©2002-2014 Prometheus. All Rights Reserved
Terms & Conditions
The following terms apply to all visitors or users of the Web site. By accessing this Web site, you acknowledge acceptance of these terms. Prometheus reserves the right to change these terms from time to time at its sole discretion. In the case of any violation of these terms, Prometheus reserves the right to seek all remedies available by law and in equity for such violations. These terms apply to all visits to the Prometheus Web site, both now and in the future.
Disclaimer and Limitation of Liability
This Web site is provided as a service to its visitors for informational purposes and for your general interest and entertainment only. By using this Web site you hereby agree not to rely on any of the information contained herein. This Web site is not designed to provide a diagnosis or medical advice and should not be relied on or interpreted as doing so. Any information in this Web site relating to various health and medical conditions is provided for information purposes only. It is not meant to be a substitute for the advice provided by a physician or other healthcare professional. You should always consult a physician or healthcare provider for your personal medical needs. Prometheus will use reasonable efforts to include accurate and up-to-date information on this Web site. The materials at this site may be out of date by the time that they may be accessed or read. Some materials presented could include technical inaccuracies or typographical errors. Prometheus reserves the right to make changes or improvements to this Web site at any time. THE MATERIALS ON THIS WEB SITE ARE PROVIDED "AS IS" AND WITHOUT WARRANTIES OF ANY KIND EITHER EXPRESS OR IMPLIED. TO THE FULLEST EXTENT PERMISSIBLE PURSUANT TO APPLICABLE LAW, PROMETHEUS DISCLAIMS ALL WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT OF INTELLECTUAL PROPERTY. INFORMATION ON THIS WEB SITE MAY REFER TO PRODUCTS, PROGRAMS, OR SERVICES THAT ARE NOT AVAILABLE IN YOUR COUNTRY.
IN NO EVENT WILL PROMETHEUS OR THIRD PARTIES MENTIONED AT THIS SITE BE LIABLE FOR ANY DAMAGES WHATSOEVER (INCLUDING, WITHOUT LIMITATION, THOSE RESULTING FROM LOST PROFITS, LOST DATA, OR BUSINESS INTERRUPTION) ARISING OUT OF THE USE, INABILITY TO USE, OR THE RESULTS OF USE OF THIS SITE, ANY WEB SITES LINKED TO THIS SITE, OR THE MATERIALS OR INFORMATION CONTAINED AT ANY OR ALL SUCH SITES, WHETHER BASED ON WARRANTY, CONTRACT, TORT, OR ANY OTHER LEGAL THEORY AND WHETHER OR NOT ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. IF YOUR USE OF THIS SITE RESULTS IN THE NEED FOR SERVICING, REPAIR, OR CORRECTION OF EQUIPMENT OR DATA, YOU ASSUME ALL COSTS THEREOF. APPLICABLE LAW MAY NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU.
Except for historical information, this Web site contains forward-looking statements that involve risks and uncertainties which may cause actual results to differ materially from the statements made, including the Company's dependence on sales of key products, uncertainty of future financial results and fluctuations in operating results, dependence on the Company's acquisition strategy, new product introductions, and other risks from time to time. These forward-looking statements represent the judgment of the Company as of the date of this Web site development and/or update, and Prometheus disclaims any intent or obligation to update these forward–looking statements.
Prometheus spends millions of dollars each year in discovery, development, acquisition and protection of its diagnostic and therapeutic products. Much of the Company's technology is protected by U.S. and foreign patents. A patent provides protection for the Company's exclusive use and development of certain product technology and methodologies for a specific period of time.
Prometheus products, services, and technology may be covered by one or more U.S. pending or issued patents. Details of the patent coverage may be found at http://www.prometheuslabs.com/Legal.asp.
In addition, foreign patents may be issued or pending on the Company's products, technologies and services.
All logos, trademarks, and service marks (the "Trademarks") displayed on this site whether or not appearing in large print or with or without the trademark symbol are registered and unregistered Trademarks of Prometheus Laboratories Inc. or of respective third parties . Your access to this Web site should not be construed as granting, by implication, estoppel or otherwise, any license or right to use any marks appearing on the Web site without the prior written consent of Prometheus or the third-party owner there of.
The content of this Web site is protected by applicable copyright, trademark and other intellectual property laws. All material published in this Web site (including but not limited to images, illustrations, information, documents and related graphics) is the sole property of Prometheus and may not be reproduced, modified, uploaded, downloaded, posted, transmitted, republished or distributed without Prometheus' written permission. Modification of the content or use of the content for any other purpose is a violation of the copyrights and other proprietary rights of Prometheus. Prometheus hereby authorizes you to copy certain materials published by Prometheus on this Web site and identified as "Resources" solely for non-commercial use within your organization. No other use of the information is authorized. In consideration of this authorization, you agree that any copy of these materials will retain all copyright and other proprietary notices in the same form and manner as on the original. Except as specified above, nothing contained herein will be construed as conferring by implication, estoppel, or otherwise, any license or right under any intellectual property rights of Prometheus or any third party.
This Web site is controlled by Prometheus from its offices in San Diego, California. Prometheus makes no representation that the information on the Web site is appropriate or available for use outside the United States, and access to it from territories where its contents is illegal is prohibited. If you chose to access this Web site from outside the United States, you do so on your own initiative and are responsible for compliance with applicable local laws. You may not use or export the information contained in this Web site in violation of U.S. export laws and regulations. Your access to this Web site is governed by all applicable federal, state, and local laws and may also be subject to the laws of the country where you reside.
