Medically reviewed on Feb 19, 2019
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- Floxin Otic Singles
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Floxin Otic: 0.3% (5 mL, 10 mL) [contains benzalkonium chloride, sodium chloride]
Generic: 0.3% (5 mL, 10 mL)
Brand Names: U.S.
- Floxin Otic
- Antibiotic, Fluoroquinolone
- Antibiotic, Otic
Inhibits DNA-Gyrase in susceptible organisms; bactericidal.
Only small amounts are absorbed systemically after otic instillation.
Use: Labeled Indications
Otitis media, acute: Treatment of acute otitis media with tympanostomy tubes due to susceptible isolates of Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa in pediatric patients 1 year and older.
Otitis media, chronic suppurative: Treatment of chronic supportive otitis media with perforated tympanic membranes due to susceptible isolates of Proteus mirabilis, P. aeruginosa, and S. aureus in patients 12 years and older.
Otitis externa: Treatment of otitis externa due to susceptible isolates of E. coli, P. aeruginosa, and S. aureus in adults and pediatric patients 6 months and older.
Off Label Uses
Tympanic membrane perforation, traumatic
Data from a limited number of clinical trials suggest that ofloxacin otic may be beneficial for promoting healing and decreasing time to closure in patients with large traumatic tympanic membrane perforation. Additional data may be necessary to further define the role of ofloxacin in this condition [Jian-Yang 2016], [Lou 2016].
Hypersensitivity to ofloxacin, other quinolones, or any component of the formulation
Otitis media, chronic suppurative (with perforated tympanic membranes): Otic: Instill 10 drops into affected ear(s) twice daily for 14 days
Otitis externa: Otic: Instill 10 drops into affected ear(s) once daily for 7 days
Tympanic membrane perforation, traumatic (off-label use): Otic: Instill 2 to 3 drops once daily until complete closure of perforation is confirmed (Jian-Yang 2016; Lou 2016). Additional data may be necessary to further define the role of ofloxacin in this condition.
Otitis media, acute (with tympanostomy tubes): Children: Otic: Instill 5 drops (0.25 mL) into the affected ear(s) twice daily for 10 days
Otitis media, chronic suppurative (with perforated tympanic membranes): Children ≥12 years and Adolescents: Otic: Instill 10 drops (0.5 mL) into the affected ear(s) twice daily for 14 days
Otitis externa, acute:
Infants ≥6 months and Children: Otic: Instill 5 drops (0.25 mL) into the affected ear(s) once daily for 7 days
Adolescents: Otic: Instill 10 drops (0.5 mL) into the affected ear(s) once daily for 7 days
For otic use only; not for injection, inhalation, or topical ophthalmic use. Prior to use, warm solution by holding container in hands for 1 to 2 minutes. Patient should lie down with affected ear upward and medication instilled. Patients should remain in this position for 5 minutes to allow penetration of solution; repeat if necessary for the opposite ear. For traumatic tympanic membrane closure (off-label use), patient should remain lying down in a lateral position with the injured ear up for 30 minutes after instillation (Jian-Yang 2016). For acute otitis media and chronic suppurative otitis media, pump tragus 4 times to ensure penetration of medication.
Store at 20°C to 25°C (68°F to 77°F). Protect from light.
There are no known significant interactions.
>10%: Local: Application site reaction (≤17%)
1% to 10%:
Central nervous system: Paresthesia (1%), dizziness (≤1%), vertigo (≤1%)
Dermatologic: Pruritus (1% to 4%), skin rash (1%)
Gastrointestinal: Dysgeusia (7%)
<1%, postmarketing, and/or case reports: Auditory disturbance (transient), diarrhea, fever, headache, hypertension, nausea, otorrhagia, psychiatric disturbance (transient), tinnitus, tremor, vomiting, xerostomia
Concerns related to adverse effects:
• Hypersensitivity reactions: Severe hypersensitivity reactions (some fatal), including anaphylaxis, have occurred (some following the first does) with systemic fluoroquinolone therapy. Prompt discontinuation of drug should occur if skin rash or other symptoms of hypersensitivity arise.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection. If superinfection occurs, discontinue use and institute appropriate alternative therapy.
• Tendon inflammation/rupture: There have been reports of tendon inflammation and/or rupture with systemic fluoroquinolones. Exposure following otic administration is substantially lower than with systemic therapy. Discontinue at first sign of tendon inflammation or pain.
Dosage form specific issues:
• Appropriate use: For otic use only; not for injection or for ophthalmic use. If infection is not improved after 1 week, consider culture to identify organism.
Pregnancy Risk Factor
Adverse events have been observed in some animal reproduction studies. When administered orally, ofloxacin crosses the placenta (Giamarellou 1989). The amount of ofloxacin available systemically following topical application of the otic drops is significantly less in comparison to oral doses.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience change in taste. Have patient report immediately to prescriber severe ear pain or severe ear irritation (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- Drug class: otic anti-infectives