BUPROPION HYDROCHLORIDE tablet, extended release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Sun Pharmaceutical Industries, Inc.

INN (mednarodno ime):

BUPROPION HYDROCHLORIDE

Sestava:

BUPROPION HYDROCHLORIDE 150 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Bupropion hydrochloride extended-release tablets, USP (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, USP (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 tri

Povzetek izdelek:

Bupropion hydrochloride extended-release tablets, USP (XL), 150 mg of bupropion hydrochloride USP, are round, biconvex, coated, peach and white to off-white bilayer extended-release tablets and imprinted with “954” with black ink on one side and plain on the other side. Bottles of 30’s with Child Resistant Cap ........................NDC 47335-954-83 Bottles of 90’s with Child Resistant Cap ........................NDC 47335-954-81 Bottles of 500’s with Non Child Resistant Cap .............NDC 47335-954-13 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].   Bupropion hydrochloride extended-release tablets (XL) may have an odor.

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

BUPROPION HYDROCHLORIDE - BUPROPION HYDROCHLORIDE TABLET, EXTENDED
RELEASE
Sun Pharmaceutical Industries, Inc.
----------
MEDICATION GUIDE
Bupropion Hydrochloride Extended-release Tablets, USP (XL)
(byoo-PRO-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?
•
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.
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Lastnosti izdelka

BUPROPION HYDROCHLORIDE - BUPROPION HYDROCHLORIDE TABLET, EXTENDED
RELEASE
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUPROPION HYDROCHLORIDE
EXTENDED-RELEASE TABLETS, USP (XL) SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP (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, USP (XL) are
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) (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 redu