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Cipro XR (Ciprofloxacin Extended Release) - Summary

 
 



CIPRO XR SUMMARY

CIPRO XR (ciprofloxacin * extended-release tablets) contains ciprofloxacin, a synthetic broad-spectrum antimicrobial agent for oral administration. CIPRO XR tablets are coated, bilayer tablets consisting of an immediate-release layer and an erosion-matrix type controlled-release layer. The tablets contain a combination of two types of ciprofloxacin drug substance, ciprofloxacin hydrochloride and ciprofloxacin betaine (base). Ciprofloxacin hydrochloride is 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride. It is provided as a mixture of the monohydrate and the sesquihydrate.

CIPRO XR is indicated only for the treatment of urinary tract infections, including acute uncomplicated pyelonephritis, caused by susceptible strains of the designated microorganisms as listed below. CIPRO XR and ciprofloxacin immediate-release tablets are not interchangeable. Please see DOSAGE AND ADMINISTRATION for specific recommendations.

Uncomplicated Urinary Tract Infections (Acute Cystitis) caused by Escherichia coli, Proteus mirabilis, Enterococcus faecalis, or Staphylococcus saprophyticus a.

Complicated Urinary Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterococcus faecalis, Proteus mirabilis, or Pseudomonas aeruginosa a.

Acute Uncomplicated Pyelonephritis caused by Escherichia coli.


a Treatment of infections due to this organism in the organ system was studied in fewer than 10 patients.

THE SAFETY AND EFFICACY OF CIPRO XR IN TREATING INFECTIONS OTHER THAN URINARY TRACT INFECTIONS HAS NOT BEEN DEMONSTRATED. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with CIPRO XR may be initiated before results of these tests are known; once results become available appropriate therapy should be continued. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO XR and other antibacterial drugs, CIPRO XR should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.


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NEWS HIGHLIGHTS

Published Studies Related to Cipro XR (Ciprofloxacin)

Adalimumab combined with ciprofloxacin is superior to adalimumab monotherapy in perianal fistula closure in Crohn's disease: a randomised, double-blind, placebo controlled trial (ADAFI). [2014]
disease (CD)... CONCLUSIONS: Combination therapy of adalimumab and ciprofloxacin is more

Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis: a phase II randomised study. [2013]
This phase II, randomised, double-blind, multicentre study (NCT00930982) investigated the safety and efficacy of ciprofloxacin dry powder for inhalation (DPI) in patients with non-cystic fibrosis bronchiectasis. Adults who were culture positive for pre-defined potential respiratory pathogens (including Pseudomonas aeruginosa and Haemophilus influenzae) were randomised to ciprofloxacin DPI 32.5 mg or placebo administered twice daily for 28 days (with 56 days of follow-up).

Evaluation of the efficacy and safety of intravenous ciprofloxacin versus meropenem in the treatment of postoperative infection. [2011.10.19]
Therapeutic options for postoperative infection in gastrointestinal surgery are limited. To identify new treatment alternatives, the Japan Society for Surgical Infection conducted a multicenter prospective, randomized, controlled clinical trial comparing the efficacy of intravenous ciprofloxacin (CIP IV) and intravenous meropenem (MEM IV).

A multi-center randomized trial to assess the efficacy of gatifloxacin versus ciprofloxacin for the treatment of shigellosis in Vietnamese children. [2011.08]
CONCLUSIONS: We conclude that in Vietnam, where nalidixic acid resistant Shigellae are highly prevalent, ciprofloxacin and gatifloxacin are similarly effective for the treatment of acute shigellosis.

Pharmacokinetic interactions between ciprofloxacin and itraconazole in healthy male volunteers. [2011.04]
OBJECTIVE: To investigate the pharmacokinetic interaction between ciprofloxacin and itraconazole in healthy male volunteers... CONCLUSION: Ciprofloxacin decreases the metabolism of itraconazole, most likely through inhibition of CYP3A4. The dosage of itraconazole should be reduced and its therapeutic outcome should be monitored closely when these two agents are concomitantly administered. Copyright (c) 2011 John Wiley & Sons, Ltd.

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Clinical Trials Related to Cipro XR (Ciprofloxacin)

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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Reports of Suspected Cipro XR (Ciprofloxacin) Side Effects

Palpitations (7)Dizziness (7)Vomiting (7)Hypoaesthesia (7)Paraesthesia (7)Arthralgia (7)Asthenia (7)Cystitis Haemorrhagic (5)Tachycardia (5)Blood Triglycerides Increased (5)more >>


Page last updated: 2014-11-30

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