Proven Therapy. Advanced.

Healthcare professionals have trusted ciprofloxacin to treat uncomplicated urinary tract infections (UTIs) for years. Once-daily Cipro XR is available in a 500 mg formulation for the treatment of uncomplicated UTIs and now a 1000 mg formulation for the treatment of complicated UTIs, including acute uncomplicated pyelonephritis.

This site contains detailed information on Cipro XR for healthcare professionals, as well as educational materials for your patients. You can also direct your patients to the Cipro XR Patients' Site.

Cipro XR offers:

Proven clinical success in UTIs

95.0% clinical success rate for Cipro XR 500 mg¹
96.1% clinical success rate for Cipro XR 1000 mg²

Rapid and sustained bactericidal activity^‡

Fast onset of action for 24 hours of bactericidal activity

The convenience of once-daily dosing

Now available in 500 mg and 1000 mg strengths
Priced less than other UTI therapies^{†† 3,4}

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**Indications

Cipro XR (500 mg qd ) is indicated for the treatment of uncomplicated urinary tract infections (acute cystitis) caused by Escherichia coli, Proteus mirabilis, Enterococcus faecalis, or Staphylococcus saprophyticus.^a

Cipro XR (1000 mg qd ) is indicated for the treatment of complicated urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterococcus faecalis, Proteus mirabilis, or Pseudomonas aeruginosa.^a

Cipro XR (1000 mg qd ) is indicated for the treatment of acute uncomplicated pyelonephritis caused by Escherichia coli.

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

Important Safety Information

Serious and fatal reactions have been reported in patients receiving concurrent administration of ciprofloxacin and theophylline. Monitor theophylline levels if concurrent administration cannot be avoided.

The safety and effectiveness of Cipro XR in children, adolescents less than 18 years of age, pregnant women and lactating women have not been established. Cipro XR is contraindicated in persons with a history of hypersensitivity to ciprofloxacin or any quinolone, and should be discontinued at the first sign of an allergic reaction.

Adverse reactions determined to be at least possibly drug- related occurring in greater than or equal to 1% of patients were nausea (3%), diarrhea (2%), headache (1%), dyspepsia (1%), dizziness (1%), and vaginal moniliasis (1%). Vomiting (1%) occurred in the 1000 mg dose.

Cipro XR should be administered at least 2 hours before or 6 hours after antacids containing magnesium, aluminium, or other products containing metal cations. A 2-hour window between substantial calcium intake (>800 mg) and dosing with Cipro XR is recommended.

DO NOT SPLIT, CRUSH, OR CHEW THE TABLET.

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

^††Price comparisons are not intended to compare efficacy.

¹At the Test-of-Cure visit, clinical success was achieved in 95.0% of the Cipro XR (500 mg qd ) group and 91.5% of the Cipro^® (250 mg bid ) group (95% CI, -1.1%, 8.1%). 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 (Days 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.^‡

²At the Test-of-Cure visit, clinical success was achieved in 96.1% of the Cipro XR (1000 mg qd ) group and 92.1% of the Cipro (500 mg bid ) group (95% CI, -0.3%, 8.5%). Study design: A prospective, double-blind, multicenter, clinical trial comparing the safety and efficacy of Cipro XR (1000 mg qd ) and Cipro (500 mg bid ) in adult men and women with clinical signs and symptoms of complicated UTI or acute uncomplicated pyelonephritis. The primary efficacy variable was bacteriological eradication at Test of Cure (Days 5-11 post-therapy); secondary variables included clinical response rates at Test of Cure. Clinical success is defined as relief of symptoms, including pyuria, dysuria, frequency, urgency, suprapubic pain, fever, chills, flank pain, nausea and/or vomiting, or CVA tenderness.^‡

³Levaquin^®, Cipro, ciprofloxacin HCI. Levaquin is a registered trademark of Ortho-McNeil Pharmaceutical, Inc. Cipro is a registered trademark of Bayer Pharmaceuticals Corporation. Ciprofloxacin HCI is distributed by Barr Laboratories, Inc.

⁴First Databank Price Alert, September 2003.