Treatment of conjunctivitis caused by susceptible Staphylococcus aureus, S. epidermidis, Streptococcus pneumoniae, Haemophilus influenzae, Enterobacter cloacae, Proteus mirabilis, or Pseudomonas aeruginosa.
Role of topical fluoroquinolones in management of uncomplicated bacterial conjunctivitis not fully elucidated; some clinicians suggest that the drugs be reserved principally for severe bacterial conjunctivitis because of potential development of quinolone resistance, and possibly, cost considerations.
Treatment of keratitis (corneal ulcers) caused by susceptible S. aureus, S. epidermidis, S. pneumoniae, Propionibacterium acnes, Ps. aeruginosa, or Serratia marcescens (designated an orphan drug by FDA for this use).
Some clinicians suggest that single-agent topical fluoroquinolone therapy be considered for initial treatment in patients with equivocal gram stain results on diagnostic corneal smear, presence of >1 organism, contact lens associated keratitis (suspected to be caused by gram-negative bacteria), or in those settings where culture and susceptibility tests are impossible or impractical.
Bacterial Otic Infections
Treatment of otitis externa caused by susceptible S. aureus, Escherichia coli, or Ps. aeruginosa.
Treatment of acute otitis media caused by susceptible S. aureus, S. pneumoniae, H. influenzae, Moraxella catarrhalis, or Ps. aeruginosa.
Treatment of chronic suppurative otitis media caused by susceptible S. aureus, P. mirabilis, or Ps aeruginosa.
Dosage and Administration
Administration
Avoid contamination of container.
Ophthalmic Administration
Apply topically to the eye as an ophthalmic solution.
Not for injection. Not for subconjunctival injection or introduction directly into anterior chamber of the eye.
For treatment of bacterial keratitis, administer around the clock for first 2 days of therapy.
Otic Administration
Instill into ear as otic solution.
For otic use only. Not for ophthalmic use. Not for injection.
Prior to administration, warm container in hand for 1–2 minutes before use to avoid dizziness associated with instillation of cold solution into ear canal.
Patient should lie with the affected ear upward and the otic preparation should be instilled into the ear canal; maintain position for 5 minutes to facilitate penetration of drops into ear canal. Repeat for opposite ear if necessary.
To administer for treatment of otitis media in pediatric patients with tympanostomy tubes, instill drops while the affected ear is upward. Pump tragus 4 times by pushing inward to facilitate penetration of drops into middle ear; maintain position 5 minutes. Repeat for opposite ear if necessary.
Dosage
Pediatric Patients
Bacterial Ophthalmic Infections
Conjunctivitis
Ophthalmic
Children≥1 year of age: 1 or 2 drops of 0.3% solution into affected eye(s) every 2–4 hours while awake for 2 days, then 1–2 drops 4 times daily for up to 5 more days.
Keratitis
Ophthalmic
Children≥1 year of age: 1 or 2 drops of 0.3% solution into affected eye(s) every 30 minutes while awake and then 4 and 6 hours after retiring, for 2 days. Beginning on the third day, instill 1 or 2 drops into affected eye(s) every hour while awake for up to an additional 4–6 days. Afterward, may instill 1 or 2 drops into affected eye(s) 4 times daily for additional 3 days or until clinical cure achieved.
Bacterial Otic Infections
Otitis Externa
Otic
Children 6 months to 13 years of age: 5 drops of 0.3% solution into canal of affected ear(s) once daily for 7 days.
Children ≥13 years of age: 10 drops of 0.3% solution into canal of affected ear(s) once daily for 7 days.
Acute Otitis Media
Otic
Children 1–12 years of age with tympanostomy tubes: 5 drops of 0.3% solution into canal of affected ear(s) twice daily for 10 days.
Chronic Suppurative Otitis Media
Otic
Children ≥12 years of age with perforated tympanic membranes: 10 drops of 0.3% solution into canal of affected ear(s) twice daily for 14 days.
