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«The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official ...»

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Otic Antibiotics Review

12/15/2009

Copyright © 2004 - 2009 by Provider Synergies, L.L.C. All rights reserved.

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10101 Alliance Rd, Ste 201 Cincinnati, Ohio 45242 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to PSTCREditor@magellanhealth.com.

Otic Antibiotics Review FDA-Approved Indications Drug Name Manufacturer Indication(s) • ciprofloxacin 0.2% Wraser Acute otitis externa due to susceptible (Cetraxal®) Pharmaceuticals isolates of Pseudomonas aeruginosa or Staphylococcus aureus in pediatrics (age one year and older) and adults • ciprofloxacin 0.3% and Alcon Acute otitis media in pediatric patients (age dexamethasone 0.1% six months and older) with tympanostomy

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Overview7,8,9,10 The standard treatment for acute otitis media (AOM) has been the use of systemic antibiotics while topical (otic) therapy antibiotic is generally used for otitis externa. Topical antibiotics such as ofloxacin (Floxin Otic) and ciprofloxacin with dexamethasone (Ciprodex) may help to decrease adverse reactions and reduce the potential for antibiotic resistance when used in patients with AOM and with tympanostomy tubes. The patent tympanostomy tube does not change the spectrum of causative agents in acute otitis media.

Otitis externa is an acute inflammation of the external auditory canal. Commonly referred to as “swimmer’s ear” or “tropical ear”, this condition is often precipitated by water exposure or trauma. Common pathogens implicated in otitis externa are Pseudomonas aeruginosa and Staphylococcus aureus, often occurring as a polymicrobial infection. Patients will typically complain of otalgia and otorrhea, and the ear canal may appear erythematous and swollen. It is imperative that the ear canal be cleared of any discharge or debris that can occlude the canal since the presence of such material can keep the canal moist and interfere with topical treatment. All ages are affected, with a peak incidence in children aged seven to 12 years. In 2006, The American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAOHNSF) released guidelines for the management of acute otitis externa (AOE) in patients over two years of age.11 Clinicians should use topical preparations for initial therapy of diffuse, uncomplicated AOE. Systemic antimicrobial therapy should not be used unless there is extension outside the ear canal or the presence of specific host factors that would indicate a need for systemic therapy. A topical aminoglycoside combined with a second antibiotic and a topical steroid such as neomycin, polymyxin B, and hydrocortisone is commonly prescribed to treat AOE. However, caution must be used to watch for a hypersensitivity reaction to the neomycin and ototoxicity from the aminoglycoside. This preparation should not be used in cases of a perforated tympanic membrane. However, if the tympanic membrane is known or suspected to be perforated, agents with ototoxic potential, such as aminoglycosides, should not be used. Fluoroquinolones are not associated with ototoxicity, and ofloxacin is safe in cases of a perforated tympanic membrane. If the patient fails to respond to the initial therapeutic option within 48 to 72 hours, the clinician should reassess the patient to confirm the diagnosis of diffuse AOE and to exclude other causes of illness.

Clinical Practice Guidelines for acute otitis media (AOM) were released in 2004 by the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP). The guidelines recommend an observatory period instead of prescribing an antibiotic. When an antibiotic is needed, amoxicillin is the first line treatment. Other antibiotic choices should be based on clinical experience and type of organism present. No specific recommendation for use of topical antibiotics was included in these guidelines.12 Chronic suppurative otitis media (CSOM) defined as a perforated tympanic membrane with persistent drainage from the middle ear and initiated by an episode of acute infection. P.





aeruginosa is the most common causative organism followed by S. aureus. The yearly incidence of CSOM is estimated to be 39 cases per 100,000 persons in children and adolescents aged 15 years and younger in the United States. CSOM responds more frequently to topical than to systemic therapy. Successful topical therapy includes administration of antibiotic drops and aural irrigation. The antibiotic should have activity against both gram-negative and gram-positive organisms. Aminoglycosides and fluoroquinolones both have spectrum of activity against gramnegative and gram-positive organisms, However, aminoglycosides may potentially be ototoxic and therefore are not recommended to be used if the tympanic membrane is perforated.13

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Pharmacology Ofloxacin and ciprofloxacin are fluoroquinolones and have activity against a wide range of gramnegative and gram-positive microorganisms. Fluoroquinolones act by inhibiting the DNA gyrase enzyme that is essential for DNA replication, repair, deactivation, and transcription.

Hydrocortisone and dexamethasone are corticosteroids that control inflammation, edema, pruritus, and other dermal reactions.

