finafloxacin

finafloxacin

(fin-a-flox-a-sin),

Xtoro

(trade name)

Classification

Therapeutic: anti infectives
Pharmacologic: fluoroquinolones
Pregnancy Category: C

Indications

Treatment of acute otitis externa (AOE) caused by susceptible strains of Pseudomonas aeruginosa or Staphylococcus aureus.

Action

Inhibits bacterial DNA synthesis by inhibiting the DNA gyrase enzyme.

Therapeutic effects

Death of susceptible bacteria with resolution of infection.

Pharmacokinetics

Absorption: Minimal systemic absorption follows otic use.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: Unknown.

Time/action profile (cessation of ear pain)

ROUTEONSETPEAKDURATION
oticunknown3.5 daysunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity; cross-sensitivity with other fluoroquinolones may occur.
Use Cautiously in: Obstetric: Use in pregnancy only if potential benefit justifies potential risk to the fetus. Lactation: Use cautiously if breastfeeding; Pediatric: Safe and effective use in children <1 yr has not been established.

Adverse Reactions/Side Effects

Gastrointestinal

  • nausea

Local

  • ear pruritus

Miscellaneous

  • allergic reactions

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Otic (Adults and Children ≥1 yr) 4 drops in infected ear(s) twice daily for seven days. Up to 8 drops may be given as an initial dose if used with an otowick.

Availability

Suspension for otic use: 0.3% suspension 5 mL in 8 mL bottle

Nursing implications

Nursing assessment

  • Assess ear pain prior to and periodically during therapy.

Potential Nursing Diagnoses

Acute pain (Indications)

Implementation

  • Otic: Warm suspension by holding bottle in hand for 1 to 2 min prior to dosing to avoid dizziness from instillation of cold suspension. Shake well before use. Instill 4 drops into affected ear twice daily for 7 days. May begin with 8 drops, followed by 4 drops, in patients requiring use of an otowick. Have patient lie with affected ear upward for 60 seconds to facilitate penetration of drops into ear canal. Repeat with other ear if necessary.

Patient/Family Teaching

  • Instruct patient in proper technique for instillation of drops.
  • Advise patient to notify health care professional if signs and symptoms of allergic reactions (rash) occur.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Resolution of signs and symptoms of acute otitis externa (AOE).
References in periodicals archive ?
MerLion announced in 2015 that XTORO, an otic suspension of finafloxacin, had been approved by the FDA for treatment of acute otitis externa, commonly known as swimmer's ear, caused by Pseu-domonas aeruginosa and Staphylococcus aureus.
MerLion Pharmaceuticals Pte Ltd is a pharmaceutical company, headquartered in Singapore with R&D operations in Berlin, Germany, which is focused on the advanced clinical development of its antibac-terial lead program, finafloxacin. MerLion is a privately held company supported by a group of lead-ing global investors including Aravis Venture, Singapore based EDBI and Heidelberg Capital.
Finafloxacin is a novel fluoroquinolone antibiotic with many best in class features.
Finafloxacin's superior profile arises from the compound's unique mode of action, being equally ac-tive at physiological pH conditions and in the acidic environments which occur at the most sites of bacterial infections.
MerLion, which is focused on the advanced clinical development of its antibacterial drug finafloxacin, now owns all rights to XTORO globally.
MerLion announced in 2015 that XTORO, an otic suspension of finafloxacin, had been approved by the FDA for treatment of acute otitis externa, commonly known as "swimmer's ear," caused by Pseudomonas aeruginosa and Staphylococcus aureus.
Along with a cash payment, the settlement includes the assignment to MerLion of all of Alcon's finafloxacin related patents and know-how, along with XTORO pharmaceutical product materials.
MerLion Pharmaceuticals is a pharmaceutical company, headquartered in Singapore with R and D operations in Berlin, Germany, which is focused on the advanced clinical development of its antibacterial lead program, finafloxacin.
Finafloxacin was also superior to the vehicle for clearing the bacteria and eased ear pain sooner,.
A total of 1,234 participants aged 6 months to 85 years were randomly assigned to receive finafloxacin or vehicle.
The Food and Drug Administration has approved finafloxacin otic suspension to treat acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus.
At the present time, three of these agents are not yet available: finafloxacin otic suspension (Xtoro) for acute otitis externa, naloxegol (Movantik) for opioid-induced constipation in adults with chronic noncancer pain, and peginterferon beta-la (Plegridy) for relapsing multiple sclerosis.