BUPROPION HYDROCHLORIDE tablet, extended release

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Sun Pharmaceutical Industries, Inc.

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Bupropion hydrochloride extended-release tablets, USP (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release (SR) formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies (14.1)] . Bupropion hydrochloride extended-release tablets, USP (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). The efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controll

Produktu pārskats:

Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 150 mg of bupropion hydrochloride, USP are white to pale yellow, round, film-coated tablets imprinted with ‘L2’ in black ink on one side and plain on the other side and are supplied as follows: Store at 20ºC to 25ºC (68ºF to 77ºF). [See USP Controlled Room Temperature.]

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, EXTENDED
RELEASE
SUN PHARMACEUTICAL INDUSTRIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUPROPION
HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) SAFELY AND EFFECTIVELY.
SEE FULL
PRESCRIBING INFORMATION FOR BUPROPION HYDROCHLORIDE EXTENDED-RELEASE
TABLETS
(XL).
BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1985
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets, USP (XL) are
aminoketone antidepressant, indicated
for: (1)
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DOSAGE AND ADMINISTRATION
General: (2)
•
•
•
•
Seasonal Affective Disorder (2)
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•
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Hepatic Impairment (2)
•
• Mild hepatic impairment: Consider reducing the dose and/or
frequency of dosing. (2.6, 8.7) (2)
Renal Impairment (2)
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DOSAGE FORMS AND STRENGTHS
• Extended-release tablets: 150 mg (3) (3)
CONTRAINDICATIONS
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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)
treatment of major depressive disorder (MDD) (1.1)
prevention of seasonal affective disorder (SAD) (1.2)
Increase dose gradually to reduce seizure risk. (2.1, 5.3)
Periodically reassess the dose and need for maintenance treatment.
(2.2) Major Depressive Disorder
Starting dose: 150 mg once daily. Usual target dose: 300 mg once daily
(2.2)
After 4 days, may increase the dose to 300 mg once daily. (2.2)
Initiate treatment in the autumn prior to onset of seasonal depressive
symptoms. (2.3)
Starting dose: 150 mg once daily. Usual target dose: 300 mg once
daily. (2.3)
After one week, may increase the dose to 300 mg once daily. (2.3)
Continue treatment through the winter season. (2.3)
Moderate to severe hepatic impairment: 150 mg every other day (