Introduction

Antibacterial; fluoroquinolone.

Uses for Ofloxacin (EENT)

Bacterial Ophthalmic Infections

Topical treatment of bacterial conjunctivitis caused by susceptible Staphylococcus aureus, S. epidermidis, Streptococcus pneumoniae, Haemophilus influenzae, Enterobacter cloacae, Proteus mirabilis, or Pseudomonas aeruginosa.

Mild, acute bacterial conjunctivitis often resolves spontaneously without anti-infective treatment. Although topical ophthalmic anti-infectives may shorten time to resolution and reduce severity and risk of complications, avoid indiscriminate use of topical anti-infectives. Treatment of acute bacterial conjunctivitis generally is empiric; use of a broad-spectrum topical ophthalmic antibacterial usually recommended. In vitro staining and/or cultures of conjunctival material may be indicated in management of recurrent, severe, or chronic purulent conjunctivitis or when acute conjunctivitis does not respond to initial empiric topical treatment.

Topical treatment of keratitis (corneal ulcers) caused by susceptible S. aureus, S. epidermidis, S. pneumoniae, Serratia marcescens, Ps. aeruginosa, or Propionibacterium acnes. Designated an orphan drug by FDA for treatment of bacterial corneal ulcers.

Because bacterial keratitis may be associated with subsequent loss of vision as the result of corneal scarring or topographic irregularities and because untreated or severe bacterial keratitis may result in corneal perforation with potential for endophthalmitis and possible loss of the eye, optimal management involves rapid evaluation and diagnosis, timely initiation of treatment, and appropriate follow-up. Treatment of community-acquired bacterial keratitis generally is empiric; use of a broad-spectrum topical ophthalmic antibacterial usually recommended. Subconjunctival anti-infectives may be necessary if scleral spread or perforation is imminent. In vitro staining and/or cultures of corneal material are indicated in management of keratitis involving corneal infiltrates that are central, large, and extend to the middle to deep stroma or when keratitis is chronic or unresponsive to a broad-spectrum topical anti-infective.

Bacterial Otic Infections

Topical treatment of otitis externa caused by susceptible S. aureus, Escherichia coli, or Ps. aeruginosa.

Topical treatment of acute otitis media caused by susceptible S. aureus, S. pneumoniae, H. influenzae, Moraxella catarrhalis, or Ps. aeruginosa in patients with tympanostomy tubes.

Topical treatment of chronic suppurative otitis media caused by susceptible S. aureus, P. mirabilis, or Ps. aeruginosa in patients with perforated tympanic membranes.

Diffuse, uncomplicated acute otitis externa in otherwise healthy patients usually treated initially with topical therapy (e.g., otic anti-infective or antiseptic with or without an otic corticosteroid). Supplement with systemic anti-infective therapy if patient has a medical condition that could impair host defenses (e.g., diabetes mellitus, HIV infection) or if infection has spread into pinna or skin of the neck or face, or into deeper tissues such as occurs with malignant otitis externa. Malignant otitis externa is an invasive, potentially life-threatening infection, especially in immunocompromised patients, and requires prompt diagnosis and long-term treatment with systemic anti-infectives.

Ofloxacin (EENT) Dosage and Administration

Administration

Ophthalmic Administration

Apply 0.3% ophthalmic solution topically to the eye.

For topical ophthalmic use only; do not inject subconjunctivally or directly into anterior chamber of the eye.

Avoid contaminating applicator tip with material from eye, fingers, or other source.

Otic Administration

Instill 0.3% otic solution topically into the ear canal.

For topical otic use only; not for ophthalmic use or injection.

To avoid dizziness that may result from instilling a cold preparation into ear, warm container of otic solution in hands for 1–2 minutes before use.

Lie with affected ear upward. Instill appropriate amount of otic solution into ear; maintain position for 5 minutes to facilitate penetration of drops into ear canal. When treating acute otitis media or chronic suppurative otitis media, pump tragus 4 times by pushing inward to facilitate penetration into middle ear. Repeat procedure for opposite ear if necessary.

Avoid contaminating applicator tip with material from fingers or other source.

Dosage

Pediatric Patients

Bacterial Ophthalmic Infections

Conjunctivitis

Ofloxacin 0.3% (ophthalmic solution) in pediatric patients ≥1 year of age: On days 1 and 2, instill 1 or 2 drops in affected eye(s) every 2–4 hours; on days 3 through 7, instill 1 or 2 drops 4 times daily.

Usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5–10 days; some experts state 5–7 days usually adequate for mild bacterial conjunctivitis.

Keratitis

Ofloxacin 0.3% (ophthalmic solution) in pediatric patients ≥1 year of age: On days 1 and 2, instill 1 or 2 drops in affected eye(s) every 30 minutes while awake and at 4 and 6 hours after retiring. On days 3 through 7 or 9, instill 1 or 2 drops every hour while awake; then instill 1 or 2 drops 4 times daily until treatment completion.

Some experts recommend reevaluating and modifying initial regimen if keratitis has not improved or stabilized within 48 hours after treatment initiation.

