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

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Mylan Institutional Inc.

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 a

Termék összefoglaló:

Bupropion Hydrochloride Extended-Release Tablets, USP (XL) are available containing 150 mg or 300 mg of bupropion hydrochloride, USP. The 150 mg tablets are supplied as off-white to pale yellow, film-coated, round, unscored tablets with M over B8 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-047-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 300 mg tablets are supplied as off-white to pale yellow, film-coated, oval, unscored tablets with M   B9 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-109-03 – Unit dose blister packages of 30 (3 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Bupropion hydrochloride extended-release tablets (XL) may have an odor. PHARMACIST: Dispense a Medication Guide with each prescription.

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

Mylan Institutional Inc.
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MEDICATION GUIDE
Bupropion Hydrochloride Extended-Release Tablets, USP (XL)
(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 (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?
1.
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.
2.
Call your healthcare provider right away to report new or sudden
changes in mood,
behavior, thoughts, or feelings.
3.
Keep all follow-up visits with your healthcare provider as scheduled.
Call the hea

Termékjellemzők

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
MYLAN INSTITUTIONAL INC.
----------
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
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 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 reduc