Dosing and uses of Xtoro (finafloxacin otic)
Adult dosage forms and strengths
otic suspension
- 0.3% (5 mL/bottle)
Otitis Externa
Indicated for treatment of acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus
Instill 4 gtt in affected ear(s) BID x7 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 BID x7 days
Pediatric dosage forms and strengths
otic suspension
- 0.3% (5 mL/bottle)
Otitis Externa
Indicated for treatment of acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus
<1 year: Safety and efficacy not established
≥1 year: Instill 4 gtt in affected ear(s) BID x7 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 BID x7 days
Xtoro (finafloxacin otic) adverse (side) effects
1-10%
Pruritus (1%)
Nausea (1%)
Warnings
Contraindications
None
Cautions
As with other antibacterial preparations, prolonged use may result in overgrowth of resistant organisms including yeast and fungi
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; if allergic reaction occurs, discontinue use and institute alternative therapy
Pregnancy and lactation
Pregnancy
Pregnancy category: C
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, use during pregnancy only if the potential benefit justifies the potential risk to the fetus
Lactation
Identified in the milk of nursing rats following oral administration
The human systemic concentration following topical otic treatment is low; it is not known whether topical otic administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk
Caution should be exercised when finafloxacin is administered to a nursing mother
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Xtoro (finafloxacin otic)
Mechanism of action
Quinolone antimicrobial; inhibits bacterial type II topoisomerase enzymes, DNA gyrase and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair and recombination
Pharmacokinetics
Quantifiable systemic concentrations
- 4 gtt BID each ear x 7 days: 0.05 ng/mL (2 of 14 healthy volunteers)
- 4 or 8 gtt each ear single dose: up to 0.234 ng/mL (2 of 36 AOE patients)
Administration
Instructions
Warm the suspension by holding the bottle in the hand for 1-2 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
Storage
- Store at 2-25°C (36-77°F)
- Do not freeze
