Country: United States
Language: English
Source: NLM (National Library of Medicine)
BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)
STAT Rx USA LLC
BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE 300 mg
ORAL
PRESCRIPTION DRUG
Major Depressive Disorder: WELLBUTRIN XL is indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL TRIALS ). A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideati
WELLBUTRIN XL Extended-Release Tablets, 300 mg of bupropion hydrochloride, are creamy-white to pale yellow, round, tablets printed with "WELLBUTRIN XL 300" in: Bottles of 30 - NDC 16590-246-30 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature] . Relabeling and Repackaging by: STAT Rx USA LLC Gainesville, GA 30501
New Drug Application
STAT Rx USA LLC ---------- MEDICATION GUIDE WELLBUTRIN XL®* (WELL byu-trin) (bupropion hydrochloride extended-release tablets) Read this Medication Guide carefully before you start using WELLBUTRIN XL and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about WELLBUTRIN XL, ask your doctor or pharmacist. IMPORTANT: Be sure to read the three sections of this Medication Guide. The first section is about the risk of suicidal thoughts and actions with antidepressant medicines, the second section is about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; and the third section is entitled " What Other Important Information Should I Know About WELLBUTRIN XL? " Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions This section of the Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your doctor or your family member's healthcare provider about: • all risks and benefits of treatment with antidepressant medicines • all treatment choices for depression or other serious mental illness What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? 1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. 2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic- depressive illness) or suicidal thoughts or actions. 3. How can I watch for and try to preven Read the complete document
WELLBUTRIN XL- BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE STAT RX USA LLC ---------- WELLBUTRIN XL (BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS) ® WARNING SUICIDALITY AND ANTIDEPRESSANT DRUGS _USE IN TREATING PSYCHIATRIC DISORDERS: _Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of WELLBUTRIN XL * or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. WELLBUTRIN XL is not approved for use in pediatric patients. (See WARNINGS: CLINICAL WORSENING AND SUICIDE RISK IN TREATING PSYCHIATRIC DISORDERS, PRECAUTIONS: INFORMATION FOR PATIENTS, AND PRECAUTIONS: PEDIATRIC US E.) _USE IN SMOKING CESSATION TREATMENT:_ WELLBUTRIN *, WELLBUTRIN SR and WELLBUTRIN XL are not approved for smoking cessation treatment, but bupropion under the name ZYBAN * is approved for this use. Serious neuropsychiatric events, including but not limited to depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking bupropion for smoking cessation. Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a Read the complete document