Country: United States
Language: English
Source: NLM (National Library of Medicine)
BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)
REMEDYREPACK INC.
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, (XL) in the prevention of seasonal major depressive episodes was established in 3 placebo-controll
Bupropion hydrochloride extended-release tablets, USP (XL), 150 mg are white to off white capsule shaped, biconvex coated tablets de-bossed with ‘I’ on one side and ‘13’ on the other side and are available in bottles of 30 tablets (NDC 69097-875-02), bottles of 90 tablets (NDC 69097-875-05) and bottles of 500 tablets (NDC 69097-875-12). Bupropion hydrochloride extended-release tablets, USP (XL), 300 mg are white to off white capsule shaped, biconvex coated tablets de-bossed with ‘I 71’ on one side and plain on the other side and are available in bottles of 30 tablets (NDC 69097-876-02) and bottle of 500 tablets (NDC 69097-876-12) . Store bupropion HCl extended-release tablets at 20° to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP .
Abbreviated New Drug Application
BUPROPION HYDROCHLORIDE (XL)- BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE REMEDYREPACK INC. ---------- MEDICATION GUIDE Bupropion Hydrochloride Extended-Release tablets (XL) (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 (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. 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? • 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. • Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. • Keep all fol Read the complete document
BUPROPION HYDROCHLORIDE (XL)- BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE REMEDYREPACK INC. ---------- 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-RELEASE TABLETS (XL). BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL), FOR ORAL USE INITIAL U.S. APPROVAL: 1985 WARNING: SUICIDAL THOUGHTS AND BEHAVIORS _ SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS TAKING ANTIDEPRESSANTS. MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS. ( 5.1) RECENT MAJOR CHANGES Boxed Warning 05/2017 Warnings and Precautions, Neuropsychiatric Adverse Events and Suicide Risk in Smoking Cessation Treatment ( 5.2) 05/2017 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablet, (XL) is 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 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 • Initiate 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 impa Read the complete document