BUPROPION HYDROCHLORIDE tablet, extended release

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

McKesson Corporation dba SKY Packaging

INN (International Adı):

BUPROPION HYDROCHLORIDE

Kompozisyon:

BUPROPION HYDROCHLORIDE 150 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM) . The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)]. Pregnancy Category C Risk Summary Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester indicate no increased risk of congenital malformations overall. All pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. No clear evidence of teratogeni

Ürün özeti:

Product: 63739-714 NDC: 63739-714-10 10 TABLET, EXTENDED RELEASE in a BLISTER PACK / 10 in a BOX, UNIT-DOSE

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, EXTENDED
RELEASE
McKesson Corporation dba SKY Packaging
----------
MEDICATION GUIDE
BuPROPion Hydrochloride Extended-Release Tablets, USP (SR)
(byoo-PROE-pee-on)
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 (SR)?”
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 foll

Ürün özellikleri

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, EXTENDED
RELEASE
MCKESSON CORPORATION DBA SKY PACKAGING
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUPROPION HYDROCHLORIDE EXTENDED-
RELEASE TABLETS (SR) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR BUPROPION
HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR).
BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR), FOR ORAL USE.
INITIAL U.S. APPROVAL: 1985
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
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
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg, 150 mg, 200 mg. (3)
CONTRAINDICATIONS
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
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)
Bupropion hydrochloride extended-release tablets (SR) are an
aminoketone antidepressant, indicated for the
treatment of major depressive disorder (MDD). (1)
Starting Dose: 150 mg per day (2.1)
General: Increase dose gradually to reduce seizure risk. (2.1, 5.3)
After 3 days, may increase the dose to 300 mg per day, given as 150 mg
twice daily at an interval of at least 8 hours.
(2.1)
Usual target dose: 300 mg per day as 150 mg twice daily. (2.1)
Maximum dose: 400 mg per day, given as 200 mg twice daily, for
patients not responding to 300 mg per day. (2.1)
Periodically reassess the dose and need for maintenance treatment.
(2.1)
Moderate to severe hepatic impairment: 100 mg daily or 150 mg every
other day. (2.2, 8.7)
Mild hepatic impairment: Consider reducing the dose and/or frequency
of dosing. (2.2, 8.7)
Renal Impairment: Consider reducing the dose