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Cipro HC Otic (Ciprofloxacin Hydrochloride / Hydrocortisone Otic) - Summary

 



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.

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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 (Cipro® 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 Cipro® 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.

Cipro® XR Excellence in Therapeutic Response and Activity (eXtRa) - Assessing Symptom Relief in Urinary Tract Infections [Completed]
The primary objective of this clinical trial was to determine the time to improvement of the signs and symptoms (eg, dysuria, frequency, urgency, gross hematuria, suprapubic pain, hesitancy, low back pain) of acute, uncomplicated, symptomatic, lower UTIs in women treated with Cipro XR 500 mg once daily for 3 days.

Food Study of Ciprofloxacin Extended-Release Tablets 1000 mg and Cipro® XR Tablets 1000 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's ciprofloxacin extended-release 1000 mg tablets to Bayer's Cipro® XR 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administered under fed conditions.

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Page last updated: 2006-01-31

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