Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)
Sun Pharmaceutical Industries, Inc.
ORAL
PRESCRIPTION DRUG
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
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.]
Abbreviated New Drug Application
BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- 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._ • • INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets, USP (XL) are aminoketone antidepressant, indicated for: (1) • • DOSAGE AND ADMINISTRATION General: (2) • • • • Seasonal Affective Disorder (2) • • • • Hepatic Impairment (2) • • Mild hepatic impairment: Consider reducing the dose and/or frequency of dosing. (2.6, 8.7) (2) Renal Impairment (2) • DOSAGE FORMS AND STRENGTHS • Extended-release tablets: 150 mg (3) (3) CONTRAINDICATIONS • • • • 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 ( Прочитайте повний документ