Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Otic:
Floxin Otic: 0.3% (5 mL [DSC], 10 mL [DSC]) [contains benzalkonium chloride, sodium chloride]
Generic: 0.3% (5 mL, 10 mL)
Pharmacology
Mechanism of Action
Inhibits DNA-Gyrase in susceptible organisms; bactericidal.
Pharmacokinetics/Pharmacodynamics
Absorption
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.
Use: Off Label
Tympanic membrane perforation, traumaticc
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.
Contraindications
Hypersensitivity to ofloxacin, other quinolones, or any component of the formulation
Dosage and Administration
Dosing: Adult
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.
Dosing: Pediatric
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
Administration
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.
Storage
Store at 20°C to 25°C (68°F to 77°F). Protect from light.
Drug Interactions
There are no known significant interactions.
Adverse Reactions
>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
Warnings/Precautions
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
Pregnancy Risk Factor
C
Pregnancy Considerations
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.
Patient Education
What is this drug used for?
- It is used to treat ear infections.
Frequently reported side effects of this drug
- Change in taste
- Ear irritation
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Severe ear pain
- Signs of a significant reaction like 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. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
