Sepracor Inc. Web Site Privacy Policy
Welcome to www.xopenex.com, a Sepracor Inc. web site. Sepracor Inc. is committed to privacy for our web site users. Please be sure to read this Policy before using and submitting information on any of our web sites. Your use of any Sepracor web site is subject to this Policy as well as the Terms of Use. By accessing and using any of our web sites you agree to be bound by the terms of this Policy.
This Policy may be subject to change. Any changes will be posted on this page. Should you have any questions, comments or concerns please contact us at: xopenex@sepracor.com.
Collection of Information
Sepracor Inc. learns certain information about you from your visit to our web site, and what we do with this information depends on what you do when you are visiting the site. Unless you register and create a profile, send us an e-mail, or use chat rooms and forums or other products and services that are or will be available on our web site, we collect and store only the following information with the goal of improving the content and services offered on our web site: (i) the domain and host from which you access the Internet; (ii) the Internet address of the web site from which you linked directly to the Sepracor web site, if applicable; (iii) the date and time you arrived at our web site and how long you spent on the web site and which pages you visited; (iv) your Internet protocol (IP) address; and (v) your computer's operating system and browser software. Sepracor does not use this information to determine the individual identity of any web site visitor.
If you do register and create a profile, create a user name and password, send us an e-mail, or use the chat rooms and forums or other products and services that are or will be available on our web site, or otherwise voluntarily submit personally identifiable information to Sepracor, we will collect and store the information you enter. This information may be used by Sepracor personnel as a means to contact you to obtain more information, to improve the site, or it might be used to provide you with information that you have or additional information that Sepracor believes may be of interest to you.
Sepracor maintains the data collected in an electronic database. Sepracor or its agents may exchange such information with each other or with you over the Internet or intranet systems for the purposes of carrying out the services described in this Policy. In addition, Sepracor reserves the right to keep all information in an off-line form, for archival purposes or as otherwise required by law.
Use and Disclosure of Information
Sepracor does not provide personally identifiable information about our web site visitors to third parties except (i) to vendors and service providers who assist us in providing services to you; (ii) in connection with security related or law enforcement investigations or in the course of cooperating with authorities; (iii) to comply with legal requirements or to establish or exercise our legal rights or defend against legal claims; (iv) when we believe it is necessary to share information in order to assist in an investigation regarding, or to prevent, illegal activities, suspected fraud, or situations involving potential threats to the safety of any person; and (v) we may transfer such information upon a sale or merger of our business or upon a sale of assets that includes the web sites. Any vendor or service provider to whom we provide personally identifiable information is required to keep your information confidential.
We may use aggregate data (information about our base of users in general, from which all personally-identifying information has been removed) for any purpose.
Opting In / Permission To Contact You And/or Send You Materials and Information
Only when specifically requested by our web site visitors, will the information we collect be used to respond to visitors' inquiries and/or to send visitors information/newsletters, fulfill e-mail messaging programs, and notify visitors about new content or services on our web sites. In other words, it is only when you have specifically requested to receive such contact and information from us that we use any of your personally identifiable information.
Unsubscribing/Opting Out
If you decide you no longer wish to receive communications from us (postal mailings and/or e-mails), you may opt out at any time by notifying us at xopenex@sepracor.com.
Contacting Us About Your Online Privacy
Web site visitors may always contact us to remove or update personally identifiable information from our database by sending an e-mail to us. If you have any questions or comments about the way your personally identifiable information collected via our web sites is used and handled, please e-mail us at xopenex@sepracor.com.
Security
Sepracor takes reasonable precautions to keep all information obtained from web site visitors secure against unauthorized access and use. Please be aware, however, that there is always some risk involved when submitting data over the Internet.
Third-Party Web Sites
As a convenience to our web site visitors, our sites may contain links to third-party web sites. Third-party web sites are not covered by this Policy and Sepracor will have no control over the information you enter or the cookies your browser accepts while on third parties' sites. You should examine the terms of service and privacy policies of other web pages whenever you leave a Sepracor web site. Sepracor is not responsible for the privacy practices or the content included on third-party web sites.
Site/Membership Registration Forms
Our site's registration forms require users to give us contact information (like name and email address), and other demographic information. We use customer contact information from the registration forms to send the user information about our company and/or our products. The customer's contact information is also used to contact the visitor when necessary.
Contest
We run contests on some sections of our site in which we ask visitors for contact information (like email address) and demographic information. The customer's contact information is also used to contact the visitor when necessary (e.g., prize distribution).
Advertising
We use an outside ad company to display ads on our site. These ads may contain cookies. While we use cookies in other parts of our web site, cookies received with banner ads are collected by our ad company and are used for advertisement banner rotation purposes only.
