Country: United States
Language: English
Source: NLM (National Library of Medicine)
BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)
NCS HealthCare of KY, Inc dba Vangard Labs
BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE 150 mg
ORAL
PRESCRIPTION DRUG
Bupropion hydrochloride extended-release tablets USP (SR) 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 tablets USP (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)]. - Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients with a seizure disorder. - Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with the immediate-rel
Bupropion hydrochloride extended-release tablets USP (SR) for oral administration are available as: 100 mg: Aquamarine, round, biconvex, film-coated tablets, debossed “E ” over “410” on one side and plain on the other side. 150 mg: Plum, round, biconvex, film-coated tablets, debossed “E ” over “415” on one side and plain on the other side and supplied as: NDC 0615-7904-39 blisterpacks of 30 200 mg: Light pink, round, biconvex, film-coated tablets, debossed “E ” on one side and debossed “1111” on the other side. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store in a dry place. Keep tightly closed. Protect from light. Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.
Abbreviated New Drug Application
BUPROPION HYDROCHLORIDE SR- BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE NCS HealthCare of KY, Inc dba Vangard Labs ---------- MEDICATION GUIDE BuPROPion Hydrochloride Extended-Release Tablets USP (SR) (byoo-PROE-pee-on) Read this Medication Guide carefully before you start taking bupropion hydrochloride extended-release tablets (SR) 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 (SR), 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 (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. 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 and actions. Some people may ha Read the complete document
BUPROPION HYDROCHLORIDE SR- BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BUPROPION HYDROCHLORIDE EXTENDED- RELEASE TABLETS USP (SR) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP (SR). INITIAL U.S. APPROVAL: 1985 WARNINGS: 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) RECENT MAJOR CHANGES Warnings and Precautions (5.7) 07/2014 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets USP (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1) DOSAGE AND ADMINISTRATION Starting Dose: 150 mg per 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 per day, given as 150 mg twice daily at an interval of at least 8 hours. (2.1) Usual target dose: 300 mg per day as 150 mg twice daily. (2.1) Maximum dose: 400 mg per day, given as 200 mg twice daily, for patients not responding to 300 mg per 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) DOSAGE FORMS AND STRENGTHS Tablets: 100 mg, 150 mg, 200 mg. (3) CONTRAINDICATIONS Seizure disorder. (4, 5.3) Current or prior diagnosis of bulimia or anorexia n Read the complete document