ofloxacin 3 mg/mL
ofloxacin otic · SOLUTION · NuCare Pharmaceuticals,Inc.
ofloxacin is a solution containing ofloxacin otic at 3 mg/mL, taken auricular (otic). Manufactured by NuCare Pharmaceuticals,Inc..
Key Facts
- Brand Name
- ofloxacin
- Generic Name
- ofloxacin otic
- NDC Code (Product)
68071-3604- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Strength
- 3 mg/mL
- Dosage Form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Marketing Status
- Application #
- ANDA216130
- Drug Class
- Quinolone Antimicrobial [EPC]
- Marketing Start
- 12/01/2023
Recall History
Akorn, Inc.
CGMP Deviations:
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
PACK Pharmaceuticals, LLC
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Pharmacy Plus, Inc. dba Vital Care Compounder
Lack of Assurance of Sterility
Altaire Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Pharmacy Plus, Inc. dba Vital Care Compounder
Lack of Assurance of Sterility
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
PACK Pharmaceuticals, LLC
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
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 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 m…
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 0.3%.
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: 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…
Frequently Asked Questions
What is ofloxacin used for?
ofloxacin contains ofloxacin otic. It is a solution taken auricular (otic). Consult your doctor for specific uses.
Is ofloxacin a controlled substance?
ofloxacin is not classified as a controlled substance by the DEA.
What is the generic name for ofloxacin?
The generic name for ofloxacin is ofloxacin otic. There are 5 other brand versions of ofloxacin otic.
What is the NDC code for ofloxacin 3 mg/mL?
The NDC (National Drug Code) for ofloxacin 3 mg/mL is 68071-3604, listed by NuCare Pharmaceuticals,Inc..