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Ocuflox eent

Generic Name: Ofloxacin eent
Class: Antibacterials
VA Class: OT101
Chemical Name: ±-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxaz ine-6-carboxylicacid
Molecular Formula: C18H20FN3O4
CAS Number: 82419-36-1

Medically reviewed on March 12, 2018

Introduction

Antibacterial; fluoroquinolone.1 2 3 5 8 26 27 29 105 127

Uses for Ocuflox

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.1 127

Mild, acute bacterial conjunctivitis often resolves spontaneously without anti-infective treatment.135 136 137 141 Although topical ophthalmic anti-infectives may shorten time to resolution and reduce severity and risk of complications,135 136 137 141 avoid indiscriminate use of topical anti-infectives.135 141 Treatment of acute bacterial conjunctivitis generally is empiric;135 136 141 use of a broad-spectrum topical ophthalmic antibacterial usually recommended.135 136 141 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.135 136 141

Topical treatment of keratitis (corneal ulcers) caused by susceptible S. aureus, S. epidermidis, S. pneumoniae, Serratia marcescens, Ps. aeruginosa, or Propionibacterium acnes.1 91 93 94 95 127 Designated an orphan drug by FDA for treatment of bacterial corneal ulcers.11

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.138 Treatment of community-acquired bacterial keratitis generally is empiric;138 use of a broad-spectrum topical ophthalmic antibacterial usually recommended.138 Subconjunctival anti-infectives may be necessary if scleral spread or perforation is imminent.138 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.138

Bacterial Otic Infections

Topical treatment of otitis externa caused by susceptible S. aureus, Escherichia coli, or Ps. aeruginosa.105 106

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.105

Topical treatment of chronic suppurative otitis media caused by susceptible S. aureus, P. mirabilis, or Ps. aeruginosa in patients with perforated tympanic membranes.105 107

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).139 143 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.139 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.110 111 139

Ocuflox Dosage and Administration

Administration

Ophthalmic Administration

Apply 0.3% ophthalmic solution topically to the eye.1 127

For topical ophthalmic use only;1 127 do not inject subconjunctivally or directly into anterior chamber of the eye.1 127

Avoid contaminating applicator tip with material from eye, fingers, or other source.1 127

Otic Administration

Instill 0.3% otic solution topically into the ear canal.105

For topical otic use only;105 not for ophthalmic use or injection.105

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.105

Lie with affected ear upward.105 Instill appropriate amount of otic solution into ear;105 maintain position for 5 minutes to facilitate penetration of drops into ear canal.105 When treating acute otitis media or chronic suppurative otitis media, pump tragus 4 times by pushing inward to facilitate penetration into middle ear.105 Repeat procedure for opposite ear if necessary.105

Avoid contaminating applicator tip with material from fingers or other source.105

Dosage

Pediatric Patients

Bacterial Ophthalmic Infections
Conjunctivitis
Ophthalmic

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.1 127

Usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5–10 days;135 136 141 some experts state 5–7 days usually adequate for mild bacterial conjunctivitis.135

Keratitis
Ophthalmic

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.1 127 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.1 127

Some experts recommend reevaluating and modifying initial regimen if keratitis has not improved or stabilized within 48 hours after treatment initiation.138

Bacterial Otic Infections
Otitis Externa
Otic

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.105

Ofloxacin 0.3% (otic solution) in children ≥13 years of age: Instill 10 drops into affected ear(s) once daily for 7 days.105

Optimal duration of topical treatment of acute otitis externa not determined, but 7–10 days usually recommended.139 Appropriate treatment should result in improvement in symptoms (otalgia, itching, fullness) within 48–72 hours, although symptom resolution may take up to 2 weeks.139 If no improvement after 1 week of treatment, manufacturer states use cultures to help guide further treatment.105 (See Precautions Related to Otic Administration under Cautions.)

Acute Otitis Media
Otic

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.105

Chronic Suppurative Otitis Media
Otic

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.105

Adults

Bacterial Ophthalmic Infections
Conjunctivitis
Ophthalmic

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.1 127

Usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5–10 days;135 136 141 some experts state 5–7 days usually adequate for mild bacterial conjunctivitis.135

Keratitis
Ophthalmic

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.1 127 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.1 127

Some experts recommend reevaluating and modifying initial regimen if keratitis has not improved or stabilized within 48 hours after treatment initiation.138

Bacterial Otic Infections
Otitis Externa
Otic

Ofloxacin 0.3% (otic solution): Instill 10 drops into affected ear(s) once daily for 7 days.105

Optimal duration of topical treatment of acute otitis externa not determined, but 7–10 days usually recommended.139 Appropriate treatment should result in improvement in symptoms (otalgia, itching, fullness) within 48–72 hours, although symptom resolution may take up to 2 weeks.139 If no improvement after 1 week of treatment, manufacturer states use cultures to help guide further treatment.105 (See Precautions Related to Otic Administration under Cautions.)

