Physician Site Cipro XR 500mg Cipro XR 1000 mg Patient Education Prescribing Information

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Cipro^® XR 500 mg

Below, you will find information about Cipro XR for uncomplicated urinary tract infections. Please see complete Cipro XR Prescribing Information.

• Proven efficacy
• Rapid and sustained bactericidal activity^‡
• Tolerability with added convenience

Proven efficacy

With a clinical success rate of 95.5% and bacterial eradication of 94.5%, you can feel confident prescribing Cipro XR.

Study design: A prospective, double-blind, multicenter, clinical trial comparing the safety and efficacy of Cipro XR (500 mg qd) and Cipro (250 mg bid) in adult women with clinical signs and symptoms of acute uncomplicated UTI. The primary efficacy variable was bacteriological eradication at Test of Cure (day 4 -11 post-therapy); secondary variables included clinical response rates at Test of Cure.

Clinical success is defined as relief of symptoms including dysuria, frequency, urgency, or suprapubic pain.¹

In patients aged 18-30 years, higher eradication rates were found in Cipro XR (n=83) vs. Cipro (n=92): 98.8% vs. 94.8%, respectively.

Cipro XR effectively eradicates E. coli, which causes 80% of all uncomplicated UTIs.²

Cipro XR effectively eradicates other uropathogens: E. faecalis (90.9%), P. mirabilis (91.7%), S. saprophyticus (85.7%).

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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 35% of Cipro XR is delivered immediately, providing high levels in the bloodstream within the first 1-2 hours.

• ~40% greater C_max than Cipro C_max achieved within 1.5 hours

The remaining 65% is gradually released over time, allowing urine concentrations that remain well above MIC90 of indicated uropathogens.3 Urine concentrations 24 hours post-dosage remain sufficiently high to kill indicated uropathogens: E. faecalis, E. coli, P. mirabilis, S. saprophyticus.<sup>a

‡</sup>In vitro activity does not necessarily imply clinical effectiveness.

Study design: An open-label, single-center, randomized, non-controlled, twofold, crossover study to assess the single dose and steady state pharmacokinetics of Cipro XR (500 mg qd) and Cipro (250 mg bid) in 20 healthy male volunteers.

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Tolerability with added convenience

Cipro XR is well tolerated. In a clinical trial, no significant differences in adverse events between Cipro XR and Cipro were observed. The most common adverse events occurring in at least 1% of patients included nausea (3%) and headache (2%).

Cipro XR is taken as one 500 mg tablet per day. It can be taken with or without food to conveniently fit into your patients' busy lives. No dosage adjustment is needed for renally impaired patients. Plus, Cipro XR costs less than Cipro (250 mg bid) on a per-day basis for a comparable course of therapy (3 days).^§

For complete information, please view the Cipro XR Prescribing Information .

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^a Treatment of infections due to this organism in this organ system was studied in fewer than 10 patients.
^§Based on average wholesale price, Red Book®, March 2003.
¹ Data on file, Bayer Pharmaceuticals Corporation
² Stamm WE, Hooton TM. Management of urinary tract infections in adults. N Engl J Med. 1993;329:1328-1334.
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 24.