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Major Depressive Disorder
APLENZIN® (bupropion hydrobromide extended-release tablets) is 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 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].
Seasonal Affective Disorder
APLENZIN is 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-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see Clinical Studies].
DOSAGE AND ADMINISTRATION
General Instructions For Use
APLENZIN should be swallowed whole and not crushed, divided, or chewed. APLENZIN should be administered in the morning and may be taken with or without regard to meals.
Equivalent Daily Doses Of APLENZIN (bupropion hydrobromide) And Bupropion hydrochloride
See Table 1 for equivalent daily doses of APLENZIN (bupropion hydrobromide) and bupropion hydrochloride.
Table 1: Equivalent Daily Doses of APLENZIN (bupropion
hydrobromide) and Bupropion hydrochloride
|APLENZIN (bupropion hydrobromide)||Bupropion hydrochloride|
|522 mg||450 mg|
|348 mg||300 mg|
|174 mg||150 mg|
Dosage For Major Depressive Disorder (MDD)
The recommended starting dose for MDD is 174 mg once daily in the morning. After 4 days of dosing, the dose may be increased to the target dose of 348 mg once daily in the morning.
It is generally agreed that acute episodes of depression require several months or longer of antidepressant treatment beyond the response in the acute episode. It is unknown whether the APLENZIN dose needed for maintenance treatment is identical to the dose that provided an initial response. Periodically reassess the need for maintenance treatment and the appropriate dose for such treatment.
Dosage For Seasonal Affective Disorder (SAD)
The recommended starting dose for SAD is 174 mg once daily. After 7 days of dosing, the dose may be increased to the target dose of 348 mg once daily in the morning. Doses above 300 mg of bupropion HCl extended-release (equivalent to APLENZIN 348 mg) were not assessed in the SAD trials.
For the prevention of seasonal MDD episodes associated with SAD, initiate APLENZIN in the autumn, prior to the onset of depressive symptoms. Continue treatment through the winter season. Taper and discontinue APLENZIN in early spring. For patients treated with 348 mg per day, decrease the dose to 150 mg once daily before discontinuing APLENZIN. Individualize the timing of initiation and duration of treatment should be individualized, based on the patient's historical pattern of seasonal MDD episodes.
To Discontinue APLENZIN, Taper The Dose
When discontinuing treatment in patients treated with APLENZIN 348 mg once daily, decrease the dose to 174 mg once daily prior to discontinuation.
Dosage Adjustment In Patients With Hepatic Impairment
In patients with moderate to severe hepatic impairment (Child-Pugh score: 7 to 15), maximum dose is 174 mg every other day. In patients with mild hepatic impairment (Child-Pugh score: 5 to 6), consider reducing dose and/or frequency of dosing [see Use In Specific Populations and CLINICAL PHARMACOLOGY].
Dosage Adjustment In Patients With Renal Impairment
Switching A Patient To Or From A Monoamine Oxidase Inhibitor (MAOI) Antidepressant
At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with APLENZIN. Conversely, at least 14 days should be allowed after stopping APLENZIN before starting an MAOI antidepressant [see CONTRAINDICATIONS and DRUG INTERACTIONS].
Use Of APLENZIN With Reversible MAOIs Such As Linezolid Or Methylene Blue
Do not start APLENZIN in a patient who is being treated with a reversible MAOI such as linezolid or intravenous methylene blue. Drug interactions can increase risk of hypertensive reactions. In a patient who requires more urgent treatment of a psychiatric condition, nonpharmacological interventions, including hospitalization, should be considered [see CONTRAINDICATIONS
In some cases, a patient already receiving APLENZIN therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of hypertensive reactions in a particular patient, APLENZIN should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first.
Therapy with APLENZIN may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with APLENZIN is unclear. The clinician should, nevertheless, be aware of the possibility of a drug interaction with such use [see CONTRAINDICATIONS and DRUG INTERACTIONS].
Dosage Forms And Strengths
APLENZIN Extended-Release Tablets, 174 mg of bupropion hydrobromide, are white to offwhite, round tablets printed with “BR” over “174”.
APLENZIN Extended-Release Tablets, 348 mg of bupropion hydrobromide, are white to offwhite, round tablets printed with “BR” over “348”.
APLENZIN Extended-Release Tablets, 522 mg of bupropion hydrobromide, are white to offwhite, round tablets printed with “BR” over “522”.
Storage And Handling
APLENZIN® Extended-Release Tablets, 174 mg of bupropion hydrobromide, are white to offwhite, round tablets printed with “BR” over “174” in bottles of 30 tablets (NDC 0187-5810-30).
APLENZIN® Extended-Release Tablets, 348 mg of bupropion hydrobromide, are white to offwhite, round tablets printed with “BR” over “348” in bottles of 30 tablets (NDC 0187-5811-30).
APLENZIN® Extended-Release Tablets, 522 mg of bupropion hydrobromide, are white to offwhite, round tablets printed with “BR” over “522” in bottles of 30 tablets (NDC 0187-5812-30).
Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA. By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada. Rev. Dec 2014
Last reviewed on RxList: 1/27/2015
This monograph has been modified to include the generic and brand name in many instances.
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