CIPRO HC SUMMARY
CIPRO® HC OTIC (ciprofloxacin hydrochloride and hydrocortisone otic suspension) contains the synthetic broad spectrum antibacterial agent, ciprofloxacin hydrochloride, combined with the anti-inflammatory corticosteroid, hydrocortisone, in a preserved, nonsterile suspension for otic use. Each mL of CIPRO® HC OTIC contains ciprofloxacin hydrochloride (equivalent to 2 mg ciprofloxacin), 10 mg hydrocortisone, and 9 mg benzyl alcohol as a preservative.
CIPRO® HC OTIC is indicated for the treatment of acute otitis externa in adult and pediatric patients, one year and older, due to susceptible strains of Pseudomonas aeruginosa, Staphylococcus aureus, and Proteus mirabilis.
Clinical Trials Related to Cipro HC (Ciprofloxacin / Hydrocortisone 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 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 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.
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.
Page last updated: 2009-10-27