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

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

REMEDYREPACK INC.

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 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

Produkt oversigt:

Bupropion Hydrochloride Extended-release Tablets USP (SR), 100 mg of bupropion hydrochloride, are white to off-white, round, bi-convex, film-coated tablets debossed with "WPI" over "858" on one side in bottles of 60 tablets (NDC 0591-3540-60) and 500 tablets (NDC 0591-3540-05). Bupropion Hydrochloride Extended-release Tablets USP (SR), 150 mg of bupropion hydrochloride, are white to off-white, round, bi-convex, film-coated tablets debossed with "WPI" over "839" on one side in bottles of 60 tablets (NDC 0591-3541-60), 250 tablets (NDC 0591-3541-25) and 500 tablets (NDC 0591-3541-05). Bupropion Hydrochloride Extended-release Tablets USP (SR), 200 mg of bupropion hydrochloride, are white to off-white, round, bi-convex, film-coated tablets debossed with "WPI" over "3385" on one side in bottles of 60 tablets (NDC 0591-3542-60). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light and moisture.

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

BUPROPION HYDROCHLORIDE SR- BUPROPION HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
REMEDYREPACK INC.
----------
MEDICATION GUIDE
Bupropion Hydrochloride (byoo-PRO-pee-on HYE-droe-KLOR-ide)
Extended-release Tablets (SR)
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

Produktets egenskaber

BUPROPION HYDROCHLORIDE SR- BUPROPION HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
REMEDYREPACK INC.
----------
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._
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)
RECENT MAJOR CHANGES
Boxed Warning 05/2017
Warnings and Precautions, Neuropsychiatric Adverse 05/2017
Events and Suicide Risk in Smoking Cessation Treatment ( 5.2)
INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (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 bul