Bacterial Otic Infections

Otitis Externa

Ofloxacin 0.3% (otic solution) in pediatric patients 6 months to 13 years of age: Instill 5 drops into affected ear(s) once daily for 7 days.

Ofloxacin 0.3% (otic solution) in children ≥13 years of age: Instill 10 drops into affected ear(s) once daily for 7 days.

Optimal duration of topical treatment of acute otitis externa not determined, but 7–10 days usually recommended. Appropriate treatment should result in improvement in symptoms (otalgia, itching, fullness) within 48–72 hours, although symptom resolution may take up to 2 weeks. If no improvement after 1 week of treatment, manufacturer states use cultures to help guide further treatment. (See Precautions Related to Otic Administration under Cautions.)

Acute Otitis Media

Ofloxacin 0.3% (otic solution) in pediatric patients 1–12 years of age with tympanostomy tubes: Instill 5 drops into affected ear(s) twice daily for 10 days.

Chronic Suppurative Otitis Media

Ofloxacin 0.3% (otic solution) in children ≥12 years of age with perforated tympanic membranes: Instill 10 drops into affected ear(s) twice daily for 14 days.

Adults

Bacterial Ophthalmic Infections

Conjunctivitis

Ofloxacin 0.3% (ophthalmic solution): On days 1 and 2, instill 1 or 2 drops in affected eye(s) every 2–4 hours; on days 3 through 7, instill 1 or 2 drops 4 times daily.

Usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5–10 days; some experts state 5–7 days usually adequate for mild bacterial conjunctivitis.

Keratitis

Ofloxacin 0.3% (ophthalmic solution): On days 1 and 2, instill 1 or 2 drops in affected eye(s) every 30 minutes and at 4 and 6 hours after retiring. On days 3 through 7 or 9, instill 1 or 2 drops every hour while awake; then instill 1 or 2 drops 4 times daily until treatment completion.

Some experts recommend reevaluating and modifying initial regimen if keratitis has not improved or stabilized within 48 hours after treatment initiation.

Bacterial Otic Infections

Otitis Externa

Ofloxacin 0.3% (otic solution): Instill 10 drops into affected ear(s) once daily for 7 days.

Optimal duration of topical treatment of acute otitis externa not determined, but 7–10 days usually recommended. Appropriate treatment should result in improvement in symptoms (otalgia, itching, fullness) within 48–72 hours, although symptom resolution may take up to 2 weeks. If no improvement after 1 week of treatment, manufacturer states use cultures to help guide further treatment. (See Precautions Related to Otic Administration under Cautions.)

Chronic Suppurative Otitis Media

Ofloxacin 0.3% (otic solution) in adults with perforated tympanic membranes: Instill 10 drops into affected ear(s) twice daily for 14 days.

Contraindications

• Ofloxacin ophthalmic or otic preparations: Hypersensitivity to ofloxacin, other quinolones, or any ingredient in the formulation.

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity

Serious and occasionally fatal hypersensitivity reactions reported rarely in patients receiving systemic quinolones, including systemic ofloxacin; these reactions have occurred with initial systemic dose.

Stevens-Johnson syndrome that progressed to toxic epidermal necrosis reported in at least one patient receiving topical ofloxacin ophthalmic solution.

Immediately discontinue ofloxacin ophthalmic or otic preparation at first sign of rash or allergic reaction.

Serious acute hypersensitivity reactions may require immediate emergency treatment; administer oxygen and airway management as clinically indicated.

Superinfection

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.

If superinfection occurs, discontinue ofloxacin ophthalmic or otic preparation and institute appropriate therapy.

Precautions Related to Ophthalmic Administration

Whenever clinical judgment dictates, examine patient with the aid of magnification (e.g., slit lamp biomicroscopy) and, if appropriate, fluorescein staining.

Precautions Related to Otic Administration

If otic infection not improved after 1 week of treatment, obtain cultures to guide treatment.

If otorrhea persists after completion of therapy or if ≥2 episodes of otorrhea occur within 6 months, further evaluate to exclude underlying condition (e.g., cholesteatoma, foreign body, tumor).

Specific Populations

Pregnancy

Data not available regarding use of ofloxacin ophthalmic or otic solutions in pregnant women; use only if potential benefits to the woman justify potential risks to fetus.

Lactation

Not known whether distributed into milk following topical application to the eye or ear; distributed into milk following systemic administration.

Discontinue nursing or the drug, taking into account importance of the drug to the woman.

Pediatric Use

Ophthalmic solution: Safety and efficacy not established in children <1 year of age.

Otic solution: Safety and efficacy for treatment of otitis externa not established in children <6 months of age. Although data not available regarding use in patients <6 months of age, manufacturer states there are no known safety concerns or differences in disease process in children in this age group that would preclude use in this population.

Otic solution: Safety and efficacy for treatment of acute otitis media not established in children <1 year of age Safety and efficacy for treatment of chronic suppurative otitis media not established in children <12 years of age.

No changes in hearing function observed on audiometric evaluation in a limited number of children treated with otic solution.

