Navigation Links
Five Days of LEVAQUIN(R) as Effective as 10 Days of Ciprofloxacin,in Complicated Urinary Tract Infections and Acute Pyelonephritis

ANAHEIM, Calif., May 19, 2007 /PRNewswire/ -- Data presented today at a major medical meeting found that Levaquin (levofloxacin) 750 mg tablets administered once-daily for five days is as effective as standard therapy of ciprofloxacin (400/500 mg) for 10 days for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis (AP).

Ortho-McNeil, Inc., the company that markets LEVAQUIN in the U.S., presented the data during a scientific session at the annual meeting of the American Urological Association (AUA), held here this week.

Each year, urinary tract infections account for more than eight million physician visits. They occur in the kidneys, ureters, bladder or the urethra and often are recurrent, resulting in treatment with several courses of antibiotics. Complicated UTIs occur nearly as frequently in men as in women and often occur in people who are susceptible to bacterial infections because of a weakened immune system. Complicated UTIs also may be caused by structural or functional difficulties that interfere with the flow of urine, such as kidney stones.

Pyelonephritis is an infection of one or both kidneys caused by bacteria. It is estimated that more than 250,000 Americans suffer from AP every year, with 10 to 30 percent of cases resulting in hospitalization.

"A short course of five, once-daily doses of LEVAQUIN 750 mg is as effective as 10 twice-daily doses of ciprofloxacin in treating complicated urinary tract infections and acute pyelonephritis," said Norman R. Rosenthal, MD, Vice President, Medical Affairs, on behalf of Ortho-McNeil, Inc. "These findings will be important to the healthcare professionals that treat patients with these conditions."

The multi-center, double-blind, randomized study of 1,109 patients with either cUTI or AP was designed to assess the efficacy and safety of LEVAQUIN (750 mg QD/five days) versus ciprofloxacin (400/ 500 mg BID/10 days). Endpoints evaluated microbiological eradication, clinical response and safety.

The microbiological eradication rates in the AP and cUTI subjects were comparable in both treatment groups, including subjects with various other complicating factors such as bacteremia, a form of blood infection. Clinical results, as defined by resolution of or improvement in urinary symptoms, were similar for both the LEVAQUIN (750 mg QD/five days) and the ciprofloxacin (400/500 mg BID/10 days) groups. The most commonly reported adverse events with both treatments were nausea, headache, and diarrhea, however, there were no significant differences in the frequency of these events between the two groups. LEVAQUIN was generally well tolerated.

Since its U.S. introduction in 1996, LEVAQUIN has gained widespread use in the treatment of adults for a variety of bacterial infections caused by susceptible pathogens, including: acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections (mild to moderate), chronic bacterial prostatitis, complicated and uncomplicated urinary tract infections (mild to moderate) and acute pyelonephritis (mild to moderate). LEVAQUIN is available in 250 mg, 500 mg and 750 mg doses in both oral and I.V. formulations. The safety profile of LEVAQUIN is similar across doses.

Important Safety Information

The most common drug-related adverse events in U.S. clinical trials were nausea (1.5%) and diarrhea (1.2%). The safety and efficacy of LEVAQUIN in pediatric patients, adolescents (under 18), pregnant women, and nursing mothers have not been established. LEVAQUIN is contraindicated in persons with a history of hypersensitivity to LEVAQUIN, quinolone antimicrobial agents, or any other components of this product. Serious and occasionally fatal events, such as hypersensitivity and/or anaphylacti c reactions, as well as some of unknown etiology have been reported in patients receiving therapy with quinolones, including LEVAQUIN.

These reactions may occur following the first dose or multiple doses. The drug should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.

As with other quinolones, LEVAQUIN should be used with caution in patients with known or suspected central nervous system disorders, peripheral neuropathy, or in patients who have a predisposition to seizures.

Tendon ruptures that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including LEVAQUIN, during and after therapy. This risk may be increased in patients receiving concomitant corticosteroids, especially the elderly. The quinolone should be discontinued in patients experiencing pain, inflammation, or rupture of a tendon.

Some quinolones, including LEVAQUIN, have been associated with prolongation of the QT interval, infrequent cases of arrhythmia, and rare cases of torsades de pointes. LEVAQUIN should be avoided in patients with known risk factors such as prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving class IA (quinidine, procainamide), or class III (amiodarone, sotalol) antiarrhythmic agents.

Antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc, or Videx(R)* (didanosine) chewable/buffered tablets or the pediatric powder for oral solution, should be taken at least 2 hours before or 2 hours after LEVAQUIN administration.

