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Sulopenem / probenecid

Class
Antibiotics
Subclass
Thiopenem / renal tubular transport inhibitor combination
Substance name
Sulopenem / probenecid
Brand names
Orlynvah®
Contains
Probenecid
Sulopenem
Common formulations
Tablet
Dosage and administration
Adults patients
Treatment of UTIs in females • Uncomplicated cystitis, caused by E. coli, K. pneumoniae, or P. mirabilis, if limited or no alternative oral antibiotic options are available
•
500/500 mg PO BID for 5 days
Taken with food.
Indications for use
Labeled indications
Adults
•
Treatment of UTIs in females (uncomplicated cystitis, caused by E. coli, K. pneumoniae, or P. mirabilis, if limited or no alternative oral antibiotic options are available)
Safety risks
Contraindications
Hypersensitivity to sulopenem/probenecid or its components or to other β-lactams
Blood dyscrasias
Uric acid nephrolithiasis
Concomitant use of ketorolac tromethamine or ketoprofen
•
Use caution in patients taking other drugs that are dependent on OAT1/3 for elimination.
Warnings and precautions
Antimicrobial resistance
•
Maintain a high level of suspicion, as the use of sulopenem/probenecid in the absence of a proven or strongly suspected susceptible uncomplicated UTI increases the risk of developing drug-resistant bacteria.
C. difficile infection
•
Maintain a high level of suspicion, as nearly all antibiotics, including sulopenem, are associated with an increased risk of C. difficile-associated diarrhea.
Exacerbation of gout
•
Use caution in patients with gout. Ensure appropriate therapy is instituted.
Increased serum sulopenem levels
•
Use caution in patients taking OAT3 inhibitors.
Increased urine glucose
•
Maintain a high level of suspicion, as sulopenem/probenecid treatment can cause false-positive results for urine glucose tests using copper reduction methods. confirm suspected glycosuria with a specific glucose test.
Uric acid nephrolithiasis
•
Use caution in patients with gout. Offer increased fluid intake and urine alkalization to reduce the risk of uric acid kidney stones.
Specific populations
Renal impairment
CrCl ≥ 15 mL/min
•
Use acceptable. No dose adjustment required.
CrCl < 15 mL/min
•
Do not use.
Renal replacement therapy
Any modality
•
Do not use.
Hepatic impairment
Any severity
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Use only if benefits outweigh potential risks. Evidence of fetal harm in animals.
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Common 1-10%
•
Abdominal pain, diarrhea, headache, vomiting, nausea, vulvovaginal candidiasis
Uncommon < 1%
•
Gastroesophageal reflux disease, bacterial vaginosis, candidiasis, myositis, tachycardia, vertigo, abdominal distension, constipation, dry mouth, dyspepsia, belching, flatulence, asthenia, fatigue, malaise, peripheral edema, fever, ↑ serum transaminases, hepatomegaly, polydipsia, arthralgia, back pain, dizziness, reduced sense of taste, change in taste, dystonia, paresthesia, migraine, somnolence, syncope, presyncope, confusion, perineal pain, vaginal discharge, vaginal itching, dyspnea, cough, skin rash, angioedema, itching, hypertension, skin flushing, urine discoloration
Unknown frequency
•
Hepatic necrosis, aplastic anemia, hemolytic anemia, anaphylaxis, acute gout flare, nephrotic syndrome, renal colic, dermatitis, loss of appetite, ↓ WBC count, urticaria, urinary frequency, hair loss, flank pain, anemia
Interactions
Drug(s)
Check Interactions
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