Mission Pharmacal Company Legal and Privacy Statements

Website Privacy Statement

Mission Pharmacal Company is aware of the importance of protecting the privacy of visitors to our websites. Personally identifiable information, such as name, addresses, telephone numbers, and visitor comments voluntarily submitted to Mission Pharmacal Company will not be utilized for marketing purposes without obtaining visitor authorization prior to the submission of information. Mission Pharmacal Company reserves the right to utilize internally, for operations purposes, any information provided by visitors to this website.

This website may track IP addresses, and may utilize "session cookies" to collect information about visitor activities on this website.

Mission Pharmacal Company has no duty or obligation to respond to emails sent to the Webmaster of this website and cannot assure the confidentiality of such communications.

Mission Pharmacal Company websites may contain links to other websites that may contain useful information. Mission Pharmacal Company's privacy policies do not apply to those websites that are not owned and operated by Mission Pharmacal Company. Please contact those other websites for information pertaining to their privacy policies.

Mission Pharmacal Company reserves the right to revise this Website Privacy Statement, as necessary.

Medical Disclaimer

If you have a medical emergency, call 911 immediately.

The contents of this website are provided for informational purposes only. The website cannot replace your healthcare provider's medical advice, diagnosis, or treatment. Only a qualified health provider can properly address specific questions regarding your health or nutritional needs. Nothing on this website should be used to replace your healthcare provider's advice. Use of any information provided by this website is done at your own risk.

Compliance Statement

Mission Pharmacal Company has implemented Compliance Programs that include, among other provisions, a code of ethical conduct for interactions with healthcare professionals, and policies to safeguard the privacy and security of patient healthcare information.

For more information on these Compliance Programs, contact Mission Pharmacal Company's Compliance Officer at our toll-free telephone number: (800) 531-3333.

Terms of Use

Through your access to and use of this website, you accept, without limitation or qualification, the terms and conditions as set forth below.

If you do not wish to accept and be bound by the following terms and conditions, you may not use this website or the information contained herein.

Mission Pharmacal Company offers services and products to prevent, diagnose, and treat diseases and improve health. The prescription medications manufactured by Mission Pharmacal Company are regulated by government agencies in each of the countries in which it does business. Some of these regulations restrict the publishing of prescribing information on this website. You must speak with your qualified health care provider regarding any questions you may have regarding prescription medications and do not rely on the content of this website for such information. Nothing contained in this website is, nor shall it be construed as, medical diagnosis, treatment, or advice. Nothing contained in this website may take the place or substitute for, or augment, consultations and/or advice from physicians or other competent health care professionals or providers. See your physician or other health care provider.

Mission Pharmacal Company has developed this website as a service to consumers. However, some of the information on this website will become outdated, making it incorrect, and will only be updated periodically, if at all. As such, Mission Pharmacal Company shall not accept liability for consumer reliance on incorrect or outdated information on this website. Mission Pharmacal Company further assumes no liability or responsibility for any errors or omissions in any of the content of this website or the information contained therein.

None of the information on this website is medical advice. Consult your health care provider with questions regarding any medication or nutritional supplement. You must read the labels and inserts and follow directions on all products manufactured and/or marketed by Mission Pharmacal Company. Mission Pharmacal Company shall not be responsible for alleged damages incurred by consumers who rely on the information on this website as medical advice. By viewing this website, it is agreed that Mission Pharmacal Company shall not be liable for any direct, indirect, consequential, incidental, exemplary, or punitive damages arising out of your access to or use of this website or its contents. Additionally and separately from the above, the information provided on this website is provided "AS IS" WITHOUT ANY WARRANTIES OF ANY KIND, EITHER IMPLIED OR EXPRESSED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, AND MERCHANTABILITY. The exclusion of implied warranties may not be enforceable in your particular jurisdiction. Further, Mission Pharmacal Company does not assume responsibility for any damages to your computer equipment which may result from accessing and/or using this website including, without limitations, that caused by computer viruses.

This website and its contents are designed to comply with United States laws and regulations. While this website and its contents may be accessible in other jurisdictions, this website and its contents are intended for access and use in the United States only.

Mission Pharmacal Company cannot control, and as such cannot take responsibility for, information found on websites posted by third parties. Any links on this website to a third-party's website is for your convenience only, and is not an endorsement of the content of the third-party's website.

Copyright and Intellectual Property

All content of this website is owned by Mission Pharmacal Company and is protected by worldwide copyright laws. The trademarks, service marks, trade names, trade dress, and products featured on this website are protected by the laws of the United States and those of other countries and jurisdictions around the world.

You may print or copy materials published by Mission Pharmacal Company on this website for personal, non-commercial use only. You may not copy, reproduce, distribute, display, or otherwise use any materials published on this website for public or commercial purposes without the prior express written consent of Mission Pharmacal Company. Materials copied from this website for personal use or with prior written consent of Mission Pharmacal Company must, in any event, retain all copyright and other proprietary notices and disclaimers appearing in connection with such materials on this website.

Images of people or places appearing on this website are either the property of Mission Pharmacal Company or used with permission. Any use of the images of such people or places by you is strictly prohibited, and may constitute infringement or violation of communications, copyright, trademark, privacy and/or publicity laws.

Nothing contained on this website shall be construed as conferring by estoppel, implication, or otherwise any license or right under any trademark, copyright, or patent of Mission Pharmacal Company or any third party. Mission Pharmacal Company vigorously enforces its intellectual property rights to the fullest extent of the law.

User Representations

You represent that you are at least 18 years of age and that you have read, understood, and agreed to the foregoing. You represent that you have the legal right and capacity to accept the foregoing terms and conditions and be bound by them. You represent that you will use this website and the information contained therein in accordance with the foregoing terms and conditions.

