BUPROPION HYDROCHLORIDE- bupropion hydrochloride tablet, extended release

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

REMEDYREPACK INC.

INN (Isem Internazzjonali):

BUPROPION HYDROCHLORIDE

Kompożizzjoni:

BUPROPION HYDROCHLORIDE 300 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 (XL) in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials

Sommarju tal-prodott:

Bupropion hydrochloride extended-release tablets, USP (XL) 150 mg, are off-white, round, tablets debossed into the surface with "141" in bottles of 30 tablets (NDC 45963-141-30), 90 tablets (NDC 45963-141-90) and 500 tablets (NDC 45963-141-05). Bupropion hydrochloride extended-release tablets, USP (XL) 300 mg, are off-white, oval, tablets debossed into the surface with "142" in bottles of 30 tablets (NDC 45963-142-30), 90 tablets (NDC 45963-142-90) and 500 tablets (NDC 45963-142-05). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers as defined in the USP. Bupropion hydrochloride extended-release tablets (XL) may have an odor.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

REMEDYREPACK INC.
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MEDICATION GUIDE
buPROPion Hydrochloride (bue proe' pee on hye'' droe klor' ide)
Extended-Release Tablets, USP (XL)
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.
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 the risk of 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 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.
3.
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 healthc

Karatteristiċi tal-prodott

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, EXTENDED
RELEASE
REMEDYREPACK INC.
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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 (XL), FOR ORAL USE
INITIAL U.S. APPROVAL: 1985
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS, AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS. MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL
THOUGHTS AND BEHAVIORS. (5.1)
RECENT MAJOR CHANGES
Boxed Warning
05/2017
Warnings and Precautions, Neuropsychiatric Adverse Events
and Suicide Risk in Smoking Cessation Treatment (5.2)
05/2017
INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (XL) are 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
General:
• 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 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
• Initiate 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 daily. ( 2.3)
• Continue treatment through the winter season. ( 2.3)
Hepatic Impairment
• Moderate to severe hepatic impairment: 150 mg every other day (
2.6)
• Mild hepatic impairment: Con