Ofloxacin

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

Use in children

• Safety and efficacy have been demonstrated in pediatric patients of the following ages for the listed indications:
• six months and older: otitis externa with intact tympanic membranes
• one year and older: acute otitis media with tympanostomy tubes
• twelve years and older:
• chronic suppurative otitis media with perforated tympanic membranes Safety and efficacy in pediatric patients below these ages have not been established. Although no data are available on patients less than age 6 months, there are no known safety concerns or differences in the disease process in this population that will preclude use of this product. No changes in hearing function occurred in 30 pediatric subjects treated with ofloxacin otic and tested for audiometric parameters. Although quinolones, including ofloxacin, have been shown to cause arthropathy in immature animals after systemic administration, young growing guinea pigs dosed in the middle ear with 0.3% ofloxacin otic solution for one month showed no systemic effects, quinolone-induced lesions, erosions of the cartilage in weight-bearing joints, or other signs of arthropathy.

Quoted from the official label, section “Pediatric Use”.

Side effects

• 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.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Avoid contaminating the applicator tip with material from the fingers or other sources.
• This precaution is necessary if the sterility of the drops is to be preserved.
• Systemic quinolones, including ofloxacin, have been associated with hypersensitivity reactions, even following a single dose.
• Discontinue use immediately and contact your physician at the first sign of a rash or allergic reaction.
• Otitis Externa:
• Prior to administration of ofloxacin otic, 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 (see DOSAGE AND ADMINISTRATION ).
• Acute Otitis Media and Chronic Suppurative Otitis Media:
• Prior to administration of ofloxacin otic, 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 (see DOSAGE AND ADMINISTRATION ).

Quoted from the official label, section “Patient Counseling Information”.

What it looks like and how it is packed

• Ofloxacin otic solution, 0.3% is supplied in plastic dropper bottles in the following sizes:
• NDC 24208-410-05 5 mL NDC 24208-410-10 10 mL

Quoted from the official label, section “How Supplied”.

What is in it

• Ofloxacin otic solution, 0.3% is a sterile aqueous anti-infective (antibacterial) 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 empirical formula of ofloxacin is C 18 H 20 FN 3 O 4 and its molecular weight is 361.38.
• The structural formula is: Each mL contains: Active: ofloxacin 0.3% (3 mg/mL);
• Inactives: sodium chloride (0.9%), and purified water.
• Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH 6.5±0.5.
• Preservative: benzalkonium chloride (0.0025%). chem

Quoted from the official label, section “Description”.

Ingredients people check for

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Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

39 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

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See every product with Ofloxacin