Chronic Suppurative Otitis Media
Otic

Ofloxacin 0.3% (otic solution) in adults with perforated tympanic membranes: Instill 10 drops into affected ear(s) twice daily for 14 days.105

Cautions for Ocuflox

Contraindications

  • Ofloxacin ophthalmic or otic preparations: Hypersensitivity to ofloxacin, other quinolones, or any ingredient in the formulation.1 105 127

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity

Serious and occasionally fatal hypersensitivity reactions reported rarely in patients receiving systemic quinolones, including systemic ofloxacin;1 105 127 these reactions have occurred with initial systemic dose.1 105 127

Stevens-Johnson syndrome that progressed to toxic epidermal necrosis reported in at least one patient receiving topical ofloxacin ophthalmic solution.1 127

Immediately discontinue ofloxacin ophthalmic or otic preparation at first sign of rash or allergic reaction.1 105 127

Serious acute hypersensitivity reactions may require immediate emergency treatment; administer oxygen and airway management as clinically indicated.1 105 127

Superinfection

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.1 105 127

If superinfection occurs, discontinue ofloxacin ophthalmic or otic preparation and institute appropriate therapy.1 105 127

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.1 127

Precautions Related to Otic Administration

If otic infection not improved after 1 week of treatment, obtain cultures to guide treatment.105

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).105

Specific Populations

Pregnancy

Data not available regarding use of ofloxacin ophthalmic or otic solutions in pregnant women;1 105 127 use only if potential benefits to the woman justify potential risks to fetus.1 105 127

Lactation

Not known whether distributed into milk following topical application to the eye or ear;1 105 127 distributed into milk following systemic administration.1 105 127

Discontinue nursing or the drug, taking into account importance of the drug to the woman.1 105 127

Pediatric Use

Ophthalmic solution: Safety and efficacy not established in children <1 year of age.1 127

Otic solution: Safety and efficacy for treatment of otitis externa not established in children <6 months of age.105 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.105

Otic solution: Safety and efficacy for treatment of acute otitis media not established in children <1 year of age 105 Safety and efficacy for treatment of chronic suppurative otitis media not established in children <12 years of age.105

No changes in hearing function observed on audiometric evaluation in a limited number of children treated with otic solution.105

Geriatric Use

Ophthalmic solution: No overall differences in safety or efficacy relative to younger adults.1 127

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.1 127

Otic administration: Application site reaction, earache, tinnitus, transient loss of hearing, otitis externa, otitis media, otorrhagia, taste perversion.105

Interactions for Ocuflox

No specific drug interaction studies using ofloxacin ophthalmic or otic preparations.1 105 127

Because some systemic absorption may occur following topical application to the eye or ear,1 19 70 71 105 127 consider possibility of drug interactions such as those reported with some systemic quinolones (e.g., interactions with theophylline, caffeine, oral anticoagulants, cyclosporine).1 88 89 127

Ocuflox Pharmacokinetics

Absorption

Bioavailability

Ophthalmic administration: Extent of ocular or systemic absorption after topical application of ofloxacin 0.3% ophthalmic solution to the eye not fully elucidated.1 19 70 127 Absorbed through the cornea into aqueous humor following topical application to the eye; absorption is enhanced in the presence of ocular inflammation and/or epithelial defects.71 73 Although some systemic absorption occurs, mean serum ofloxacin concentrations after 10 days of topical ophthalmic dosing are >1000 times lower than those reported with standard oral doses.1 19 70 127

Otic administration: Extent of otic or systemic absorption after topical application of ofloxacin 0.3% otic solution to the ear not fully elucidated.105 108 When tympanic membrane intact, minimal penetration into middle ear occurs following topical application into ear canal; penetration is enhanced in the presence of perforated tympanic membrane.105 108 Although some systemic absorption occurs, serum ofloxacin concentrations achieved after topical otic application are minimal relative to those produced by usual oral doses.105 108

Distribution

Extent

Distributed into milk following oral administration;1 105 127 not known whether distributed into milk following topical application to the eye or ear.1 105 127

Elimination

Elimination Route

Systemically absorbed ofloxacin is excreted principally in urine unchanged.1 127

Stability

Storage

Ophthalmic

Solution

15–25°C.1 127

Otic

Solution

20–25°C;105 protect from light.105

Actions and Spectrum

  • Fluoroquinolone anti-infective.1 2 3 5 8 26 27 29 105 127

  • Like other fluoroquinolones, inhibits bacterial DNA gyrase and topoisomerase IV.1 3 4 5 8 9 27 30 33 44 64 65 85 127

  • Usually bactericidal.1 3 8 14 26 27 29 32 33 34 35 36 44 64 65 66 71 84 85

  • Spectrum of activity includes gram-positive aerobic bacteria and some gram-negative aerobic bacteria.1 Less active against gram-positive than gram-negative bacteria.3 8 25 26 Inactive against fungi8 44 and viruses.8

  • Active in vitro and in vivo in conjunctival and/or corneal infections against some gram-positive aerobic bacteria, including Staphylococcus aureus, S. epidermidis, and Streptococcus pneumoniae, and some gram-negative aerobic bacteria, including Haemophilus influenzae, Enterobacter cloacae, Proteus mirabilis, Serratia marcescens, and Pseudomonas aeruginosa.1 8 20 27 65 84 127 Also active in vitro and in vivo in conjunctival and/or corneal ulcers caused by the anaerobe Propionibacterium acnes.1 127

  • Active in vitro and in vivo in otic infections against S. aureus, S. pneumoniae, Escherichia coli, H. influenzae, Moraxella catarrhalis, P. mirabilis, and Ps. aeruginosa.105

  • Cross-resistance can occur between ofloxacin and other fluoroquinolones.1 105 127

Advice to Patients

  • Advise patients to avoid contaminating applicator tip with material from the eye, fingers, or other source.1 105 127

  • Inform patients that systemic fluoroquinolones, including ofloxacin, have been associated with hypersensitivity reactions, even following a single dose.1 105 127 Advise patients to immediately discontinue ofloxacin ophthalmic or otic solution and contact a clinician at first sign of rash or allergic reaction.1 105 127

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illness.1 105 127

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 105 127

  • Importance of informing patients of other important precautionary information.1 105 127 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Ofloxacin

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

0.3%*

Ocuflox

Allergan

Ofloxacin Ophthalmic Solution

Otic

Solution

0.3%*

Ofloxacin Otic Solution

AHFS DI Essentials. © Copyright 2018, Selected Revisions March 12, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

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