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Privacy Policy and Terms of Use

Legal/Privacy
Thank you for visiting the DEXEDRINE Spansule website. By using this website, you agree to abide by the following terms and conditions. If you do not accept these conditions, do not use this website. Amedra Pharmaceuticals (Amedra) reserves the right to change this Privacy Policy and User Agreement (Agreement) from time to time, based upon any changes to our website and our users’ experience on it. We recommend that you read our Privacy Policy whenever you visit this Site so that you are aware of any changes. Please note that our Privacy Policy applies only to online activities.

Privacy Policy Amedra respects the privacy of visitors to this website. This policy describes how and when we gather information from visitors to our website.

Aggregate Data We generally record certain usage information, such as the number and frequency of visitors to this website. This information may include the websites that you access immediately before and after your visit to our website, the Internet browser you are using, and your IP address. If we use such data at all, it will be on an aggregate basis, and we will not disclose to third parties any information that could be used to identify you personally.

Personally Identifiable Information If you voluntarily submit information to our website, for example, in a request for general information, we may record and use any personally identifiable information, such as your name, phone number and e-mail address, for reasonable business purposes including, but not limited to, fulfilling your request. We will not use your personally identifiable information for any other purpose without your permission.

We may use internal service providers to operate our website and employ other persons to perform work on our behalf, such as sending postal mail and e-mail. These persons may have access to the personally identifiable information you submit through the website, but only for the purpose of performing their duties. These persons may not use your personally identifiable information for any other purpose.

We will not provide any personally identifiable information to any other persons, except if we are required to make disclosures to the government or private parties in connection with a lawsuit, subpoena, investigation or similar proceeding. We can (and you authorize us to) disclose any such information in those circumstances.

User Agreement
Restrictions on Use Any person using this website is permitted to copy and print individual website pages for non-commercial purposes. Users may also copy or print minimal copies of any research or reports posted on the site solely for informational, non-commercial use. These copies must not alter the original website content, including all legal notices and legends. Our prior permission is required for (i) any commercial use of materials on this website; (ii) making more than minimal copies of website materials; and (iii) copying large portions of our website, such as by bots, robots or spiders that "harvest" the website. If you seek permission for such use of our website, please contact us.

Linking and Framing We do not permit others to frame this website or any portion thereof. Please note that this Privacy Policy and User Agreement applies only to this website and not to other websites that may be accessible from this website via hyperlink. We are responsible only for the content of our own website. We encourage you to review the privacy policies and user agreements of all other websites that you visit.

Ownership All content included on this website, such as graphics, logos, articles and other materials, is the property of our organization or others and is protected by copyright and other laws. All trademarks and logos displayed on this website are the property of their respective owners, who may or may not be affiliated with our organization.

Submissions As our website indicates, we welcome your questions about us. Please be advised that any comments, suggestions, ideas or other information that you send to us through our website will not be treated as confidential, and that we will own and have the right to use them as we choose, without payment to you.

International Use Due to the global nature of the Internet, this website may be accessed by users in countries other than the United States. We make no warranties that materials on this website are appropriate or available for use in such locations outside of the United States. If it is illegal or prohibited in your country of origin to access or use this website, then you should not do so. Those who choose to access this site outside the United States do so on their own initiative and are responsible for compliance with all local laws and regulations.

Limitations of Liability We are not responsible for any damages or injury, including but not limited to special or consequential damages, that result from your use of (or inability to use) this website, including any damages or injury caused by any failure of performance, error, omission, interruption, defect, delay in operation, computer virus, line failure, or other computer malfunction. You acknowledge that we provide the contents of this website on an "as is" basis with no warranties of any kind. Your use of this website and use or reliance upon any of the materials on it is solely at your own risk. We make no representations or warranties as to the merchantability, fitness for a particular purpose, or completeness of the information available on this website.

AMEDRA, ITS SUBSIDIARIES, AFFILIATES, LICENSORS, SERVICE PROVIDERS, CONTENT PROVIDERS, EMPLOYEES, AGENTS, OFFICERS, AND DIRECTORS WILL NOT BE LIABLE FOR ANY INCIDENTAL, DIRECT, INDIRECT, PUNITIVE, ACTUAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, OR OTHER DAMAGES, INCLUDING LOSS OF REVENUE OR INCOME, PAIN AND SUFFERING, EMOTIONAL DISTRESS, OR SIMILAR DAMAGES, EVEN IF AMEDRA HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

Medical Advice PLEASE CONSULT WITH YOUR DOCTOR BEFORE USING ANY PRODUCT DISCUSSED WITHIN THIS OR ANY OTHER WEB SITE.

The information presented here is not intended as a substitute for medical care, treatment or advice. From time to time, this website may contain information relating to various medical diseases and conditions and their treatment. Should you have a medical condition or suspect that you have a medical condition, you should promptly see your physician or other medical professional. This site is not intended to be used to diagnosis or prescribe any medication or medical condition. All medical questions should be addressed to your physician or other medical professional.

Governing Law You agree that your use of this website, this Privacy Policy and User Agreement and any disputes relating to any of them shall be governed in all respects by the laws of the State of New Jersey. Any dispute relating to the above shall be resolved solely in the state or federal courts located in New Jersey.

Termination or Restriction of Access Amedra reserves the right, in its sole discretion, to terminate your access to the Site or any portion thereof at any time, without notice.

Contact Us Thank you for visiting our website. Please contact us if you have any questions about our website or our Privacy Policy and User Agreement.


Important Safety Information

DEXEDRINE is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep DEXEDRINE in a safe place to prevent misuse and abuse. Selling or giving away DEXEDRINE may harm others, and is against the law.

Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

WARNING:

AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.

MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.

Serious Cardiovascular Events
Sudden Death in Patients With Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems:

Children and Adolescents: Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.

Adults: Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs (see CONTRAINDICATIONS).

Hypertension and Other Cardiovascular Conditions: Stimulant medications cause a modest increase in average blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia (see CONTRAINDICATIONS).

Assessing Cardiovascular Status in Patients Being Treated With Stimulant Medications: Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.

Psychiatric Adverse Events
Pre-Existing Psychosis: Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Bipolar Illness: Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

Emergence of New Psychotic or Manic Symptoms: Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with events out of 3,482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients.

Aggression: Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of, or worsening of, aggressive behavior or hostility.

Long-Term Suppression of Growth: Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children older than 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

Seizures: There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.

Visual Disturbance: Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

Only a doctor or health care professional can decide if DEXEDRINE is right for you or your child.

Read the Patient Product Information or the Prescribing Information or Medication Guide for DEXEDRINE.

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