Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)
REMEDYREPACK INC.
ORAL
PRESCRIPTION DRUG
Bupropion hydrochloride extended-release tablets (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 (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 and supplied as: NDC 0185-0410-60 bottles of 60 NDC 0185-0410-01 bottles of 100 NDC 0185-0410-52 bottles of 250 NDC 0185-0410-05 bottles of 500 150 mg Plum, round, biconvex, film-coated tablets, debossed “ E ” over “415” on one side and plain on the other side and supplied as: NDC 0185-0415-60 bottles of 60 NDC 0185-0415-01 bottles of 100 NDC 0185-0415-52 bottles of 250 NDC 0185-0415-05 bottles of 500 200 mg Light pink, round, biconvex, film-coated tablets, debossed “ E ” on one side and debossed “1111” on the other side and supplied as: NDC 0185-1111-60 bottles of 60 NDC 0185-1111-01 bottles of 100 NDC 0185-1111-52 bottles of 250 NDC 0185-1111-05 bottles of 500 NDC 0185-1111-10 bottles of 1000 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Protect from light and moisture. Keep tightly closed KEEP OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE REMEDYREPACK INC. ---------- MEDICATION GUIDE BuPROPion Hydrochloride Extended-Release Tablets, USP (SR) (byoo-PROE-pee-on) 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? 4. 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. 5. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. 6. Keep all follow-up visits with your Preberite celoten dokument
BUPROPION HYDROCHLORIDE- 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 (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._ 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) 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 tablets (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 anore Preberite celoten dokument