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Proquin XR (Ciprofloxacin Hydrochloride) - Summary

 
 



WARNING:

Fluoroquinolones, including Proquin XR, are associated with an increased risk of tendinitis and tendon rupture in all ages. The risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart and lung transplant recipients (See WARNINGS ).

 

PROQUIN XR SUMMARY

ProQuin XR (ciprofloxacin hydrochloride) extended-release tablets contain ciprofloxacin hydrochloride, a synthetic broad-spectrum fluoroquinolone antimicrobial agent for oral administration. Ciprofloxacin hydrochloride is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride.

ProQuin XR is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of the designated microorganisms listed below. ProQuin XR is not interchangeable with other ciprofloxacin extended-release or immediate release oral formulations. See DOSAGE AND ADMINISTRATION  for specific recommendations.

Uncomplicated urinary tract infections (acute cystitis) caused by Escherichia coli and Klebsiella pneumoniae.

THE SAFETY AND EFFICACY OF PROQUIN XR IN TREATING PYELONEPHRITIS, COMPLICATED URINARY TRACT INFECTIONS, AND INFECTIONS OTHER THAN UNCOMPLICATED URINARY TRACT INFECTIONS HAVE NOT BEEN DEMONSTRATED. Alternative therapy should be considered for patients who remain symptomatic or develop fever and back pain while on treatment with ProQuin XR.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ProQuin XR and other antibacterial drugs, ProQuin XR should only be used to treat uncomplicated urinary tract infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and sensitivity 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.


See all Proquin XR indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Proquin XR (Ciprofloxacin)

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.

Daily ciprofloxacin treatment for patients with advanced liver disease awaiting liver transplantation reduces hospitalizations. [2011.04]
BACKGROUND: Progressive deterioration in liver function is a common cause of hepatic decompensation and indication for liver transplantation in patients with advanced liver disease. Previous studies in animal models of acute and chronic liver disease revealed that daily ciprofloxacin improves biochemical parameters of hepatic function. AIMS: The primary objective of this study was to determine whether hepatic function improves in patients with advanced liver disease after 1 month of daily ciprofloxacin therapy. A secondary objective was to determine whether ciprofloxacin treatment for 1 or 3 months results in fewer hospitalizations for decompensated liver disease... CONCLUSIONS: The results of this study suggest that daily ciprofloxacin may result in fewer hospitalizations for patients with advanced liver diseases awaiting liver transplantation but not by enhancing hepatic function.

Topical ciprofloxacin is superior to topical saline and systemic antibiotics in the treatment of tympanostomy tube otorrhea in children: the results of a randomized clinical trial. [2010.12]
OBJECTIVES/HYPOTHESIS: To compare the clinical failure rates among children with otorrhea through tympanostomy tubes treated with topical or systemic antibiotics versus topical saline. STUDY DESIGN: Randomized, double-blind, controlled patient study... CONCLUSIONS: The significant effect of topical ciprofloxacin is probably related to a higher local concentration of antibiotics in the middle ear rather than the result of mechanical rinsing and dissolution of the bacterial load.

more studies >>

Clinical Trials Related to Proquin 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.

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 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.

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.

more trials >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 7 ratings/reviews, Proquin XR has an overall score of 5. The effectiveness score is 7.14 and the side effect score is 5.71. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Proquin XR review by 52 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   kidney infection
Dosage & duration:   500mg 2 times daily (12 hrs apart) taken 1st day: 500 mg. 2 times/day for the period of Days 2-5: 250 mg every 8 hrs.
Other conditions:   Back pain: kidney area, frequent urination
Other drugs taken:   none
  
Reported Results
Benefits:   After the third day, I could tell the pain was subsiding.
Side effects:   Diarrhea and stomach pain
Comments:   The first dayI started taking the medication 500mg 12 hrs apart. Then my stomach was hurting and I had diarrhea. I decreased the dosage (on my own, which I would not advise others to do) because I have a history of pseudo-membranous colitis, and I need to be cautious of antibiotics. However, I needed the med for the kidney infection. On days 2-5 I took 250mg 3 times a day (eight hrs apart). This reduction in dosage relieved the stomach pain and the diarrhea. After the third day of antibiotics, I noticed a decrease in back pain so I knew the medication was working.

 

Proquin XR review by 61 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   pneumonia
Dosage & duration:   250mg taken 2 x day for the period of 7 days
Other conditions:   bronchiectasis
Other drugs taken:   none
  
Reported Results
Benefits:   My cough was reduced, from 24 hours a day, to a few episodes per day
Side effects:   First, what I termed "Cipro brain", which is not thiking clearly and making mistakes (like jet-lag). Then, I started getting ulcers on my tongue. They spread to my gums and inside lips and my tongue was swollen, making it difficult to talk. I was afraid that if I got stopped, driving, the cop would think I was drunk, because I was slurring my words. Now, several days after stopping the drug, I still have extreme fatigue. I'm hoping to return to normal! When I had pneumonia, I actually felt fine, but the cough had to to be treated. I doubt if I would ever take Ciprofloxacin again.
Comments:   I took the pill twice a day, morning and evening, after meals. I also kept up with my daily exercise regimen (walking and swimming).

 

Proquin XR review by 28 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   u/i
Dosage & duration:   500 2x a day for 5 days (dosage frequency: every 12 hours) for the period of 3.5 days
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   cleared my UI i didnt even know i had one..
Side effects:   feeling sick dizzy made vision in eye go funny. made tendons in whole body swell made muscels feel like they are burning. i cant excercise now because i have to let me tentons heal . i dont know how long it will take. brain fog extream fear and emotional .
Comments:   please dont ever take this medication im horrified by how it made me feel in such a short amout of time

See all Proquin XR reviews / ratings >>

Page last updated: 2011-12-09

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