देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)
Proficient Rx LP
BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE 75 mg
ORAL
PRESCRIPTION DRUG
Bupropion hydrochloride tablets, USP are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM) . The efficacy of bupropion hydrochloride tablets, USP 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)] . Risk Summary: Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester indicate no increased risk of congenital malformations overall. All pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. No clear evidence of teratogenic activity was found in reproductive developmental studies conducted in rats and rabbits; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observed at doses approximately equal to the maximum recommen
Bupropion hydrochloride tablets, USP , 75 mg of bupropion hydrochloride, are lavender, round, film-coated tablets, debossed GG 929 on one side and plain on the reverse side. NDC 63187-416-30 in bottles of 30 tablets Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP.
Abbreviated New Drug Application
BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED Proficient Rx LP ---------- MEDICATION GUIDE Bupropion Hydrochloride Tablets, USP (bue proe' pee on) Read this Medication Guide carefully before you start taking bupropion hydrochloride tablets 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 tablets, 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 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. 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 have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family his पूरा दस्तावेज़ पढ़ें
BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED PROFICIENT RX LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BUPROPION HYDROCHLORIDE TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUPROPION HYDROCHLORIDE TABLETS, USP. BUPROPION HYDROCHLORIDE TABLETS, USP, FOR ORAL USE INITIAL U.S. APPROVAL: 1985 WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC REACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • • RECENT MAJOR CHANGES Warnings and Precautions, Angle-Closure Glaucoma (5.7) 07/2014 INDICATIONS AND USAGE Bupropion hydrochloride, USP is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1) DOSAGE AND ADMINISTRATION • • • • • • • • • DOSAGE FORMS AND STRENGTHS Tablets: 75 mg and 100 mg. (3) 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) SERIOUS NEUROPSYCHIATRIC EVENTS HAVE BEEN REPORTED IN PATIENTS TAKING BUPROPION FOR SMOKING CESSATION. (5.2) Starting dose: 200 mg per day given as 100 mg twice daily (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 100 mg 3 times daily at an interval of at least 6 hours between doses. (2.1) Usual target dose: 300 mg per day as 100 mg 3 times daily. (2.1) Maximum dose: 450 mg per day given as 150 mg 3 times daily. (2.1) Periodically reassess the dose and need for maintenance treatment. (2.1) Moderate to severe hepatic impairment: 75 mg once daily. (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) Seizure disorder. (4, 5.3) Current or pri पूरा दस्तावेज़ पढ़ें