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Ciprodex (Ciprofloxacin / Dexamethasone Otic) - Summary

 
 



CIPRODEX SUMMARY

Ciprodex®
(ciprofloxacin 0.3% and
dexamethasone 0.1%)
Sterile Otic Suspension

CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension contains the synthetic broad-spectrum antibacterial agent, ciprofloxacin hydrochloride, combined with the anti-inflammatory corticosteroid, dexamethasone, in a sterile, preserved suspension for otic use. Each mL of CIPRODEX® Otic contains ciprofloxacin hydrochloride (equivalent to 3 mg ciprofloxacin base), 1 mg dexamethasone, and 0.1 mg benzalkonium chloride as a preservative.

CIPRODEX® Otic is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:

Acute Otitis Media in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.

Acute Otitis Externa in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa.


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NEWS HIGHLIGHTS

Published Studies Related to Ciprodex (Ciprofloxacin / Dexamethasone Otic)

Topical ciprofloxacin/dexamethasone superior to oral amoxicillin/clavulanic acid in acute otitis media with otorrhea through tympanostomy tubes. [2006.09]
OBJECTIVE: This study was a comparison of topical ciprofloxacin/dexamethasone otic suspension to oral amoxicillin/clavulanic acid suspension in children with acute otitis media with otorrhea through tympanostomy tubes... CONCLUSIONS: Topical otic treatment with ciprofloxacin/dexamethasone otic suspension is superior to treatment with oral amoxicillin/clavulanic acid suspension and results in more clinical cures and earlier cessation of otorrhea with fewer adverse effects in children with acute otitis media with otorrhea through tympanostomy tubes.

Efficacy and safety of topical ciprofloxacin/dexamethasone versus neomycin/polymyxin B/hydrocortisone for otitis externa. [2004.08]
OBJECTIVES: To compare the efficacy and safety of ciprofloxacin 0.3%/dexamethasone 0.1% (CIP/DEX) otic suspension with that of neomycin 0.35%/polymyxin B 10,000 IU/mL/hydrocortisone 1.0% (N/P/H) otic suspension in patients with acute otitis externa (AOE)... CONCLUSIONS: 7 days treatment with CIP/DEX otic suspension administered twice daily is clinically and microbiologically superior to N/P/H otic suspension administered 3 times daily in the treatment of mild to severe AOE, and is equally well tolerated.

Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of granulation tissue in children with acute otitis media with otorrhea through tympanostomy tubes. [2004.06]
OBJECTIVE: Comparison of topical ciprofloxacin/dexamethasone otic suspension (CIP/DEX) to ofloxacin otic solution (OFL) for treatment of granulation tissue in children with AOMT... CONCLUSION: CIP/DEX was superior to OFL in the treatment of granulation tissue in children with AOMT.

Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of children with acute otitis media with otorrhea through tympanostomy tubes. [2004.01]
OBJECTIVE: To determine the efficacy and safety of topical ciprofloxacin/dexamethasone otic suspension compared with ofloxacin otic solution in the treatment of acute otitis media with otorrhea through tympanostomy tubes (AOMT) in pediatric patients... CONCLUSION: Topical ciprofloxacin/dexamethasone treatment is superior to topical ofloxacin in the treatment of AOMT.

Topical ciprofloxacin/dexamethasone is superior to ciprofloxacin alone in pediatric patients with acute otitis media and otorrhea through tympanostomy tubes. [2003.12]
OBJECTIVE: To determine whether topical administration of a corticosteroid improves resolution of acute tympanostomy tube otorrhea when combined with topical antibiotic drops. STUDY DESIGN: Randomized, patient-masked, parallel-group, multicenter trial of topical otic ciprofloxacin/dexamethasone versus topical ciprofloxacin alone in 201 children aged 6 months to 12 years with acute otitis media with tympanostomy tubes (AOMT) of less than or equal to 3 weeks' duration and visible otorrhea... CONCLUSIONS: Topical otic treatment with ciprofloxacin/dexamethasone is superior to treatment with ciprofloxacin alone and results in a faster clinical resolution in children with AOMT. The contribution of the corticosteroid in achieving a 20% reduction (1.1 day) in time to cessation of otorrhea is clinically meaningful and represents an important advance over single-agent antibiotic therapy.

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Clinical Trials Related to Ciprodex (Ciprofloxacin / Dexamethasone Otic)

FST-201 in the Treatment of Acute Otitis Externa [Recruiting]
The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in the treatment of acute otitis externa. This study will be conducted at one site, the LBJ Tropical Medical Center, Department of Otolaryngology, in Pago Pago, American Samoa.

Topical Treatment of Acute Otitis Media With Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora [Recruiting]
Study conducted to evaluate possible formation/growth of antibiotic resistant bacteria at distal sites.

N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media [Not yet recruiting]
Chronic suppurative otitis media (CSOM) can be particularly difficult to treat as a number of patients do not respond to routine antibiotic or surgical treatments. The current treatment involves administering combination antibiotic anti-inflammatory ear drops such as Ciprodex (ciprofloxacin 0. 3% / dexamethasone 0. 1%). Although most patients experience a relief of symptoms, a fraction of patients remain refractory to treatment. Recent findings suggest that the addition of N-acetylcysteine (0. 5-2%) to Ciprodex is a superior treatment for otitis media with effusion compared to the use of Ciprodex alone.

Comparative Efficacy and Safety of Two Ciprofloxacin 0.3% and Dexamethasone 0.1% Formulations in Subjects With Acute Otitis Externa [Recruiting]
The purpose of the study is to demonstrate the clinical therapeutic non-inferiority of EXL CDOS to commercially available Ciprofloxacin 0. 3% and Dexamethasone 0. 1% Sterile Otic Suspension (Ciprodex®, Alcon) in the treatment of acute otitis externa (AOE) when administered twice daily for 7 days.

A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa [Recruiting]

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Page last updated: 2006-11-04

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