WELLBUTRIN XL- bupropion hydrochloride tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

BUPROPION HYDROCHLORIDE

Composition:

BUPROPION HYDROCHLORIDE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Major Depressive Disorder: WELLBUTRIN XL is 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, a suicide attempt, or suicidal ideati

Product summary:

WELLBUTRIN XL Extended-Release Tablets, 150 mg of bupropion hydrochloride, are creamy-white to pale yellow, round, tablets printed with "WELLBUTRIN XL 150" in bottles of 30  (NDC 54868-5010-0) and 60 (NDC 54868-5010-1). WELLBUTRIN XL Extended-Release Tablets, 300 mg of bupropion hydrochloride, are creamy-white to pale yellow, round, tablets printed with "WELLBUTRIN XL 300" in bottles of 30  (NDC 54868-4935-0). Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature] .

Authorization status:

New Drug Application

Patient Information leaflet

Physicians Total Care, Inc.
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MEDICATION GUIDE
WELLBUTRIN XL®* (WELL byu-trin)
(bupropion hydrochloride extended-release tablets)
Read this Medication Guide carefully before you start using WELLBUTRIN
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 WELLBUTRIN 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
WELLBUTRIN
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 include people who have (or have a family history of) bipolar
illness (also called manic-
depressive illness) or suicidal thoughts or actions.
3.
How can I watch for and tr

Summary of Product characteristics

WELLBUTRIN XL - BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE
PHYSICIANS TOTAL CARE, INC.
----------
WELLBUTRIN XL
(BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS)
®
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 WELLBUTRIN 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. WELLBUTRIN XL is 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
US E.)
_USE IN SMOKING CESSATION TREATMENT:_ WELLBUTRIN *, WELLBUTRIN SR and
WELLBUTRIN 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
completed suicide have been
reported in patients taking bupropion for smoking cessation. Some
cases may have been
complicated by the symptoms of nicotine withdrawal in patients who
stopped smoking. Depressed