Public Forums
This site may make chat rooms, forums, List Serves and message boards available to its users. Please remember that any information that is disclosed in these areas becomes public information and you should exercise caution when deciding to disclose your personal information. Sepracor cannot ensure or warrant the security of any information provided by you in such forums, and you do so at your own risk.
Children
Our web sites are intended for use by adults and young adults only. We do not knowingly collect information from children under the age of 18.
Use of "Cookies"
Our site uses cookies to maintain user session identity, and to store your username and password locally for ease of access. "Cookies" are small pieces of information that are stored by your browser on your computer's hard drive. Most web browsers automatically accept cookies, but if you prefer, you can edit your browser options to block them in the future; however, if you disable cookies, our web site will not remember your customizations and cannot help you find what you want on the site most easily. If you accept cookies, you can delete them later by going to the preferences, tools or options menus of your browser.
©2007 Sepracor Inc. All rights reserved |
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Patient Prescribing Information
XOPENEX® (levalbuterol HCl) Inhalation Solution
0.31 mg,* 0.63 mg,* 1.25 mg*
*Potency expressed as levalbuterol
CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION
Patient Information about XOPENEX
What is XOPENEX used for?
XOPENEX (Zō–pen-eks) is used to treat or prevent narrowing of airways (bronchospasm) in patients 6 years of age and older with reversible obstructive airway disease, such as asthma.
What are the symptoms of bronchospasm?
Symptoms of bronchospasm include: coughing, wheezing, chest tightness, and shortness of breath.
Who should not take XOPENEX?
You should not take XOPENEX if you have had any type of reaction (hypersensitivity) to levalbuterol or albuterol.
Special Warnings Concerning XOPENEX:
Like other inhaled beta-agonists, XOPENEX Inhalation Solution can produce a narrowing of the airways called paradoxical bronchospasm, which may be life-threatening.
Your health care provider may need to prescribe other medications in addition to XOPENEX to help control your asthma. Do not stop taking other asthma medications unless advised by your health care provider.
XOPENEX can cause significant heart-related side effects, such as an increase in pulse, blood pressure and/or related symptoms. If you have a heart condition, your doctor will determine if XOPENEX is right for you.
Use as directed by your doctor or health care provider. Deaths have been reported with similar inhaled medications in asthma patients who use too much medication.
Hypersensitivity reactions (severe allergic reactions) may occur immediately after taking XOPENEX. If you experience itching, areas of skin swelling (angioedema), skin rash, or narrowing of the airways, these may be signs of a hypersensitivity reaction. Seek immediate medical attention if this happens.
If you find that treatment becomes less effective, your symptoms become worse and/or you need to use the product more frequently than usual, you should seek medical attention immediately.
General Precautions with XOPENEX:
If you currently have, or have had, a history of the following conditions, your health care provider will evaluate you to decide if XOPENEX is right for you:
- heart disease (e.g., reduced heart circulation, high blood pressure, and irregular heartbeat)
- seizures
- high levels of thyroid hormone
- diabetes
- reactions to medications similar to XOPENEX
What should I tell my doctor or health care provider?
Review all medications that you are taking with your health care provider, including those that you take without prescription. Because of the potential to interact with XOPENEX and cause side effects, tell your doctor if you are taking other medications such as:
- diuretics, such as furosemide and HCTZ (hydrochlorothiazide)
- antidepressants such as monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants
- drugs known to affect the heart’s regular rhythm
- drugs used for high blood pressure or after a heart attack, such as metoprolol or atenolol
Tell your doctor if you are trying to become pregnant, are already pregnant, or are nursing.
What are some possible side effects of XOPENEX? (This is not a complete list of side effects reported with XOPENEX. Your health care provider can discuss with you a more complete list of side effects.)
Side effects of XOPENEX may depend on dose. XOPENEX may result in a temporary increase in heart rate, tremors, or nervousness.
How is XOPENEX taken?
XOPENEX Inhalation Solution is administered by the use of a nebulizer (NEB-yoo-ly-zer). A nebulizer is a device that converts XOPENEX Inhalation Solution into a fine mist that can be inhaled. Your doctor will instruct you on the correct use of your nebulizer and also give you written instructions. It is very important that you take your XOPENEX as directed by your physician.
Xopenex Inhalation Solution Patient's Instructions for Use
How is XOPENEX stored?
Store XOPENEX in the protective foil pouch at room temperature (68°F - 77°F). Protect from light and excessive heat. Keep unopened vials in the foil pouch. Once the pouch is opened, the vials should be used within two weeks. Vials removed from the pouch, if not used immediately, should be protected from light and used within one week. Discard any vial if the solution is not colorless.
What are the inactive ingredients in XOPENEX Inhalation Solution?
The inactive ingredients are water, sodium chloride, and sulfuric acid.
