BUPROPION HYDROCHLORIDE tablet, film coated, extended release

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

RxChange Co.

INN (Међународно име):

BUPROPION HYDROCHLORIDE

Састав:

BUPROPION HYDROCHLORIDE 150 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Bupropion hydrochloride extended-release tablets, USP (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 hydrochloride extended-release tablets, USP (SR) 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)] . - Bupropionhydrochloride extended-release tablets (SR) are contraindicated in patients with a seizure disorder. - Bupropion hydrochloride extended-release tablets (SR) arecontraindicated 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 the immediate-re

Резиме производа:

Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg of bupropion hydrochloride, are white to off white colored, round shaped, bevel edged biconvex film-coated tablets debossed with “736” on one side and plain on the other side. Bottles of 60’s with Child Resistant Cap . . . . . . . . . . . . . . . . . . . . . . . . . . NDC 47335-736-86 Bottles of 100’s with Child Resistant Cap . . . . . . . . . . . . . . . . . . . . . . . . . NDC 47335-736-88 Bottles of 100’s with Non Child Resistant Cap . . . . . . . . . . . . . . . . . . . . . NDC 47335-736-08 Bottles of 500’s with Non Child Resistant Cap . . . . . . . . . . . . . . . . . . . . . NDC 47335-736-13 Bupropion hydrochloride extended-release tablets, USP (SR), 150 mg of bupropion hydrochloride, are white to off white colored, round shaped, bevel edged biconvex film-coated tablets debossed with “737” on one side and plain on the other side. Bottles of 60’s with Child Resistant Cap . . . . . . . . . . . . . . . . . . . . . . . . . . NDC 47335-737-86 Bottles of 100’s with Child Resistant Cap . . . . . . . . . . . . . . . . . . . . . . . . . NDC 47335-737-88 Bottles of 100’s with Non Child Resistant Cap . . . . . . . . . . . . . . . . . . . . . NDC 47335-737-08 Bottles of 500’s with Non Child Resistant Cap . . . . . . . . . . . . . . . . . . . . . NDC 47335-737-13 Bupropion hydrochloride extended-release tablets, USP (SR), 200 mg of bupropion hydrochloride, are white to off white colored, round shaped, bevel edged biconvex film-coated tablets debossed with “738” on one side and plain on the other side. Bottles of 60’s with Child Resistant Cap . . . . . . . . . . . . . . . . . . . . . . . . . . NDC 47335-738-86 Bottles of 100’s with Child Resistant Cap . . . . . . . . . . . . . . . . . . . . . . . . . NDC 47335-738-88 Bottles of 100’s with Non Child Resistant Cap . . . . . . . . . . . . . . . . . . . . . NDC 47335-738-08 Bottles of 500’s with Non Child Resistant Cap . . . . . . . . . . . . . . . . . . . . . NDC 47335-738-13 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
RXCHANGE CO.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUPROPION HYDROCHLORIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUPROPION
HYDROCHLORIDE.
BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP (SR) 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)
RECENT MAJOR CHANGES
Warnings and Precautions (5.7) 07/2014
INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets, USP (SR) are
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) (3)
CONTRAINDICATIONS
Seizure disorder. (4, 5.3)
Current or prior diagnosis of bulimia or anorexia nervosa. (4, 5.