Olfoxacin Otic Soln 3 mg/mL
Olfoxacin Otic Soln · SOLUTION · Direct_Rx
Olfoxacin Otic Soln is a solution containing olfoxacin otic soln at 3 mg/mL, taken auricular (otic). Manufactured by Direct_Rx.
Key Facts
- Brand Name
- Olfoxacin Otic Soln
- Generic Name
- Olfoxacin Otic Soln
- NDC Code (Product)
72189-490- Manufacturer
- Direct_Rx
- Strength
- 3 mg/mL
- Dosage Form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Marketing Status
- Application #
- ANDA216130
- Drug Class
- Quinolone Antimicrobial [EPC]
- Marketing Start
- 06/08/2023
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
Ofloxacin Otic Solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus. Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa and Staphylococcus aureus. Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus and Streptococcus pneumoniae.
Dosage & Administration
Otitis Externa: The recommended dosage regimen for the treatment of otitis externa is: For pediatric patients (from 6 months to 13 years old): Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear once daily for seven days. For patients 13 years and older: Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear once daily for seven days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for five minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear. Acute Otitis Media in pediatric patients with tympanostomy tubes: The recommended dosage regimen for the treatment of acute otitis media in pediatric patients (from 1 to 12 years old) with tympanostomy tubes is: Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear twice daily for ten days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness …
Warnings
NOT FOR OPHTHALMIC USE. NOT FOR INJECTION. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones, including ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to ofloxacin is suspected, stop the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management, including intubation, should be administered as clinically indicated.
Contraindications
Ofloxacin Otic Solution 0.3% is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication.
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† 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 (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, t…
Frequently Asked Questions
What is Olfoxacin Otic Soln used for?
Olfoxacin Otic Soln contains Olfoxacin Otic Soln. It is a solution taken auricular (otic). Consult your doctor for specific uses.
Is Olfoxacin Otic Soln a controlled substance?
Olfoxacin Otic Soln is not classified as a controlled substance by the DEA.
What is the generic name for Olfoxacin Otic Soln?
The generic name for Olfoxacin Otic Soln is Olfoxacin Otic Soln. There are no other listed brand versions of Olfoxacin Otic Soln.
What is the NDC code for Olfoxacin Otic Soln 3 mg/mL?
The NDC (National Drug Code) for Olfoxacin Otic Soln 3 mg/mL is 72189-490, listed by Direct_Rx.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)