BUPROPION HYDROCHLORIDE- bupropion hydrochloride tablet, film coated, extended release

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Isem Internazzjonali):

BUPROPION HYDROCHLORIDE

Kompożizzjoni:

BUPROPION HYDROCHLORIDE 150 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies (14.1) ]. Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). The efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in ad

Sommarju tal-prodott:

Bupropion Hydrochloride Extended-Release Tablets USP (XL) 150 mg, are white to off-white, round tablets, printed with “A101”. They are supplied as follows: Blistercards of 30 NDC # 0615-7915-39 Bupropion Hydrochloride Extended-Release Tablets USP (XL) 300 mg, are white to off-white, round tablets, printed with “A102”. Store at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature] Bupropion hydrochloride extended-release tablets (XL) may have an odor.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
NCS HealthCare of KY, Inc dba Vangard Labs
----------
MEDICATION GUIDE
BuPROPion Hydrochloride (bue proe' pee on hye'' droe klor' ide)
Extended-Release Tablets USP (XL)
Read this Medication Guide carefully before you start using bupropion
hydrochloride extended-release
tablets (XL) 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 (XL), 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 (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 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?
•
1.Antidepressant medicines may increase suicidal thoughts or actions
in some children, teenagers,
or young adults within the first few months of treatment.
•
2.Depression or other serious mental illnesses are the most important
causes of suici

Karatteristiċi tal-prodott

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUPROPION HYDROCHLORIDE EXTENDED-RELEASE
TABLETS (XL) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR BUPROPION HYDROCHLORIDE EXTENDED-
RELEASE TABLETS (XL).
BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1985
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; ANDNEUROPSYCHIATRIC
REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS, AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS. (5.1)
•MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND
BEHAVIORS. (5.1)
•SERIOUS NEUROPSYCHIATRIC EVENTS HAVE BEEN REPORTED IN PATIENTS
TAKING BUPROPION FOR SMOKING
CESSATION. (5.2)
RECENT MAJOR CHANGES
Boxed Warning 12/2014
Dosage and Administration (2.6, 2.7, 2.8, 2.9) 12/2014
Contraindications (4) 12/2014
Warnings and Precautions (5.4, 5.8) 12/2014
INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (XL) is an
aminoketone antidepressant, indicated for the treatment of
major depressive disorder (MDD) and prevention of seasonal affective
disorder (SAD). Periodically reevaluate long-term
usefulness for the individual patient. (1)
DOSAGE AND ADMINISTRATION
Ge ne ral:
•Increase dose gradually to reduce seizure risk. (2.1, 5.3)
•Periodically reassess the dose and need for maintenance treatment.
(2.2)
Major Depressive Disorder
•Starting dose: 150 mg/day once daily. Usual target dose: 300 mg
once daily (2.2)
•After 4 days, may increase the dose to 300 mg once daily. (2.2)
Seasonal Affective Disorder
•Initiative treatment in the autumn prior to onset of seasonal
depressive symptoms. (2.3)
•Starting dose: 150 mg once daily. Usual target dose: 300 mg once
daily. (2.3)
•After one week, may increase the dose to 300 mg once