Gepotidacin

Class
Antibiotics
Subclass
Topoisomerase II inhibitors
Substance name
Gepotidacin
Brand names
Bludepa®
Common formulations
Tablet
Dosage and administration
Adults patients
Treatment of UTIs in females • Uncomplicated
•
1,500 mg PO BID for 5 days
Taken after a meal.
Pediatric patients
Treatment of UTIs in females • Uncomplicated
Weight ≥ 40 kg
•
1,500 mg PO BID for 5 days
Taken after a meal.
Indications for use
Labeled indications
Adults
•
Treatment of UTIs in females (uncomplicated)
Children
•
Treatment of UTIs in females (uncomplicated)
Safety risks
Contraindications
Hypersensitivity to gepotidacin or its components
QT prolongation
•
Avoid gepotidacin in patients with a history of QT interval prolongation or those with relevant pre-existing cardiac disease, patients taking antiarrhythmic agents, or other QT-prolonging medications. Monitor and correct serum electrolyte abnormalities and obtain an ECG before administration and during treatment if administration of gepotidacin cannot be avoided.
Concomitant use of strong CYP3A4 inhibitors
•
Avoid concomitant use of gepotidacin with strong CYP3A4 inhibitors (such as itraconazole, ketoconazole) due to an increase in gepotidacin exposure and the risk of QT interval prolongation.
Warnings and precautions
Acetylcholinesterase inhibition
•
Maintain a high level of suspicion, as gepotidacin is a reversible acetylcholinesterase inhibitor and can cause cholinergic side effects, exaggerate the neuromuscular effects of succinylcholine-type muscle relaxation during anesthesia, and antagonize the effects of systemic anticholinergic medications or non-depolarizing neuromuscular blocking agents. Monitor patients with medical conditions that may be exacerbated by acetylcholinesterase inhibition. Monitor for exaggerated neuromuscular blockade or excessive cholinergic effects.
Antimicrobial resistance
•
Maintain a high level of suspicion, as the use of gepotidacin in the absence of a proven or strongly suspected bacterial infection increases the risk of developing drug-resistant bacteria.
C. difficile infection
•
Maintain a high level of suspicion, as nearly all antibiotics, including gepotidacin, are associated with an increased risk of C. difficile-associated diarrhea.
Drug hypersensitivity reaction
•
Maintain a high level of suspicion, as drug hypersensitivity reactions, including anaphylaxis, have been reported with gepotidacin.
Specific populations
Renal impairment
eGFR ≥ 30 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
eGFR < 30 mL/min/1.73 m²
•
Avoid use.
Renal replacement therapy
Any modality
•
Avoid use.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Use acceptable. No dose adjustment required.
Child-Pugh C (severe)
•
Avoid use.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Insufficient evidence. 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
Very common > 10%
•
Diarrhea
Common 1-10%
•
Abdominal pain, flatulence, headache, dizziness, vomiting, nausea, vulvovaginal candidiasis
Uncommon < 1%
•
Abdominal distension, dyspepsia, belching, presyncope, dysarthria, muscle spasms, hot flashes, tachycardia, blurred vision, vertigo, fatigue, ↑ serum ALT, ↑ serum AST, hyperhidrosis, skin rash, Clostridioides difficile infection, drug hypersensitivity reaction
Unknown frequency
•
Hypersalivation, ↑QT interval, AV block, bradycardia, bronchospasm, seizure, vasovagal syncope
Interactions
Drug(s)
Check Interactions
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