Salix Pharmaceuticals, Inc.:
Metozolv ODT Web Site Privacy Notice
Salix Pharmaceuticals, Inc. respects your concerns about privacy. This Privacy Notice applies to personal information we collect on MetozolvODT.com.
This Privacy Notice describes the types of personal information we collect on MetozolvODT.com, how we may use that information and with whom we may share it.
The Privacy Notice also describes the measures we take to protect the security of the personal information. We also tell you how you can reach us to ask us to
update your preferences regarding how we communicate with you or answer any questions you may have about our privacy practices.
Click on one of the links below to jump to the listed section:
Information We Collect
Information You Provide Directly to Us
You may choose to provide personal information through MetozolvODT.com when you sign up to receive information about Metozolv ODT and new features added
to the site. If you sign up for these updates, we ask you for your name, email address and postal address. We use the information you submit to provide the
information you requested.
Information We Collect by Automated Means
We obtain certain information by automated means when you visit our Web site, such as the IP address of the device you use to connect to the Internet and
the pages accessed. By collecting this information, we learn how to best tailor our Web site to our visitors. We collect this information through
various means, such as "cookie" technology and "web beacons."
Cookies
Like many companies, we use "cookies" on this Web site. Cookies are bits of text that are placed on your computer's hard drive when you visit certain Web sites.
Cookies may enhance your online experience by saving your preferences while you are visiting a particular site. We use cookies, for example,
to measure activity on the site and determine which areas and features of the site are the most popular.
Most browsers will tell you how to stop accepting new cookies, how to be notified when you receive a new cookie and how to disable existing cookies.
Web Beacons
Certain pages on this Web site contain "web beacons" (also known as Internet tags, pixel tags and clear GIFs). These web beacons allow third parties to
obtain information such as the IP address of the computer that downloaded the page on which the beacon appears, the URL of the page on which the beacon
appears, the time the page containing the beacon was viewed, the type of browser used to view the page, and the information in cookies set by the
third party.
We use Google Analytics on this Web site. Google Analytics is a web analytics service that uses cookies and web beacons to help us analyze how users use
the site. The information generated by the cookie and web beacons about your use of the Web site (including your IP address) will be disclosed to Google,
which uses the information to evaluate your use of the Web site.
Information We Share
We may share personal information you provide on this Web site with our service providers who perform services on our behalf. These service providers are
not authorized by us to use or disclose the information except as necessary to perform services on our behalf or comply with legal requirements.
We also may disclose information about you (i) if we are required to do so by law or legal process, (ii) to law enforcement authorities, or (iii) when we believe disclosure is necessary or appropriate to prevent physical harm or financial loss or in connection with an investigation of suspected or actual
illegal activity. We also reserve the right to transfer personal information we have about you in the event we sell or transfer all or a portion
of our business or assets. Should such a sale or transfer occur, we will use reasonable efforts to direct the transferee to use personal information
you have provided to us in a manner that is consistent with our Privacy Notice.
Your Choices
You may amend your preferences regarding how we communicate with you by clicking on the "unsubscribe" link in email you receive or by contacting us as described
in the "How to Contact Us" section below.
How We Protect Personal Information
We maintain appropriate administrative, technical and physical safeguards to protect the personal information you provide on this Web site against accidental,
unlawful or unauthorized destruction, loss, alteration, access, disclosure or use and other unlawful forms of processing.
Links to Other Sites
This Web site may provide links to other sites for your convenience and information. These sites may be operated by companies not affiliated with Salix.
Linked sites may have their own privacy policies, which we strongly suggest you review if you visit any linked Web sites. We are not responsible for the content of
any Web sites that are not affiliated with Salix, any use of those sites, or the privacy practices of those sites.
Updates to Our Privacy Notice
This Privacy Notice may be updated periodically and without prior notice to you to reflect changes in our personal information practices or relevant laws.
We will post a prominent notice on the site to notify you of any significant changes to our Privacy Notice and indicate at the bottom of the notice
when it was updated.
If you have any questions or comments about this Privacy Notice, or if you would like us to update information we have about you or your preferences, please
contact us as indicated below:
Salix Pharmaceuticals Corporate Headquarters
1700 Perimeter Park Drive
Morrisville, NC 27560-8404
Phone: 919-862-1000
Fax: 919-862-1095
Effective Date: 10/2009
IMPORTANT SAFETY INFORMATION
Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose.
Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.
Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.
METOZOLV® ODT (metoclopramide HCl) is indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (diabetic gastric stasis) in adults. Therapy should not exceed 12 weeks in duration. Take on an empty stomach up to four times daily, at least 30 minutes before eating and at bedtime.
METOZOLV ODT is contraindicated in patients with intestinal obstruction, hemorrhage, or perforation; pheochromocytoma; known sensitivity or intolerance to metoclopramide; epilepsy; or are receiving concomitant medications with extrapyramidal reactions.
Extrapyramidal symptoms (EPS), manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients treated with the usual adult dosages of 30 to 40 mg/day of metoclopramide. These usually are seen during the first 24 to 48 hours of treatment with metoclopramide, occur more frequently in pediatric patients and adult patients less than 30 years of age and are even more frequent at higher doses.
Drug-induced Parkinsonism can occur during metoclopramide therapy, more commonly within the first 6 months after beginning treatment, but also after longer periods. Patients with a history of Parkinson’s disease should be given metoclopramide cautiously, if at all, since such patients can experience exacerbation of Parkinsonian symptoms when taking metoclopramide.
There have been rare reports of an uncommon but potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) associated with metoclopramide. Clinical manifestations of NMS include hyperthermia, muscle rigidity, altered consciousness, and evidence of autonomic instability. The management of NMS should include immediate discontinuation of metoclopramide and other drugs not essential to concurrent therapy.
Depression associated with metoclopramide use has occurred in patients with and without a history of depression. For those patients with a prior history of depression, metoclopramide should only be given if the expected benefits outweigh the potential risks.
In one study in hypertensive patients, intravenously administered metoclopramide was shown to release catecholamines; hence, caution should be exercised when metoclopramide is used in patients with hypertension. Any rapid rise in blood pressure associated with METOZOLV ODT use should result in immediate cessation of metoclopramide use in those patients.
Since metoclopramide produces a transient increase in plasma aldosterone, patients with cirrhosis or congestive heart failure may be at risk of developing fluid retention and volume overload. If these side effects occur at any time in any patients during metoclopramide therapy, the drug should be discontinued.
Adverse reactions, especially those involving the nervous system, may occur after stopping the use of METOZOLV ODT.
In clinical studies, the most frequently reported adverse events (≥2% occurrence) were headache, nausea, fatigue, somnolence, and vomiting.
Full Prescribing Information for METOZOLV ODT, including BOXED WARNING.
References: 1. METOZOLV ODT [package insert]. Morrisville, NC: Salix Pharmaceuticals, Inc; 2009.
2. Overview. US Food and Drug Administration. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=REGLAN. Accessed May 6, 2009.
3. Overview. US Food and Drug Administration. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=METOCLOPRAMIDE%20HYDROCHLORIDE. Accessed May 6, 2009.