil use during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Probenecid
  • Available published data over several decades of probenecid use in pregnant women have not identified a drug-associated risk of miscarriage, major birth defects, or adverse maternal or fetal outcomes
  • Probenecid crosses the placental barrier and appears in cord blood
• Lactation
  • Data are unavailable regarding the presence of sulopenem etzadroxil or its metabolite in human milk, its effects on breastfed infants, or its effects on milk production
  • Sulopenem was present in rat milk after oral dosing of sulopenem etzadroxil to lactating female rats
  • When a drug is present in animal milk, it is likely that it will be present in human milk
  • Probenecid is present in human milk based on a case report
  • There are no reports of adverse effects in infants associated with probenecid exposure through breastmilk
  • No information is available regarding the effects of probenecid on milk production