BUPROPION HYDROCHLORIDE SR tablet, film coated, extended release

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

DirectRx

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Bupropion hydrochloride extended-release tablets (SR) is 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 (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)] . Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients with a seizure disorder. Bupropion hydrochloride extended-release tablets (SR) are contraindicated 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-release

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

DirectRx
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MEDICATION GUIDE
Bupropion Hydrochloride Extended-Release Tablets, USP (SR)
(bue proe' pee on hye'' droe klor' ide)
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.
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 the risk of 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
include people who have (or have a family history of) bipolar illness
(also called manic- depressive
illness) or suicidal thoughts or actions.
How can I watch for and try to prevent suicidal thoughts and actions
in myself or a family member?
Pay close attention to any changes, especially sudden changes, in
mood, behaviors, thoughts, or feelings.
This is very important when an antidepressant medicine is started or
when the dose is changed.
Call your healthcare provider right away to report new or sudden
changes in mood, behavior, thoughts, or
feelings.
Keep all follow-up visits with your healthcare provider as scheduled.
Call the healthcare provider
between visits a

Svojstava lijeka

BUPROPION HYDROCHLORIDE SR- BUPROPION HYDROCHLORIDE SR TABLET, FILM
COATED, EXTENDED RELEASE
DIRECTRX
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BUPROPION HCL ER (SR)
Bupropion hydrochloride extended-release tablets (SR) is 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 (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)] .
2.1 General Instructions for Use
To minimize the risk of seizure, increase the dose gradually [see
Warnings and
Precautions ( 5.3)] . Bupropion hydrochloride extended-release tablets
(SR) should be
swallowed whole and not crushed, divided, or chewed. Bupropion
hydrochloride
extended-release tablets (SR) may be taken with or without food.
The usual adult target dose for bupropion hydrochloride
extended-release tablets (SR) is
300 mg/day, given as 150 mg twice daily. Initiate dosing with 150
mg/day given as a
single daily dose in the morning. After 3 days of dosing, the dose may
be increased to
the 300-mg/day target dose, given as 150 mg twice daily. There should
be an interval of
at least 8 hours between successive doses. A maximum of 400 mg/day,
given as 200
mg twice daily, may be considered for patients in whom no clinical
improvement is noted
after several weeks of treatment at 300 mg/day. To avoid high peak
concentrations of
bupropion and/or its metabolites, do not exceed 200 mg in any single
dose.
It is generally agreed that acute episodes of depression require
several months or
longer of antidepressant drug treatment beyond the response in the
acute episode. It is
unknown whether the dose of bupropion hydrochloride extended-releas