Cipro HC Otic (Ciprofloxacin Hydrochloride Otic) - Summary

CIPRO HC OTIC SUMMARY

CIPRO® HC OTIC
(ciprofloxacin hydrochloride and hydrocortisone otic suspension)

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.

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NEWS HIGHLIGHTS

Published Studies Related to Cipro HC Otic (Ciprofloxacin Otic)

Effects of middle ear application of Cipro HC Otic Suspension in an animal model. [2004.06]
The objective of this study was to examine whether ciprofloxacin-containing otic drops (Cipro HC Otic Suspension; 0.2% ciprofloxacin, 0.1% hydrocortisone; Alcon, Ontario, Canada) are cochleotoxic in the chinchilla animal model. Five chinchillas in total underwent these studies.

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Clinical Trials Related to Cipro HC Otic (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 [Completed]
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.

Safety and Efficacy Study of Foam Otic Cipro Compared to a Standard Solution ( Ciloxan - Alcon Labs ) to Treat Acute Otitis Externa [Completed]
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 [Completed]
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.

A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension [Completed]
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.

Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis [Completed]
The purpose of this study is to find out if bacterial load in the airways can be reduced after inhalation of ciprofloxacin for 28 days.

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