Ofloxacin eent

Pronunciation

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

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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 Spectrum

  • 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

Ofloxacin

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 02/2013. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Ocuflox 0.3% Solution (ALLERGAN): 5/$65.51 or 15/$174.68

Ofloxacin 0.3% Solution (APOTEX): 5/$59.99 or 15/$159.98

Ofloxacin 0.3% Solution (APOTEX): 10/$92.99 or 30/$276.96

Ofloxacin 0.3% Solution (SANDOZ): 5/$17.99 or 15/$51.97

Ofloxacin 0.3% Solution (SANDOZ): 10/$40.00 or 30/$118.51

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, 1959-2013, Selected Revisions June 1, 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

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