OFLOXACIN OTIC 3 mg/mL
OFLOXACIN · SOLUTION · DIRECT RX
Ofloxacin otic solution is a prescription antibiotic drop used to treat bacterial ear infections. You apply it directly into the affected ear to help clear the infection.
Key Facts
- Brand Name
- OFLOXACIN OTIC
- Generic Name
- OFLOXACIN
- NDC Code (Product)
72189-108- Manufacturer
- DIRECT RX
- Strength
- 3 mg/mL
- Dosage Form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Marketing Status
- Application #
- ANDA076527
- Drug Class
- Quinolone Antimicrobial [EPC]
- Marketing Start
- 06/08/2020
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND 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
DOSAGE AND 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 one 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…
Warnings
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
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.
Drug Interactions
Drug Interactions Specific drug interaction studies have not been conducted with ofloxacin otic solution.
Adverse Reactions
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. Incidence Rate Adverse Event Studies 002/003 Studies 002/003 (BID) and 016/017 (QD) were active-controlled and comparative. Study 020 (QD) was open and non-comparative. BID (N=229) Studies 016/017 QD (N=3109) Studies 002 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% 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 d…
Frequently Asked Questions
What is OFLOXACIN OTIC used for?
Ofloxacin otic solution is a prescription antibiotic drop used to treat bacterial ear infections. You apply it directly into the affected ear to help clear the infection.
Is OFLOXACIN OTIC a controlled substance?
OFLOXACIN OTIC is not classified as a controlled substance by the DEA.
What is the generic name for OFLOXACIN OTIC?
The generic name for OFLOXACIN OTIC is OFLOXACIN. There are 11 other brand versions of OFLOXACIN.
What is the NDC code for OFLOXACIN OTIC 3 mg/mL?
The NDC (National Drug Code) for OFLOXACIN OTIC 3 mg/mL is 72189-108, listed by DIRECT RX.