Version June 2024
Otitis media, chronic suppurative (with perforated tympanic membranes): Otic: Instill 10 drops into affected ear(s) twice daily for 14 days.
There are no dosage adjustments provided in manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
(For additional information see "Ofloxacin (otic): Pediatric drug information")
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.
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.
Infants ≥6 months, Children, and Adolescents: There are no dosing adjustments provided in the manufacturer's labeling.
Infants ≥6 months, Children, and Adolescents: There are no dosing adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults and pediatric patients.
>10%: Local: Application-site reaction (≤17%)
1% to 10%:
Dermatologic: Pruritus (1% to 4%), skin rash (1%)
Gastrointestinal: Dysgeusia (7%)
Nervous system: Dizziness (≤1%), paresthesia (1%), vertigo (≤1%)
<1%:
Cardiovascular: Flushing, hypertension, tachycardia
Dermatologic: Dermatitis, eczema, erythematous rash, follicular rash, seborrhea, urticaria
Endocrine & metabolic: Hot flash
Gastrointestinal: Abdominal pain, diarrhea, dyspepsia, halitosis, nausea, vomiting, xerostomia
Infection: Fungal infection
Nervous system: Dysesthesia, headache, hypoesthesia, tremor
Otic: Bleeding from ear, tinnitus
Respiratory: Cough, pharyngitis, rhinitis, sinusitis
Miscellaneous: Fever
Postmarketing: Nervous system: Psychiatric disturbance (transient)
Hypersensitivity to ofloxacin, other quinolones, or any component of the formulation
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. Avoid contaminating the bottle tip with material from the ear, fingers, or other source.
In pediatric patients, use of quinolone ear drops may increase the risk of tympanic rupture. A retrospective cohort study of over 96,000 patients (<18 years of age) compared patients who received a quinolone-containing ear drop (n=78,275) to those who received a neomycin plus hydrocortisone ear drop (n=18,320). Patients who received quinolone ear drops after tympanostomy tube placement had an increased incidence of tympanic perforation requiring tympanoplasty with an adjusted hazard ratio of 1.61 (95% confidence interval [CI]: 1.15 to 2.26); combination products containing corticosteroids may amplify adverse effect risk (Alrawisan 2017).
In another retrospective cohort study of patients with acute otitis externa comparing patients who received quinolone-containing otic drops (n=35,851 pediatric and 7,802 adult) to those who received neomycin with hydrocortisone otic drops (n=32,753 pediatric and 17,927 adult), it was reported that patients who received quinolone-containing ear drops had an increased risk of tympanic membrane perforation with an adjusted hazard ratio of 2.19 (95% CI: 1.01 to 4.73); ofloxacin specifically was associated with an adjusted hazard ratio of 2.53 (95% CI: 1.27 to 5.05) (Wang 2020). Monitor and counsel patients accordingly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Otic:
Generic: 0.3% (5 mL, 10 mL)
Yes
Solution (Ofloxacin Otic)
0.3% (per mL): $30.86 - $31.47
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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 (Ref). For acute otitis media and chronic suppurative otitis media, pump tragus 4 times to ensure penetration of medication.
Otic: For otic use only; not for oral use, ophthalmic use, or injection. Gently clean any discharge that can be easily removed from the outer ear. Warm otic solution by holding bottle in hand for 1 to 2 minutes prior to instillation. The tip of the bottle should not touch the fingers, ear, or any surface. Patient should lie on side with affected ear upward. For middle ear infections, gently press the tragus 4 times in a pumping motion to allow the drops to pass through the hole or tube in the eardrum and into the middle ear. For otitis externa infection, pull the outer ear upward and backward to allow the ear drops to flow down into the ear canal. Patient should remain on his/her side for at least 5 minutes. If necessary, repeat procedure for the other ear.
Otitis externa, acute: Treatment of otitis externa due to susceptible isolates of Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus in adults and pediatric patients 6 months and older.
Otitis media, acute: Treatment of acute otitis media with tympanostomy tubes due to susceptible isolates of S. aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and P. 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.
Floxin may be confused with Flexeril
Floxin: Brand name for ofloxacin [US], but also the brand name for flunarizine [Thailand], norfloxacin [South Africa], and perfloxacin [Philippines]
Floxin [US] may be confused with Flexin brand name for diclofenac [Argentina], cyclobenzaprine [Chile], and orphenadrine [Israel]; Flogen brand name for naproxen [Mexico]
None known.
There are no known significant interactions.
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.
When administered orally, ofloxacin enters breast milk. It is not known if ofloxacin can be detected in breast milk following otic administration. Due to the potential for serious adverse reactions in the nursing infant, the manufacturer recommends a decision be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother.
Inhibits DNA-Gyrase in susceptible organisms; bactericidal.
Absorption: Only small amounts are absorbed systemically after otic instillation.
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