Dosing and uses of Floxin Otic, Oflaxacin Otic (ofloxacin otic)
Adult dosage forms and strengths
otic solution
- 0.3%
Chronic Suppurative Otitis Media With Perforated Tympanic Membranes
Instill 10 gtt twice daily for 14 days in affected ear(s)
Otitis Externa
Instill 10 gtt qDay for 7 days in affected ear(s)
Pediatric dosage forms and strengths
<1 year old: Safety & efficacy not established
Dosage forms and strengths
otic solution
- 0.3%
Otitis Externa
< 6 months
- Safety and efficacy not established
6 months to 12 years
- Instill 5 gtt into affected ear twice daily for 7 days
>12 years
- Instill 10 gtt qDay for 7 days in affected ear(s)
Acute Otitis Media With Tympanostomy Tubes
< 1 year
- Safety and efficacy not established
1-12 years
- Instill 5 gtt into affected ear twice daily for 7 days
Chronic Suppurative Otitis Media With Perforated Tympanic Membranes
>12 years: Instill 10 gtt twice daily for 14 days in affected ear(s)
Floxin Otic, Oflaxacin Otic (ofloxacin otic) adverse (side) effects
>10%
Application site reaction (1-17%)
1-10%
Taste perversion (7%)
Pruritus (4%)
Dizziness (1%)
Earache (1%)
Paresthesia (1%)
Rash (1%)
Vertigo (1%)
<1%
Otorrhagia
Tinnitus
Transient hearing loss
Tremor
Xerostomia
Diarrhea
Warnings
Contraindications
Hypersensitivity to drug or product components
Cautions
Warm solution with hands to prevent dizziness
May result in overgrowth of nonsusceptible organisms, including fungi
Careful monitoring, including slit-lamp biomicroscopy and fluorescein staining when appropriate, may be necessary in some patients receiving topical ophthalmic ofloxacin therapy
Not for injection or ophthalmic use
Tendon rupture reported with systemic quinolones
Pregnancy and lactation
Pregnancy category: C
Lactation: Not known if distributed in milk; not recommended
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 Floxin Otic, Oflaxacin Otic (ofloxacin otic)
Mechanism of action
Inhibits DNA gyrase, which in turn inhibits DNA replication, recombination, transcription, and transposition; bactericidaL
Pharmacokinetics
Absorption: MinimaL
