Gepotidacin Application Scope

Treatment of uncomplicated urinary tract infections (uUTIs) in female adults and pediatric patients aged 12 years and older, weighing at least 40 kg.

Gepotidacin Characteristics

Ingredients:
- Each Blujepa tablet contains 750 mg of gepotidacin, equivalent to 910.7 mg of gepotidacin mesylate (anhydrous).
Properties
Packaging Specification: Each tablet contains 750 mg of gepotidacin.
Storage: Store at room temperature, between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
Expiry Date: Refer to the packaging for the specific expiration date.
Executive Standard: As per FDA approval standards.
Approval Number: NDA 218230.
Date of Revision: March 2025.
Manufacturer: GlaxoSmithKline LLC.

Dosage and Administration:
- Recommended Dosage: 1,500 mg (two 750 mg tablets) taken orally twice daily (approximately every 12 hours) for 5 days.
- Administration Instructions: Take after a meal to reduce the potential for gastrointestinal intolerance.
- Missed Dose: If a dose is missed, take it as soon as possible. Do not double the dose to make up for a missed dose
Adverse Reactions:
- Common Side Effects (>10%): Diarrhea.
- Other Side Effects (1–10%): Nausea, abdominal pain, flatulence, headache, soft stools, dizziness, vomiting, vulvovaginal candidiasis.
- Rare Side Effects (<1%): Abdominal distension, dyspepsia, hypersalivation, presyncope, dysarthria, muscle spasms, hot flush, tachycardia, blurred vision, vertigo, fatigue.
- Serious Adverse Reactions: QTc prolongation, acetylcholinesterase inhibition effects (e.g., bradycardia, seizures), hypersensitivity reactions including anaphylaxis, and Clostridioides difficile infection.
Contraindications: Known hypersensitivity to gepotidacin or any component of the formulation.
Precautions:
- Avoid use in patients with a history of QTc interval prolongation or those taking medications that may prolong the QTc interval.
- Use caution in patients with severe hepatic or renal impairment.
- Monitor for signs of hypersensitivity reactions during treatment.

Drug Interactions:
CYP3A4 Inhibitors: Concomitant use with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole) may increase gepotidacin exposure; avoid co-administration.
QTc-Prolonging Agents: Avoid concurrent use with other medications known to prolong the QTc interval.
Acetylcholinesterase Inhibitors: Use caution when co-administered with other acetylcholinesterase inhibitors due to potential additive effects.

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.