Is Gatifloxacin (Garenofloxacin is not a valid medication, however a similar medication is Gatifloxacin) FDA approved?

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Last updated: March 23, 2025View editorial policy

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From the Guidelines

Gatifloxacin is not FDA approved for use in the United States, as evidenced by the lack of its inclusion in the list of currently approved fluoroquinolones, which includes ciprofloxacin, levofloxacin, moxifloxacin, delafloxacin, and ofloxacin 1. However, it is mentioned in the guidelines for antimicrobial treatment of acute bacterial rhinosinusitis as an option for switch therapy or initial therapy in certain cases, indicating its potential efficacy in treating bacterial infections 1. The guidelines suggest that Gatifloxacin, along with other fluoroquinolones like levofloxacin and moxifloxacin, has good coverage for both S pneumoniae and H influenzae, which are common pathogens in acute bacterial rhinosinusitis 1. It's worth noting that while Gatifloxacin may have been considered for use in the past, its approval status has not changed, and healthcare providers should only use FDA-approved medications for treatment of bacterial infections. Some key points to consider when selecting antibiotic therapy include:

  • The severity of the disease
  • Recent antimicrobial use
  • Risk factors for infection with resistant organisms
  • The potential for treatment failure or resistant pathogens 1. In the context of real-life clinical medicine, it is essential to prioritize the use of FDA-approved medications to ensure patient safety and efficacy of treatment.

From the Research

FDA Approval of Gatifloxacin

  • Gatifloxacin is approved by the FDA for use in the treatment of various bacterial infections, including community-acquired pneumonia, acute exacerbations of chronic bronchitis, acute sinusitis, and uncomplicated and complicated urinary tract infections 2.
  • The FDA approval of gatifloxacin is based on its broad spectrum of antibacterial activity and good clinical and bacteriological efficacy in patients with indicated infections 2.
  • Gatifloxacin is administered once-daily by the intravenous or oral routes and is generally well tolerated, with the most common adverse events associated with the gastrointestinal tract and CNS 2.

Safety Considerations

  • Gatifloxacin should not be used due to glucose alterations which may be serious, as stated in a review of new fluoroquinolones 3.
  • Fluoroquinolones, including gatifloxacin, can cause QT interval prolongation and should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypakaemia or hypomagnesaemia, and patients receiving class IA or class III antiarrhythmic agents 4.
  • Gatifloxacin may cause dysglycemia, including hyperglycemia and hypoglycemia, especially in patients with diabetes mellitus or those receiving sulfonylureas 5.

Comparison with Other Fluoroquinolones

  • Gatifloxacin has a similar rate of dysglycemia compared to levofloxacin, but a higher rate compared to ceftriaxone 5.
  • The risk of hypoglycemia and hyperglycemia varies among different fluoroquinolones, with moxifloxacin being shown to have a higher risk of hypoglycemia compared to ciprofloxacin 6.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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