Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
Bupropion Hydrochloride Extended-release (SR) tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)] . The efficacy of Bupropion Hydrochloride Extended-release (SR) tablets in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)] . Pregnancy Exposure Registry There is an independent pregnancy exposure registry that monitors pregnancy outcomes in women exposed to any antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-4056185 or visiting online at https://womensmentalhealth.org/clinic
NDC: 63629-8036-1: 30 Tablets in a BOTTLE
Abbreviated New Drug Application
BUPROPION- BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE Bryant Ranch Prepack ---------- MEDICATION GUIDE Bupropion Hydrochloride Extended-release (SR) Tablets, USP (bue-PROE-pee-on HYE-droe-KLOR-ide) Dispense with Medication Guide available at: www.solcohealthcare.com/medguide/bupropion-sr-tablets.pdf 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 (SR) Tablets? 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. What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? 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 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 prevent suicidal thoughts and actions in myself or a family member? • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feeli Læs hele dokumentet
BUPROPION- BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE BRYANT RANCH PREPACK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP (SR) FOR ORAL USE INITIAL U.S. APPROVAL: 1985 WARNING: SUICIDAL THOUGHTS AND BEHAVIORS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • INDICATIONS AND USAGE Bupropion Hydrochloride Extended-release (SR) tablets are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1) DOSAGE AND ADMINISTRATION • • • • • • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • • • • WARNINGS AND PRECAUTIONS • 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) Starting dose: 150 mg/day (2.1) General: Increase dose gradually to reduce seizure risk. (2.1, 5.3) After 3 days, may increase the dose to 300 mg/day, given as 150 mg twice daily at an interval of at least 8 hours. (2.1) Usual target dose: 300 mg/day as 150 mg twice daily. (2.1) Maximum dose: 400 mg/day, given as 200 mg twice daily, for patients not responding to 300 mg/day. (2.1) Periodically reassess the dose and need for maintenance treatment. (2.1) Moderate to severe hepatic impairment: 100 mg daily or 150 mg every other day. (2.2, 8.7) Mild hepatic impairment: Consider reducing the dose and/or frequency of dosing. (2.2, 8.7) Renal impairment: Consider reducing the dose and/or frequency. (2.3, 8.6) Tablets: 100 mg, 150 mg, 200 mg. (3) Seizure disorder. (4, 5.3) Current or prior diagnosis of bulimia or anorexia nervosa. (4, 5.3) Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, antiepileptic drugs. (4 Læs hele dokumentet