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Cipro XR 1000 mg

Below, you will find information about Cipro XR 1000 mg for complicated urinary tract infections - which occur when a patient's urinary tract is complicated by functional abnormality, metabolic disorder such as diabetes, or anatomic abnormality. You will also find information relating to acute uncomplicated pyelonephritis. Please also see the complete Cipro XR 1000 mg Prescribing Information .

• Proven clinical success
• Rapid and sustained bactericidal activity^†
• Tolerability with added convenience

Proven clinical success

With its clinical success rate of 96.1% in cases of complicated urinary tract infection and acute uncomplicated pyelenophritis and bacterial eradication of 89.2% in cases of complicated urinary tract infection, you can feel confident prescribing Cipro XR 1000 mg. Study design: A prospective, double-blind, multicenter, clinical trial comparing the safety and efficacy of Cipro XR (1000 mg qd ) and ciprofloxacin (500 mg bid ) in adult men and women with clinical signs and symptoms of complicated UTI and/or acute uncomplicated pyelonephritis. The primary efficacy variable was bacteriological eradication at Test of Cure (day 5-11 post- therapy); secondary variable included clinical success rates at Test of Cure. Clinical success is defined as relief of symptoms, including pyuria, dysuria, frequency, urgency and suprapubic pain, fever, chills, flank pain, nausea and/or vomiting, or CVA tenderness 1.

Cipro XR effectively eradicates the most common uropathogens: E. coli (96.8%), E. faecalis (100%), K. pneumoniae (95.2%), P. mirabilis (91.6%), P. aeruginosa^a (100%).

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Rapid and sustained bactericidal activity^†

The advanced bi-layer matrix formulation of Cipro XR provides rapid and sustained in vitro activity. Thirty-five percent of Cipro XR is delivered immediately, providing high levels in the bloodstream within the first one to two hours.

The remaining sixty-five percent of Cipro XR is gradually released over time, allowing urine concentrations that remain well above MIC₉₀ of indicated uropathogens¹. As a result of higher peak concentrations, Cipro XR provides more rapid and extensive in vitro bacterial killing than ciprofloxacin.

~51% greater Cmax than Cipro XR 500 mg Cmax achieved within 1.5 hours In vitro eradication is achieved within 5 hours

C_max study design: Two open-label, single-center, randomized, non-controlled, twofold, crossover studies; the first assessing the single-dose and steady-state pharmacokinetics of Cipro XR (500 mg qd ) vs. ciprofloxacin (250mg bid ); the second to compare Cipro XR (1000 mg qd ) vs. ciprofloxacin (500 mg bid ) ^2,3

Ciprofloxacin has a high volume of distribution, often achieving tissue levels several fold higher than corresponding serum levels. Plasma concentrations 24 hours post-dose remain above the MIC₉₀ of E. coli, the most common uropathogen in complicated UTIs. During the first 12 hours plasma concentrations were greater than with 500 mg bid.

Eradication study design: Normal pharmacokinetic studies comparing Cipro XR (500 mg qd and 1000 mg qd) with corresponding regimens of immediate-release Cipro (250 mg bid and 500 mg bid) in 19 healthy males. Urine and plasma samples were taken on the first and last day of treatment and analyzed for Cipro concentrations.

A separate study, using an in vitro pharmacokinetic/pharmacodynamic model, compared the separate dosage regimens using a strain of E.coli with an MIC value of 0.03¹

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Tolerability with added convenience

In clinical trials, the overall incidence, type and distribution of adverse events were similar in patients receiving 500 mg of Cipro XR and 1000 mg of Cipro XR.

Cipro XR is taken as one 1000 mg tablet per day, with or without food. Patients with a creatinine clearance of less than 30 mL/min should have the dose reduced from 1000 mg to 500 mg daily.

Levaquin is a registered trademark of Ortho-McNeil Pharmaceutical, Inc. Cipro is a registered trademark of Bayer Pharmaceuticals Corporation. Ciprofloxacin HCl is distributed by Barr Laboratories, Inc.

^† In vitro activity does not necessarily imply clinical effectiveness.

¹ Data on file, Bayer Pharmaceuticals Corporation.

² Stass H, Nagelschmitz J, Brendel E, Schueckler F. Pharmacokinetic characterization of a new ciprofloxacin once daily formulation for treatment of uncomplicated urinary tract infections. Poster presented at: American Federation of Medical Researchers; April 10-13, 2002; Baltimore, MD. Abstract 24.

³ Stass H, Nagelschmitz J, Brendel E, Schueckler F. Pharmacokinetic characterization of a new ciprofloxacin once daily formulation for treatment of uncomplicated urinary tract infections. Poster presented at: American Federation of Medical Researchers; April 10-13, 2002; Baltimore, MD. Abstract 25.