Links to Others
Links to third-party Web sites on this site are provided solely as a convenience to you. If you use these links, you are leaving this Web site. Prometheus has not reviewed all of these third-party sites and does not control and is not responsible for any of their content. Furthermore, Prometheus does not endorse or make any representations about them, or any information, software or other products or materials found there, or any results that may be obtained from using them. If you access any of the third-party sites linked to this Web site, you do this entirely at your own risk and expressly release Prometheus, and its subsidiaries, officers, directors and employees from any and all consequences, damages, and liabilities resulting there from.
In some circumstances, Prometheus may request personal information from you, such as your name, E-mail address, company name, or telephone number. Your response to these inquiries is strictly voluntary. The information we collect is used to improve the content of our Web site and may be used to contact you, via E-mail or regular mail, to provide you with information we believe may be of interest to you. We do not share this information with other organizations for commercial purposes. Information that is not personal or is not associated with any personally identifiable data, such as questions, comments, ideas, and suggestions, shall be deemed to be non-confidential, and Prometheus shall be free to disclose and use the same for any purpose, without any obligation whatsoever to you.
Prometheus also collects domain information as part of its analysis of the use of this site. The data enables us to become more familiar with customers that visit our site, such as how often they visit and what parts of the site they visit most often. This information is used to improve our Web site.
Use of "Cookies"
Privacy Protections for Minors
Prometheus' web site is not directed at or intended for minors. Therefore, we do not wish to receive, nor do we knowingly collect, personal information from minors via this Web site.
INDICATION: LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome who have: chronic irritable bowel syndrome symptoms (generally lasting 6 months or longer), had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and not responded adequately to conventional therapy. Diarrhea-predominant irritable bowel syndrome is severe if it includes diarrhea and one or more of the following: frequent and severe abdominal pain/discomfort, frequent bowel urgency or fecal incontinence, disability or restriction of daily activities due to irritable bowel syndrome. Because of infrequent but serious gastrointestinal adverse events associated with LOTRONEX, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable. Clinical studies have not been performed to adequately confirm the benefits of LOTRONEX in men.
PEDIATRIC USE: Safety and effectiveness have not been established in pediatric patients.
IMPORTANT SAFETY INFORMATION: Infrequent but serious gastrointestinal adverse events have been reported with the use of LOTRONEX. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization, and rarely, blood transfusion, surgery, and death. Some patients have experienced serious complications of constipation or ischemic colitis without warning. In IBS clinical trials, approximately 10% of patients on LOTRONEX withdrew prematurely because of constipation. The incidence of serious complications of constipation was approximately 0.1% (1 per 1,000 patients) in women receiving either LOTRONEX or placebo. In IBS clinical trials, the cumulative incidence of ischemic colitis in women receiving LOTRONEX was 0.2% (2 per 1,000 patients, 95% confidence interval 1 to 3) through 3 months and was 0.3% (3 per 1,000 patients, 95% confidence interval 1 to 4) through 6 months. Ischemic colitis was not reported in women receiving placebo. The patient experience in controlled clinical trials is insufficient to estimate the incidence of ischemic colitis in patients taking LOTRONEX for longer than 6 months.
LOTRONEX should be discontinued immediately in patients who develop constipation or symptoms of ischemic colitis such as rectal bleeding, bloody diarrhea or new or worsening abdominal pain. Patients should immediately report constipation or symptoms of ischemic colitis to their physician. LOTRONEX should not be resumed in patients who develop ischemic colitis. Patients who have constipation should immediately contact their physician if the constipation does not resolve after LOTRONEX is discontinued. Patients with resolved constipation should resume LOTRONEX only on the advice of their treating physician.
LOTRONEX should not be initiated in IBS patients who are constipated. LOTRONEX is contraindicated in patients with a history of chronic or severe constipation or a history of sequelae from constipation; with a history of intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation, and/or adhesions; with a history of ischemic colitis, impaired intestinal circulation, thrombophlebitis, or hypercoagulable state; with current or a history of Crohn's disease or ulcerative colitis; with severe hepatic impairment; with active diverticulitis or a history of diverticulitis; in patients who are unable to understand or comply with the Patient-Physician Agreement; and/or in patients with known hypersensitivity to any component of the product. Concomitant administration of alosetron with fluvoxamine is contraindicated.
DOSING: To lower the risk of constipation, LOTRONEX should be started at a dosage of 0.5 mg twice a day. Patients well controlled on 0.5 mg twice a day may be maintained on this regimen. If, after 4 weeks, the 0.5-mg twice-daily dosage is well tolerated but does not adequately control IBS symptoms, then the dosage can be increased to up to 1 mg twice a day, the dose used in controlled clinical trials. LOTRONEX should be discontinued in patients who have not had adequate control of IBS symptoms after 4 weeks of treatment with 1 mg twice per day. LOTRONEX should be used with caution in debilitated patients, elderly patients, patients with mild or moderate hepatic impairment, and patients taking medications that decrease gastrointestinal motility. LOTRONEX should not be used in patients with severe hepatic impairment.
Please consult the Complete Prescribing Information.