Finafloxacin

Finafloxacin is a fluoroquinolone antimicrobial [see Microbiology ( 12.4 )] .

• XTORO® is indicated for the treatment of acute otitis externa (AOE) with or without an otowick, caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus in patients age 1 year and older. XTORO® is a quinolone antimicrobial indicated for the treatment of acute otitis externa (AOE) caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus .

• None. None.contraindicated

Instill four drops into the affected ear(s) twice daily for seven days. For patients requiring use of an otowick, the initial dose can be doubled (to 8 drops), followed by 4 drops instilled into the affected ear twice daily for seven days. Important administration instructions include: Warm the suspension by holding the bottle in the hand for one or two minutes prior to dosing in order to avoid dizziness which may result from the instillation of a cold suspension. Shake bottle well before use. Lie with the affected ear upward, instill the drops, and maintain the position for 60 seconds to facilitate penetration of the drops into the ear canal. Repeat if necessary for the opposite ear. Instill four drops in the affected ear(s) twice daily for seven days. For patients requiring use of an otowick, the initial dose can be doubled (to 8 drops), followed by 4 drops instilled into the affected ear twice daily for seven days. ( 2 )

Prolonged use of this product may lead to overgrowth of nonsusceptible organisms. Discontinue use if this occurs. ( 5.1 ) Allergic reactions may occur in patients with a history of hypersensitivity to finafloxacin, to other quinolones, or to any of the components in this medication. Discontinue use if this occurs. ( 5.2 ) 5.1 Growth of Resistant Organisms with Prolonged Use As with other antibacterial preparations, prolonged use of XTORO may lead to overgrowth of nonsusceptible organisms, including yeast and fungi. If this occurs, discontinue use and institute alternative therapy. 5.2 Allergic Reactions Allergic reactions to XTORO may occur in patients with a history of hypersensitivity to finafloxacin, to other quinolones, or to any of the components in this medication. If this occurs, discontinue use and institute alternative therapy.

The most common adverse reactions occurring in 1% of patients with XTORO were ear pruritus and nausea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fonseca Biosciences, LLC at 1-877-436-6732 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 618 patients were treated with XTORO in two Phase 3 clinical trials. The most frequently reported adverse reactions of those exposed to XTORO occurring at an incidence of 1% included ear pruritus and nausea.

8.1 Pregnancy Risk Summary There are no adequate or well-controlled studies with XTORO in pregnant women. Finafloxacin was shown to be teratogenic in rabbits and rats following oral administration. Neural tube defects and skeletal anomalies in both species, and limb anomalies in rabbits, were observed at exposures estimated to be at least 1300 times the maximum human systemic exposure following topical otic administration of 0.3% finafloxacin. Because animal studies are not always predictive of human responses, XTORO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data Animal Data In rabbit embryofetal studies, maternal toxicity was not observed at oral doses up to 9 mg/kg/day (estimated 8000 times the maximum human systemic exposure [0.234 ng/mL] following topical otic administration with 0.3% finafloxacin). Fetal toxicity was observed at the lowest dose tested, 1 mg/kg/day (estimated 1300 times the maximum human systemic exposure following topical otic administration with 0.3% finafloxacin), and included exencephaly, enlarged fontanel, spina bifida, phocomelia, paw hyperflexure, missing lumbar vertebra, missing lumbar arch, and sternebra fusion.

Metabolism

Finafloxacin plasma concentrations were evaluated following single or repeated ototopical doses of XTORO (finafloxacin otic suspension) 0.3%. In healthy subjects administered 4 drops in each ear twice daily for seven days, quantifiable finafloxacin concentrations were observed in 2 of 14 subjects; and these concentrations were just above the quantitation limit (0.05 ng/mL).

• Dec 17, 2014NDANDA206307Fonseca Biosciences

1. 1Dysarthria1100%
2. 2Dysphagia1100%
3. 3Dysphonia1100%
4. 4Dyspnoea1100%

The 7 most recently updated of 7 ClinicalTrials.gov registrations naming Finafloxacin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Effect of Age and Gender on the PK and Tolerability of Finafloxacin
  Completed · Phase 1 · Interventional · 40 enrolled · MerLion Pharmaceuticals GmbH
  NCT01904162updated 2024-03-13
• Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis
  Completed · Phase 2 · Interventional · 225 enrolled · MerLion Pharmaceuticals GmbH
  NCT01928433updated 2017-06-20
• Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin
  Completed · Phase 1 · Interventional · 18 enrolled · MerLion Pharmaceuticals GmbH
  NCT01907867updated 2017-02-20
• Safety and Tolerability of Single and Multiple Intravenous Doses of Finafloxacin in Healthy Subjects
  Completed · Phase 1 · Interventional · 58 enrolled · MerLion Pharmaceuticals GmbH
  NCT01910883updated 2013-07-30
• Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients
  Completed · Phase 2 · Interventional · 30 enrolled · MerLion Pharmaceuticals GmbH
  NCT00723502updated 2009-06-16
• Finafloxacin 300 mg Twice a Day (b.i.d.) Versus Ciprofloxacin 250 mg Twice a Day (b.i.d) in Patients With Lower Uncomplicated UTI (uUTI)
  Completed · Phase 2 · Interventional · 36 enrolled · MerLion Pharmaceuticals GmbH
  NCT00722735updated 2009-06-11
• First Time in Man Study of Finafloxacin Hydrochloride
  Completed · Phase 1 · Interventional · 95 enrolled · MerLion Pharmaceuticals GmbH
  NCT00483158updated 2008-07-29

Frequently asked questions

How does Finafloxacin work?

Finafloxacin is a fluoroquinolone antimicrobial [see Microbiology ( 12.4 )] .

What is Finafloxacin used for?

According to FDA labeling, Finafloxacin carries indications including: XTORO® is indicated for the treatment of acute otitis externa (AOE) with or without an otowick, caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus in patients age 1 year and older. XTORO® is a quinolone antimicrobial indicated for the treatment of acute otitis externa (AOE) caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Finafloxacin?

Finafloxacin is classified as Quinolone Antimicrobial, DNA Gyrase Inhibitors, Topoisomerase Inhibitors, Decreased DNA Replication.

What are the brand names for Finafloxacin?

Finafloxacin is marketed under brand names including Xtoro.

What are the contraindications for Finafloxacin?

Finafloxacin labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.