Indemnification by User

YOU AGREE TO INDEMNIFY, DEFEND, AND HOLD HARMLESS MISSION PHARMACAL COMPANY, ITS OFFICERS, DIRECTORS, EMPLOYEES, AND AGENTS FROM ANY AND ALL DAMAGES, LOSSES, COSTS AND EXPENSES, INCLUDING REASONABLE ATTORNEYS FEES, RESULTING FROM ANY VIOLATION OF THESE TERMS AND CONDITIONS BY YOU.

Waiver and Release of Liability by User

YOU AGREE THAT NEITHER MISSION PHARMACAL COMPANY, ITS OFFICERS, DIRECTORS, EMPLOYEES, OR AGENTS SHALL HAVE ANY LIABILITY TO YOU UNDER ANY THEORY OF LIABILITY INCLUDING, WITHOUT LIMITATION, NEGLIGENCE OR GROSS NEGLIGENCE, OR INDEMNIFICATION, IN CONNECTION WITH YOUR USE OF THIS SITE AND/OR THE CONTENTS AND/OR INFORMATION HEREIN. YOU HEREBY RELEASE AND FOREVER WAIVE ANY AND ALL CLAIMS YOU MAY HAVE AGAINST MISSION PHARMACAL COMPANY, ITS OFFICERS, DIRECTORS, EMPLOYEES, AND/OR AGENTS BASED UPON OR RELATED TO SUCH USE.

Governing Law and Exclusive Venue

You agree that any dispute arising from or related to your access to or use of this website, and/or the content or information contained herein, and/or the foregoing terms and conditions, shall be governed by Texas law. You agree that exclusive venue for any dispute arising from or related to your access to or use of this website, and/or the content or information contained herein, and/or the foregoing terms or conditions, shall be exclusively in a court of competent jurisdiction in Bexar County, Texas, and you hereby agree to submit to personal jurisdiction and exclusive venue in such court of competent jurisdiction in Bexar County, Texas.

Terms and Conditions Subject to Revision

The foregoing terms and conditions are subject to revision and/or modification by Mission Pharmacal Company at anytime. Such revisions or modifications are effective immediately upon posting, publishing, or otherwise notifying you of the same. You are bound immediately by any such modifications or revisions, and consequently you should visit this page periodically to review these terms and conditions and to check for modifications or revisions.

Important Safety Information

Warnings

Despite apparent lower toxicity of THIOLA^®, THIOLA^® may potentially cause all the serious adverse reactions reported for d-penicillamine. Thus, although no death has been reported to result directly from THIOLA^® treatment, a fatal outcome from THIOLA^® is possible, as has been reported with d-penicillamine therapy from such complications as aplastic anemia, agranulocytosis, thrombocytopenia, Goodpasture's syndrome or myasthenia gravis.

Leukopenia of the granulocytic series may develop without eosinophilia. Thrombocytopenia may be immunologic in origin or occur on an idiosyncratic basis. The reduction in peripheral blood white count to less than 3500/cubic mm or in platelet count to below 100,000 cubic mm mandates cessation of therapy. Patients should be instructed to report promptly the occurrence of any symptom or sign of these hematological abnormalities, such as fever, sore throat, chills, bleeding or easy bruisability.

Proteinuria, sometimes sufficiently severe to cause nephrotic syndrome, may develop from membranous glomerulopathy. A close observation of affected patients is mandatory.

The following complications, though rare, have been reported during d-penicillamine therapy and could occur during THIOLA^® treatment. When there are abnormal urinary findings associated with hemoptysis and pulmonary infiltrates suggestive of Goodpasture's syndrome, THIOLA^® treatment should be stopped. Appearance of myasthenic syndrome or myasthenia gravis requires cessation of treatment. When pemphigus-type reactions develop, THIOLA^® therapy should be stopped. Steroid treatment may be necessary.

Precautions

Patients should be advised of the potential development of complications and to report promptly the occurrence of any symptom or sign of them.

To help monitor potential complications, the following tests are recommended: peripheral blood counts, direct platelet count, hemoglobin, serum albumin, liver function tests, 24-hour urinary protein and routine urinalysis at 3-6 month intervals during treatment. In order to assess effect on stone disease, urinary cystine analysis should be monitored frequently during the first 6 months when the optimum dose schedule is being determined, and at 6-month intervals thereafter. Abdominal roentogenogram (KUB) is advised on a yearly basis to monitor the size and appearance/disappearance of stone(s).

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Long-term carcino-genicity studies in animals have not been performed. High doses of THIOLA^® in experimental animals have been shown to interfere with maintenance of pregnancy and viability of the fetus.

USE IN PREGNANCY: Pregnancy category C. D-penicillamine has been shown to cause skeletal defects and cleft palates in the fetus when given to pregnant rats at 10 times the dose recommended for human use. A similar teratogenicity might be expected for THIOLA^® although no such findings could be related to the drug in studies in mice and rats at doses up to 10 times the highest recommended human dose. There are no adequate and well-controlled studies in pregnant women. THIOLA^® should be used during pregnancy only if the potential benefit justifies potential risk to the fetus.

NURSING MOTHERS: Because THIOLA? may be excreted in milk and because of the potential serious adverse reactions of nursing infants from THIOLA^®, mothers taking THIOLA^® should not nurse their infants.

PEDIATRIC USE: Safety and effectiveness below the age of 9 have not been established.

This material is intended to provide basic information. Patients should discuss all medical advice, diagnosis, and treatment with their healthcare provider.

Please see full Prescribing Information