Medical Editor: John P. Cunha, DO, FACOEP
- mild irritation or discomfort in the ear
- ear itching
- earache, or
- changes in taste
The recommended dosage regimen of Floxin Otic Singles for the treatment of otitis externa is: For pediatric patients (from 6 months to 13 years old): instill the contents of 1 single-dispensing container into the affected ear once daily for seven days. For patients 13 years and older: instill the contents of 2 single-dispensing containers into the affected ear once daily for seven days. Floxin Otic Singles may interact with other ear drops. Tell your doctor all medications and supplements you use. During pregnancy, Floxin Otic Singles should be used only if prescribed. It is unknown if this medication passes into breast milk. However, it is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.
Our Floxin Otic Singles (ofloxacin otic) solution 0.3% Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Stop using ofloxacin otic and seek emergency medical attention or contact your doctor if you experience:
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- skin rash; or
- ear drainage, discharge, or worsening pain.
Other less serious side effects may also occur such as ear discomfort or itching, and headache. Continue to use the medication and talk to your doctor if these side effects seem excessive or unusual.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Floxin Otic Singles (Ofloxacin Otic Solution)
Subjects with Otitis Externa
In the phase III clinical trials performed in support of once-daily dosing, 799 subjects with otitis externa and intact tympanic membranes were treated with ofloxacin otic solution. The studies, which served as the basis for approval, were 020 (pediatric, adolescents and adults), 016 (adolescents and adults) and 017 (pediatric). The following treatment-related adverse events occurred in two or more of the subjects.
|Adverse Event||Studies 002/003†
|Application Site Reaction||3%||16.8%||0.6%|
|† Studies 002/003 (BID) and 016/017 (QD) were active-controlled and comparative. Study 020 (QD) was open and non-comparative.|
An unexpected increased incidence of application site reaction was seen in studies 016/017 and was similar for both ofloxacin and the active control drug (neomycinpolymyxin B sulfate-hydrocortisone). This finding is believed to be the result of specific questioning of the subjects regarding the incidence of application site reactions.
In once daily dosing studies, there were also single reports of nausea, seborrhea, transient loss of hearing, tinnitus, otitis externa, otitis media, tremor, hypertension and fungal infection.
In twice daily dosing studies, the following treatment-related adverse events were each reported in a single subject: dermatitis, eczema, erythematous rash, follicular rash, hypoaesthesia, tinnitus, dyspepsia, hot flushes, flushing and otorrhagia.
Subjects with Acute Otitis Media with Tympanostomy Tubes (AOM TT) and Subjects with Chronic Suppurative Otitis Media (CSOM) with Perforated Tympanic Membranes
In phase III clinical trials which formed the basis for approval, the following treatment-related adverse events occurred in 1% or more of the 656 subjects with non-intact tympanic membranes in AOM TT or CSOM treated twice-daily with ofloxacin otic solution:
Other treatment-related adverse reactions reported in subjects with non-intact tympanic membranes included: diarrhea (0.6%), nausea (0.3%), vomiting (0.3%), dry mouth (0.5%), headache (0.3%), vertigo (0.5%), otorrhagia (0.6%), tinnitus (0.3%), fever (0.3%). The following treatment-related adverse events were each reported in a single subject: application site reaction, otitis externa, urticaria, abdominal pain, dysaesthesia, hyperkinesia, halitosis, inflammation, pain, insomnia, coughing, pharyngitis, rhinitis, sinusitis, and tachycardia.
Post-marketing Adverse Events
Cases of uncommon transient neuropsychiatric disturbances have been included in spontaneous post-marketing reports. A causal relationship with ofloxacin otic solution 0.3% is unknown.
Read the entire FDA prescribing information for Floxin Otic Singles (Ofloxacin Otic Solution)
© Floxin Otic Singles Patient Information is supplied by Cerner Multum, Inc. and Floxin Otic Singles Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.