BUPROPION HYDROCHLORIDE tablet, extended release

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Aidarex Pharmaceuticals LLC

INN（国際名）:

BUPROPION HYDROCHLORIDE

構図:

BUPROPION HYDROCHLORIDE 100 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Bupropion hydrochloride extended-release tablets USP, (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 tablet (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)] . - Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients with a seizure disorder. - Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with the immediate-releas

製品概要:

Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg, are blue, round, biconvex, film-coated tablets debossed with “IG” on one side and “484” on other side in the following sizes. Store Bupropion hydrochloride extended-release tablets, USP (SR) at 20o to 25oC (68oF to 77oF) [see USP Controlled Room Temperature]. Dispense in a tight-light resistant container as defined in the USP. Repackaged by Aidarex Pharmaceuticals, LLC Corona, CA 92880

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, EXTENDED
RELEASE
Aidarex Pharmaceuticals LLC
----------
MEDICATION GUIDE
BUPROPION hydrochloride extended-release tablets USP (SR)
(bue proe' pee on hye'' droe klor' ide)
Read this Medication Guide carefully before you start taking bupropion
hydrochloride extended-release
tablets (SR) and each time you get a refill. There may be new
information. This information does not take
the place of talking with your healthcare provider about your medical
condition or your treatment. If you
have any questions about bupropion hydrochloride extended-release
tablets (SR), ask your healthcare
provider or pharmacist.
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. Talk to your healthcare provider or your
family member’s healthcare provider
about:
•
all risks and benefits of treatment with antidepressant medicines
•
all treatment choices for depression or other serious mental illness
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 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 m

製品の特徴

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, EXTENDED
RELEASE
AIDAREX PHARMACEUTICALS LLC
----------
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; AND NEUROPSYCHIATRIC
REACTIONS
_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)
SERIOUS NEUROPSYCHIATRIC EVENTS HAVE BEEN REPORTED IN PATIENTS TAKING
BUPROPION FOR SMOKING
CESSATION. (5.2)
INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets, USP (SR) are an
aminoketone antidepressant, indicated for the
treatment of major depressive disorder (MDD). (1)
DOSAGE AND ADMINISTRATION
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 and/or frequency. (2.3,
8.6)
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg, 150 mg, 200 mg. (3)
CONTRAINDICATIONS
Seizure disorder. (4, 5.3)
Current or prior diagnosis of bulimia or anorexia nervosa. (4, 5.3)
Ab