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Floxin Otic Singles

Last reviewed on RxList: 11/28/2016
Floxin Otic Singles Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 6/14/2016

Floxin Otic Singles (ofloxacin otic) solution 0.3% is an antibiotic used to treat ear infections. Floxin Otic Singles is available in generic form. Common side effects of Floxin Otic Singles include:

  • mild irritation or discomfort in the ear
  • ear itching
  • dizziness
  • headache
  • 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.

SLIDESHOW

Ear Infection Symptoms, Causes, and Treatment See Slideshow
Floxin Otic Singles Consumer Information

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Get emergency medical help if you have any of these signs of an allergic reaction: hives, rash, itching; slow heart rate, weak pulse, fainting; difficult breathing, slow breathing (breathing may stop); swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • the first sign of any skin rash, no matter how mild; or
  • ear drainage, discharge, or worsening pain.

Common side effects may include:

  • headache;
  • dizziness; or
  • mild ear pain or itching after using the ear drops.

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.

Read the entire detailed patient monograph for Floxin Otic Singles (Ofloxacin Otic Solution)

QUESTION

Ear infection or acute otitis media is an infection of the middle ear. See Answer
Floxin Otic Singles Professional Information

SIDE EFFECTS

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.

  Incidence Rate
Adverse Event Studies 002/003†
BID
(N=229)
Studies 016/017†
QD
(N=310)
Study 020†
QD
(N=489)
Application Site Reaction 3% 16.8% 0.6%
Pruritus 4% 1.2% 1.0%
Earache 1% 0.6% 0.8%
Dizziness 1% 0.0% 0.6%
Headache 0% 0.3% 0.2%
Vertigo 1% 0.0 0.0%
† 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:

Adverse Event Incidence
(N=656)
Taste Perversion 7%
Earache 1%
Pruritus 1%
Paraesthesia 1%
Rash 1%
Dizziness 1%

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)

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© 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.

SLIDESHOW

Ear Infection Symptoms, Causes, and Treatment See Slideshow

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