BUPROPION HYDROCHLORIDE- 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:

St Marys Medical Park Pharmacy

INN (International Name):

BUPROPION HYDROCHLORIDE

Composition:

BUPROPION HYDROCHLORIDE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Bupropion hydrochloride extended-release tablets, USP (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 concentrati

Product summary:

Bupropion hydrochloride extended-release tablets, USP (SR), 150 mg of bupropion hydrochloride, are pale yellow, round, biconvex, film-coated tablets debossed with an “A” over “133” NDC 60760-488-98 bottles of 180 60760-488-60 bottles of 60 Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]. The following are registered trademarks of GlaxoSmithKline: WELLBUTRIN ® , WELLBUTRIN XL ® and ZYBAN ® and KALETRA ® /Abbott Laboratories. Manufactured by: Catalent Pharma Solutions Winchester, KY 40391 Distributed by: Actavis South Atlantic LLC 13800 N.W. 2 nd Street, Suite 190 Sunrise, FL 33325 USA 8013360/0610 Rev. 06/10

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Bupropion hydrochloride extended-release tablets, USP (SR)

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BUPROPION HYDROCHLORIDE-
bupropion hydrochloride tablet, film coated, extended
release  St Marys Medical Park Pharmacy

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Medguide
MEDICATION GUIDE

BuPROPion Hydrochloride Extended-
Release Tablets, USP (SR)
Rx Only
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 c

Read the complete document

Summary of Product characteristics

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
ST MARYS MEDICAL PARK PHARMACY
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BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP (SR)
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 (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
, 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 hav