BUPROPION HYDROCHLORIDE tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

PD-Rx Pharmaceuticals, Inc.

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 (

Descriptif du produit:

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: Bottles of 30 (NDC 72789-070-30) 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. Store in a tight, light resistant container [see USP].

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED
PD-Rx Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Bupropion Hydrochloride Tablets, USP
(bue proe' pee on hye'' droe klor' ide).
Medication Guide available at
https://www.apotex.com/products/us/mg.asp
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?
•
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

Résumé des caractéristiques du produit

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUPROPIONHYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR BUPROPIONHYDROCHLORIDE 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 wi