Ofloxacin

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 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 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. The tragus should then be pumped 4 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear. Chronic Suppurative Otitis Media with perforated tympanic membranes: The recommended dosage regimen for the treatment of chronic suppurative otitis media with perforated tympanic membranes in patients 12 years and older is: Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear twice daily for fourteen 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, before instilling the drops. The tragus should then be pumped 4 times by pushing inward to facilitate penetration into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear.

CONTRAINDICATIONS Ofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication ( see Warnings ).

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* 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, 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 Earache Pruritus Paraesthesia Rash Dizziness 7% 1% 1% 1% 1% 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%), and 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 post-marketing reports. A causal relationship with ofloxacin otic solution, 0.3% is unknown. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions Specific drug interaction studies have not been conducted with ofloxacin ophthalmic solution. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.

DESCRIPTION Ofloxacin otic solution, 0.3% is a sterile aqueous anti-infective (anti-bacterial) solution for otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated carboxyquinolone with a benzoxazine ring. The chemical name of ofloxacin is: (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid. The molecular formula of ofloxacin is C 18 H 20 FN 3 O 4 and its molecular weight is 361.37. The structural formula is: Ofloxacin, USP is white to off-white or pale yellow crystalline powder. It is soluble in glacial acetic acid; sparingly soluble in chloroform and in 0.1N sodium hydroxide; sparingly soluble to slightly soluble in methylene chloride; slightly soluble in dimethylformamide and very slightly soluble in methyl alcohol and water. Ofloxacin otic solution contains 0.3% (3 mg/mL) ofloxacin, USP with benzalkonium chloride (0.0025%), sodium chloride (0.9%), and water for injection. Hydrochloric acid and sodium hydroxide are added to adjust the pH between 6.0 and 7.0. 10

HOW SUPPLIED Ofloxacin otic solution 0.3% is supplied in a translucent LDPE bottle with insert cap assembly comprising of grey colored HDPE screw cap over a LDPE nozzle with tamper evident LDPE dust cover sealing the bottle cap. 5 mL in 5 mL bottle NDC 64980-432-05 10 mL in 10 mL bottle NDC 64980-432-01 Storage: Store at 25°C (77°F), excursions permitted to 15 -30°C (59°-86°F). Protect from light. Rx Only Manufactured By: FDC Limited B-8, MIDC Industrial Area, Waluj, Chhatrapati Sambhajinagar 431 136, Maharashtra, India. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Revised: 11/2025 --------- DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT ------ Patient Information IMPORTANT PATIENT INFORMATION AND INSTRUCTIONS. READ BEFORE USE. What is Ofloxacin Otic Solution 0.3%? Ofloxacin Otic Solution 0.3% is an antibiotic in a sterile solution used to treat ear infections caused by certain bacteria found in: patients (12 years and older) who have a middle ear infection and have a hole in the eardrum pediatric patients (between 1 and 12 years of age) who have a middle ear infection and have a tube in the eardrum patients (6 months and older) who have an infection in the ear canal. Middle Ear Infection: A middle ear infection is a bacterial infection behind the eardrum. People with a hole or a tube in the eardrum may notice a discharge (fluid draining) from the ear canal. Ear Canal Infection: An ear canal infection (also known as "Swimmer's Ear") is a bacterial infection of the ear canal. The ear canal and the outer part of the ear may swell, turn red, and be painful. Also, a fluid discharge may appear in the ear canal. Who should NOT use Ofloxacin Otic Solution 0.3%? Do not use this product if you are allergic to ofloxacin or to other quinolone antibiotics. Do not give this product to pediatric patients who: have an ear canal infection and are less than 6 months of age because no data were collected from this population have a middle ear infection and have a tube in the eardrum and are less than one year of age because no data were collected from this population have a middle ear infection and have a hole in the eardrum and are less than twelve years of age because no data were collected from this population How should Ofloxacin Otic Solution 0.3% be given? 1. Wash hands The person giving Ofloxacin Otic Solution 0.3% should wash his/her hands with soap and water. 2. Clean ear and warm bottle Gently clean any discharge that can be removed easily from the outer ear. DO NOT INSERT ANY OBJECT OR SWAB INTO THE EAR CANAL. Hold the bottle of Ofloxacin Otic Solution 0.3% in the hand for one or two minutes to warm the solution. 3. Add drops For a Middle Ear Infection: The person receiving Ofloxacin otic solution 0.3% should lie on his/her side with the infected ear up. Patients (12 and older) should have 10 drops of Ofloxacin otic solution 0.3% put into the infected ear. Pediatric patients under 12 should have 5 drops put into the infected ear. The tip of the bottle should not touch the fingers or the ear or any other surfaces. For an Ear Canal Infection ("Swimmer's Ear"): The person receiving ofloxacin otic should lie on his/her side with the infected ear up. Patients (13 and older) should have 10 drops of ofloxacin otic put into the infected ear. Pediatric patients under 13 should have 5 drops put into the infected ear. The tip of the bottle should not touch the fingers or the ear or any other surfaces. Before using the medication for the first time, be sure the dust cover seal is unbroken. BE SURE TO FOLLOW THE INSTRUCTIONS BELOW FOR THE PATIENT'S SPECIFIC EAR INFECTION. 4. Press ear or pull ear For a Middle Ear Infection: While the person receiving Ofloxacin otic solution 0.3% lies on his/her side, the person giving the drops should gently press the TRAGUS (see diagram) 4 times in a pumping motion. This will allow the drops to pass through the hole or tube in the eardrum and into the middle ear. For an Ear Canal Infection …