finafloxacin otic (Discontinued)

1-10%

Pruritus (1%)

Nausea (1%)

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

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.

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)

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