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Cetraxal (Ciprofloxacin Otic) - Summary

 
 



CETRAXAL SUMMARY

CETRAXAL (ciprofloxacin otic solution) 0.2% contains the synthetic antimicrobial agent ciprofloxacin hydrochloride. CETRAXAL is a sterile, preservative-free solution for otic use. Each single use container of CETRAXAL delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin.

CETRAXAL is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus.


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NEWS HIGHLIGHTS

Published Studies Related to Cetraxal (Ciprofloxacin Otic)

Comparison of safety and efficacy of foam-based versus solution-based ciprofloxacin for acute otitis externa. [2010.10]
OBJECTIVE: To compare and evaluate the efficacy and safety of a foam-based antibiotic formulation in the treatment of acute otitis externa (AOE) with the more conventional solution-based formulation... CONCLUSION: Foam-based ciprofloxacin is a safe and an effective new treatment for AOE. Copyright (c) 2010 American Academy of Otolaryngology-Head and Neck Surgery Foundation. Published by Mosby, Inc. All rights reserved.

Comparison of efficacy and safety of ciprofloxacin otic solution 0.2% versus polymyxin B-neomycin-hydrocortisone in the treatment of acute diffuse otitis externa*. [2008.12]
OBJECTIVE: To compare the efficacy and safety of ciprofloxacin otic solution 0.2% to polymyxin B-neomycin-hydrocortisone (PNH) otic solution in the treatment of acute diffuse otitis externa in children, adolescents, and adults... CONCLUSIONS: Ciprofloxacin otic solution 0.2% was found to be noninferior to PNH. This efficacy, good tolerability, and ease of administration make ciprofloxacin otic solution 0.2% without a topical steroid an attractive option for the treatment of acute otitis externa.

Treatment of acute otitis externa with ciprofloxacin otic 0.2% antibiotic ear solution. [2011]
BACKGROUND/OBJECTIVE: An inflammation of the cutis and subcutis of the external auditory canal is a primary symptom in cases of acute otitis externa. It is usually treated locally, since this type of therapy ensures a high concentration of the drug and interacts at the site of inflammation with no systemic effects. This systematic review compares the efficacy of treatment using a ciprofloxacin 0.2% solution with other therapeutic options... CONCLUSION: This systematic review confirms the hypothesis of ciprofloxacin's noninferiority in the treatment of otitis externa, in terms of the cure rate and microbiological eradication.

Comparison of safety and efficacy of foam-based versus solution-based ciprofloxacin for acute otitis externa. [2010]
more conventional solution-based formulation... CONCLUSION: Foam-based ciprofloxacin is a safe and an effective new treatment for

Auditory function after a prolonged course of ciprofloxacin-dexamethasone otic suspension in a murine model. [2009.03]
OBJECTIVE: To test for ototoxicity after prolonged ototopical fluoroquinolone use in the middle ear space using a murine model... CONCLUSION: Ciprofloxacin-dexamethasone suspension did not cause either immediate or delayed ototoxicity after 21 days of intratympanic administration in the CBA/J mouse model.

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Clinical Trials Related to Cetraxal (Ciprofloxacin Otic)

Safety and Efficacy of Once-Daily Dosing of FoamOtic Cipro Compared to Twice-Daily Dosing of Ciloxan Ear Drops in Patients With Acute External Otitis [Recruiting]
The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro (0. 3% Ciprofloxacin Otic Foam), used once-daily for 7 days for the treatment of Acute Diffuse Otitis Externa, compared to commercial ear drops used twice daily for 7 days.

Study in COPD (Chronic Obstructive Pulmonary Disease) Subjects to Investigate Safety, Tolerability, and Pharmacokinetics of Ciprofloxacin After Single Dose Inhalations of 50 mg and 75 mg Ciprofloxacin Inhalation Powder [Recruiting]
The purpose of this study is to compare the safety and pharmacokinetics of ciprofloxacin after inhalation of single 52. 5 and 48. 75 mg doses in COPD patients. In this study the 48. 75 mg dose will be administered for the first time using a new high dose strength (i. e. one capsule containing 75 mg powder = 48. 75 mg ciprofloxacin) formulation. Safety investigations will focus on local tolerability in the lung and evaluate whether the patient can inhale the higher amount of powder compared to the lower dose strength. Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug. Results from this study will be used to decide whether the new dose strength is suitable for larger clinical trials planned for the COPD patients population.

Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) in Patients With Cystic Fibrosis [Recruiting]
To evaluate the change in forced expiratory volume (FEV1) from baseline to Day 28-30 between Cipro Inhale-treated and placebo-treated subjects after a 4-week treatment period.

Cipro Inhaler for Cystic Fibrosis Children Ages 6-12 [Recruiting]
Ciprofloxacin PulmoSphere Inhalation Powder appears to be an effective and adequate antibiotic treatment for cystic fibrosis patients with P. aeruginosa colonisation. This planned study is the first study on the use of this new Ciprofloxacin PulmoSphere Inhalation Powder in the pediatric population of 6 to 12 years of age.

A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension [Not yet recruiting]
The objective of this study is to compare the efficacy and safety profiles of the test product containing 2 mg/mL ciprofloxacin hydrochloride associated with 10 mg/mL of hydrocortisone with the reference product Cipro HC®, in patients with acute otitis externa.

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Page last updated: 2013-02-10

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