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 ).
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PROQUIN XR SUMMARY
WARNING:
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.
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NEWS HIGHLIGHTSMedia Articles Related to Proquin XR (Ciprofloxacin)
Aradigm Doses First Patient In Long-Term Phase 2 Study Of A Novel Inhaled Ciprofloxacin Formulation For The Management Of Respiratory Infections
Source: Respiratory / Asthma News From Medical News Today [2009.11.18]
Aradigm Corporation (OTCBB:ARDM) (the "Company") announced that the first patient was dosed in a 6-month, multicenter, international Phase 2 clinical trial of a novel version of inhaled ciprofloxacin (ARD-3150) in 40 adult patients with non-cystic fibrosis bronchiectasis. The randomized, double-blind, placebo-controlled trial will be conducted in Australia and New Zealand.
ciprofloxacin/dexamethasone-otic suspension, Ciprodex
Source: MedicineNet Ear Tubes Specialty [2005.03.02]
Title: ciprofloxacin/dexamethasone-otic suspension, Ciprodex
Category: Medications
Created: 3/2/2005
Last Editorial Review: 3/2/2005
Published Studies Related to Proquin XR (Ciprofloxacin)
Ciprofloxacin dosage and emergence of resistance in human commensal bacteria. [2009.08.01]
BACKGROUND: Although optimization of the fluoroquinolone dosage increases the efficacy of this class of drugs against bacterial infections, its impact on the emergence of resistance in commensal bacteria is unknown... CONCLUSIONS: Selection of resistant commensals during ciprofloxacin therapy is a frequent ecological side effect that is not preventable by dosage optimization. Trial registration. Clinical Trials.gov identifier: NCT00190151.
Bioavailability of ciprofloxacin tablets in humans and its correlation with the dissolution rates. [2009.07]
Bioavailabilities of seven tablets of ciprofloxacin were determined. The correlation between in-vivo bioavailability parameters and in-vitro dissolution rates were studied...
A single intraoperative sub-tenon's capsule injection of triamcinolone and ciprofloxacin in a controlled-release system for cataract surgery. [2009.07]
PURPOSE: To compare intraoperative injection of triamcinolone and ciprofloxacin in a controlled-release system (DuoCat) with prednisolone and ciprofloxacin eye drops after cataract surgery... CONCLUSIONS: One injection of DuoCat had a therapeutic response and ocular tolerance that were equivalent to conventional eye drops in controlling inflammation after cataract surgery. (ClinicalTrials.gov number, NCT00431028.).
Effect of a Kampo preparation, byakkokaninjinto, on pharmacokinetics of ciprofloxacin and tetracycline. [2009.06]
The effect on the bioavailability of the antimicrobial agents (ciprofloxacin and tetracycline), which are well known to form chelates with cationic metals such as calcium, was evaluated in 20 healthy male volunteers according to an open, random crossover fashion using a Kampo preparation, byakkokaninjinto (TJ-34) which contains various cationic metals including calcium.
Single Dose Azithromycin Versus Ciprofloxacin for Cholera in Children: A Randomized Controlled Trial. [2009.05.20]
OBJECTIVE: To compare the clinical and bacteriological success of single dose treatment with azithromycin and ciprofloxacin in children with cholera... CONCLUSION: Single dose azithromycin is superior to ciprofloxacin for treating cholera in children.
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 (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.
Ciprofloxacin on Burn Patients [Completed]
This was a non randomised, multi center, italian study performed in burn patients receiving
an antibiotic (ciprofloxacin) in order to treat an active infection. The aim of the study
was to validate a pharmacokinetics model useful to verify if a standard dose regimen of
ciprofloxacin, given to patients with a compromised metabolism, is a correct dose or instead
is over or under dosed.
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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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Proquin XR has an overall score of 5.50. The effectiveness score is 5 and the side effect score is 5. The scores are on ten point scale: 10 - best, 1 - worst.
| | 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. |
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| | Proquin XR review by 26 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Ineffective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | possible UTI - I think? |
| Dosage & duration: | | 500mg for 5 days taken 1 dose for the period of 1 day |
| Other conditions: | | back pain |
| Other drugs taken: | | pain reliever, muscle relaxer | | |
Reported Results |
| Benefits: | | There were no benefits of taking this medicine unless you count the fact that now I know I should NEVER take this medicine again. I'm severely allergic to it. |
| Side effects: | | Swelling of the face, tingling, itchy eyes, and tighness of chest/difficulty breathing. |
| Comments: | | I went to the doctor for back pain. My UTI test came back negative except my leukocites were up. I guess she prescribed this to me to be cautious. I took one dose and ended up in the emergency room within an hour. I am now the proud owner of an epi-pen! |
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Page last updated: 2009-11-18
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