How can I find out more about XOPENEX?
Talk to your doctor. Your doctor is the best source of information, or you can call the Sepracor Customer Assistance Center at 1-888-394-7377.
Ask your doctor for the complete prescribing information and the attached Patient's Instructions for Use. This information is also available at www.xopenex.com.
September 2007
Sepracor Inc.
Marlborough, MA 01752
XOPENEX HFA® (levalbuterol tartrate) Inhalation Aerosol
CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION
Patient Information about XOPENEX HFA
For Oral Inhalation Only
What is XOPENEX HFA used for?
XOPENEX (Zō–pen-eks) HFA is used to treat or prevent narrowing of airways (bronchospasm) in patients 4 years of age and older with reversible obstructive airway disease, such as asthma.
What are the symptoms of bronchospasm?
Symptoms of bronchospasm include: coughing, wheezing, chest tightness, and shortness of breath.
Who should not take XOPENEX HFA?
You should not take XOPENEX HFA if you have had any type of reaction (hypersensitivity) to levalbuterol, albuterol, or any other component of XOPENEX HFA.
Special Warnings Concerning XOPENEX HFA:
Like other inhaled beta-agonists, XOPENEX HFA can produce a narrowing of the airways called paradoxical bronchospasm, which may be life-threatening.
Your health care provider may need to prescribe other medications in addition to XOPENEX HFA to help control your asthma. Do not stop taking other asthma medications unless advised by your health care provider.
XOPENEX HFA can cause significant heart-related side effects, such as an increase in pulse, blood pressure and/or related symptoms. If you have a heart condition, your doctor will determine if XOPENEX HFA is right for you.
Use as directed by your doctor or health care provider. Deaths have been reported with similar inhaled medications in asthma patients who use too much medication.
Hypersensitivity reactions (severe allergic reactions) may occur immediately after taking XOPENEX HFA. If you experience itching, areas of skin swelling (angioedema), skin rash, or narrowing of the airways, these may be signs of a hypersensitivity reaction. Seek immediate medical attention if this happens.
If you find that treatment becomes less effective, your symptoms become worse and/or you need to use the product more frequently than usual, you should seek medical attention immediately.
General Precautions with XOPENEX HFA:
If you currently have, or have had, a history of the following conditions, your health care provider will evaluate you to decide if XOPENEX HFA is right for you:
- heart disease (e.g., reduced heart circulation, high blood pressure, and irregular heartbeat)
- seizures
- high levels of thyroid hormone
- diabetes
- reactions to medications similar to XOPENEX HFA
What should I tell my doctor or health care provider?
Review all medications that you are taking with your health care provider, including those that you take without prescription. Because of the potential to interact with XOPENEX HFA and cause side effects, tell your doctor if you are taking other medications such as:
- diuretics, such as furosemide and HCTZ (hydrochlorothiazide)
- antidepressants such as monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants
- drugs known to affect the heart’s regular rhythm
- drugs used for high blood pressure or after a heart attack, such as metoprolol or atenolol
Tell your doctor if you are trying to become pregnant, are already pregnant, or are nursing.
What are some possible side effects of XOPENEX HFA? (This is not a complete list of side effects reported with XOPENEX HFA. Your health care provider can discuss with you a more complete list of side effects.)
Side effects of XOPENEX HFA may depend on the number of actuations used within a given time period. XOPENEX HFA may result in a temporary increase in heart rate, tremors, or nervousness.
How is XOPENEX HFA taken?
XOPENEX HFA is administered by the use of a pressurized metered-dose inhaler, which produces a fine mist that can be inhaled. Your doctor will instruct you on the correct use of your metered-dose inhaler and also give you written instructions. The usual dose of XOPENEX HFA is 2 inhalations repeated every 4 to 6 hours. One inhalation every four hours may be sufficient in some patients. It is very important that you use XOPENEX HFA as directed by your doctor.
Xopenex HFA Patient's Instructions for Use
How is XOPENEX HFA stored?
Store XOPENEX HFA at room temperature (68°F - 77°F). Protect from freezing temperatures and direct sunlight. Store with the actuator (mouthpiece) down. The contents are under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Avoid spraying in eyes. Keep out of reach of children.
What are the inactive ingredients in XOPENEX HFA?
The inactive ingredients are propellant HFA-134a (1,1,1,2-tetrafluoroethane), dehydrated alcohol USP, and oleic acid NF.
How can I find out more about XOPENEX HFA?
Talk to your doctor. Your doctor is the best source of information, or you can call the Sepracor Customer Assistance Center at 1-888-394-7377.
Ask your doctor for the complete prescribing information and the attached Patient’s Instructions for Use. This information is also available at www.xopenex.com.
September 2007
Sepracor Inc.
Marlborough, MA 01752
