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:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 tr

Product summary:

Bupropion Hydrochloride Extended-Release Tablets USP (XL) 150 mg, are white to off-white, round tablets, printed with “A101”. They are supplied as follows: Bottles of 30 NDC 72162-1218-3 Bottles of 500 NDC 72162-1218-5 Store at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. Preserve in well-closed containers. Protect from light. Bupropion hydrochloride extended-release tablets (XL) may have an odor.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
Bryant Ranch Prepack
----------
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.
•

Summary of Product characteristics

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED RELEASE
BRYANT RANCH PREPACK
----------
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. ( 5.1)
MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND
BEHAVIORS. ( 5.1)
INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (XL) is an
aminoketone antidepressant, indicated for:
treatment of major depressive disorder (MDD) ( 1.1)
prevention of seasonal affective disorder (SAD) ( 1.2)
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: Consider reducing the dose and/or frequency
of dosing. ( 2.6, 8.7)
Renal Impairment
Consider reducing the dose and/or frequency of dosing. ( 2.7, 8.6)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets: 150 mg, 300 mg (3)
CONTRAINDICATIONS
Seizure disord