NEWS HIGHLIGHTS
Published Studies Related to Cetraxal (Ciprofloxacin Otic)
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.
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.
Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension for the topical treatment of ear infections: a review of the literature. [2009.02]
The objective of this article is to review the literature related to ciprofloxacin 0.3% and dexamethasone 0.1% sterile otic suspension. A systematic literature search utilizing Medline was conducted to identify peer-reviewed articles related to safety and efficacy... Additionally, the literature also provides clear evidence for the contribution of dexamethasone when added to ciprofloxacin for the topical treatment of ear infections.
Ototoxicity of topical ciprofloxacin/dexamethasone otic suspension in a chinchilla animal model. [2008.12]
OBJECTIVE: To determine the ototoxic potential of ciprofloxacin/dexamethasone eardrops... CONCLUSION: Ciprofloxacin/dexamethasone eardrops did not appear ototoxic when used in chinchillas post-ventilation tube insertion.
Ciprofloxacin 0.3%/dexamethasone 0.1% topical drops for the management of otic infections. [2008.12]
The American Academy of Otolaryngology-Head and Neck Surgery has recommended that, where possible, infections of the external auditory canal and middle ear be treated with topical preparations... The authors believe that the use of topical ciprofloxacin/dexamethasone will increase as the advantages of fluoroquinolone/steroid combination therapy become more widely recognized.
Clinical Trials Related to Cetraxal (Ciprofloxacin Otic)
Safety and Efficacy Study of Foam Otic Cipro Compared to a Standard Solution ( Ciloxan - Alcon Labs ) to Treat Acute Otitis Externa [Recruiting]
The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro, a novel
medication developed to treat Acute Diffuse Otitis Externa of bacterial origin.
The working hypothesis is that Foam Otic Cipro is as effective as registered ear drops.
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.
Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) [Recruiting]
Objectives of the study are to investigate the safety, tolerability and levels of
ciprofloxacin in the lung after single and multiple inhalative administration to patients
with moderate to severe COPD (stage II-III according to GOLD Criteria).
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.
Impact of Formulation on Ciprofloxacin Oral Absorption [Not yet recruiting]
Dogs and humans exhibit differences in gastrointestinal physiology. The development of
pharmaceuticals for both humans and dogs typically depends upon pharmacokinetic studies in
the other species. Product design and quality attributes for dogs (and for humans)generally
conduct such extrapolations in a simplistic fashion, without a systematic account of the
differential intestinal physiology between dog and human. This project aims to elucidate
product quality differences between human and dog oral solid dosage forms as a result of the
differential physiology between the two specifies. This insight will facilitate the
regulation of canine medicines by highlighting how product standards for human medicines are
either too liberal or too restrictive for canine medicines.
Ciprofloxacin hydrochloride will be used as a model poorly soluble drug. A range of
immediate-release (IR) tablets will be formulated to map the design space. Formulations will
be fast, medium, and slow, with respect to dissolution rate of drug. Ciprofloxacin is
expected to exhibit formulation-dependent pharmacokinetics, which is additionally impacted
by the differential physiology between dog and humans. In particular, the investigators
anticipate a greater sensitivity to formulation for dogs than for humans. Consequently, the
investigators anticipate dogs to be more sensitive to formulations, where such critical
formulation factors must be considered in canine product design and regulation.
Objectives: 1) The primary objective of this human study is to assess whether specific
formulation factors impact the rate and extent of ciprofloxacin oral absorption, as well as
the absolute absorption profile of ciprofloxacin. 2) The secondary objective is to assess if
dogs exhibit a greater sensitivity to formulation than do humans.
Hypotheses: The investigators anticipate that humans exhibit a modest sensitivity to
specific tablet formulation factors. 1) Hence, the hypothesis of this human study is that
humans do not exhibit a sensitivity to specific formulation factors and show no in vitro -
in vivo correlation to dissolution rate. 2) Alternative hypothesis is that humans do exhibit
a sensitivity to specific formulation factors and show an in vitro - in vivo correlation to
dissolution rate.
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