국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)
Preferred Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Bupropion hydrochloride extended-release tablets (SR) is 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 tablets (SR) 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 i
Bupropion hydrochloride extended-release tablets, USP (SR), 200 mg of bupropion hydrochloride, are pink, blackberry flavored, round, biconvex, film coated tablets, debossed with ‘SG, 176’ on one side and plain on other side in Bottles of 20 (NDC 68788-7793-2) Tablets Bottles of 30 (NDC 68788-7793-3) Tablets Bottles of 60 (NDC 68788-7793-9) Tablets Bottles of 90 (NDC 68788-7793-6) Tablets Bottles of 100 (NDC 68788-7793-1) Tablets Bottles of 120 (NDC 68788-7793-8) Tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure (as required). Protect from light and moisture.
Abbreviated New Drug Application
BUPROPION HYDROCHLORIDE SR- BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE Preferred Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Bupropion Hydrochloride Extended-Release Tablets, USP (SR) (bue proe' pee on hye'' droe klor' ide) 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, (SR)?” 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? 1. Antidepressant medicines may increase the risk of 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? o Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. o Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or 전체 문서 읽기
BUPROPION HYDROCHLORIDE SR- BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE PREFERRED PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (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 • DOSAGE AND ADMINISTRATION • • • • • • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • • 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) Bupropion hydrochloride extended-release tablets, (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( 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, 전체 문서 읽기