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Floxin Otic (Ofloxacin Otic) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Subjects with Otitis Externa

In a 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 2 or more of the subjects:

Incidence Rate

Adverse Event
Studies 002/003†
BID
(N=229)
Studies 016/017†
QD
(N=3109)
Studies 002†
QD
(N=489)

†Studies 002/003 (BID) and 016/017 (QD) were active-controlled and comparative.

Application Site3%16.8%0.6%
Reaction
Pruritus4%1.2%1.0%
Earache1%0.6%0.8%
Dizziness1%0.0%0.6%
Headache0%0.3%0.2%
Vertigo1%0.0%0.0%

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 (neomycin-polymyxin 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 EventIncidence (N=656)
Taste Perversion7%
Earache1%
Pruritus1%
Paraesthesia1 %.
Rash1%
Dizziness1%

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 neurospsychiatric disturbances have been included in spontaneous post-marketing reports. A casual relationship with ofloxacin otic solution 0.3% is unknown.

Drug label data at the top of this Page last updated: 2008-03-17

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