Gepotidacindrug info

gepotidacin 750 MG Oral Tablet [Blujepa]

What it is used for

BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of the following infections caused by susceptible microorganisms:

Uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg).

Uncomplicated urogenital gonorrhea in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms who have limited or no alternative treatment options. Approval of this indication is based on limited clinical safety data for this indication. Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of BLUJEPA and other antibacterial drugs, BLUJEPA should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

1.1 Treatment of

Uncomplicated Urinary Tract Infections BLUJEPA is indicated in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg) for the treatment of uncomplicated urinary tract infections (uUTI) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.

1.2 Treatment of

Uncomplicated Urogenital Gonorrhea BLUJEPA is indicated in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms (kg) who have limited or no alternative options for the treatment of uncomplicated urogenital gonorrhea caused by susceptible strains of Neisseria gonorrhoeae. Approval of this indication is based on limited clinical safety data for BLUJEPA.

1.3 Usage to

Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of BLUJEPA and other antibacterial drugs, BLUJEPA should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective February 10, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

Description

BLUJEPA tablets contain gepotidacin mesylate, a triazaacenaphthylene antibacterial that inhibits bacterial DNA gyrase and topoisomerase IV. The chemical name is ( R )-2-((4-(((3,4-dihydro-2 H -pyrano[2,3- c ]pyridin-6-yl)methyl)amino)piperidin-1-yl)methyl)-1,2-dihydro-3 H,8 H -2a,5,8a-triazaacenaphthylene-3,8-dione methanesulfonate dihydrate. The molecular formula is C 24 H 28 N 6 O 3 ●CH 4 O 3 S●2H 2 O and its molecular mass is 580.66. The structural formula is shown below. *stereogenic center Each BLUJEPA oral tablet contains gepotidacin 750 mg (equivalent to 910.7 mg of gepotidacin mesylate [anhydrous]). Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide. Gepotidacin mesylate dihydrate chemical structure

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