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
Brands: Floxin Otic, Ocuflox
Introduction
Fluoroquinolone antibacterial.1 2 3 5 8 26 27 29
Uses for Ofloxacin
Bacterial Ophthalmic Infections
Treatment of conjunctivitis caused by susceptible Staphylococcus aureus, S. epidermidis, Streptococcus pneumoniae, Haemophilus influenzae, Enterobacter cloacae, Proteus mirabilis, or Pseudomonas aeruginosa.1
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.7 80 83
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).1 11 91 93 94 95
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.91
Bacterial Otic Infections
Treatment of otitis externa caused by susceptible S. aureus, Escherichia coli, or Ps. aeruginosa.105 106 a
Treatment of acute otitis media caused by susceptible S. aureus, S. pneumoniae, H. influenzae, Moraxella catarrhalis, or Ps. aeruginosa.105
Treatment of chronic suppurative otitis media caused by susceptible S. aureus, P. mirabilis, or Ps aeruginosa.105 107
Ofloxacin Dosage and Administration
Administration
Avoid contamination of container.1 105
Ophthalmic Administration
Apply topically to the eye as an ophthalmic solution.1
Not for injection.1 Not for subconjunctival injection or introduction directly into anterior chamber of the eye.1
For treatment of bacterial keratitis, administer around the clock for first 2 days of therapy.1
Otic Administration
Instill into ear as otic solution.105
For otic use only.105 Not for ophthalmic use.105 Not for injection.105
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.105
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.105 Repeat for opposite ear if necessary.105
To administer for treatment of otitis media in pediatric patients with tympanostomy tubes, instill drops while the affected ear is upward.105 Pump tragus 4 times by pushing inward to facilitate penetration of drops into middle ear; maintain position 5 minutes.105 Repeat for opposite ear if necessary.105
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.1
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.1 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.1 Afterward, may instill 1 or 2 drops into affected eye(s) 4 times daily for additional 3 days or until clinical cure achieved.1
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.a
Children ≥13 years of age: 10 drops of 0.3% solution into canal of affected ear(s) once daily for 7 days.a
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.105
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.105
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.1
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.1 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.1 Afterward, may instill 1 or 2 drops into affected eye(s) 4 times daily for additional 3 days or until clinical cure achieved.1
Bacterial Otic Infections
Otitis Externa
Otic
10 drops of 0.3% solution into canal of affected ear(s) once daily for 7 days.a
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.105
Cautions for Ofloxacin
Contraindications
Hypersensitivity to ofloxacin, other quinolones, or any ingredient in the formulation.1 105
Warnings/Precautions
Sensitivity Reactions
Hypersensitivity
Serious, potentially fatal hypersensitivity reactions reported following systemic administration of ofloxacin or other quinolones, some following the initial dose.1 105
If allergic reaction occurs, discontinue ofloxacin and institute appropriate therapy if indicated.1 105
General Precautions
Superinfection.
Possible overgrowth of nonsusceptible organisms (e.g., fungi) with prolonged use; if superinfection occurs, discontinue drug and institute appropriate therapy.1 105
Patient Monitoring
In patients with ophthalmic infections, careful monitoring, including slit-lamp biomicroscopy and fluorescein staining when appropriate, may be necessary in some patients.1
If otic infection is 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
Category C.1 105
Lactation
Distributed into milk following systemic administration; not known whether distributed into milk following topical application to the eye or ear.1 105 Discontinue nursing or the drug.1 105
Pediatric Use
Ophthalmic solution: safety and efficacy not established in children <1 year of age.1
Otic solution: safety and efficacy for treatment of otitis externa with intact typanic membrane not established in children <6 months of age.a Safety and efficacy for treatment of acute otitis media with tympanostomy tubes not established in children <1 year of age.105 Safety and efficacy for treatment of chronic suppurative otitis media with perforated tympanic membranes not established in children <12 years of age.105 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.a
No changes in hearing function observed on audiometric evaluation in a limited number of children treated with otic solution.105
Geriatric Use
No substantial differences in safety or efficacy of ophthalmic solution relative to younger adults.1
Common Adverse Effects
With ophthalmic therapy, transient ocular burning or discomfort.1 With otic therapy, application site reaction, pruritus, taste perversion.105 a
Ofloxacin 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.1 19 70
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.105 108
Distribution
Extent
Distributed into milk following systemic administration; not known whether distributed into milk following topical application to the eye or ear.1 105
Elimination
Elimination Route
Excreted principally in urine unchanged.1
Stability
Storage
Ophthalmic
Solution
15–25°C.1
Otic
Solution
25°C (may be exposed to 15–30°C).a
Actions and SpectrumActions
Usually bactericidal.1 3 8 14 26 27 29 32 33 34 35 36 44 64 65 66 71 84 85
Like other fluoroquinolones, ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV.1 3 4 5 8 9 27 30 33 44 64 65 85
Spectrum of activity includes gram-positive aerobic bacteria and some gram-negative aerobic bacteria.1 Inactive against fungi8 44 and viruses.8
Active in vitro against most gram-negative aerobic bacteria, including Enterobacteriaceae and Ps. aeruginosa.1 3 8 21 22 25 26 27 44 64 65 66 67 68 72 84 85 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).1 3 8 21 22 25 26 27 44 64 65 66 67 68 72 84 85 Less active against gram-positive than -negative bacteria.3 8 25 26
Advice to Patients
Importance of discontinuing drug and informing clinician at first sign of rash or other sign of hypersensitivity.1 105
Importance of learning and adhering to proper administration techniques to avoid contamination of the product.1 105
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1 105
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 105
Importance of informing patients of other important precautionary information.1 105 a (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
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Solution | 0.3%* | Ocuflox (with benzalkonium chloride) | Allergan |
Ofloxacin Ophthalmic Solution | Bausch & Lomb | |||
Otic | Solution | 0.3% | Floxin Otic (with benzalkonium chloride) | Daiichi |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Floxin Otic 0.3% Solution (DAIICHI PHARMACEUTICAL CORP): 10/$142.91 or 30/$392.49
Floxin Otic 0.3% Solution (DAIICHI PHARMACEUTICAL CORP): 5/$79.79 or 15/$226.78
Ocuflox 0.3% Solution (ALLERGAN): 5/$62.39 or 15/$166.37
Ofloxacin 0.3% Solution (FALCON PHARMACEUTICALS): 5/$17.99 or 15/$51.97
Ofloxacin 0.3% Solution (FALCON PHARMACEUTICALS): 10/$40 or 30/$118.51
Ofloxacin 0.3% Solution (APOTEX): 5/$59.99 or 15/$159.98
Ofloxacin 0.3% Solution (APOTEX): 10/$92.99 or 30/$276.96
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions June 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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