Blujepa 750 mg/1
gepotidacin · TABLET, FILM COATED · GlaxoSmithKline LLC
Blujepa is a tablet, film coated containing gepotidacin at 750 mg/1, taken oral. Manufactured by GlaxoSmithKline LLC.
Key Facts
- Brand Name
- Blujepa
- Generic Name
- gepotidacin
- NDC Code (Product)
0173-0922- Manufacturer
- GlaxoSmithKline LLC
- Strength
- 750 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA218230
- Marketing Start
- 03/25/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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). ( 1.1 ) • 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. ( 1.2 , 6.1 ) 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. ( 1.3 ) 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 foll…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • uUTI: The recommended dosage of BLUJEPA is 1,500 mg (two 750 mg tablets) taken orally, twice daily (approximately 12 hours apart), for 5 days. ( 2.1 ) • Uncomplicated Urogenital Gonorrhea: The recommended dosage of BLUJEPA is 3,000 mg (four 750 mg tablets) taken orally, followed by a second dose of 3,000 mg (four 750 mg tablets) approximately 12 hours later. ( 2.2 ) • Administer BLUJEPA tablets after a meal to reduce the possibility of gastrointestinal intolerance. ( 2.3 ) 2.1 Recommended Dosage for Female Adult and Pediatric Patients 12 Years of Age and Older Weighing at Least 40 kg for Uncomplicated UTI The recommended dosage of BLUJEPA is 1,500 mg (two 750 mg tablets) taken orally, twice daily (approximately 12 hours apart) for 5 days in female adult and pediatric patients 12 years of age and older with uncomplicated uUTI [see Dosage and Administration ( 2.3 )] . 2.2 Recommended Dosage for Adult and Pediatric Patients 12 Years of Age and Older Weighing at Least 45 kg for Uncomplicated Urogenital Gonorrhea The recommended dose of BLUJEPA is 3,000 mg (four 750 mg tablets) taken orally, followed by a second dose of 3,000 mg (four 750 mg tablets) approx…
Contraindications
4 CONTRAINDICATIONS BLUJEPA is contraindicated in patients with a history of severe hypersensitivity to BLUJEPA [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 )] . A history of severe hypersensitivity to BLUJEPA. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • CYP3A4 Inhibitors: Increase gepotidacin exposure. ( 7.1 ) • Strong CYP3A4 inhibitors: Avoid concomitant use of BLUJEPA with strong CYP3A4 inhibitors. ( 5.1 , 7.1 ) • Moderate CYP3A4 inhibitors: Avoid concomitant use of BLUJEPA with moderate CYP3A4 inhibitors in patients with uncomplicated urogenital gonorrhea. ( 5.1 , 7.1 ) • CYP3A4 Inducers: Decrease gepotidacin exposure. ( 7.1 ) • For uUTI: Avoid concomitant use of BLUJEPA with strong CYP3A4 inducers. ( 7.1 ) • For uncomplicated urogenital gonorrhea: Avoid concomitant use of BLUJEPA with strong and moderate CYP3A4 inducers. ( 7.1 ) • CYP3A4 Substrates: Avoid concomitant use of BLUJEPA with drugs that are extensively metabolized by CYP3A4 where minimal concentration changes may lead to serious adverse reactions. ( 7.2 ) • Digoxin: Due to an increase in digoxin exposures, consider monitoring digoxin serum concentration, as appropriate, with concomitant administration of BLUJEPA. ( 7.2 ) 7.1 Effect of Other Drugs on BLUJEPA CYP3A4 Inhibitors Table 3. Recommendations for Concomitant Administration of CYP3A4 Inhibitors with BLUJEPA Indication Moderate CYP3A4 Inhibitors Strong CYP3A4 Inhibitors Uncomplicated UTI N…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • QTc Prolongation [see Warnings and Precautions ( 5.1 )] . • Acetylcholinesterase Inhibition [see Warnings and Precautions ( 5.2 )] . • Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] . • Clostridioides difficile Infection [see Warnings and Precautions ( 5.4 )] . • uUTI: The most common adverse reactions occurring in ≥1% of patients are diarrhea, nausea, abdominal pain, flatulence, headache, soft feces, dizziness, vomiting, and vulvovaginal candidiasis. ( 6.1 ) • Uncomplicated Urogenital Gonorrhea: The most common adverse reactions occurring in ≥2% of patients are diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, soft feces, headache, fatigue, and hyperhidrosis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of an…
Frequently Asked Questions
What is Blujepa used for?
Blujepa contains gepotidacin. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Blujepa a controlled substance?
Blujepa is not classified as a controlled substance by the DEA.
What is the generic name for Blujepa?
The generic name for Blujepa is gepotidacin. There are no other listed brand versions of gepotidacin.
What is the NDC code for Blujepa 750 mg/1?
The NDC (National Drug Code) for Blujepa 750 mg/1 is 0173-0922, listed by GlaxoSmithKline LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)