Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)
Aidarex Pharmaceuticals LLC
BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE 150 mg
ORAL
PRESCRIPTION DRUG
Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies (14.1)] . Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). The efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in ad
Bupropion Hydrochloride Extended-Release Tablets (XL), 150 mg of bupropion hydrochloride, are white to off-white, round, film-coated tablets with “WPI ”over “3331 ”printed in black ink. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Bupropion hydrochloride extended-release tablets (XL) may have an odor. Repackaged by Aidarex Pharmaceuticals, LLC Corona, CA 92880
Abbreviated New Drug Application
BUPROPION HYDROCHLORIDEXL XL- BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE Aidarex Pharmaceuticals LLC ---------- MEDICATION GUIDE BuPROPion Hydrochloride (byoo-PRO-pee-on HYE-droe-KLOR-ide) Extended-Release Tablets (XL) Read this Medication Guide carefully before you start using bupropion hydrochloride extended-release tablets (XL) and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have any questions about bupropion hydrochloride extended-release tablets (XL), ask your healthcare provider 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 Bupropion Hydrochloride Extended-Release Tablets (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 healthcare provider 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, or young adults within the first few months of treatment. 2. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Some Прочитать полный документ
BUPROPION HYDROCHLORIDEXL XL- BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE AIDAREX PHARMACEUTICALS LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUPROPION HYDROCHLORIDE EXTENDED- RE LE ASE TABLETS (XL). BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL), FOR ORAL USE INITIAL U.S. APPROVAL: 1985 WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC REACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS TAKING ANTIDEPRESSANTS. (5.1) MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS. (5.1) SERIOUS NEUROPSYCHIATRIC EVENTS HAVE BEEN REPORTED IN PATIENTS TAKING BUPROPION FOR SMOKING CESSATION. (5.2) INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. (1) DOSAGE AND ADMINISTRATION Ge ne ral: • Increase dose gradually to reduce seizure risk. (2.1, 5.3) • Periodically reassess the dose and need for maintenance treatment. (2.2) Major Depressive Disorder • Starting dose: 150 mg/day once daily. Usual target dose: 300 mg once daily (2.2) • After 4 days, may increase the dose to 300 mg once daily. (2.2) Seasonal Affective Disorder • Initiative treatment in the autumn prior to onset of seasonal depressive symptoms. (2.3) • Starting dose: 150 mg once daily. Usual target dose: 300 mg once daily. (2.3) • After one week, may increase the dose to 300 mg once daily. (2.3) • Continue treatment through the winter season. (2.3) Hepatic Impairment • Moderate to severe hepatic impairment: 150 mg every other day (2.6) • Mild hepatic im Прочитать полный документ