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Orlynvah
sulopenem etzadroxil/ probenecid
Adult Dosing .
Dosage forms: TAB: 500 mg/500 mg
UTI, uncomplicated
- [1 tab PO bid x5 days]
- Info: give with food
renal dosing
- [see below]
- CrCl <15: avoid use
- HD: avoid use; PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- CrCl <15
- uric acid nephrolithiasis
- gout attack, acute
- blood dyscrasia
- caution: hypersensitivity to beta-lactams
- caution: hypersensitivity to sulfa
- caution: gout history
- caution: tumor lysis syndrome risk
- caution: PUD
- caution: antibiotic-associated colitis history, recent
Drug Interactions .
Overview
probenecid
uricosuric agent; renal tubular transport inhibitor
- MRP4 inhibitor
- OAT1 inhibitor
- OAT2 inhibitor
- OAT3 inhibitor
- UGT1A1 inhibitor
- UGT1A4 inhibitor
- UGT1A6 inhibitor
- UGT1A9 inhibitor
- UGT2B4 inhibitor
- UGT2B7 inhibitor
- UGT2B15 inhibitor
- hypouricemic agent
sulopenem
penem
- OAT3 substrate
- affected by altered gastrointestinal motility
- alters GI flora
- impairs immunomodulatory bacterial infective agent
- sulopenem etzadroxil (prodrug) converted to sulopenem
Contraindicated
- ketorolac
Avoid/Use Alternative
- avibactam
- BCG live intravesical
- belinostat
- bremelanotide
- bumetanide
- cefazolin
- cefotaxime
- cephalexin
- cholera vaccine, live
- deferiprone
- ertapenem
- fecal microbiota, live
- irinotecan
- ketoprofen
- lenacapavir
- lorazepam
- meropenem
- methotrexate
- pegloticase
- pemetrexed
- pexidartinib
- pralatrexate
- sacituzumab govitecan
- seladelpar
- sulbactam
- typhoid vaccine, live
- vaborbactam
Monitor/Modify Tx
- acetaminophen
- adefovir dipivoxil
- aspirin
- baricitinib
- bempedoic acid
- bendamustine
- bismuth subsalicylate
- carfilzomib
- chlorothiazide
- chlorthalidone
- ciprofloxacin
- clofarabine
- cyclosporine
- cytarabine
- dasatinib
- daunorubicin
- diazoxide
- docetaxel
- doxorubicin
- ensartinib
- entrectinib
- epirubicin
- estradiol (contraceptive)
- ethacrynic acid
- ethambutol
- ethanol (alcoholic beverage)
- ethanol (in some formulations)
- ethinyl estradiol (contraceptive)
- exenatide
- furosemide
- ganaxolone
- ganciclovir
- glimepiride
- glipizide
- glyburide
- hydrochlorothiazide
- imatinib
- indapamide
- indomethacin
- lamotrigine
- lixisenatide
- magnesium salicylate
- meclofenamate
- methyl salicylate topical
- metolazone
- mycophenolate mofetil
- mycophenolic acid
- nelarabine
- niacin (vitamin B3)
- nilotinib
- pancrelipase
- phenyl salicylate
- ponatinib
- posaconazole
- pramlintide
- propofol
- pyrazinamide
- repotrectinib
- ribavirin
- ritonavir
- rituximab
- salsalate
- spironolactone
- sulfate bowel prep
- tacrolimus
- taletrectinib
- torsemide
- trolamine salicylate topical
- vadadustat
- valganciclovir
- warfarin
- willow bark
Therapeutic Advantage
- amoxicillin
- ampicillin
- cefdinir
- cefoxitin
- cefpodoxime
- dicloxacillin
- nafcillin
- oxacillin
- penicillin G
- penicillin V
Caution Advised
- artesunate
- bictegravir
- cabotegravir
- cefaclor
- cefprozil
- cefuroxime axetil
- cefuroxime sodium
- dapsone
- dichlorphenamide
- diflunisal
- dulaglutide
- entacapone
- famciclovir
- fexinidazole
- gemfibrozil
- glycerol phenylbutyrate
- lactulose
- leflunomide
- liraglutide
- naproxen
- nitisinone
- nitrofurantoin
- orforglipron
- pretomanid
- rifampin
- silodosin
- sodium benzoate
- sodium phenylacetate
- sodium phenylbutyrate
- sodium picosulfate
- sulfadiazine
- sulfamethoxazole
- sulindac
- tazobactam
- tenofovir disoproxil
- teriflunomide
- tirzepatide
- trifluoperazine
- trimethoprim
- zidovudine
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- anaphylaxis
- hemolytic anemia
- aplastic anemia
- hepatic necrosis
- uric acid nephropathy
- C. difficile-associated diarrhea
Common Reactions
- diarrhea
- nausea
- infection, vulvovaginal mycotic
- headache
- vomiting
- gout exacerbation
Safety/Monitoring .
Monitoring Parameters
Cr at baseline; CBC
Pregnancy/Lactation .
Pregnancy
Clinical Summary
sulopenem: weigh risk/benefit during pregnancy; no human data available; risk of fetal harm not expected based on animal data at 3x MRHD; possible risk of fetal malformations and decr. fetal wt based on animal data at 6x and 23x MRHD
probenecid: may use during pregnancy; risk of teratogenicity not expected based on limited human data
Lactation
Clinical Summary
sulopenem: weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
probenecid: weigh risk/benefit while breastfeeding; no known risk of infant harm based on limited human data; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for sulopenem etzadroxil: hydrolysis; CYP450: none; for probenecid: liver; CYP450: unknown; Info: active metabolites
Excretion: for sulopenem etzadroxil: feces 44.3% (26.9% unchanged), urine 40.8% (3.1% unchanged); Half-life: 1.28h; for probenecid: unknown; Half-life: 3.83h
Subclass: Beta-Lactams ; Penems
Mechanism of Action
for sulopenem etzadroxil: binds to peptidoglycan, inhibiting cell wall synthesis; for probenecid: inhibits renal tubular secretion, preventing beta-lactam elimination
Formulary .
No Formulary Selected
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