WELLBUTRIN SR (bupropion hcl er- sr tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

DIRECT RX

INN (International Name):

BUPROPION HYDROCHLORIDE

Sammensætning:

BUPROPION HYDROCHLORIDE 100 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Bupropion hydrochloride extended-release tablets, USP (SR)are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion hydrochloride extended-release tablets, USP (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)]. Bupropionhydrochloride extended-release tablets (SR) are contraindicated in patients with a seizure disorder. Bupropion hydrochloride extended-release tablets (SR) arecontraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with the immediate-

Produkt oversigt:

Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg of bupropion hydrochloride, are white to off white colored, round shaped, bevel edged biconvex film-coated tablets debossed with “736” on one side and plain on the other side. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

WELLBUTRIN SR- BUPROPION HCL ER (SR) TABLET
DIRECT RX
----------
Bupropion Hydrochloride Extended-release Tablets, USP (SR)
(byoo-PRO-pee-on HYE-droe-KLOR-ide)
Read this Medication Guide carefully before you start taking 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 healthcare provider about your medical
condition or your treatment. If you
have any questions about bupropion hydrochloride extended-release
tablets (SR), ask your healthcare
provider 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 healthcare provider 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?
Antidepressant medicines may increase suicidal thoughts or actions in
some children, teenagers, or young
adults within the first few months of treatment.
Depression or 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
inc

Produktets egenskaber

WELLBUTRIN SR- BUPROPION HCL ER (SR) TABLET
DIRECT RX
----------
BUPROPION HCL ER (SR)
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC
REACTIONS
SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk of suicidal thoughts and behavior
in children, adolescents, and
young adults in short-term trials. These trials did not show an
increase in the risk of suicidal
thoughts and behavior with antidepressant use in subjects over age 24;
there was a reduction in
risk with antidepressant use in subjects aged 65 and older [see
Warnings and Precautions (5.1)].
In patients of all ages who are started on antidepressant therapy,
monitor closely for worsening,
and for emergence of suicidal thoughts and behaviors. Advise families
and caregivers of the need
for close observation and communication with the prescriber [see
Warnings and Precautions
(5.1)].
NEUROPSYCHIATRIC REACTIONS IN PATIENTS TAKING BUPROPION FOR SMOKING
CESSATION
Serious neuropsychiatric reactions have occurred in patients taking
bupropion for smoking
cessation [see Warnings and Precautions (5.2)]. The majority of these
reactions occurred during
bupropion treatment, but some occurred in the context of discontinuing
treatment. In many cases, a
causal relationship to bupropion treatment is not certain, because
depressed mood may be a
symptom of nicotine withdrawal. However, some of the cases occurred in
patients taking
bupropion who continued to smoke. Although bupropion hydrochloride
extended-release tablets
(SR) are not approved for smoking cessation, observe all patients for
neuropsychiatric reactions.
Instruct the patient to contact a healthcare provider if such
reactions occur [see Warnings and
Precautions (5.2)].
Bupropion hydrochloride extended-release tablets, USP (SR)are
indicated for the treatment of major
depressive disorder (MDD), as defined by the Diagnostic and
Statistical Manual (DSM).
The efficacy of bupropion in the treatment of a major depressive
episode was established in two 4-
week controlled inpatient trials and o