CIPRO HC OTIC 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.
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NEWS HIGHLIGHTS
Published Studies Related to Cipro HC Otic (Ciprofloxacin / Hydrocortisone 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.
Clinical Trials Related to Cipro HC Otic (Ciprofloxacin / Hydrocortisone Otic)
Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract Infections [Completed]
To assess and compare the efficacy and safety of ciprofloxacin extended-release (CIPRO XR)
tablet 1000 mg PO once-daily (OD) versus ciprofloxacin immediate-release (CIPRO IR) tablet
500 mg PO twice-daily (BID) for 7-14 days in patients with complicated and/or nosocomial
urinary tract infections (cUTI).
Study To Evaluate The Efficacy And Safety Of Ciprofloxacin Extended-Release (CiproŽ XR) 1000 mg Tablets Given Once Daily For 7 To 14 Days In The Treatment Of Patients 18 Years Or Older With Complicated Urinary Tract Infections Caused By Pseudomonas Aeruginosa And Other Common Uropathogens [Completed]
Researchers want to find out if a drug called CiproŽ XR (ciprofloxacin extended-release) can
help people with a complicated urinary tract infection caused by a kind of bacteria called
Pseudomonas aeruginosa. The study doctor will give Cipro XR to some people to see if it is
safe and works to treat complicated urinary tract infections caused by Pseudomonas
aeruginosa. The study doctor will also gather information about using Cipro XR to treat
complicated urinary tract infections caused by other bacteria. About 500 people with
complicated urinary tract infections who are 18 years old and older will join this study.
Cipro XR is approved by the U. S. Food and Drug Administration (FDA) for the treatment of
complicated urinary tract infections and acute uncomplicated pyelonephritis (inflammation of
the kidney). The dose of Cipro XR used in this study (1000 mg a day for 7 to 14 days), has
been shown to be safe and effective. This study is being done to gather more information on
using this dose of Cipro XR for complicated urinary tract infections caused by Pseudomonas
aeruginosa, as well as by other bacteria.
A Phase IV Study of Cipro XR in Uncomplicated UTI [Completed]
Women with urinary tract infections were treated with Cipro XR. They were also given a
brochure with information about urinary tract infections and later tested on the
information.
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.
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Page last updated: 2006-01-31
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