Geriatric Use

Ophthalmic solution: No overall differences in safety or efficacy relative to younger adults.

Common Adverse Effects

Ophthalmic administration: Transient ocular burning or discomfort, stinging, redness, pruritus, chemical conjunctivitis/keratitis, foreign body sensation, blurred vision, ocular/periocular/facial edema, eye pain, photophobia, tearing, dryness.

Otic administration: Application site reaction, earache, tinnitus, transient loss of hearing, otitis externa, otitis media, otorrhagia, taste perversion.

Administration

Ophthalmic Administration

Apply 0.3% ophthalmic solution topically to the eye.

For topical ophthalmic use only; do not inject subconjunctivally or directly into anterior chamber of the eye.

Avoid contaminating applicator tip with material from eye, fingers, or other source.

Otic Administration

Instill 0.3% otic solution topically into the ear canal.

For topical otic use only; not for ophthalmic use or injection.

To avoid dizziness that may result from instilling a cold preparation into ear, warm container of otic solution in hands for 1–2 minutes before use.

Lie with affected ear upward. Instill appropriate amount of otic solution into ear; maintain position for 5 minutes to facilitate penetration of drops into ear canal. When treating acute otitis media or chronic suppurative otitis media, pump tragus 4 times by pushing inward to facilitate penetration into middle ear. Repeat procedure for opposite ear if necessary.

Avoid contaminating applicator tip with material from fingers or other source.

Dosage

Pediatric Patients

Bacterial Ophthalmic Infections

Conjunctivitis

Ofloxacin 0.3% (ophthalmic solution) in pediatric patients ≥1 year of age: On days 1 and 2, instill 1 or 2 drops in affected eye(s) every 2–4 hours; on days 3 through 7, instill 1 or 2 drops 4 times daily.

Usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5–10 days; some experts state 5–7 days usually adequate for mild bacterial conjunctivitis.

Keratitis

Ofloxacin 0.3% (ophthalmic solution) in pediatric patients ≥1 year of age: On days 1 and 2, instill 1 or 2 drops in affected eye(s) every 30 minutes while awake and at 4 and 6 hours after retiring. On days 3 through 7 or 9, instill 1 or 2 drops every hour while awake; then instill 1 or 2 drops 4 times daily until treatment completion.

Some experts recommend reevaluating and modifying initial regimen if keratitis has not improved or stabilized within 48 hours after treatment initiation.

Bacterial Otic Infections

Otitis Externa

Ofloxacin 0.3% (otic solution) in pediatric patients 6 months to 13 years of age: Instill 5 drops into affected ear(s) once daily for 7 days.

Ofloxacin 0.3% (otic solution) in children ≥13 years of age: Instill 10 drops into affected ear(s) once daily for 7 days.

Optimal duration of topical treatment of acute otitis externa not determined, but 7–10 days usually recommended. Appropriate treatment should result in improvement in symptoms (otalgia, itching, fullness) within 48–72 hours, although symptom resolution may take up to 2 weeks. If no improvement after 1 week of treatment, manufacturer states use cultures to help guide further treatment. (See Precautions Related to Otic Administration under Cautions.)

Acute Otitis Media

Ofloxacin 0.3% (otic solution) in pediatric patients 1–12 years of age with tympanostomy tubes: Instill 5 drops into affected ear(s) twice daily for 10 days.

Chronic Suppurative Otitis Media

Ofloxacin 0.3% (otic solution) in children ≥12 years of age with perforated tympanic membranes: Instill 10 drops into affected ear(s) twice daily for 14 days.

Adults

Bacterial Ophthalmic Infections

Conjunctivitis

Ofloxacin 0.3% (ophthalmic solution): On days 1 and 2, instill 1 or 2 drops in affected eye(s) every 2–4 hours; on days 3 through 7, instill 1 or 2 drops 4 times daily.

Usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5–10 days; some experts state 5–7 days usually adequate for mild bacterial conjunctivitis.

Keratitis

Ofloxacin 0.3% (ophthalmic solution): On days 1 and 2, instill 1 or 2 drops in affected eye(s) every 30 minutes and at 4 and 6 hours after retiring. On days 3 through 7 or 9, instill 1 or 2 drops every hour while awake; then instill 1 or 2 drops 4 times daily until treatment completion.

Some experts recommend reevaluating and modifying initial regimen if keratitis has not improved or stabilized within 48 hours after treatment initiation.

Bacterial Otic Infections

Otitis Externa

Ofloxacin 0.3% (otic solution): Instill 10 drops into affected ear(s) once daily for 7 days.

Optimal duration of topical treatment of acute otitis externa not determined, but 7–10 days usually recommended. Appropriate treatment should result in improvement in symptoms (otalgia, itching, fullness) within 48–72 hours, although symptom resolution may take up to 2 weeks. If no improvement after 1 week of treatment, manufacturer states use cultures to help guide further treatment. (See Precautions Related to Otic Administration under Cautions.)

Chronic Suppurative Otitis Media

Ofloxacin 0.3% (otic solution) in adults with perforated tympanic membranes: Instill 10 drops into affected ear(s) twice daily for 14 days.