BUPROPION HYDROCHLORIDE tablet film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

St Marys Medical Park Pharmacy

INN (Algemene Internationale Benaming):

BUPROPION HYDROCHLORIDE

Samenstelling:

BUPROPION HYDROCHLORIDE 100 mg

Prescription-type:

PRESCRIPTION DRUG

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED
ST MARYS MEDICAL PARK PHARMACY
----------
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 USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1985
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC
REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
RECENT MAJOR CHANGES
Dosage and Administration (2.4, 2.5) 03/2013
Contraindications (4) 03/2013
INDICATIONS AND USAGE
Bupropion hydrochloride is an aminoketone antidepressant, indicated
for the treatment of major depressive disorder
(MDD). (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 75 mg and 100 mg. (3)
CONTRAINDICATIONS
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
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)
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)
Seizure disorder. (4, 5.3)
Current or prior