BUPROPION HYDROCHLORIDE tablet, film coated

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

NuCare Pharmaceuticals, Inc.

INN (Isem Internazzjonali):

BUPROPION HYDROCHLORIDE

Kompożizzjoni:

BUPROPION HYDROCHLORIDE 100 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 d

Sommarju tal-prodott:

Bupropion hydrochloride tablets, USP, 100 mg of bupropion hydrochloride, are lavender, round, film-coated tablets, debossed GG 930 on one side and plain on the reverse side. NDC 66267-614-60 in bottles of 60 tablets Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED
NuCare Pharmaceuticals, Inc.
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MEDICATION GUIDE
Bupropion Hydrochloride Tablets, USP
(bue proe' pee on)
Read this Medication Guide carefully before you start taking bupropion
hydrochloride tablets 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 tablets, 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 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. 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 may have a particularly high risk of having suicidal
thoughts or actions. These include people
who have (or have

Karatteristiċi tal-prodott

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED
NUCARE PHARMACEUTICALS, INC.
----------
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; 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 is an aminoketone antidepressant, indicated
for the treatment of major depressive disorder
(MDD). ( 1)
DOSAGE AND ADMINISTRATION
Starting dose: 200 mg per 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 per 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 per day as 100 mg 3 times daily. ( 2.1)
Maximum dose: 450 mg per 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 Inhi