BUPROPION HYDROCHLORIDE tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

American Health Packaging

INN (שם בינלאומי):

BUPROPION HYDROCHLORIDE

הרכב:

BUPROPION HYDROCHLORIDE 75 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets 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)]. - Bupropion hydrochloride tablets are contraindicated in patients with a seizure disorder. - Bupropion hydrochloride tablets 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 bupropion hydrochloride tablets [ see Warnings and Precautions (5.3)]. - Bupropion hydrochloride tablets are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [ see Warnings and Precautions (5.3), Drug Inter

leaflet_short:

Bupropion hydrochloride tablets, USP 75 mg are available for oral administration as orange, round, unscored, film coated tablets, imprinted "APO" on one side and "BU" over "75" on the other side. They are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 60687-340-01 Bupropion hydrochloride tablets, USP 100 mg are available for oral administration as purple, round, unscored, film coated tablets, imprinted "APO" on one side and "BUP" over "100" on the other side. They are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 60687-351-01 Store at 20ºC to 25ºC (68ºF to 77ºF): excursions permitted from 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

מצב אישור:

Abbreviated New Drug Application

עלון מידע

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED
American Health Packaging
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MEDICATION GUIDE
8434001/0921F
Bupropion Hydrochloride Tablets, USP
(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 Tablets?"
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?
4.
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.
5.
Call your healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
6.
Keep all follow-up visits with your healthcare

מאפייני מוצר

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUPROPION
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
BUPROPION HYDROCHLORIDE TABLETS.
BUPROPION HYDROCHLORIDE TABLETS, 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)
INDICATIONS AND USAGE
Bupropion hydrochloride tablets are an aminoketone antidepressant,
indicated for the treatment of major
depressive disorder (MDD). ( 1)
DOSAGE AND ADMINISTRATION
Starting dose: 200 mg/day given as 100 mg twice daily ( 2.1)
General: Increase dose gradually to reduce seizure risk. ( 2.1, 5.3)
After 3 days, may increase the dose to 300 mg/day, given as 100 mg 3
times daily at an interval of at
least 6 hours between doses. ( 2.1)
Usual target dose: 300 mg/day as 100 mg 3 times daily. ( 2.1)
Maximum dose: 450 mg/day given as 150 mg 3 times daily. ( 2.1)
Periodically reassess the dose and need for maintenance treatment. (
2.1)
Moderate to severe hepatic impairment: 75 mg once daily. ( 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: 75 mg and 100 mg. ( 3)
CONTRAINDICATIONS
Seizure disorder. ( 4, 5.3)
Current or prior diagnosis of bulimia or anorexia nervosa. ( 4, 5.3)
Abrupt discontinuation of alcohol, benzodiazepines, barbiturates,
antiepileptic drugs. ( 4,5.3)
Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to
treat psychiatric disorders with
bupropion hydrochloride tablets or within 14 days of stopping
treatment wit