BUPROPION HYDROCHLORIDE- bupropion hydrochloride tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)

متاح من:

Proficient Rx LP

INN (الاسم الدولي):

BUPROPION HYDROCHLORIDE

تركيب:

BUPROPION HYDROCHLORIDE 75 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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

ملخص المنتج:

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.

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED
Proficient Rx LP
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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

خصائص المنتج

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED
PROFICIENT RX LP
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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._
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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
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DOSAGE FORMS AND STRENGTHS
Tablets: 75 mg and 100 mg. (3)
CONTRAINDICATIONS
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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