BUDEPRION XL XL- bupropion hydrochloride tablet, film coated, extended release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Medzinárodný Name):

BUPROPION HYDROCHLORIDE

Zloženie:

BUPROPION HYDROCHLORIDE 150 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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,

Prehľad produktov:

Bupropion hydrochloride extended-release tablets USP (XL) 150 mg, are white to off-white, round, tablets printed with “A101”.  They are supplied as follow: Blisterpacks of 30 NDC # 0615-7560-39 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 08/07

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

NCS HealthCare of KY, Inc dba Vangard Labs
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MEDGUIDE
Medguide
Medication Guide
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 both sections of this Medication Guide. The
first section is about the risk
of suicidal thoughts and actions with antidepressant medicines; the
second 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
Read the Medication Guide that comes with you or your family
member’s antidepressant medicine.
This section of the Medication Guide is only about the risk of
suicidal thoughts and actions with
antidepressant medicines. Talk to your, 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
include people who have (or have a family history of) bipolar illness
(also called manic-depressive
illness) or

Súhrn charakteristických

BUDEPRION XL XL- BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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BUDEPRION XL ER
BOX WARNING
BOXED WARNING
SUICIDALITY AND ANTIDEPRESSANT DRUGS
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, PRECAUTIONS: INFORMATION FOR PATIENTS, AND
PRECAUTIONS:
PEDIATRIC USE)
DES CRIPTION
DESCRIPTION
Bupropion hydrochloride extended-release tablets (XL), an
antidepressant of the aminoketone class, are
chemically unrelated to tricyclic, tetracyclic, selective serotonin
re-uptake inhibitor, or other known
antidepressant agents. Its structure closely resembles that of
diethylpropion; it is related to
phenylethylamines.
It is designated as
(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone
hydrochloride.
The molecular weight is 276.2. The molecular formula is C
H ClNO•HCl. Bup