BUDEPRION- bupropion hydrochloride tablet, extended release

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Bryant Ranch Prepack

INN (इंटरनेशनल नाम):

BUPROPION HYDROCHLORIDE

रचना:

BUPROPION HYDROCHLORIDE 150 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Major Depressive Disorder: Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL TRIALS ). A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration

उत्पाद समीक्षा:

BUDEPRION XL® [bupropion hydrochloride extended-release tablets USP (XL)] 150 mg, are white to off-white, round, tablets printed with “A101”. They are supplied as follow: Bottles of 30 NDC 0093-5350-56 Bottles of 500 NDC 0093-5350-05 Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. *The following are registered trademarks of their respective manufacturers: ZYBAN® , WELLBUTRIN® , and WELLBUTRIN SR® /GlaxoSmithKline. Rx only Manufactured by: ANCHEN PHARMACEUTICALS, INC. Irvine, CA 92618 Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. E 6/2010 06/10

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

BUDEPRION- BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE
Bryant Ranch Prepack
----------
MEDICATION GUIDE
BUDEPRION XL®
(buPROPion hydrochloride 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 doctor about your medical condition or
your treatment. If you have any
questions about bupropion hydrochloride extended-release tablets (XL),
ask your doctor 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 doctor 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,
and young adults within the first few months of treatment.
2.
Depression and 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 inc

उत्पाद विशेषताएं

BUDEPRION- BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE
BRYANT RANCH PREPACK
----------
BUDEPRION XL
(BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS)
RX ONLY
®
WARNING
SUICIDALITY AND ANTIDEPRESSANT DRUGS
_USE IN TREATING PSYCHIATRIC DISORDERS:_ Antidepressants increased the
risk compared to placebo of
suicidal thinking and behavior (suicidality) in children, adolescents,
and young adults in short-term
studies of major depressive disorder (MDD) and other psychiatric
disorders. Anyone considering
the use of bupropion hydrochloride extended-release tablets (XL) or
any other antidepressant in a
child, adolescent, or young adult must balance this risk with the
clinical need. Short-term studies
did not show an increase in the risk of suicidality with
antidepressants compared to placebo in
adults beyond age 24; there was a reduction in risk with
antidepressants compared to placebo in
adults aged 65 and older. Depression and certain other psychiatric
disorders are themselves
associated with increases in the risk of suicide. Patients of all ages
who are started on
antidepressant therapy should be monitored appropriately and observed
closely for clinical
worsening, suicidality, or unusual changes in behavior. Families and
caregivers should be
advised of the need for close observation and communication with the
prescriber. Bupropion
hydrochloride extended-release tablets (XL) are not approved for use
in pediatric patients. (See
WARNINGS: CLINICAL WORSENING AND SUICIDE RISK IN TREATING PSYCHIATRIC
DISORDERS,
PRECAUTIONS: INFORMATION FOR PATIENTS, AND PRECAUTIONS: PEDIATRIC
USE.)
_USE IN SMOKING CESSATION TREATMENT:_ WELLBUTRIN (bupropion
hydrochloride tablets),
WELLBUTRIN SR (bupropion hydrochloride extended-release tablets (SR)),
and bupropion
hydrochloride extended-release tablets (XL) are not approved for
smoking cessation treatment,
but bupropion under the name ZYBAN is approved for this use. Serious
neuropsychiatric
events, including but not limited to depression, suicidal ideation,
suicide attempt, and complete