Colistin sulfate is an antibiotic with bactericidal action against most gram-negative organisms, notably P. aeruginosa, Eschericia coli, and Klebsiella-Aerobacter sp.

Neomycin sulfate is an aminoglycoside and broad-spectrum antibiotic that is bactericidal to many pathogens, notably S. aureus and Proteus sp. Neomycin irreversibly binds to the 30S subunit of bacterial ribosomes, blocking the recognition step in protein synthesis and causing misreading of the genetic code.

Polymyxin B increases the permeability of bacterial cell membranes and is bactericidal against almost all gram-negative bacilli except the Proteus group.

Thonzonium bromide is a surface-active agent that promotes tissue contact by dispersion and penetration of the cellular debris and exudate.

It is thought that because topical application establishes and maintains drug concentrations at the site of infection that are well above the minimum inhibitory concentration, resistance is not likely to develop following topical use. A systematic review of the evidence regarding the development of antibiotic resistance with ototopical treatment indicated that antibiotic resistance is rare, although in none of the studies was resistance the main study question.14,15,16 Pharmacokinetics Due to the topical application of these products, minimal systemic absorption is expected.17 Ciprofloxacin (Cetraxal): After administration of 0.25 mL of Cetraxal, plasma concentrations were not measurable (total dose: 0.5 mg ciprofloxacin). The maximum plasma concentration is less than 5 ng/mL.18 Ofloxacin (Floxin Otic): The concentration of ofloxacin in middle ear fluid is variable based on the patient’s disease state. Serum ofloxacin concentrations were low in patients with tympanostomy tubes and/or perforated tympanic membranes.19 Ciprofloxacin/dexamethasone (Ciprodex): Both ciprofloxacin and dexamethasone appear in the plasma at measurable concentrations although the concentrations are approximately 0.1 percent and 14 percent, respectively, of an oral dose of ciprofloxacin 250 mg tablet and dexamethasone 0.5 mg tablet.20 Peak plasma concentrations for both components were seen between 15 minutes and 2 hours after dose application.

Ciprofloxacin/hydrocortisone (Cipro HC): Ciprofloxacin concentrations in the blood are expected to be below the level of detection, and therefore have not been measured. Levels of hydrocortisone are not distinguishable from naturally occurring levels.21

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Contraindications/Warnings22,23,24,25,26,27,28 Corticosteroid and neomycin containing products should not be used in viral infections involving the external ear canal such as varicella and herpes simplex.

Neomycin may induce permanent sensorineural hearing loss due to cochlear damage.

Neomycin containing products should be used cautiously in any patient with a perforated tympanic membrane. It may also cause cutaneous sensitization.

Ciprodex Otic and Floxin Otic are both sterile products. Cipro HC Otic is a non-sterile product and should not be used if the tympanic membrane is perforated.

Cipro HC and Ciprodex Otic are contraindicated in patients with a history of hypersensitivity to ciprofloxacin, quinolones or other components, (i.e. dexamethasone or hydrocortisone), of these product. Ofloxacin Otic is contraindicated in patients with a history of hypersensitivity to ofloxacin, other quinolones or any components of this product. Ciprofloxacin otic is contraindicated in patients with ciprofloxacin hypersensitivity.

None of the products included in this review are approved for ophthalmic use, inhalation, or for injection.

Drug Interactions29,30,31,32,33,34,35 Since all agents are applied topically and have negligible systemic absorption; no documented drug interactions are currently available.

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Neomycin-containing products46 47 48: Neomycin sensitization appears as a low-grade reddening with swelling, dry scaling, and itching; it may be manifest simply as a failure to heal.

Hydrocortisone:49 50 51 This drug may be associated with the following adverse effects: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

Special Populations52,53,54,55,56,57,58 Pediatrics Otic fluoroquinolones, Coly-mycin S, and Cortisporin TC are approved for use in pediatric patients, however the age is not specified.

Cetraxal and Cipro HC are indicated for use in children one year of age and older.

Cortisporin is approved for use in children two years of age and older.

Floxin Otic and CiproDex are approved for usage in children as young as six months old.

Pregnancy All agents in this class are Pregnancy Category C.

–  –  –

Clinical Trials Search Strategy Studies were identified through searches performed on PubMed and review of information sent by manufacturers. Search strategy included the use of all drugs in this class and the FDAapproved indications. Comparative clinical trials have been performed with some of the agents in this class. Studies included for analysis in the review were published in English, performed with human participants and randomly allocated participants to comparison groups. In addition, studies must contain clearly stated, predetermined outcome measure(s) of known or probable clinical importance, use data analysis techniques consistent with the study question and include follow-up (endpoint assessment) of at least 80 percent of participants entering the investigation.



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