For information on Warnings, Precautions, and additional Adverse Reactions that may occur, regardless of drug relationship, please see full Prescribing Information on

PriCara (TM), Unit of Ortho-McNeil, Inc.

Or tho-McNeil, Inc. is headquartered in Raritan, N.J. PriCara, Unit of Ortho-McNeil, Inc. provides innovative, high-quality, prescription medicines, education and resources for primary healthcare providers and their patients in the areas of pain, gastrointestinal and infectious diseases. For more information about the company, please visit

*Videx is a registered trademark of Bristol-Myers Squibb Company

CONTACT: Media, Amy Firsching, +1-908-218-7583, Samina Bari,+1-908-218-6483, or Investors, Stan Panasewicz, +1-732-524-2524, LesleyFishman, +1-732-524-3922 or Louise Mehrotra, +1-732-524-6491

Web site:

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


Related medicine technology :

1. New Study Shows That Extending Prophylaxis With Clexane / Lovenox (enoxaparin Sodium Injection) to 5 Weeks is More Effective Than 10 Days for Reducing the Risk of Venous Thromboembolism (VTE) in Acutely ill Medical Patients With Reduced Mobility
2. Eurands Zentase Effective in Treating Exocrine Pancreatic Insufficiency, Studies Show
3. Cimzia Effective in Reducing Signs and Symptoms of Rheumatoid Arthritis
4. Gabapentin Shown Effective for Fibromyalgia Pain
5. ApoCells Cancer Predictive Index Helps Oncologists Select the Most Effective Targeted Drug Therapy
6. Roxro Pharma’s Novel Intranasal Pain Reliever Effective, Well Tolerated in Phase 3 Study
7. XYOTAX More Cost Effective With Fewer Side Effects Than Gemcitabine or Vinorelbine in Treating Non-Small Cell Lung Cancer
8. Soliris Effective in PNH Patients With History of Aplastic Anemia and Myelodysplastic Syndromes
9. Repeated Radioimmunotherapy With 131I-Labetuzumab Appears Safe and Effective in Colorectal Cancer with Liver Metastases
10. Biotheras Imprime PGG Enhanced Effectiveness of Avastin in Cancer Study
11. Targanta Study Shows Oritavancin Treatment Effective in a Mouse Model of Anthrax
Post Your Comments:
(Date:11/26/2015)... , Nov. 26, 2015 Research ... addition of the "2016 Future Horizons and ... (TDM) Market: Supplier Shares, Country Segment Forecasts, Competitive ... --> --> ... analysis of the Italian therapeutic drug monitoring market, ...
(Date:11/25/2015)...  Amgen (NASDAQ: AMGN ) today announced the ... the United States (U.S.) Food and ... to Humira ® (adalimumab). Amgen believes this submission ... FDA and represents Amgen,s first BLA submission using the ... M.D., executive vice president of Research and Development at ...
(Date:11/25/2015)... MINNEAPOLIS , Nov. 25, 2015  ARKRAY ... care products, continues to provide evidence demonstrating the accuracy ... the World Congress on Insulin Resistance, Diabetes and Cardiovascular ... showed that both the Company,s GLUCOCARD ® 01 ... met high accuracy requirements. The ability to accurately measure ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... Intellitec Solutions announced ... User Group (MSDSLUG). Recognized as Microsoft’s official group for end users of Dynamics ... software users, partners, industry experts and representatives. Intellitec Solutions’ membership status demonstrates their ...
(Date:11/27/2015)... ... 2015 , ... The men and women on this list ... the country. They have overseen financial turnarounds, shown commitment to their community through ... as a whole through their advocacy and professional efforts. , Becker's Hospital Review ...
(Date:11/26/2015)... ... November 26, 2015 , ... Inevitably when people think Thanksgiving, they also ... buy during the Black Friday and Cyber Monday massage chair sales to ... Internet high and low to find the best massage chair deals, they can see ...
(Date:11/26/2015)... ... 2015 , ... PRMA Plastic Surgery is updating their record books yet again ... free flap breast reconstruction surgery! , “What an accomplishment for the PRMA team, says ... and it’s an honor to have served all of these women.” , PRMA is ...
(Date:11/25/2015)... OAK BROOK, Ill. (PRWEB) , ... November 25, ... ... sometimes larger and potentially more aggressive than those found on mammography, according to ... cases MRI findings of additional cancers not seen on mammography may necessitate a ...
Breaking Medicine News(10 mins):