BUPROPION- bupropion tablet, extended release

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Preferred Pharmaceuticals, Inc.

INN（国际名称）:

BUPROPION HYDROCHLORIDE

组成:

BUPROPION HYDROCHLORIDE 300 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Bupropion hydrochloride extended-release tablets, USP (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, USP (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 in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled tr

產品總結:

Bupropion Hydrochloride Extended-release Tablets USP (XL), 300 mg are creamy-white to pale-yellow, round, biconvex, coated-tablets imprinted with '354' in black ink on one side and plain on other side and are supplied as follows: Bottle of 30 - 68788-9255-3  Bottle of 60 - 68788-9255-6 Bottle of 90 - 68788-9255-9 Bottle of 100 - 68788-9255-1 Bottle of 120 - 68788-9255-8 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Bupropion Hydrochloride Extended-release Tablets USP (XL) may have an odor.

授权状态:

Abbreviated New Drug Application

资料单张

BUPROPION- BUPROPION TABLET, EXTENDED RELEASE
Preferred Pharmaceuticals, Inc.
----------
SPL MEDGUIDE
MEDICATION GUIDE
Bupropion Hydrochloride
(bue-PROE-pee-on HYE-droe-KLOR-ide )
Extended-release Tablets, USP (XL)
Read this Medication Guide carefully before you start using bupropion
hydrochloride extended-release
tablets (XL) 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 (XL), 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 (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. 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 or
actions. Some people may have a particularl

产品特点

BUPROPION- BUPROPION TABLET, EXTENDED RELEASE
PREFERRED PHARMACEUTICALS, 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 AND NEUROPSYCHIATRIC
REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets, USP (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
GENERAL:
•
•
MAJOR DEPRESSIVE DISORDER:
•
•
SEASONAL AFFECTIVE DISORDER:
•
•
•
•
HEPATIC IMPAIRMENt:
•
•
RENAL IMPAIRMENT:
•
DOSAGE FORMS AND STRENGTHS
•
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)
Increase dose gradually to reduce seizure risk. (2.1, 5.3)
Periodically reassess the dose and need for maintenance treatment.
(2.2)
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)
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.