Ofloxacin
Ofloxacin Otic Solution 0.3% (Sterile) Rx only
2bb61a24-87a6-4e74-a319-fc5e7c483bbb
HUMAN PRESCRIPTION DRUG LABEL
Jan 9, 2024
Caplin Steriles Limited
DUNS: 650744670
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ofloxacin Otic solution
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Ofloxacin Otic
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Drug Labeling Information
ADVERSE REACTIONS SECTION
ADVERSE REACTIONS
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 |
Incidence Rate | ||
|
Studies 002/003† |
Studies 016/017† |
Study 020† | |
|
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 (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 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 postmarketing reports. A causal relationship with Ofloxacin Otic Solution 0.3% is unknown.
To report SUSPECTED ADVERSE REACTIONS, contact Caplin Steriles Limited at 1-866-978-6111 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.