Bupropiondosage

General

Increase dose gradually to reduce seizure risk. Major Depressive Disorder

Starting dose: 174 mg once daily (equivalent to 150 mg bupropion HCl). Usual target dose: 348 mg once daily (equivalent to 300 mg bupropion HCl).

After 4 days, may increase the dose to 348 mg once daily. Seasonal Affective Disorder

Initiate treatment in the autumn prior to onset of seasonal depressive symptoms.

Starting dose: 174 mg once daily (equivalent to 150 mg bupropion HCl). Usual target dose: 348 mg once daily (equivalent to 300 mg bupropion HCl).

After one week, may increase the dose to 348 mg once daily.

Continue treatment through the winter season. Hepatic Impairment

Moderate to severe hepatic impairment: Maximum dose 174 mg every other day

Mild hepatic impairment: Consider reducing the dose and/or frequency of dosing. Renal Impairment

Consider reducing the dose and/or frequency of dosing.

2.1 General

Instructions for Use To minimize the risk of seizure, increase the dose gradually. 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.

2.2 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

2.3 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.

2.4 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 174 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.

2.5 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.

2.6 Dosage Adjustment in

Patients with Hepatic Impairment In patients with moderate to severe hepatic impairment (Child-Pugh score: 7 to 15), the maximum dose is 174 mg every other day. In patients with mild hepatic impairment (Child-Pugh score: 5 to 6), consider reducing the dose and/or frequency of dosing.

2.7 Dosage Adjustment in

Patients with Renal Impairment Consider reducing the dose and/or frequency of APLENZIN in patients with renal impairment (glomerular filtration rate less than 90 mL/min).

2.8 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.

2.9 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, non-pharmacological interventions, including hospitalization, should be considered. 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 per kg with APLENZIN is unclear. The clinician should, nevertheless, be aware of the possibility of a drug interaction with such use.