BUPROPION HYDROCHLORIDE tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Dispensing Solutions, Inc.

INN (International Name):

BUPROPION HYDROCHLORIDE

Composition:

BUPROPION HYDROCHLORIDE 150 mg

Administration route:

OCCLUSIVE DRESSING TECHNIQUE

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Bupropion hydrochloride extended-release tablets (SR) 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 depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL PHARMACOLOGY). 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

Product summary:

Bupropion hydrochloride extended-release tablets (SR), 100 mg of bupropion hydrochloride, are white to off-white, round, film-coated tablets with WPI over 858 in bottles of 60 tablets (NDC 0591-3540-60), 100 tablets (NDC 0591-3540-01) and 500 tablets (NDC 0591-3540-05). Bupropion hydrochloride extended-release tablets (SR), 150 mg of bupropion hydrochloride, are white to off-white, round, film-coated tablets with WPI over 839 in bottles of 60 tablets (NDC 0591-3541-60), 100 tablets (NDC 0591-3541-01), 250 tablets (NDC 0591-3541-25) and 500 tablets (NDC 0591-3541-05). Bupropion hydrochloride extended-release tablets (SR), 200 mg of bupropion hydrochloride, are white to off-white, round, film-coated tablets with WPI over 3385 in bottles of 60 tablets (NDC 0591-3542-60), 100 tablets (NDC 0591-3542-01) and 500 tablets (NDC 0591-3542-05). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA Distributed by: Watson Pharma, Inc. Corona, CA 92880 USA Issued: September 2010                         172395-3

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

BUPROPION HYDROCHLORIDE - BUPROPION HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
Dispensing Solutions, Inc.
----------
MEDICATION GUIDE
BuPROPion Hydrochloride Extended-release Tablets USP (SR)
Read this Medication Guide carefully before you start using bupropion
hydrochloride extended-release
tablets (SR) 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 (SR),
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 (SR)?”
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, 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 action

Summary of Product characteristics

BUPROPION HYDROCHLORIDE - BUPROPION HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
DISPENSING SOLUTIONS, INC.
----------
BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP (SR)
ISSUED: SEPTEMBER 2010
RX ONLY
172395-3
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 (SR) 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 (SR) 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 extended-
release tablets (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 repor