BUPROPION HYDROCHLORIDE XL- bupropion hydrochloride tablet, film coated, extended release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Lake Erie Medical DBA Quality Care Products LLC

INN (Διεθνής Όνομα):

BUPROPION HYDROCHLORIDE

Σύνθεση:

BUPROPION HYDROCHLORIDE 150 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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,

Περίληψη προϊόντος:

Bupropion Hydrochloride Extended-Release Tablets (XL), 150 mg of bupropion hydrochloride, are white to off-white, round, film-coated tablets with WPI over 3331 printed in black ink in bottles of 30 tablets (NDC 0591-3331-30), bottles of 90 tablets (NDC 0591-3331-19) and bottles of 500 tablets (NDC 0591-3331-05). Bupropion Hydrochloride Extended-Release Tablets (XL), 300 mg of bupropion hydrochloride, are white to off-white, round, film-coated tablets with WPI over 3332 printed in black ink in bottles of 30 tablets (NDC 0591-3332-30), bottles of 500 tablets (NDC 0591-3332-05) and bottles of 1000 tablets (NDC 0591-3332-10). Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] * The following are registered trademarks of their respective manufacturers: ZYBAN® /GlaxoSmithKline, WELLBUTRIN® /GlaxoSmithKline, WELLBUTRIN SR® /GlaxoSmithKline. Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA Distributed by: Watson Pharma, Inc. Corona, CA 92880 USA Revised: August 2010 174662-3

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

BUPROPION HYDROCHLORIDE XL- BUPROPION HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
Lake Erie Medical DBA Quality Care Products LLC
----------
MEDICATION GUIDE
BuPROPion Hydrochloride Extended-Release Tablets (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
s

Αρχείο Π.Χ.Π.

BUPROPION HYDROCHLORIDE XL- BUPROPION HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
PRESCRIBING INFORMATION
BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL)
REVISED: AUGUST 2010
RX ONLY 174662-3
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
, Wellbutrin 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, an