Adults
Bacterial Ophthalmic Infections
Conjunctivitis
Ophthalmic
1 or 2 drops of 0.3% solution into affected eye(s) every 2–4 hours while awake for 2 days, then 1–2 drops 4 times daily for up to 5 more days.
Keratitis
Ophthalmic
1 or 2 drops of a 0.3% solution into affected eye(s) every 30 minutes while awake and then 4 and 6 hours after retiring, for 2 days. Beginning on third day, instill 1 or 2 drops into affected eye(s) every hour while awake for up to an additional 4–6 days. Afterward, may instill 1 or 2 drops into affected eye(s) 4 times daily for additional 3 days or until clinical cure achieved.
Bacterial Otic Infections
Otitis Externa
Otic
10 drops of 0.3% solution into canal of affected ear(s) once daily for 7 days.
Chronic Suppurative Otitis Media
Otic
10 drops of 0.3% solution into canal of affected ear(s) twice daily for 14 days in patients with perforated tympanic membranes.
Serious, potentially fatal hypersensitivity reactions reported following systemic administration of ofloxacin or other quinolones, some following the initial dose.
If allergic reaction occurs, discontinue ofloxacin and institute appropriate therapy if indicated.
General Precautions
Superinfection.
Possible overgrowth of nonsusceptible organisms (e.g., fungi) with prolonged use; if superinfection occurs, discontinue drug and institute appropriate therapy.
If otic infection is 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
Category C.
Lactation
Distributed into milk following systemic administration; not known whether distributed into milk following topical application to the eye or ear. Discontinue nursing or the drug.
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 with intact typanic membrane not established in children <6 months of age. Safety and efficacy for treatment of acute otitis media with tympanostomy tubes not established in children <1 year of age. Safety and efficacy for treatment of chronic suppurative otitis media with perforated tympanic membranes not established in children <12 years of age. Although no data are available in patients <6 months of age, there are no known safety concerns or differences in disease process to preclude use in this population.
No changes in hearing function observed on audiometric evaluation in a limited number of children treated with otic solution.
Geriatric Use
No substantial differences in safety or efficacy of ophthalmic solution relative to younger adults.
Common Adverse Effects
With ophthalmic therapy, transient ocular burning or discomfort. With otic therapy, application site reaction, pruritus, taste perversion.
Pharmacokinetics
Absorption
Bioavailability
Ophthalmic solution: extent of ocular or systemic absorption after topical application to the eye not fully elucidated, but mean serum ofloxacin concentrations after 10 days of topical ophthalmic dosing are >1000 times lower than those reported with standard oral doses.
Otic solution: extent of otic or systemic absorption after topical application to the ear not fully elucidated, but serum ofloxacin concentrations achieved after such application are minimal relative to those produced by usual oral or parenteral doses.
Distribution
Extent
Distributed into milk following systemic administration; not known whether distributed into milk following topical application to the eye or ear.
Elimination
Elimination Route
Excreted principally in urine unchanged.
Stability
Storage
Ophthalmic
Solution
15–25°C.
Otic
Solution
25°C (may be exposed to 15–30°C).
Actions
Usually bactericidal.
Like other fluoroquinolones, ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV.
Spectrum of activity includes gram-positive aerobic bacteria and some gram-negative aerobic bacteria. Inactive against fungi and viruses.
Active in vitro against most gram-negative aerobic bacteria, including Enterobacteriaceae and Ps. aeruginosa. Active in vitro against many gram-positive aerobic bacteria, including penicillinase-producing, nonpenicillinase-producing, and some oxacillin-resistant staphylococci (previously known as methicillin-resistant staphylococci). Less active against gram-positive than -negative bacteria.
Advice to Patients
Importance of discontinuing drug and informing clinician at first sign of rash or other sign of hypersensitivity.
Importance of learning and adhering to proper administration techniques to avoid contamination of the product.
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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